Trial · NCT03223428
Real-world Evidence Study EvaLuating PAtient-Reported Outcomes With XERMELO
NCT03223428, Completed, TerSera Therapeutics LLC; results first posted 2024-07-15
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Real-world Evidence Study EvaLuating PAtient-Reported Outcomes With XERMELO. Trials, record NCT03223428. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03223428
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Real-world Evidence Study EvaLuating PAtient-Reported Outcomes With XERMELO
- NCT number
- NCT03223428
- Status
- Completed
- Enrollment
- 223 participants, actual
- Lead sponsor
- TerSera Therapeutics LLC
- Conditions
- Carcinoid Syndrome
- Interventions
- Xermelo
- First posted
- 2017-07-21
- Last updated
- 2024-07-24
- Results first posted
- 2024-07-15
- Limitations and caveats
A potential for responder bias was possible as results were self-reported. Decreased number of responders presented challenges to interpretation after approx. 24-30 months, hence findings should be interpreted with caution.~Adverse event safety data collection: Out of scope of this study. Reported adverse events, if occurred, were to be collected and reported to the Sponsor outside of the survey collection process.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients Who Are Satisfied With Their Overall Symptom Control | Baseline to 6 months | The percentage of CS patients who are satisfied with their overall symptom control, 6 months after initiating treatment with telotristat ethyl (XERMELO). Satisfaction with how Xermelo has controlled diarrhea, flushing, and overall CS symptoms was assessed at the initial 6-month follow-up. The questionnaire allowed participants to choose a response on a 5-level Likert scale ranging from "Very dissatisfied" (level 1) to "Very satisfied" (level 5). For the assessments of satisfaction with control of diarrhea and flushing, "Not applicable" (level 0) was a response option for participants who do not have the particular symptom that is being assessed. |
| Secondary | Percentage of Patients Reporting Satisfaction of CS-related Diarrhea Control | Baseline to 6 months | Estimate percentage of patients reporting satisfaction with CS-related diarrhea control from Baseline to 6 months after starting Xermelo. At baseline participants were asked, "Currently, how satisfied are you with how your diarrhea is controlled?" At the 6-month follow-up survey, participants were asked, "Currently, how satisfied are you with how Xermelo has controlled your diarrhea?" |
| Secondary | Percentage of Patients Reporting Satisfaction of CS- Related Flushing Control | Baseline to 6 months | Estimate percentage of patients reporting satisfaction with CS-related flushing control from Baseline to 6 Months. At baseline, participants who had reported flushing as a symptom were asked, "Currently, how satisfied are you with how your flushing is controlled?" At 6 months, participants who had reported flushing as a symptom at Baseline were asked, "Currently, how satisfied are you with how Xermelo has controlled your flushing?" |
| Secondary | Number of Patients Reporting Reduction in Rescue SSA Use | Baseline to 6 months | Number of participants reporting a reduction in rescue SSA use at 6 months after initiating treatment with Xermelo. |
| Secondary | Percentage of Patients Reporting Reduction in the Dose of Long-acting SSA Injection | Baseline to 6 months | Percentage of patients reporting a reduction in the dose of long-acting SSA injection 6 months after patients initiated treatment with Xermelo |
| Secondary | Percentage of Patients Reporting Reduction in the Frequency of Long-acting SSA Injection | Baseline to 6 months | Estimate Percentage of Patients Reporting Reduction in the Frequency of Long-acting SSA Injection 6 months after patients initiated treatment with Xermelo |
| Secondary | Percentage of Patients Reporting an Overall Improvement in CS Symptom Control Based on Patient Global Impression of Change (PGIC) | Baseline to 6 months | Estimate percentage of patients reporting an overall improvement in CS symptom control (diarrhea, flushing, frequency of BMs) after initiating Xermelo based on Patient Global Impression of Change (PGIC) |
| 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 | Baseline to 6 months | Estimate of the percentage of patients who had reduction 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). The percentage change was measured from baseline to 6 months after treatment with telotristat ethyl. |
| Secondary | Percentage of Patients Reporting Weight Gain | Baseline to 6 months | Estimate of the percentage of patients reporting weight gain after initiating Xermelo therapy. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients Who Are Satisfied With Their Overall Symptom Control | Baseline to 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of Patients Reporting Satisfaction of CS-related Diarrhea Control | Baseline to 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of Patients Reporting Satisfaction of CS- Related Flushing Control | Baseline to 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Patients Reporting Reduction in Rescue SSA Use | Baseline to 6 months | participants | NUMBER | |
| SECONDARY | Percentage of Patients Reporting Reduction in the Dose of Long-acting SSA Injection | Baseline to 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of Patients Reporting Reduction in the Frequency of Long-acting SSA Injection | Baseline to 6 months | There was a discrepancy between how many patients answered the survey for Reduction in dose of long-acting SSA (n=125) and Reduction in frequency of long-acting SSA (n=123). Two people did not answer the latter question but did answer the former. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Patients Reporting an Overall Improvement in CS Symptom Control Based on Patient Global Impression of Change (PGIC) | Baseline to 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| 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 | Baseline to 6 months | Only 124 patients answered the work activity and impairment questionnaire. Not all patients were employed and only a small subset were eligible to answer the Absenteeism, Presenteeism and Work Productivity Loss. Only 34, 32 and 32 patients answered those questionnaires, respectively. | percentage change baseline to Month 6 | MEAN |
| SECONDARY | Percentage of Patients Reporting Weight Gain | Baseline to 6 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients Who Are Satisfied With Their Overall Symptom Control | Carcinoid Syndrome Patients Initiating Xermelo | Very Satisfied with symptom control | 37 | Participants | |
| Percentage of Patients Who Are Satisfied With Their Overall Symptom Control | Carcinoid Syndrome Patients Initiating Xermelo | Somewhat satisfied with symptom control | 58 | Participants | |
| Percentage of Patients Who Are Satisfied With Their Overall Symptom Control | Carcinoid Syndrome Patients Initiating Xermelo | Neither satisfied or dissatisfied with symptom control | 22 | Participants | |
| Percentage of Patients Who Are Satisfied With Their Overall Symptom Control | Carcinoid Syndrome Patients Initiating Xermelo | Somewhat dissatisfied with symptom control | 5 | Participants | |
| Percentage of Patients Who Are Satisfied With Their Overall Symptom Control | Carcinoid Syndrome Patients Initiating Xermelo | Very dissatisfied with symptom control | 3 | Participants | |
| Percentage of Patients Reporting Satisfaction of CS-related Diarrhea Control | Carcinoid Syndrome Patients Initiating Xermelo | Very satisfied | 46 | Participants | |
| Percentage of Patients Reporting Satisfaction of CS-related Diarrhea Control | Carcinoid Syndrome Patients Initiating Xermelo | Somewhat satisfied | 51 | Participants | |
| Percentage of Patients Reporting Satisfaction of CS-related Diarrhea Control | Carcinoid Syndrome Patients Initiating Xermelo | Neither satisfied nor dissatisfied | 12 | Participants | |
| Percentage of Patients Reporting Satisfaction of CS-related Diarrhea Control | Carcinoid Syndrome Patients Initiating Xermelo | Somewhat dissatisfied | 11 | Participants | |
| Percentage of Patients Reporting Satisfaction of CS-related Diarrhea Control | Carcinoid Syndrome Patients Initiating Xermelo | Very dissatisfied | 5 | Participants |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Carcinoid Syndrome Patients Initiating Xermelo | 223 | |
| Overall Study | COMPLETED | Carcinoid Syndrome Patients Initiating Xermelo | 125 | |
| Overall Study | NOT COMPLETED | Carcinoid Syndrome Patients Initiating Xermelo | 98 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Carcinoid Syndrome Patients Initiating Xermelo | 0 | 0 |
| Total, other adverse events | Carcinoid Syndrome Patients Initiating Xermelo | 0 | 0 |
| Total, serious adverse events | Carcinoid Syndrome Patients Initiating Xermelo | 0 | 0 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36262750 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03223428
GET https://conductscience.org/api/trials/v1/NCT03223428/results?page=2