Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

1 to 11 of 11

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Any Treatment Emergent Adverse Events (TEAEs) and Drug-Related TEAEs in the Core Phase	Baseline up to Week 12 in the Core Phase	The safety set (SS) included all the enrolled participants who received at least 1 dose of study drug.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Any Treatment Emergent Adverse Events (TEAEs) and Drug-Related TEAEs in the Extension Period	Up to 124 Weeks in the Extension Period	SS included all enrolled participants who had received at least 1 dose of study drug in the 124-week Extension Period.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change From Baseline in Number of Bowel Movements (BMs)	Core Phase: Baseline to Weeks 9-12; Extension Period: Baseline to Week 24	Efficacy full analysis set (EFAS) in Core Phase included all participants with at least 1 post-Baseline efficacy assessment and full analysis set (FAS) in Extension Period(EP) included all participants in SS with at least 1 post-Baseline efficacy assessment in 124-week EP. Number analyzed is the participants with evaluable data at given time point.	number of bowel movements/day	MEAN
SECONDARY	Change From Baseline in Stool Form/Consistency	Core Phase: Baseline to Weeks 9-12; Extension Period: Baseline to Week 24	EFAS in the Core Phase included all participants who had at least 1 post-Baseline efficacy assessment and FAS in the Extension period included all participants in the safety set who had at least 1 post-Baseline efficacy assessment in 124-week Extension Period. Number analyzed is the number of participants with evaluable data at given time-point.	score on a scale	MEAN
SECONDARY	Change From Baseline in Percentage of Days With Sensation of Urgency to Defecate	Core Phase: Baseline to Weeks 9-12; Extension Period: Baseline to Week 24	EFAS in Core Phase included all participants who had at least 1 post-Baseline efficacy assessment and FAS in Extension Period included all participants in the safety set who had at least 1 post-Baseline efficacy assessment in the 124-week Extension Period. Number analyzed is the number of participants with evaluable data at the given time-point.	percentage of days	MEAN
SECONDARY	Change From Baseline in Sensation/Severity of Nausea Using 100 mm Visual Analog Scale (VAS)	Core Phase: Baseline to Weeks 9-12; Extension Period: Baseline to Week 24	EFAS in Core Phase included all participants who had at least 1 post-Baseline efficacy assessment and FAS in Extension Period included all participants in the safety set who had at least 1 post-Baseline efficacy assessment in the 124-week Extension Period. Number analyzed is the number of participants with evaluable data at the given time-point.	score on a scale	MEAN
SECONDARY	Number of Participants With an Improvement in Global Assessment of Symptoms Associated With Carcinoid Syndrome	Core Phase: Weeks 9-12; Extension Period: Week 24	EFAS in Core Phase included all participants who had at least 1 post-Baseline efficacy assessment and FAS in Extension Period included all participants in the safety set who had at least 1 post-Baseline efficacy assessment in the 124-week Extension Period. Number analyzed is the number of participants with evaluable data at the given time-point.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change From Baseline in Daily Severity of Abdominal Pain or Discomfort Using 100 mm Visual Analog Scale (VAS)	Core Phase: Baseline to Weeks 9-12; Extension Period: Baseline to Week 24	EFAS in Core Phase included all participants who had at least 1 post-Baseline efficacy assessment and FAS in Extension Period included all participants in the safety set who had at least 1 post-Baseline efficacy assessment in the 124-week Extension Period. Number analyzed is the number of participants with evaluable data at the given time-point.	score on a scale	MEAN
SECONDARY	Change From Baseline in Daily Number of Cutaneous Flushing Episodes	Core Phase: Baseline to Weeks 9-12; Extension Period: Baseline to Week 24	EFAS in Core Phase included all participants who had at least 1 post-Baseline efficacy assessment and FAS in Extension Period included all participants in the safety set who had at least 1 post-Baseline efficacy assessment in the 124-week Extension Period. Number analyzed is the number of participants with evaluable data at the given time-point.	Daily number of flushing episodes	MEAN
SECONDARY	Number of Participants Achieving Clinically Meaningful Symptom Reduction in the Core Phase	Baseline to Week 12	EFAS included all participants who had at least 1 post-baseline efficacy assessment.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change From Baseline in Urinary 5-Hydroxyindoleacetic Acid (HIAA) Levels	Core Phase: Baseline to Week 12; Extension Period: Baseline to Weeks 20-21	Pharmacodynamic (PD) analysis set included all participants who had received at least 1 dose of study drug, had a valid baseline PD assessment, and at least 1 valid post-baseline PD assessment (whole blood 5-HT or u5-HIAA) in Core Phase and Extension Period.	mg/24 hours	MEAN

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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.

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GET https://conductscience.org/api/trials/v1/NCT01104415/outcomes

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