N/A
Completed N=223
Real-world Evidence Study EvaLuating PAtient-Reported Outcomes With XERMELO
Carcinoid Syndrome
Source: ClinicalTrials.gov NCT03223428 ↗
Enrolled (actual)
223
Serious AEs
—
Results posted
Jul 2024
Primary outcomePrimary: Percentage of Patients Who Are Satisfied With Their Overall Symptom Control — 37; 58; 22; 5 Participants
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Who Are Satisfied With Their Overall Symptom Control |
37; 58; 22; 5; 3 | — |
| SECONDARY Percentage of Patients Reporting Satisfaction of CS-related Diarrhea Control |
46; 51; 12; 11; 5 | — |
| SECONDARY Percentage of Patients Reporting Satisfaction of CS- Related Flushing Control |
24; 39; 34; 7; 4 | — |
| SECONDARY Number of Patients Reporting Reduction in Rescue SSA Use |
21 | — |
| SECONDARY Percentage of Patients Reporting Reduction in the Dose of Long-acting SSA Injection |
7 | — |
| SECONDARY Percentage of Patients Reporting Reduction in the Frequency of Long-acting SSA Injection |
9 | — |
| SECONDARY Percentage of Patients Reporting an Overall Improvement in CS Symptom Control Based on Patient Global Impression of Change (PGIC) |
20; 28; 49; 20; 6; 1 | — |
| SECONDARY Percentage Change of Patients Who Had Reduction in Work-related Absenteeism, Presenteeism, Activity Impairment, and Overall Productivity Loss From Baseline to 6 Months After Initiating Telotristat Ethyl Based on WPAI-SHP |
4.1; -9.7; -10.1; -8.1 | — |
| SECONDARY Percentage of Patients Reporting Weight Gain |
24 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03223428). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.