| Primary | Number of Participants With Progression-free Survival (PFS) as Evaluated by Central Radiologist's Assessment | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions", or similar definition as accurate and appropriate. | | Posted | | Count of Participants | | Participants | | Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study |
| | | Title | Denominators | Categories |
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| Safety Population | | | Title | Measurements |
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| Responders, Central Reviewer | | | Non-Responders, Central Reviewer | |
|
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| Primary | Project Overall Survival Rate at Month 6 | Overall Survival (OS) was defined as the time from the frist dose of study treatment until the date of death due to any cause. Duration of Overall Survival (OS) in days is defined as (Date of event/censoring- date of First dose +1). Use Kaplan Meier method to project survival rate at month 6. | | Posted | | Number | 95% Confidence Interval | Proportion of participants | | 6 Months | | | | ID | Title | Description |
|---|
| OG000 | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study |
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| Secondary | Overall Survival (OS) | Overall Survival (OS) was defined as the time from first dose of study treatment until the date of death due to any cause. | | Posted | | Median | 95% Confidence Interval | Months | | First dose of study treatment until the date of death due to any cause, whichever came first, a median of approximately 17.67 months | | | | ID | Title | Description |
|---|
| OG000 | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study |
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| Secondary | Project Overall Survival Rate at Month 12 | Overall Survival (OS) was defined as the time from the first dose of study treatment until the date of death due to any cause. Duration of Overall Survival (OS) in days is defined as (Date of event/censoring - date of first dose +1). Use Kaplan Meier method to project survival rate at month 12. | | Posted | | Number | 95% Confidence Interval | Proportion of participants | | 12 Months | | | | ID | Title | Description |
|---|
| OG000 | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study |
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| Secondary | Median Progression Free Survival | Scheduled disease assessment at Cycle 19 Day 1 was used to determine PFS response rate at Month 12. | | Posted | | Median | 95% Confidence Interval | Months | | Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study |
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| Secondary | Disease Control Rate (DCR), Central Radiologist's Assessment | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.". | | Posted | | Count of Participants | | Participants | | Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study |
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| Secondary | Disease Control Rate (DCR), Central Radiologist's Assessment | Disease control rate (DCR) was defined as the proportion of patients with best overall response of SD longer than 6 weeks from first dosing, confirmed PR, or confirmed CR. | | Posted | | Count of Participants | | Participants | | Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study |
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| Secondary | Disease Control Rate (DCR), Central Radiologist's Assessment | Disease control rate (DCR) was defined as the proportion of patients with best overall response of SD longer than 6 weeks from first dosing, confirmed PR, or confirmed CR. | | Posted | | Count of Participants | | Participants | | End of Study up to 24 months | | | | ID | Title | Description |
|---|
| OG000 | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study |
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| Secondary | Overall (Objective) Response Rate (ORR), Central Radiologist's Assessment | Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until the EOS considering any requirement for confirmation. (CR) + partial response (PR) at Months 6 | | Posted | | Count of Participants | | Participants | | Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study |
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| Secondary | Overall (Objective) Response Rate (ORR), Central Radiologist's Assessment | Overall response rate (ORR) was defined as the proportion of patients (Number of Responders) with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until Month 12. | | Posted | | Count of Participants | | Participants | | Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study |
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| Secondary | Overall (Objective) Response Rate, Central Radiologist's Assessment | Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until the EOS considering any requirement for confirmation. | | Posted | | Count of Participants | | Participants | | End of Study as defined up to 24 months | | | | ID | Title | Description |
|---|
| OG000 | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study |
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| Secondary | Summary of Duration of Progression Free Survival, Local Radiologist's Assessment | Summary of Duration of Median Progression Free Survival, Local Radiologist's Assessment. Patient progression was defined from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 months. | | Posted | | Median | 95% Confidence Interval | Months | | up to 7 months | | | | ID | Title | Description |
|---|
| OG000 | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study |
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| Secondary | Progression Free Survival, Local Radiologist's Assessment | Summary of Median Progression Free Survival, Local Radiologist's Assessment. Defined as the time from first dose of study treatment until the first date of either disease progression or death due to any cause. Scheduled disease assessment at Cycle 19 Day 1 was used to determine PFS response rate at Month 12. | | Posted | | Median | 95% Confidence Interval | Months | | Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study |
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| Secondary | Progression Free Survival, Local Radiologist's Assessment | Summary of Median Progression Free Survival, Local Radiologist's Assessment, End of Study | | Posted | | Median | 95% Confidence Interval | Months | | End of Study as defined up to 24 months | | | | ID | Title | Description |
|---|
| OG000 | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study |
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| Secondary | Overall (Objective) Response Rate, Local Read | Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment at Month 6. | | Posted | | Count of Participants | | Participants | | 6 Months | | | | ID | Title | Description |
|---|
| OG000 | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study |
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| Secondary | Overall (Objective) Response Rate, Local Reader's Assessment | Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment at Month 12. | | Posted | | Count of Participants | | Participants | | 12 Months | | | | ID | Title | Description |
|---|
| OG000 | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study |
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| Secondary | Overall (Objective) Response Rate (ORR), Local Reader's Assessment | Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until the EOS considering any requirement for confirmation. | | Posted | | Count of Participants | | Participants | | End of Study as defined up to 24 months | | | | ID | Title | Description |
|---|
| OG000 | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study |
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| Secondary | Disease Control Rate (DCR), Local Reviewer | Disease control rate (DCR) was defined as the proportion of patients with best overall response of SD longer than 6 weeks from first dosing, confirmed PR, or confirmed CR. | | Posted | | Count of Participants | | Participants | | Month 12 as defined by 1 year | | | | ID | Title | Description |
|---|
| OG000 | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study |
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| Secondary | Disease Control Rate (DCR), Local Reviewer | Disease control rate (DCR), Local Reviewer, 6 Months | | Posted | | Count of Participants | | Participants | | Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study |
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| Secondary | Disease Control Rate End of Study, Local Reviewer | Disease control rate (DCR) was defined as the proportion of patients with best overall response of SD longer than 6 weeks from first dosing, confirmed PR, or confirmed CR. | | Posted | | Count of Participants | | Participants | | End of Study as defined up to 24 months | | | | ID | Title | Description |
|---|
| OG000 | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study |
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| Secondary | Mean Change From Baseline in Plasma 5-hydroxyindoleacetic Acid (5-HIAA) | Mean change from Baseline to Month 6 plasma level 5-hydroxyindoleacetic acid (5-HIAA) | | Posted | | Mean | Standard Deviation | micrograms/Liter | | Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study |
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| Secondary | Mean Change From Baseline in Plasma 5-hydroxyindoleacetic Acid (5-HIAA) | Mean change from Baseline to Month 12 in plasma level 5-hydroxyindoleacetic Acid (5-HIAA) | | Posted | | Mean | Standard Deviation | micrograms/Liter | | Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study |
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| Secondary | Mean Change From Baseline in Plasma 5-hydroxyindoleacetic Acid (5-HIAA) | Mean change from Baseline to End of Study in plasma 5-hydroxyindoleacetic acid (5-HIAA) | | Posted | | Mean | Standard Deviation | micrograms/Liter | | End of Study as defined up to 24 months | | | | ID | Title | Description |
|---|
| OG000 | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study |
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| Secondary | Change From Baseline in Carbohydrate Antigen 19-9 (CA 19-9) | Mean change from Baseline to month 6 in plasma carbohydrate antigen 19-9 (CA 19-9) | | Posted | | Mean | Standard Deviation | U/mL | | Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study |
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| Secondary | Change From Baseline in Carbohydrate Antigen 19-9 (CA 19-9) | Mean change from Baseline to Month 12 in plasma carbohydrate antigen 19-9 (CA 19-9) | | Posted | | Mean | Standard Deviation | U/mL | | Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study |
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| Secondary | Change From Baseline in Plasma Carbohydrate Antigen 19-9 (CA 19-9) | Mean change from Baseline to End of Study in plasma carbohydrate antigen 19-9 (CA 19-9) | | Posted | | Mean | Standard Deviation | Units per milliliter | | End of Study as defined up to 24 months | | | | ID | Title | Description |
|---|
| OG000 | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study |
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| Secondary | Weight Change From Baseline | Mean change in weight at Month 6 from baseline measurement | | Posted | | Mean | Standard Deviation | kg | | Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study |
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| Secondary | Weight Change From Baseline | Mean change in weight at Month 12 from baseline measurement | | Posted | | Mean | Standard Deviation | kg | | Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study |
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| Secondary | Weight Change From Baseline | Mean change in weight from baseline to End of Study | | Posted | | Mean | Standard Deviation | kg | | End of Study as defined up to 24 months | | | | ID | Title | Description |
|---|
| OG000 | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study |
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| Secondary | Change From Baseline in Serum Albumin | Mean change from Baseline to Month 6 serum albumin levels | | Posted | | Mean | Standard Deviation | g/L | | Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study |
| |
| Secondary | Change From Baseline in Serum Albumin | Mean change from Baseline to Month 12 serum albumin levels | | Posted | | Mean | Standard Deviation | g/L | | Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study |
| |
| Secondary | Change From Baseline in Serum Albumin | Mean change from Baseline to End of Study serum albumin levels | | Posted | | Mean | Standard Deviation | g/L | | End of Study as defined up to 24 months | | | | ID | Title | Description |
|---|
| OG000 | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study |
| |