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| ID | Type | Description | Link |
|---|---|---|---|
| LX1606.302 | Other Identifier | Lexicon Pharmaceuticals, Inc. | |
| 2013-002596-18 | EudraCT Number |
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The primary objective of this study is to evaluate the long-term safety and tolerability of orally administered telotristat etiprate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 250 mg Telotristat Etiprate | Experimental | One telotristat etiprate (250 mg) tablet administered three times daily. |
|
| 500 mg Telotristat Etiprate | Experimental | Two telotristat etiprate (250 mg) tablets administered three times daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telotristat etiprate | Drug | Telotristat etiprate tablet (250 mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE includes any noxious, pathological, or unintended change in anatomical, physiological, or metabolic functions as indicated by physical signs or symptoms occurring in any phase of the clinical study whether or not considered related to the study medication. A TEAE is an AE that occurs or worsens after receiving study drug. | First dose of study drug (Day 1) up to 15 days post last dose (approximately up to 236 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) Score at Each Visit | QLQ-C30 is a standardized 30-item scale to assess health-related quality of life composed of 5 functional scales (physical functioning [5 items], role functioning [2 items], emotional functioning [4 items], cognitive functioning [2 items], and social functioning [2 items]); 3 symptom scales (fatigue [3 items], nausea/vomiting [2 items], and pain [2 items]); a global health status (GHS) /quality of life (QOL) scale [2 items]; 6 single items (dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties). 28 questions answered:1 (not at all) to 4 (very much) and 2 questions on overall health/QOL answered:1 (poor) to 7 (excellent). All of the scales and single-item measures are transformed to a score:0 to 100. For functioning scales and global QOL higher scores indicate better functioning (a positive change from Baseline indicates improvement); for symptom scales higher scores indicate more severe symptoms (a negative change from Baseline indicates improvement). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pablo Lapuerta, MD | Lexicon Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lexicon Investigational Site | Mobile | Alabama | 36604 | United States | ||
| Lexicon Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33940581 | Derived | Horsch D, Anthony L, Gross DJ, Valle JW, Welin S, Benavent M, Caplin M, Pavel M, Bergsland E, Oberg K, Kassler-Taub KB, Binder P, Banks P, Lapuerta P, Kulke MH. Long-Term Treatment with Telotristat Ethyl in Patients with Carcinoid Syndrome Symptoms: Results from the TELEPATH Study. Neuroendocrinology. 2022;112(3):298-310. doi: 10.1159/000516958. Epub 2021 May 3. |
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Participants whose participation was ongoing in 1 of the following studies [LX1606.1-202-CS (NCT00853047), LX1606.1-203-CS (NCT01104415), LX1606.1-301-CS (NCT01677910), LX1606.1-303-CS (NCT02063659)] were eligible to enroll in this long-term safety study at the same dose received in the previous (parent) study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Telotristat Etiprate 250 mg | Participants were treated with telotristat etiprate in a previous study for 9 to 46 months. Participants received one telotristat etiprate (250 mg) tablet three times daily (tid) up to an additional 228 weeks in this long-term extension study. |
| FG001 | Telotristat Etiprate 500 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 2, 2015 | Aug 20, 2019 |
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| Baseline, Weeks 24, 48, 72 and 84 |
| Change From Baseline in Gastrointestinal Symptoms of Carcinoid Neuroendocrine Tumors (GI.NET21) Score at Each Visit | GI.NET21 is a standardized 21-item scale composed of both multi-item scales and single-item measures that include 5 functional scales (gastrointestinal (GI) [5 items], endocrine [3 items], treatment-related [3 items], social functioning [3 items], and disease-related worries scale [DRWS] [3 items]) and 4 single items (muscle and bone pain symptom (BPS), sexual functioning, communication function (CF), body image and information about the disease). Each item is scored from 1 (not at all) to 4 (very much). All of the scales and single-item measures are transformed to a score of 0 to 100. For functioning scales higher scores indicate better functioning (a positive change from Baseline indicates improvement); for symptom scales higher scores indicate more severe symptoms (a negative change from Baseline indicates improvement). | Baseline, Weeks 24, 48, 72 and 84 |
| Percentage of Participants With Adequate Relief as Per Subjective Global Assessment Question | Participants were asked to respond to 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 percentage of participants reporting adequate relief (answered Yes) were reported. | Baseline, Weeks 12, 24, 36, 48, 60, 72 and 84 |
| Change From Baseline in Subjective Global Assessment of Carcinoid Syndrome Symptoms on 11-Point Numeric Scale at Each Visit | Participants were asked the following question to assess global symptoms associated with carcinoid syndrome (CS) on an 11-point scale: "Rate the severity of your overall carcinoid symptoms over the past 7 days on a scale from 0 to 10, where 0=no symptoms and 10=worst symptoms ever experienced. A negative change from baseline indicated improvement. | Baseline, Weeks 12, 24, 36, 48, 60, 72 and 84 |
| Stanford |
| California |
| 94305 |
| United States |
| Lexicon Investigational Site | Iowa City | Iowa | 52242 | United States |
| Lexicon Investigational Site | Lexington | Kentucky | 40536 | United States |
| Lexicon Investigational Site | Boston | Massachusetts | 02215 | United States |
| Lexicon Investigational Site | New York | New York | 10029 | United States |
| Lexicon Investigational Site | Philadelphia | Pennsylvania | 19104 | United States |
| Lexicon Investigational Site | St Leonards | New South Wales | 2065 | Australia |
| Lexicon Investigational Site | Herston | Queensland | 4029 | Australia |
| Lexicon Investigational Site | East Melbourne | Victoria | 3002 | Australia |
| Lexicon Investigational Site | Edegem | B-2650 | Belgium |
| Lexicon Investigational Site | Ghent | 9000 | Belgium |
| Lexicon Investigational Site | Yvoir | 5530 | Belgium |
| Lexicon Investgational Site | Calgary | Alberta | T2N4N2 | Canada |
| Lexicon Investigational Site | Halifax | Nova Scotia | B0J1N0 | Canada |
| Lexicon Investigational Site | Lille | 59037 | France |
| Lexicon Investigational Site | Lyon | 69437 | France |
| Lexicon Investigational Site | Villejuif | 94805 | France |
| Lexicon Investigational Site | Bad Berka | 99437 | Germany |
| Lexicon Investigational Site | Berlin | 13353 | Germany |
| Lexicon Investigational Site | Essen | 45147 | Germany |
| Lexicon Investigational Site | Hamburg | 20246 | Germany |
| Lexicon Investigational Site | Marburg | 35043 | Germany |
| Lexicon Investigational Site | Jerusalem | 91120 | Israel |
| Lexicon Investigational Site | Milan | 20089 | Italy |
| Lexicon Investigational Site | Milan | 20141 | Italy |
| Lexicon Investigational Site | Pisa | 56124 | Italy |
| Lexicon Investigational Site | Torino | 10043 | Italy |
| Lexicon Investigational Site | Amsterdam | 1105AZ | Netherlands |
| Lexicon Investigational Site | Noord Holland | 1066CX | Netherlands |
| Lexicon Investigational Site | Noord-Brahant | 5631BM | Netherlands |
| Lexicon Investigational Site | Barcelona | 08035 | Spain |
| Lexicon Investigational Site | Madrid | 28034 | Spain |
| Lexicon Investigational Site | Seville | 41013 | Spain |
| Lexicon Investigational Site | Lund | 22185 | Sweden |
| Lexicon Investigational Site | Uppsala | 75185 | Sweden |
| Lexicon Investigational Site | Coventry | CV22DX | United Kingdom |
| Lexicon Investigational Site | Glasgow | G120YN | United Kingdom |
| Lexicon Investigational Site | London | NW32QG | United Kingdom |
| Lexicon Investigational Site | London | SE59RS | United Kingdom |
| Lexicon Investigational Site | London | W120HS | United Kingdom |
| Lexicon Investigational Site | Manchester | M204BX | United Kingdom |
| Lexicon Investigational Site | Newcastle upon Tyne | NE14LP | United Kingdom |
Participants were treated with telotristat etiprate in a previous study for 9 to 46 months. Participants received two telotristat etiprate (250 mg) tablets tid up to an additional 204 weeks in this long-term extension study. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Population included all participants who received any fraction of a dose of telotristat etiprate during the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Telotristat Etiprate 250 mg | Participants were treated with telotristat etiprate in a previous study for 9 to 46 months. Participants received one telotristat etiprate (250 mg) tablet three times daily (tid) up to an additional 228 weeks in this long-term extension study. |
| BG001 | Telotristat Etiprate 500 mg | Participants were treated with telotristat etiprate in a previous study for 9 to 46 months. Participants received two telotristat etiprate (250 mg) tablets tid up to an additional 204 weeks in this long-term extension study. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE includes any noxious, pathological, or unintended change in anatomical, physiological, or metabolic functions as indicated by physical signs or symptoms occurring in any phase of the clinical study whether or not considered related to the study medication. A TEAE is an AE that occurs or worsens after receiving study drug. | Safety Population included all participants who received any fraction of a dose of telotristat etiprate during the study. | Posted | Count of Participants | Participants | First dose of study drug (Day 1) up to 15 days post last dose (approximately up to 236 weeks) |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) Score at Each Visit | QLQ-C30 is a standardized 30-item scale to assess health-related quality of life composed of 5 functional scales (physical functioning [5 items], role functioning [2 items], emotional functioning [4 items], cognitive functioning [2 items], and social functioning [2 items]); 3 symptom scales (fatigue [3 items], nausea/vomiting [2 items], and pain [2 items]); a global health status (GHS) /quality of life (QOL) scale [2 items]; 6 single items (dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties). 28 questions answered:1 (not at all) to 4 (very much) and 2 questions on overall health/QOL answered:1 (poor) to 7 (excellent). All of the scales and single-item measures are transformed to a score:0 to 100. For functioning scales and global QOL higher scores indicate better functioning (a positive change from Baseline indicates improvement); for symptom scales higher scores indicate more severe symptoms (a negative change from Baseline indicates improvement). | Per-Protocol (PP) population=participants who received telotristat etiprate;had no major protocol deviations that interfered with collection/interpretation of efficacy data. Number analyzed=participants with data at given time-point.Participants were combined for this outcome measure as they received dose adjustments per investigator's discretion. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Weeks 24, 48, 72 and 84 |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Gastrointestinal Symptoms of Carcinoid Neuroendocrine Tumors (GI.NET21) Score at Each Visit | GI.NET21 is a standardized 21-item scale composed of both multi-item scales and single-item measures that include 5 functional scales (gastrointestinal (GI) [5 items], endocrine [3 items], treatment-related [3 items], social functioning [3 items], and disease-related worries scale [DRWS] [3 items]) and 4 single items (muscle and bone pain symptom (BPS), sexual functioning, communication function (CF), body image and information about the disease). Each item is scored from 1 (not at all) to 4 (very much). All of the scales and single-item measures are transformed to a score of 0 to 100. For functioning scales higher scores indicate better functioning (a positive change from Baseline indicates improvement); for symptom scales higher scores indicate more severe symptoms (a negative change from Baseline indicates improvement). | PP population included the participants who received telotristat etiprate; had no major protocol deviations that interfered with collection/interpretation of efficacy data. Number analyzed=participants with data at given time-point. Participants were combined for this outcome measure as they received dose adjustments per investigator's discretion. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Weeks 24, 48, 72 and 84 |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Adequate Relief as Per Subjective Global Assessment Question | Participants were asked to respond to 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 percentage of participants reporting adequate relief (answered Yes) were reported. | PP population included the participants who received telotristat etiprate; had no major protocol deviations that interfered with collection/interpretation of efficacy data. Number analyzed=participants with data at given time-point. Participants were combined for this outcome measure as they received dose adjustments per investigator's discretion. | Posted | Number | percentage of participants | Baseline, Weeks 12, 24, 36, 48, 60, 72 and 84 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Subjective Global Assessment of Carcinoid Syndrome Symptoms on 11-Point Numeric Scale at Each Visit | Participants were asked the following question to assess global symptoms associated with carcinoid syndrome (CS) on an 11-point scale: "Rate the severity of your overall carcinoid symptoms over the past 7 days on a scale from 0 to 10, where 0=no symptoms and 10=worst symptoms ever experienced. A negative change from baseline indicated improvement. | PP population included the participants who received telotristat etiprate; had no major protocol deviations that interfered with collection/interpretation of efficacy data. Number analyzed=participants with data at given time-point. Participants were combined for this outcome measure as they received dose adjustments per investigator's discretion. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Weeks 12, 24, 36, 48, 60, 72 and 84 |
|
|
First dose of study drug (Day 1) up to 15 days post last dose (approximately up to 236 weeks)
Safety population included all participants who received any fraction of a dose of telotristat etiprate during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Telotristat Etiprate 250 mg | Participants were treated with telotristat etiprate in a previous study for 9 to 46 months. Participants received one telotristat etiprate (250 mg) tablet three times daily (tid) up to an additional 228 weeks in this long-term extension study. | 2 | 22 | 12 | 22 | 22 | 22 |
| EG001 | Telotristat Etiprate 500 mg | Participants were treated with telotristat etiprate in a previous study for 9 to 46 months. Participants received two telotristat etiprate (250 mg) tablets tid up to an additional 204 weeks in this long-term extension study. | 18 | 102 | 54 | 102 | 100 | 102 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Embolism | Vascular disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Radiotherapy | Surgical and medical procedures | MedDRA (15.1) | Systematic Assessment |
| |
| Ileocolectomy | Surgical and medical procedures | MedDRA (15.1) | Systematic Assessment |
| |
| Investigation | Investigations | MedDRA (15.1) | Systematic Assessment |
| |
| Neuroendocrine tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) | Systematic Assessment |
| |
| Carcinoid tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) | Systematic Assessment |
| |
| Chronic myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) | Systematic Assessment |
| |
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) | Systematic Assessment |
| |
| Metastases to ovary | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) | Systematic Assessment |
| |
| Metastases to testicle | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) | Systematic Assessment |
| |
| Metastatic carcinoid tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) | Systematic Assessment |
| |
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) | Systematic Assessment |
| |
| Cervicobrachial syndrome | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Complication of device insertion | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Device failure | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Anastomotic leak | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (15.1) | Systematic Assessment |
| |
| General physical condition abnormal | Investigations | MedDRA (15.1) | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA (15.1) | Systematic Assessment |
| |
| Laparoscopy | Investigations | MedDRA (15.1) | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA (15.1) | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Anaemia of chronic disease | Blood and lymphatic system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Localised intraabdominal fluid collection | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Ureteric obstruction | Renal and urinary disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Acute hepatic failure | Hepatobiliary disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Gallbladder perforation | Hepatobiliary disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Osteochondritis | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Hepatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) | Systematic Assessment |
| |
| Basedow's disease | Endocrine disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Carcinoid crisis | Endocrine disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Abdominal wall abscess | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Campylobacter gastroenteritis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Meningitis bacterial | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Perihepatic abscess | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flushing | Vascular disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Radiotherapy | Surgical and medical procedures | MedDRA (15.1) | Systematic Assessment |
| |
| Neuroendocrine tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (15.1) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (15.1) | Systematic Assessment |
| |
| Investigation | Investigations | MedDRA (15.1) | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA (15.1) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Glossodynia | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pablo Lapuerta, MD | Lexicon Pharmaceuticals, Inc. | 281-863-3000 | plapuerta@lexpharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 24, 2014 | Aug 20, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D020230 | Serotonin Syndrome |
| ID | Term |
|---|---|
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C000592493 | telotristat |
Not provided
Not provided
Not provided
| Male |
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| Black or African American |
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| American Indian or Alaska Native |
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| Other |
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| Not Hispanic or Latino |
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| Unknown |
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| Sweden |
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| Netherlands |
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| Belgium |
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| United States |
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| United Kingdom |
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| Italy |
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| Israel |
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| France |
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| Australia |
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| Germany |
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| Spain |
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