Telotristat Etiprate - Expanded Treatment for Patients With Carcinoid Syndrome Symptoms

Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) Score at Each Visit

QLQ-C30 is a standardized 30-item scale to assess health-related quality of life composed of 5 functional scales (physical functioning \[5 items\], role functioning \[2 items\], emotional functioning \[4 items\], cognitive functioning \[2 items\], and social functioning \[2 items\]); 3 symptom scales (fatigue \[3 items\], nausea/vomiting \[2 items\], and pain \[2 items\]); a global health status (GHS) /quality of life (QOL) scale \[2 items\]; 6 single items (dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties). 28 questions answered:1 (not at all) to 4 (very much) and 2 questions on overall health/QOL answered:1 (poor) to 7 (excellent). All of the scales and single-item measures are transformed to a score:0 to 100. For functioning scales and global QOL higher scores indicate better functioning (a positive change from Baseline indicates improvement); for symptom scales higher scores indicate more severe symptoms (a negative change from Baseline indicates improvement).

Time frame: Baseline, Weeks 24, 48, 72 and 84

Change From Baseline in Gastrointestinal Symptoms of Carcinoid Neuroendocrine Tumors (GI.NET21) Score at Each Visit

GI.NET21 is a standardized 21-item scale composed of both multi-item scales and single-item measures that include 5 functional scales (gastrointestinal (GI) \[5 items\], endocrine \[3 items\], treatment-related \[3 items\], social functioning \[3 items\], and disease-related worries scale \[DRWS\] \[3 items\]) and 4 single items (muscle and bone pain symptom (BPS), sexual functioning, communication function (CF), body image and information about the disease). Each item is scored from 1 (not at all) to 4 (very much). All of the scales and single-item measures are transformed to a score of 0 to 100. For functioning scales higher scores indicate better functioning (a positive change from Baseline indicates improvement); for symptom scales higher scores indicate more severe symptoms (a negative change from Baseline indicates improvement).