Real-world Evidence Study EvaLuating PAtient-Reported Outcomes With XERMELO

Study Overview
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Brief Summary
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The primary objective of the study is to estimate the proportion of carcinoid syndrome (CS) patients who are satisfied with their overall symptom control, 6 months after initiating treatment with telotristat ethyl (XERMELO).

Official Title
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An Observational Study to Evaluate the Real-world Experience of Patients Who Are Initiating Treatment With Telotristat Ethyl (XERMELO™)

Conditions
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Carcinoid Syndrome

Intervention / Treatment
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* Drug: Xermelo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult, ≥18 years of age at the time of informed consent A new, valid prescription for XERMELO Initiating XERMELO for the treatment of carcinoid syndrome Able and willing to provide informed consent prior to participation in the study Exclusion Criteria: Unable to understand and read English Unable to access the internet Prior exposure to XERMELO

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Carcinoid Syndrome patients initiating Xermelo<br>Patients with Carcinoid Syndrome who are initiating treatment with XERMELO. | Drug: Xermelo<br>* This study will include patients with carcinoid syndrome who are initiating treatment with XERMELO.<br>* Other names: Telotristat ethyl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who are satisfied with their overall symptom control | The proportion of CS patients who are satisfied with their overall symptom control, 6 months after initiating treatment with telotristat ethyl (XERMELO). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients reporting satisfaction of CS-related diarrhea control | Estimate proportion of patients reporting satisfaction with CS-related diarrhea control | 6 months | 
| Proportion of patients reporting satisfaction of CS- related flushing control | Estimate proportion of patients reporting satisfaction with CS-related flushing control | 6 months | 
| Proportion of patients reporting reduction in rescue somatostatin analog (SSA) use | Estimate proportion of patients reporting reduction in rescue SSA use | 6 months | 
| Proportion of patients reporting reduction in the dose of long-acting SSA injection | Estimate proportion of patients reporting reduction in the dose of long-acting SSA injection | 6 months | 
| Proportion of patients reporting reduction in the frequency of long-acting SSA injection | Estimate proportion of patients reporting reduction in frequency of long-acting SSA injection | 6 months | 
| Proportion of patients reporting an overall improvement in CS control after initiating XERMELO based on patient global impression of change (PGIC) | Estimate proportion of patients reporting an overall improvement in CS control after initiating Xermelo based on PGIC | 6 months | 
| Proportion of patients that had reduction in in work-related absenteeism, presenteeism, activity impairment, and overall productivity loss based on Worker Productivity and Activity Impairment: Specific Health Problem v2.0 (WPAI- SHP) | Estimate the proportion of patients that had reduction in work-related absenteeism, presenteeism, activity impairment, and overall productivity loss after initiating telotristat ethyl based on WPAI-SHP | 6 months | 
| Proportion of patients reporting weight gain | Estimate the proportion of patients reporting weight gain | 6 months |