Neuroendocrine Tumors
Conditions
Brief summary
This record combines the results of CRAD001K24133 and CRAD001K24133E1. The purpose of the CRAD001K24133 study was to evaluate the safety profile of everolimus in patients with advanced neuroendocrine tumors of pancreatic origin (pNETs) and to provide access of everolimus to this patient population. Everolimus was taken by participants until disease progression, unacceptable toxicity, death, discontinuation from the trial for any other reason, or when it became commercially available for this indication, or until May 30, 2012, whichever came first. Prior to amendment 1, the study enrolled participants with NET of the lung (L-NETs) and gastrointestinal (GI) (GI-NETs) origin. The core study was stopped (per protocol) because everolimus was approved for pNETs. All ongoing patients with pNETs were switched to commercially available everolimus. For GI and lung NETs, everolimus was not approved at the time the core study was stopped. Therefore, patients with GI or lung NETs were not able to switch to commercial drug. To provide study medication access to these patients beyond 30 May 2012, the open label extension study, CRAD001K24133E1, was conducted. In the extension study, RAD001K24133E1, participants with GI or lung NETs who had not progressed during therapy with everolimus in the core study and who had not suffered from intolerable toxicity, were enrolled and treated with everolimus in order to provide data on long-term safety and efficacy. Patients were treated until it became commercially available in the respective indication or until documented tumor progression, unacceptable toxicity, any other reason or until study end on 31 May 2017, whichever came first.
Interventions
DRUGEverolimus (RAD001)
Everolimus was supplied as tablets of 5mg strength.
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Core Inclusion: * Age ≥ 18 years old * Advanced (unresectable or metastatic) biopsy-proven NETs of pancreatic origin * World health organization (WHO) Performance status of 0-2 * Adequate bone marrow function as shown by: * Absolute neutrophil count (ANC) ≥ 1.5 x 109/L * Platelets ≥ 100 x 109/L * Hemoglobin \>9 g/dL * Adequate liver function as shown by: * Serum bilirubin ≤ 1.5 x upper limit of normal (ULN) * Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 x ULN. Patients with known liver metastases with an AST and ALT ≤ 5 x ULN * International normalized ratio (INR) \<1.3 (INR \<3 in patients treated with anticoagulants) * Adequate renal function as shown by: Serum creatinine ≤ 1.5 x ULN * Fasting serum cholesterol ≤ 300 mg/dL or ≤ 7.75 mmol/L and fasting triglycerides ≤ 2.5 x ULN * Written informed consent obtained before any trial related activity and according to local guidelines. Core Exclusion: * Patients with poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid and small cell carcinoma were not eligible. * Following Amendment 1, patients with neuroendocrine tumors of GI or lung origin * Cytotoxic chemotherapy, immunotherapy or radiotherapy within 4 weeks prior to enrollment * Hepatic artery embolization within the last two months or cryoablation or radiofrequency ablation of hepatic metastasis within two months of enrollment * Prior therapy with mTOR inhibitors (for example sirolimus, temsirolimus, everolimus) * Patients with a known hypersensitivity to everolimus or other rapamycin analogs (sirolimus, temsirolimus) or to its excipients * Patients receiving chronic treatment with immunosuppressives * Uncontrolled diabetes mellitus as defined by fasting serum glucose \>1.5 x ULN * Patients who had any severe and/or uncontrolled medical conditions such as: Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤ 6 months prior to enrollment, serious uncontrolled cardiac arrhythmia * Active or uncontrolled severe infection * A history of invasive fungal infections * Severe hepatic impairment (Child Pugh class C) * Severely impaired lung function * Active bleeding diathesis * Patients with a known history of Human immunodeficiency virus (HIV) seropositivity * No other prior or concurrent malignancy was allowed except for, adequately treated basal cell or squamous cell skin cancer, or other adequately treated in situ cancer, or any other cancer from which the patient had been disease free for ≥ 3 years * Patients within four weeks post-major surgery, open-biopsy, or significant traumatic injury to avoid wound healing complications. Minor procedures and percutaneous biopsies or placement of vascular access device required seven days prior to study entry * Female patients who were pregnant or nursing * Adults who were of reproductive potential who were not using effective birth control methods. Adequate contraceptives were to be used throughout the trial and for eight weeks after last study drug administration in female patients. Women of child bearing potential must have had a negative serum pregnancy test within seven days prior to first administration of study drug * Patients who were unwilling to or unable to comply with the protocol Extension Inclusion and
Exclusion criteria
* The patient must provide a signed Informed Consent Form (ICF) for the extension study prior to any study related procedures * Age ≥18 years old * Completion of the whole treatment period in the CRAD001K24133 study * Neuroendocrine tumor of gastrointestinal or pulmonary origin (pancreatic neuroendocrine tumors are excluded) * No tumor progression during therapy with everolimus during CRAD001K24133 study (checked via radiologically assessment) * No intolerable toxicity during therapy everolimus, or during combination therapy of everolimus and somatostatin analogues
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths (Core) | from the day of first treatment up to 19 months | The number of participants with AEs, SAEs and deaths were assessed. |
| Number and Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths During the Extension Phase (E1) | from the first day of treatment in the extension up to 4 years | The number of participants with AEs, SAEs and deaths were assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean EORTC QLQ-G.I. NET21 Score (Core) | Baseline, weeks 4, 8, 20, 32, 44, and end of treatment (EOT) up to week 82 | The EORTC QLQ-G.I. NET21 contains 21 questions and has three defined multi-item symptom scales (endocrine - 3 questions, gastrointestinal - 5 questions, and treatment related side effects - 3 questions), two single item symptoms (bone/muscle pain and concern about weight loss), two psychosocial scales (social function - 3 questions and disease-related worries - 3 questions) and two other single items (sexuality and communication). For each of the 9 domains, final scores are transformed such that they range from 0-100, where higher scores indicate worsening. |
| Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Baseline, weeks 4, 8, 20, 32, 44, and end of treatment (EOT) up to week 82 | The EQ-5D is divided into two distinct sections. The first section includes one item addressing each of five dimensions (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression). Patients rate each of these items from no problem, some problem, or extreme problem. A composite health index is then defined by combining the levels for each dimension. The second section of the questionnaire measures self-rated (global) health status utilizing a vertically oriented visual analogue scale where 100 represents the best possible health state and 0 represents the worst possible health state. Respondents are asked to rate their current health by placing a mark along this continuum. The scores from each section are then transformed into a single health utility score. Overall scores range from 0 to 1 with lower scores representing a higher level of dysfunction. |
| Mean EQ-5D Visual Analogue Scale (VAS) Score (Core) | Baseline, weeks 4, 8, 20, 32, 44, and end of treatment (EOT) up to week 82 | The EQ-5D is divided into two distinct sections. The first section includes one item addressing each of five dimensions (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression). Patients rate each of these items from no problem, some problem, or extreme problem. A composite health index is then defined by combining the levels for each dimension. The second section of the questionnaire measures self-rated (global) health status utilizing a vertically oriented visual analogue scale where 100 represents the best possible health state and 0 represents the worst possible health state. Respondents are asked to rate their current health by placing a mark along this continuum. The scores from each section are then transformed into a single health utility score. Overall scores range from 0 to 1 with lower scores representing a higher level of dysfunction. |
| Investigator-assessed Best Overall Response (Core) | from the start of treatment, every 12 weeks for the first year and then every 6 months up to 19 months | Best overall response was determined from the sequence of investigator overall lesions responses according to Response Evaluation Criteria in Solid Tumors (RECIST). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Progression, a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Investigator-assessed Progression Free Survival (PFS) (Core) | from the day of first treatment up to 19 months | PFS was defined as the time from the date of the first dose to the date of the first radiologically documented disease progression or death due to any cause. If a participant had not progressed or died at the study end date or when he/she received any further anti-neoplastic therapy, PFS was censored at the time of the last tumor assessment before the end of study date. Progression was defined,using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | baseline, every 12 weeks and up to 4 years | The EORTC QLQ-C30 contains 30 questions assessed by the participant. There are 9 multiple-item scales: 5 scales that assess aspects of functioning (physical, role, cognitive, emotional, and social); 3 symptom scales (Fatigue, Pain, and Nausea and Vomiting); and a global health status and QOL scale. There are 5 single-item measures assessing additional symptoms (i.e., dyspnea, loss of appetite, insomnia, constipation, and diarrhea) and a single item concerning perceived financial impact of the disease. All but two questions have 4-point scales ranging from Not at all to Very much. The two questions concerning global health status and QOL have 7 point scales with ratings ranging from Very poor to Excellent. For each of the 14 domains, changes are calculated as value at later time point minus value at baseline, and final scores are transformed such that they range from 0-100, where higher scores indicate better outcomes. A positive change from baseline indicates improvement. |
| Change in EORTC QLQ-G.I. NET21 Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | baseline, every 12 weeks and up to 4 years | The EORTC QLQ-G.I. NET21 contains 21 questions and has three defined multi-item symptom scales (endocrine - 3 questions, gastrointestinal - 5 questions, and treatment related side effects - 3 questions), two single item symptoms (bone/muscle pain and concern about weight loss), two psychosocial scales (social function - 3 questions, disease-related worries - 3 questions) and two other single items (sexuality and communication). For each of the 9 domains, final scores are transformed such that they range from 0-100, where higher scores indicate worsening outcomes. A positive change from baseline indicates worsening. |
| Change in EuroQol Five Dimensions Questionnaire (EQ-5D) Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | baseline, every 12 weeks and up to 4 years | The EQ-5D contains 2 sections:1st section has 1 item addressing each of 5 dimensions (mobility, self-care, usual activity, pain/discomfort, anxiety/depression). Each dimension has 3 levels: no problems, some problems, extreme problems, 1-3, respectively. A health state is defined by combining 1 level from each dimension. 243 health states are possible. Each state is referred to in a 5 digit code. E.g., state 11111 indicates no problems on any dimension, while state 11223 indicates no problems with mobility and self-care, some problems with performing usual activities, moderate pain or discomfort and extreme anxiety or depression. The 2nd section measures self-rated health status using a visual analogue scale (VAS) where 100 represents best possible health and 0 represents worst possible health. Patients are asked to rate their current health by placing a mark on the VAS. Scores from each section are then transformed into an overall score of 0 or 1, with 0= higher level of dysfunction. |
| Investigator-assessed Best Overall Response During the Extension Phase (E1) | from the start of treatment, every 12 weeks for the first year and then every 6 months up to 4 years | Best overall response was determined from the sequence of investigator overall lesions responses according to Response Evaluation Criteria in Solid Tumors (RECIST). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Progression, a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Investigator-assessed Progression Free Survival (PFS) (E1) | from first date of treatment in the extension up to 4 years | PFS was defined as the time from the date of the start of therapy in the extension study to the date of the first radiologically documented disease progression or death due to any cause. If a participant had not progressed or died at the analysis cut-off date or when he/she received any further anti-neoplastic therapy, PFS was censored at the time of the last adequate tumor evaluation before the cut-off date or the anti-neoplastic therapy start date. |
| Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Baseline, weeks 4, 8, 20, 32, 44, and end of treatment (EOT) up to week 82 | The EORTC QLQ-C30 contains 30 questions assessed by the participant. There are 9 multiple-item scales: 5 scales that assess aspects of functioning (physical, role functioning, cognitive, emotional, and social); 3 symptom scales (Fatigue, Pain, and Nausea and Vomiting); and a global health status/Quality of Life (QOL) scale. There are 5 single-item measures assessing additional symptoms (i.e., dyspnea, loss of appetite, insomnia, constipation, and diarrhea) and a single item concerning perceived financial impact of the disease. All but two questions have 4-point scales ranging from Not at all to Very much. The two questions concerning global health status/ QOL have 7 point scales with ratings ranging from Very poor to Excellent. For each of the 14 domains, final scores are transformed such that they range from 0-100, where higher scores indicate improvement. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| pNET (Core) Participants with NETs of a pancreatic origin received Everolimus 10 mg orally once daily until documented tumor progression, unacceptable toxicity or any other reason. | 126 |
| Non-pNET (Core) Participants with NETs of a GI or lung origin received Everolimus 10 mg orally once daily until documented tumor progression, unacceptable toxicity or any other reason. | 120 |
| Total | 246 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Core | Administrative problems | 0 | 1 | 0 | 0 |
| Core | Adverse Event | 19 | 23 | 0 | 0 |
| Core | Death | 3 | 6 | 0 | 0 |
| Core | Disease progression | 14 | 26 | 0 | 0 |
| Core | Lost to Follow-up | 1 | 2 | 0 | 0 |
| Core | Patients completed per protocol | 85 | 44 | 0 | 0 |
| Core | Protocol deviation | 0 | 1 | 0 | 0 |
| Core | Withdrawal by Subject | 4 | 17 | 0 | 0 |
| Extension | Administrative problems | 0 | 0 | 0 | 1 |
| Extension | Adverse Event | 0 | 0 | 0 | 1 |
| Extension | Disease progression | 0 | 0 | 4 | 7 |
| Extension | Patients completed per protocol | 0 | 0 | 0 | 2 |
Baseline characteristics
| Characteristic | pNET (Core) | Non-pNET (Core) | Total |
|---|---|---|---|
| Age, Continuous | 59.3 years STANDARD_DEVIATION 13.04 | 64.4 years STANDARD_DEVIATION 9.28 | 61.8 years STANDARD_DEVIATION 11.62 |
| Sex: Female, Male Female | 58 Participants | 61 Participants | 119 Participants |
| Sex: Female, Male Male | 68 Participants | 59 Participants | 127 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 73 / 123 | 89 / 117 | 4 / 4 | 11 / 11 |
| serious Total, serious adverse events | 25 / 123 | 59 / 117 | 1 / 4 | 4 / 11 |
Outcome results
Primary
Number and Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths (Core)
The number of participants with AEs, SAEs and deaths were assessed.
Time frame: from the day of first treatment up to 19 months
Population: The safety population, which consisted of all patients who received at least one dose of everolimus and had at least one post-baseline safety assessment, was analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| pNET (Core) | Number and Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths (Core) | Deaths | 5 Participants |
| pNET (Core) | Number and Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths (Core) | Adverse events | 90 Participants |
| pNET (Core) | Number and Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths (Core) | Serious adverse events | 25 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths (Core) | Serious adverse events | 59 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths (Core) | Deaths | 10 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths (Core) | Adverse events | 109 Participants |
Primary
Number and Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths During the Extension Phase (E1)
The number of participants with AEs, SAEs and deaths were assessed.
Time frame: from the first day of treatment in the extension up to 4 years
Population: The safety set, which consisted of all participants who received at least one dose of everolimus during the extension and had at least one post-baseline safety assessment during the extension, was analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| pNET (Core) | Number and Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths During the Extension Phase (E1) | AEs | 4 Participants |
| pNET (Core) | Number and Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths During the Extension Phase (E1) | SAEs | 1 Participants |
| pNET (Core) | Number and Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths During the Extension Phase (E1) | Deaths | 0 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths During the Extension Phase (E1) | AEs | 11 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths During the Extension Phase (E1) | SAEs | 4 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths During the Extension Phase (E1) | Deaths | 1 Participants |
Secondary
Change in EORTC QLQ-G.I. NET21 Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1)
The EORTC QLQ-G.I. NET21 contains 21 questions and has three defined multi-item symptom scales (endocrine - 3 questions, gastrointestinal - 5 questions, and treatment related side effects - 3 questions), two single item symptoms (bone/muscle pain and concern about weight loss), two psychosocial scales (social function - 3 questions, disease-related worries - 3 questions) and two other single items (sexuality and communication). For each of the 9 domains, final scores are transformed such that they range from 0-100, where higher scores indicate worsening outcomes. A positive change from baseline indicates worsening.
Time frame: baseline, every 12 weeks and up to 4 years
Population: Only participants from the full analysis set, who had both baseline and end of treatment measurements, were included in the analysis. The full analysis set, which consisted of all participants who received at least one dose of everolimus during the extension, was analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| pNET (Core) | Change in EORTC QLQ-G.I. NET21 Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | Communicative functioning | 0.00 units on a scale | — |
| pNET (Core) | Change in EORTC QLQ-G.I. NET21 Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | Endocrine scale | 11.11 units on a scale | — |
| pNET (Core) | Change in EORTC QLQ-G.I. NET21 Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | Treatment scale | -16.67 units on a scale | — |
| pNET (Core) | Change in EORTC QLQ-G.I. NET21 Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | Social function | 11.11 units on a scale | — |
| pNET (Core) | Change in EORTC QLQ-G.I. NET21 Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | G.I. scale | 0.00 units on a scale | — |
| pNET (Core) | Change in EORTC QLQ-G.I. NET21 Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | Body image | 0.00 units on a scale | — |
| pNET (Core) | Change in EORTC QLQ-G.I. NET21 Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | Disease-related worries | 44.44 units on a scale | — |
| Non-pNET (Core) | Change in EORTC QLQ-G.I. NET21 Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | Muscle/bone pain symptom | 33.33 units on a scale | Standard Deviation 29.814 |
| Non-pNET (Core) | Change in EORTC QLQ-G.I. NET21 Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | Disease-related worries | -0.93 units on a scale | Standard Deviation 7.384 |
| Non-pNET (Core) | Change in EORTC QLQ-G.I. NET21 Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | Body image | 0.00 units on a scale | Standard Deviation 21.082 |
| Non-pNET (Core) | Change in EORTC QLQ-G.I. NET21 Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | Sexual function | 50.00 units on a scale | Standard Deviation 43.033 |
| Non-pNET (Core) | Change in EORTC QLQ-G.I. NET21 Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | Communicative functioning | 11.11 units on a scale | Standard Deviation 17.213 |
| Non-pNET (Core) | Change in EORTC QLQ-G.I. NET21 Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | G.I. scale | 14.44 units on a scale | Standard Deviation 23.633 |
| Non-pNET (Core) | Change in EORTC QLQ-G.I. NET21 Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | Social function | 7.41 units on a scale | Standard Deviation 22.951 |
| Non-pNET (Core) | Change in EORTC QLQ-G.I. NET21 Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | Endocrine scale | 5.56 units on a scale | Standard Deviation 18.257 |
| Non-pNET (Core) | Change in EORTC QLQ-G.I. NET21 Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | Treatment scale | 5.56 units on a scale | Standard Deviation 12.423 |
Secondary
Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1)
The EORTC QLQ-C30 contains 30 questions assessed by the participant. There are 9 multiple-item scales: 5 scales that assess aspects of functioning (physical, role, cognitive, emotional, and social); 3 symptom scales (Fatigue, Pain, and Nausea and Vomiting); and a global health status and QOL scale. There are 5 single-item measures assessing additional symptoms (i.e., dyspnea, loss of appetite, insomnia, constipation, and diarrhea) and a single item concerning perceived financial impact of the disease. All but two questions have 4-point scales ranging from Not at all to Very much. The two questions concerning global health status and QOL have 7 point scales with ratings ranging from Very poor to Excellent. For each of the 14 domains, changes are calculated as value at later time point minus value at baseline, and final scores are transformed such that they range from 0-100, where higher scores indicate better outcomes. A positive change from baseline indicates improvement.
Time frame: baseline, every 12 weeks and up to 4 years
Population: Only participants from the full analysis set, who had both baseline and end of treatment measurements, were included in the analysis. The full analysis set, which consisted of all participants who received at least one dose of everolimus during the extension, was analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| pNET (Core) | Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | Functional scale: Cognitive functioning | -66.67 score on a scale | — |
| pNET (Core) | Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | Symptom scale: Pain | 0.00 score on a scale | — |
| pNET (Core) | Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | Functional scale: Role functioning | -16.67 score on a scale | — |
| pNET (Core) | Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | Symptom scale: Dyspnea | 0.00 score on a scale | — |
| pNET (Core) | Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | Symptom scale: Fatigue | 0.00 score on a scale | — |
| pNET (Core) | Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | Symptom scale: Insomnia | 33.33 score on a scale | — |
| pNET (Core) | Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | Functional scale: Emotional functioning | -25.00 score on a scale | — |
| pNET (Core) | Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | Symptom scale: Appetite loss | 0.00 score on a scale | — |
| pNET (Core) | Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | Global health status/QoL | 0.00 score on a scale | — |
| pNET (Core) | Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | Symptom scale: Constipation | 0.00 score on a scale | — |
| pNET (Core) | Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | Functional scale: Social functioning | 0.00 score on a scale | — |
| pNET (Core) | Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | Symptom scale: Diarrhea | 0.00 score on a scale | — |
| pNET (Core) | Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | Functional scale: Physical functioning | 6.67 score on a scale | — |
| pNET (Core) | Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | Symptom scale: Financial difficulties | -33.33 score on a scale | — |
| pNET (Core) | Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | Symptom scale: Nausea and vomiting | 0.00 score on a scale | — |
| Non-pNET (Core) | Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | Symptom scale: Financial difficulties | 16.67 score on a scale | Standard Deviation 18.257 |
| Non-pNET (Core) | Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | Functional scale: Emotional functioning | -1.85 score on a scale | Standard Deviation 17.003 |
| Non-pNET (Core) | Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | Functional scale: Social functioning | -8.33 score on a scale | Standard Deviation 9.129 |
| Non-pNET (Core) | Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | Functional scale: Physical functioning | 0.00 score on a scale | Standard Deviation 7.303 |
| Non-pNET (Core) | Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | Functional scale: Role functioning | 5.56 score on a scale | Standard Deviation 22.771 |
| Non-pNET (Core) | Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | Functional scale: Cognitive functioning | -16.67 score on a scale | Standard Deviation 21.082 |
| Non-pNET (Core) | Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | Symptom scale: Fatigue | -3.70 score on a scale | Standard Deviation 22.951 |
| Non-pNET (Core) | Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | Symptom scale: Nausea and vomiting | 0.00 score on a scale | Standard Deviation 18.257 |
| Non-pNET (Core) | Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | Symptom scale: Pain | 16.67 score on a scale | Standard Deviation 27.889 |
| Non-pNET (Core) | Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | Symptom scale: Dyspnea | -5.56 score on a scale | Standard Deviation 13.608 |
| Non-pNET (Core) | Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | Symptom scale: Insomnia | 11.11 score on a scale | Standard Deviation 17.213 |
| Non-pNET (Core) | Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | Symptom scale: Appetite loss | 0.00 score on a scale | Standard Deviation 21.082 |
| Non-pNET (Core) | Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | Symptom scale: Constipation | 5.56 score on a scale | Standard Deviation 25.092 |
| Non-pNET (Core) | Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | Symptom scale: Diarrhea | -16.67 score on a scale | Standard Deviation 45.947 |
| Non-pNET (Core) | Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | Global health status/QoL | -0.00 score on a scale | Standard Deviation 11.785 |
Secondary
Change in EuroQol Five Dimensions Questionnaire (EQ-5D) Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1)
The EQ-5D contains 2 sections:1st section has 1 item addressing each of 5 dimensions (mobility, self-care, usual activity, pain/discomfort, anxiety/depression). Each dimension has 3 levels: no problems, some problems, extreme problems, 1-3, respectively. A health state is defined by combining 1 level from each dimension. 243 health states are possible. Each state is referred to in a 5 digit code. E.g., state 11111 indicates no problems on any dimension, while state 11223 indicates no problems with mobility and self-care, some problems with performing usual activities, moderate pain or discomfort and extreme anxiety or depression. The 2nd section measures self-rated health status using a visual analogue scale (VAS) where 100 represents best possible health and 0 represents worst possible health. Patients are asked to rate their current health by placing a mark on the VAS. Scores from each section are then transformed into an overall score of 0 or 1, with 0= higher level of dysfunction.
Time frame: baseline, every 12 weeks and up to 4 years
Population: Only participants from the full analysis set, who had both baseline and end of treatment measurements, were included in the analysis. The full analysis set, which consisted of all participants who received at least one dose of everolimus during the extension, was analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| pNET (Core) | Change in EuroQol Five Dimensions Questionnaire (EQ-5D) Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | Composite health index | 7.26 units on a scale | — |
| pNET (Core) | Change in EuroQol Five Dimensions Questionnaire (EQ-5D) Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | Self-rated health status | -10.00 units on a scale | — |
| Non-pNET (Core) | Change in EuroQol Five Dimensions Questionnaire (EQ-5D) Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | Composite health index | -8.58 units on a scale | Standard Deviation 13.302 |
| Non-pNET (Core) | Change in EuroQol Five Dimensions Questionnaire (EQ-5D) Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1) | Self-rated health status | -4.17 units on a scale | Standard Deviation 21.479 |
Secondary
Investigator-assessed Best Overall Response (Core)
Best overall response was determined from the sequence of investigator overall lesions responses according to Response Evaluation Criteria in Solid Tumors (RECIST). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Progression, a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: from the start of treatment, every 12 weeks for the first year and then every 6 months up to 19 months
Population: The full analysis set, which consisted of all participants who received at least one dose, was analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| pNET (Core) | Investigator-assessed Best Overall Response (Core) | Objective response rate (complete response or PR) | 2 Participants |
| pNET (Core) | Investigator-assessed Best Overall Response (Core) | Partial response (PR) | 2 Participants |
| pNET (Core) | Investigator-assessed Best Overall Response (Core) | Stable disease (SD) | 74 Participants |
| pNET (Core) | Investigator-assessed Best Overall Response (Core) | Progressive disease (PD) | 9 Participants |
| pNET (Core) | Investigator-assessed Best Overall Response (Core) | Unknown | 41 Participants |
| Non-pNET (Core) | Investigator-assessed Best Overall Response (Core) | Unknown | 27 Participants |
| Non-pNET (Core) | Investigator-assessed Best Overall Response (Core) | Progressive disease (PD) | 8 Participants |
| Non-pNET (Core) | Investigator-assessed Best Overall Response (Core) | Partial response (PR) | 1 Participants |
| Non-pNET (Core) | Investigator-assessed Best Overall Response (Core) | Objective response rate (complete response or PR) | 1 Participants |
| Non-pNET (Core) | Investigator-assessed Best Overall Response (Core) | Stable disease (SD) | 84 Participants |
Secondary
Investigator-assessed Best Overall Response During the Extension Phase (E1)
Best overall response was determined from the sequence of investigator overall lesions responses according to Response Evaluation Criteria in Solid Tumors (RECIST). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Progression, a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: from the start of treatment, every 12 weeks for the first year and then every 6 months up to 4 years
Population: The full analysis set, which consisted of all participants who received at least one dose of everolimus during the extension, was analyzed
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| pNET (Core) | Investigator-assessed Best Overall Response During the Extension Phase (E1) | Unknown | 0 Participants |
| pNET (Core) | Investigator-assessed Best Overall Response During the Extension Phase (E1) | Complete response | 0 Participants |
| pNET (Core) | Investigator-assessed Best Overall Response During the Extension Phase (E1) | Partial response | 0 Participants |
| pNET (Core) | Investigator-assessed Best Overall Response During the Extension Phase (E1) | Stable disease | 2 Participants |
| pNET (Core) | Investigator-assessed Best Overall Response During the Extension Phase (E1) | Progressive disease | 2 Participants |
| Non-pNET (Core) | Investigator-assessed Best Overall Response During the Extension Phase (E1) | Progressive disease | 3 Participants |
| Non-pNET (Core) | Investigator-assessed Best Overall Response During the Extension Phase (E1) | Stable disease | 7 Participants |
| Non-pNET (Core) | Investigator-assessed Best Overall Response During the Extension Phase (E1) | Complete response | 0 Participants |
| Non-pNET (Core) | Investigator-assessed Best Overall Response During the Extension Phase (E1) | Unknown | 0 Participants |
| Non-pNET (Core) | Investigator-assessed Best Overall Response During the Extension Phase (E1) | Partial response | 1 Participants |
Secondary
Investigator-assessed Progression Free Survival (PFS) (Core)
PFS was defined as the time from the date of the first dose to the date of the first radiologically documented disease progression or death due to any cause. If a participant had not progressed or died at the study end date or when he/she received any further anti-neoplastic therapy, PFS was censored at the time of the last tumor assessment before the end of study date. Progression was defined,using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: from the day of first treatment up to 19 months
Population: The full analysis set, which consisted of all participants who received at least one dose, was analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| pNET (Core) | Investigator-assessed Progression Free Survival (PFS) (Core) | 7.62 Months |
| Non-pNET (Core) | Investigator-assessed Progression Free Survival (PFS) (Core) | 10.78 Months |
Secondary
Investigator-assessed Progression Free Survival (PFS) (E1)
PFS was defined as the time from the date of the start of therapy in the extension study to the date of the first radiologically documented disease progression or death due to any cause. If a participant had not progressed or died at the analysis cut-off date or when he/she received any further anti-neoplastic therapy, PFS was censored at the time of the last adequate tumor evaluation before the cut-off date or the anti-neoplastic therapy start date.
Time frame: from first date of treatment in the extension up to 4 years
Population: The full analysis set, which consisted of all participants who received at least one dose of everolimus during the extension, was analyzed
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| pNET (Core) | Investigator-assessed Progression Free Survival (PFS) (E1) | 159 Days |
| Non-pNET (Core) | Investigator-assessed Progression Free Survival (PFS) (E1) | 655 Days |
Secondary
Mean EORTC QLQ-G.I. NET21 Score (Core)
The EORTC QLQ-G.I. NET21 contains 21 questions and has three defined multi-item symptom scales (endocrine - 3 questions, gastrointestinal - 5 questions, and treatment related side effects - 3 questions), two single item symptoms (bone/muscle pain and concern about weight loss), two psychosocial scales (social function - 3 questions and disease-related worries - 3 questions) and two other single items (sexuality and communication). For each of the 9 domains, final scores are transformed such that they range from 0-100, where higher scores indicate worsening.
Time frame: Baseline, weeks 4, 8, 20, 32, 44, and end of treatment (EOT) up to week 82
Population: The full analysis set, which consisted of all participants who received at least one dose of everolimus, was considered for the analysis. Only participants with measurement at each given time point were analyzed for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Muscle/bone pain, week 20 | 41.67 units on a scale | Standard Deviation 15.43 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Endocrine, Baseline | 12.99 units on a scale | Standard Deviation 20.372 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Endocrine, week 4 | 13.21 units on a scale | Standard Deviation 17.44 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Endocrine, week 8 | 13.47 units on a scale | Standard Deviation 17.293 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Endocrine, week 20 | 12.50 units on a scale | Standard Deviation 12.511 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Endocrine, week 32 | 16.67 units on a scale | Standard Deviation 14.344 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Endocrine, week 44 | 0.00 units on a scale | — |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Endocrine, EOT up to week 82 | 9.49 units on a scale | Standard Deviation 15.627 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | G.I., Baseline | 23.69 units on a scale | Standard Deviation 20.183 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | G.I., week 4 | 23.02 units on a scale | Standard Deviation 20.488 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | G.I., week 8 | 22.34 units on a scale | Standard Deviation 18.398 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | G.I., week 20 | 25.63 units on a scale | Standard Deviation 14.056 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | G.I., week 32 | 25.00 units on a scale | Standard Deviation 11.386 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | G.I., week 44 | 0.00 units on a scale | — |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | G.I., EOT up to week 82 | 25.85 units on a scale | Standard Deviation 19.899 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Treatment, baseline | 9.26 units on a scale | Standard Deviation 11.675 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Treatment, week 4 | 17.72 units on a scale | Standard Deviation 15.337 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Treatment, week 8 | 16.18 units on a scale | Standard Deviation 19.528 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Treatment, week 20 | 28.70 units on a scale | Standard Deviation 21.493 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Treatment, week 32 | 27.78 units on a scale | Standard Deviation 7.857 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Treatment, week 44 | 16.67 units on a scale | — |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Treatment, EOT up to week 82 | 22.06 units on a scale | Standard Deviation 21.705 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Social function, Baseline | 39.56 units on a scale | Standard Deviation 23.721 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Social function, week 4 | 36.52 units on a scale | Standard Deviation 26.294 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Social function, week 8 | 38.35 units on a scale | Standard Deviation 23.629 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Social function, week 20 | 40.28 units on a scale | Standard Deviation 14.472 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Social function, week 32 | 38.89 units on a scale | Standard Deviation 14.344 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Social function, week 44 | 33.33 units on a scale | — |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Social function, EOT up to week 82 | 38.89 units on a scale | Standard Deviation 25.051 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Disease-related worries, Baseline | 43.10 units on a scale | Standard Deviation 25.599 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Disease-related worries, week 4 | 39.20 units on a scale | Standard Deviation 28.562 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Disease-related worries, week 8 | 40.56 units on a scale | Standard Deviation 28.183 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Disease-related worries, week 20 | 37.50 units on a scale | Standard Deviation 8.267 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Disease-related worries, week 32 | 38.89 units on a scale | Standard Deviation 11.111 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Disease-related worries, week 44 | 33.33 units on a scale | — |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Disease-related worries, EOT up to week 82 | 42.89 units on a scale | Standard Deviation 28.876 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Muscle/bone pain, Baseline | 26.67 units on a scale | Standard Deviation 33.347 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Muscle/bone pain, week 4 | 24.07 units on a scale | Standard Deviation 29.966 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Muscle/bone pain, week 8 | 31.18 units on a scale | Standard Deviation 34.357 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Muscle/bone pain, week 32 | 50.00 units on a scale | Standard Deviation 19.245 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Muscle/bone pain, week 44 | 33.33 units on a scale | — |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Muscle/bone pain, EOT up to week 82 | 34.13 units on a scale | Standard Deviation 28.973 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Sexual function, Baseline | 35.46 units on a scale | Standard Deviation 32.899 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Sexual function, week 4 | 21.05 units on a scale | Standard Deviation 26.191 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Sexual function, week 8 | 28.79 units on a scale | Standard Deviation 33.007 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Sexual function, week 20 | 33.33 units on a scale | Standard Deviation 33.333 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Sexual function, week 32 | 11.11 units on a scale | Standard Deviation 19.245 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Sexual function, EOT up to week 82 | 25.81 units on a scale | Standard Deviation 28.166 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Communication function, Baseline | 7.58 units on a scale | Standard Deviation 16.325 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Communication function, week 4 | 8.18 units on a scale | Standard Deviation 17.179 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Communication function, week 8 | 12.22 units on a scale | Standard Deviation 18.535 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Communication function, week 20 | 14.29 units on a scale | Standard Deviation 17.817 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Communication function, week 32 | 8.33 units on a scale | Standard Deviation 16.667 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Communication function, week 44 | 0.00 units on a scale | — |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Communication function, EOT up to week 82 | 12.70 units on a scale | Standard Deviation 22.028 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Body image, Baseline | 15.90 units on a scale | Standard Deviation 28.932 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Body image, week 4 | 15.09 units on a scale | Standard Deviation 27.399 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Body image, week 8 | 21.51 units on a scale | Standard Deviation 27.953 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Body image, week 20 | 16.67 units on a scale | Standard Deviation 17.817 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Body image, week 32 | 0.00 units on a scale | Standard Deviation 0 |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Body image, week 44 | 0.00 units on a scale | — |
| pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Body image, EOT up to week 82 | 23.02 units on a scale | Standard Deviation 32.5 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Sexual function, week 44 | 47.62 units on a scale | Standard Deviation 46.576 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Disease-related worries, week 8 | 47.32 units on a scale | Standard Deviation 28.541 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Communication function, EOT up to week 82 | 12.61 units on a scale | Standard Deviation 23.214 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Endocrine, Baseline | 23.52 units on a scale | Standard Deviation 23.771 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Disease-related worries, week 20 | 46.83 units on a scale | Standard Deviation 32.096 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Endocrine, week 4 | 17.85 units on a scale | Standard Deviation 21.403 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Sexual function, EOT up to week 82 | 48.94 units on a scale | Standard Deviation 43.323 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Endocrine, week 8 | 16.79 units on a scale | Standard Deviation 20.216 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Disease-related worries, week 32 | 53.51 units on a scale | Standard Deviation 27.137 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Endocrine, week 20 | 15.87 units on a scale | Standard Deviation 21.067 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Body image, week 20 | 30.30 units on a scale | Standard Deviation 34.708 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Endocrine, week 32 | 13.74 units on a scale | Standard Deviation 17.978 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Disease-related worries, week 44 | 44.05 units on a scale | Standard Deviation 32.647 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Endocrine, week 44 | 7.14 units on a scale | Standard Deviation 11.202 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Communication function, Baseline | 9.88 units on a scale | Standard Deviation 22.904 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Endocrine, EOT up to week 82 | 15.20 units on a scale | Standard Deviation 18.755 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Disease-related worries, EOT up to week 82 | 55.04 units on a scale | Standard Deviation 31.667 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | G.I., Baseline | 26.19 units on a scale | Standard Deviation 21.328 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Body image, Baseline | 22.43 units on a scale | Standard Deviation 34.195 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | G.I., week 4 | 23.39 units on a scale | Standard Deviation 18.958 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Muscle/bone pain, Baseline | 29.66 units on a scale | Standard Deviation 31.21 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | G.I., week 8 | 27.53 units on a scale | Standard Deviation 21.341 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Communication function, week 4 | 6.46 units on a scale | Standard Deviation 15.626 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | G.I., week 20 | 22.31 units on a scale | Standard Deviation 18.837 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Muscle/bone pain, week 4 | 33.00 units on a scale | Standard Deviation 31.956 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | G.I., week 32 | 26.84 units on a scale | Standard Deviation 19.879 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Body image, week 44 | 30.95 units on a scale | Standard Deviation 27.625 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | G.I., week 44 | 20.95 units on a scale | Standard Deviation 16.714 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Muscle/bone pain, week 8 | 33.33 units on a scale | Standard Deviation 33.524 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | G.I., EOT up to week 82 | 30.48 units on a scale | Standard Deviation 24.484 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Muscle/bone pain, week 20 | 34.52 units on a scale | Standard Deviation 33.614 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Treatment, baseline | 18.44 units on a scale | Standard Deviation 19.374 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Communication function, week 8 | 9.69 units on a scale | Standard Deviation 19.714 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Treatment, week 4 | 22.22 units on a scale | Standard Deviation 20.077 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Muscle/bone pain, week 32 | 40.35 units on a scale | Standard Deviation 34.795 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Treatment, week 8 | 20.27 units on a scale | Standard Deviation 17.283 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Body image, week 4 | 22.79 units on a scale | Standard Deviation 31.239 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Treatment, week 20 | 19.74 units on a scale | Standard Deviation 19.755 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Muscle/bone pain, week 44 | 26.19 units on a scale | Standard Deviation 26.726 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Treatment, week 32 | 24.49 units on a scale | Standard Deviation 23.684 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Communication function, week 20 | 10.30 units on a scale | Standard Deviation 19.108 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Treatment, week 44 | 18.18 units on a scale | Standard Deviation 18.936 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Muscle/bone pain, EOT up to week 82 | 40.89 units on a scale | Standard Deviation 33.141 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Treatment, EOT up to week 82 | 24.81 units on a scale | Standard Deviation 21.735 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Body image, week 32 | 28.83 units on a scale | Standard Deviation 33.483 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Social function, Baseline | 47.42 units on a scale | Standard Deviation 25.726 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Sexual function, Baseline | 39.32 units on a scale | Standard Deviation 40.468 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Social function, week 4 | 45.28 units on a scale | Standard Deviation 27.483 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Communication function, week 32 | 7.89 units on a scale | Standard Deviation 19.658 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Social function, week 8 | 46.49 units on a scale | Standard Deviation 26.265 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Sexual function, week 4 | 40.89 units on a scale | Standard Deviation 40.483 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Social function, week 20 | 42.66 units on a scale | Standard Deviation 25.648 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Body image, week 8 | 26.10 units on a scale | Standard Deviation 31.256 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Social function, week 32 | 48.54 units on a scale | Standard Deviation 23.735 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Sexual function, week 8 | 43.92 units on a scale | Standard Deviation 40.083 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Social function, week 44 | 40.08 units on a scale | Standard Deviation 26.165 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Communication function, week 44 | 4.76 units on a scale | Standard Deviation 12.105 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Social function, EOT up to week 82 | 54.22 units on a scale | Standard Deviation 28.428 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Body image, EOT up to week 82 | 34.70 units on a scale | Standard Deviation 37.449 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Disease-related worries, Baseline | 53.94 units on a scale | Standard Deviation 27.664 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Sexual function, week 32 | 29.17 units on a scale | Standard Deviation 35.864 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Sexual function, week 20 | 38.10 units on a scale | Standard Deviation 39.724 |
| Non-pNET (Core) | Mean EORTC QLQ-G.I. NET21 Score (Core) | Disease-related worries, week 4 | 46.33 units on a scale | Standard Deviation 28.165 |
Secondary
Mean EQ-5D Visual Analogue Scale (VAS) Score (Core)
The EQ-5D is divided into two distinct sections. The first section includes one item addressing each of five dimensions (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression). Patients rate each of these items from no problem, some problem, or extreme problem. A composite health index is then defined by combining the levels for each dimension. The second section of the questionnaire measures self-rated (global) health status utilizing a vertically oriented visual analogue scale where 100 represents the best possible health state and 0 represents the worst possible health state. Respondents are asked to rate their current health by placing a mark along this continuum. The scores from each section are then transformed into a single health utility score. Overall scores range from 0 to 1 with lower scores representing a higher level of dysfunction.
Time frame: Baseline, weeks 4, 8, 20, 32, 44, and end of treatment (EOT) up to week 82
Population: The full analysis set, which consisted of all participants who received at least one dose of everolimus, was considered for the analysis. Only participants with measurement at each given time point were analyzed for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| pNET (Core) | Mean EQ-5D Visual Analogue Scale (VAS) Score (Core) | Week 8 | 64.6 units on a scale | Standard Deviation 21.77 |
| pNET (Core) | Mean EQ-5D Visual Analogue Scale (VAS) Score (Core) | Baseline | 68.8 units on a scale | Standard Deviation 19.9 |
| pNET (Core) | Mean EQ-5D Visual Analogue Scale (VAS) Score (Core) | Week 44 | 66.7 units on a scale | Standard Deviation 15.28 |
| pNET (Core) | Mean EQ-5D Visual Analogue Scale (VAS) Score (Core) | Week 20 | 67.4 units on a scale | Standard Deviation 19.58 |
| pNET (Core) | Mean EQ-5D Visual Analogue Scale (VAS) Score (Core) | Week 4 | 69.3 units on a scale | Standard Deviation 18.06 |
| pNET (Core) | Mean EQ-5D Visual Analogue Scale (VAS) Score (Core) | EOT up to Week 82 | 66.5 units on a scale | Standard Deviation 20.64 |
| pNET (Core) | Mean EQ-5D Visual Analogue Scale (VAS) Score (Core) | Week 32 | 42.6 units on a scale | Standard Deviation 24.67 |
| Non-pNET (Core) | Mean EQ-5D Visual Analogue Scale (VAS) Score (Core) | EOT up to Week 82 | 55.3 units on a scale | Standard Deviation 23.02 |
| Non-pNET (Core) | Mean EQ-5D Visual Analogue Scale (VAS) Score (Core) | Week 32 | 62.0 units on a scale | Standard Deviation 17.65 |
| Non-pNET (Core) | Mean EQ-5D Visual Analogue Scale (VAS) Score (Core) | Baseline | 63.9 units on a scale | Standard Deviation 19.09 |
| Non-pNET (Core) | Mean EQ-5D Visual Analogue Scale (VAS) Score (Core) | Week 20 | 64.6 units on a scale | Standard Deviation 15.51 |
| Non-pNET (Core) | Mean EQ-5D Visual Analogue Scale (VAS) Score (Core) | Week 4 | 63.8 units on a scale | Standard Deviation 18.78 |
| Non-pNET (Core) | Mean EQ-5D Visual Analogue Scale (VAS) Score (Core) | Week 8 | 61.2 units on a scale | Standard Deviation 18.65 |
| Non-pNET (Core) | Mean EQ-5D Visual Analogue Scale (VAS) Score (Core) | Week 44 | 68.6 units on a scale | Standard Deviation 18.71 |
Secondary
Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core)
The EORTC QLQ-C30 contains 30 questions assessed by the participant. There are 9 multiple-item scales: 5 scales that assess aspects of functioning (physical, role functioning, cognitive, emotional, and social); 3 symptom scales (Fatigue, Pain, and Nausea and Vomiting); and a global health status/Quality of Life (QOL) scale. There are 5 single-item measures assessing additional symptoms (i.e., dyspnea, loss of appetite, insomnia, constipation, and diarrhea) and a single item concerning perceived financial impact of the disease. All but two questions have 4-point scales ranging from Not at all to Very much. The two questions concerning global health status/ QOL have 7 point scales with ratings ranging from Very poor to Excellent. For each of the 14 domains, final scores are transformed such that they range from 0-100, where higher scores indicate improvement.
Time frame: Baseline, weeks 4, 8, 20, 32, 44, and end of treatment (EOT) up to week 82
Population: The full analysis set, which consisted of all participants who received at least one dose of everolimus, was considered for the analysis. Only participants with measurement at each given time point were analyzed for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Emotional functioning, week 8 | 73.38 units on a scale | Standard Deviation 24.73 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Global health status/QOL, EOT up to Week 82 | 61.40 units on a scale | Standard Deviation 20.847 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Emotional functioning, week 20 | 76.19 units on a scale | Standard Deviation 19.072 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Emotional functioning, week 32 | 81.67 units on a scale | Standard Deviation 14.907 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Dyspnea, EOT up to week 82 | 25.19 units on a scale | Standard Deviation 30.222 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Emotional functioning, week 44 | 75.00 units on a scale | Standard Deviation 8.333 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Appetite loss, Baseline | 20.56 units on a scale | Standard Deviation 30.613 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Emotional functioning, EOT up to week 82 | 74.61 units on a scale | Standard Deviation 23.602 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Dyspnea, Baseline | 16.11 units on a scale | Standard Deviation 22.448 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Appetitie loss, week 4 | 25.16 units on a scale | Standard Deviation 31.618 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Cognitive functioning, week 4 | 86.11 units on a scale | Standard Deviation 20.05 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Insomnia, Baseline | 24.72 units on a scale | Standard Deviation 30.093 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Cognitive functioning, week 8 | 81.94 units on a scale | Standard Deviation 21.803 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Pain, week 32 | 43.33 units on a scale | Standard Deviation 27.889 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Cognitive functioning, week 20 | 83.93 units on a scale | Standard Deviation 19.501 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Physical functioning, Baseline | 79.89 units on a scale | Standard Deviation 20.85 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Cognitive functioning, week 32 | 86.67 units on a scale | Standard Deviation 18.257 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Insomnia, week 4 | 27.78 units on a scale | Standard Deviation 29.324 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Cognitive functioning, week 44 | 94.44 units on a scale | Standard Deviation 9.623 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Physical functioning, week 4 | 77.02 units on a scale | Standard Deviation 22.38 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Cognitive functioning, EOT up to week 82 | 81.35 units on a scale | Standard Deviation 21.241 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Dyspnea, week 4 | 17.80 units on a scale | Standard Deviation 24.171 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Social functioning, Baseline | 75.56 units on a scale | Standard Deviation 28.249 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Appetitie loss, week 8 | 24.66 units on a scale | Standard Deviation 30.946 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Social functioning, week 4 | 78.71 units on a scale | Standard Deviation 23.347 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Insomnia, week 8 | 32.88 units on a scale | Standard Deviation 30.171 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Physical functioning, week 8 | 76.22 units on a scale | Standard Deviation 25.81 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Social functioning, week 20 | 73.21 units on a scale | Standard Deviation 24.148 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Cognitive functioning, Baseline | 84.17 units on a scale | Standard Deviation 19.63 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Social functioning, week 32 | 60.00 units on a scale | Standard Deviation 27.889 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Physical functioning, week 20 | 79.77 units on a scale | Standard Deviation 18.212 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Social functioning, week 44 | 66.67 units on a scale | Standard Deviation 0 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Appetitie loss, week 24 | 18.39 units on a scale | Standard Deviation 27.583 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Insomnia, week 24 | 24.14 units on a scale | Standard Deviation 26.572 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Fatigue, baseline | 31.30 units on a scale | Standard Deviation 22.361 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Constipation, week 8 | 10.50 units on a scale | Standard Deviation 24.137 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Appetitie loss, week 36 | 20.00 units on a scale | Standard Deviation 18.257 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Dyspnea, week 8 | 21.00 units on a scale | Standard Deviation 27.502 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Fatigue, week 4 | 35.22 units on a scale | Standard Deviation 22.887 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Physical functioning, week 32 | 68.00 units on a scale | Standard Deviation 26.415 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Constipation, week 20 | 6.90 units on a scale | Standard Deviation 16.377 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Fatigue, week 8 | 36.91 units on a scale | Standard Deviation 25.515 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Fatigue, week 20 | 34.29 units on a scale | Standard Deviation 18.43 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Fatigue, week 32 | 42.22 units on a scale | Standard Deviation 18.257 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Global health status/QOL, Baseline | 64.93 units on a scale | Standard Deviation 20.946 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Fatigue, week 44 | 37.04 units on a scale | Standard Deviation 6.415 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Social functioning, week 8 | 75.69 units on a scale | Standard Deviation 24.695 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Fatigue, EOT up to week 82 | 38.83 units on a scale | Standard Deviation 24.896 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Appetitie loss, week 44 | 11.11 units on a scale | Standard Deviation 19.245 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Nausea and vomiting, Baseline | 11.25 units on a scale | Standard Deviation 17.442 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Global health status/QOL, Week 4 | 63.15 units on a scale | Standard Deviation 19.673 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Nausea and vomiting, week 4 | 10.52 units on a scale | Standard Deviation 15.998 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Appetitie loss, EOT up to week 82 | 24.14 units on a scale | Standard Deviation 29.505 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Nausea and vomiting, week 8 | 9.59 units on a scale | Standard Deviation 17.984 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Physical functioning, week 44 | 68.89 units on a scale | Standard Deviation 13.878 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Nausea and vomiting, week 20 | 8.05 units on a scale | Standard Deviation 15.185 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Global health status/QOL, Week 8 | 59.72 units on a scale | Standard Deviation 21.303 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Constipation, week 32 | 0.00 units on a scale | Standard Deviation 0 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Dyspnea, week 20 | 11.49 units on a scale | Standard Deviation 18.422 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Constipation, week 44 | 0.00 units on a scale | Standard Deviation 0 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Constipation, Baseline | 13.06 units on a scale | Standard Deviation 24.175 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Constipation, EOT up to week 82 | 12.79 units on a scale | Standard Deviation 24.611 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Global health status/QOL,Week 20 | 63.10 units on a scale | Standard Deviation 22.387 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Diarrhea, Baseline | 19.89 units on a scale | Standard Deviation 29.535 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Constipation, week 4 | 11.00 units on a scale | Standard Deviation 24.427 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Nausea and vomiting, week 32 | 6.67 units on a scale | Standard Deviation 9.129 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Diarrhea, week 4 | 20.92 units on a scale | Standard Deviation 25.658 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Pain, week 44 | 38.89 units on a scale | Standard Deviation 9.623 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Diarrhea, week 8 | 27.40 units on a scale | Standard Deviation 29.576 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Physical functioning, EOT up to week 82 | 75.70 units on a scale | Standard Deviation 24.509 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Nausea and vomiting, week 44 | 11.11 units on a scale | Standard Deviation 9.623 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Global health status/QOL, Week 32 | 50.0 units on a scale | Standard Deviation 26.352 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Nausea and vomiting, EOT up to week 82 | 9.69 units on a scale | Standard Deviation 17.048 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Role functioning, Baseline | 75.28 units on a scale | Standard Deviation 28.663 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Pain, Baseline | 21.57 units on a scale | Standard Deviation 24.582 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Dyspnea, week 32 | 13.33 units on a scale | Standard Deviation 18.257 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Diarrhea, week 20 | 16.67 units on a scale | Standard Deviation 21.276 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Role functioning, week 4 | 72.49 units on a scale | Standard Deviation 28.364 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Global health status/QOL, Week 44 | 61.11 units on a scale | Standard Deviation 9.623 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Pain, week 4 | 25.91 units on a scale | Standard Deviation 26.716 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Role functioning, week 8 | 71.83 units on a scale | Standard Deviation 30.025 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Diarrhea, week 32 | 13.33 units on a scale | Standard Deviation 18.257 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Pain, week 8 | 25.23 units on a scale | Standard Deviation 27.972 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Insomnia, week 32 | 26.67 units on a scale | Standard Deviation 27.889 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Pain, week 20 | 27.98 units on a scale | Standard Deviation 22.247 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Role functioning, week 20 | 79.76 units on a scale | Standard Deviation 25.803 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Social functioning, EOT up to week 82 | 75.10 units on a scale | Standard Deviation 27.533 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Diarrhea, week 44 | 22.22 units on a scale | Standard Deviation 19.245 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Role functioning, week 32 | 66.67 units on a scale | Standard Deviation 26.352 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Diarrhea, EOT up to week 82 | 25.97 units on a scale | Standard Deviation 32.095 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Insomnia, week 48 | 22.22 units on a scale | Standard Deviation 19.245 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Financial difficulties, Baseline | 18.77 units on a scale | Standard Deviation 26.975 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Role functioning, week 44 | 61.11 units on a scale | Standard Deviation 9.623 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Financial difficulties, week 4 | 16.67 units on a scale | Standard Deviation 24.845 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Dyspnea, week 44 | 22.22 units on a scale | Standard Deviation 19.245 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Financial difficulties, week 8 | 19.44 units on a scale | Standard Deviation 26.091 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Role functioning, EOT up to week 82 | 67.84 units on a scale | Standard Deviation 31.788 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Financial difficulties, week 20 | 21.43 units on a scale | Standard Deviation 22.616 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Emotional functioning, Baseline | 74.79 units on a scale | Standard Deviation 22.65 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Financial difficulties, week 32 | 40.00 units on a scale | Standard Deviation 27.889 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Insomnia, EOT up o week 82 | 32.17 units on a scale | Standard Deviation 31.289 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Financial difficulties, week 44 | 22.22 units on a scale | Standard Deviation 19.245 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Emotional functioning, week 4 | 76.31 units on a scale | Standard Deviation 20.991 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Financial difficulties, EOT up to week 82 | 21.71 units on a scale | Standard Deviation 27.897 |
| pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Pain, EOT up to week 82 | 27.33 units on a scale | Standard Deviation 28.343 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Financial difficulties, EOT up to week 82 | 27.63 units on a scale | Standard Deviation 30.496 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Role functioning, EOT up to week 82 | 49.13 units on a scale | Standard Deviation 33.212 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Emotional functioning, week 20 | 63.16 units on a scale | Standard Deviation 27.456 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Fatigue, week 8 | 48.86 units on a scale | Standard Deviation 29.878 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Fatigue, week 20 | 44.44 units on a scale | Standard Deviation 27.698 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Nausea and vomiting, week 20 | 6.14 units on a scale | Standard Deviation 12.048 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Pain, week 32 | 34.62 units on a scale | Standard Deviation 32.977 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Pain, EOT up to week 82 | 43.90 units on a scale | Standard Deviation 33.362 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Pain, week 44 | 26.19 units on a scale | Standard Deviation 30.462 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Dyspnea, Baseline | 24.32 units on a scale | Standard Deviation 29.11 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Dyspnea, week 4 | 26.14 units on a scale | Standard Deviation 28.388 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Dyspnea, week 8 | 29.12 units on a scale | Standard Deviation 31.665 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Dyspnea, week 20 | 28.07 units on a scale | Standard Deviation 30.072 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Dyspnea, week 32 | 35.90 units on a scale | Standard Deviation 31.885 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Dyspnea, week 44 | 21.43 units on a scale | Standard Deviation 28.063 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Dyspnea, EOT up to week 82 | 33.77 units on a scale | Standard Deviation 30.824 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Insomnia, Baseline | 28.18 units on a scale | Standard Deviation 32.929 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Insomnia, week 4 | 32.36 units on a scale | Standard Deviation 30.769 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Insomnia, week 8 | 29.02 units on a scale | Standard Deviation 28.54 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Insomnia, week 24 | 35.09 units on a scale | Standard Deviation 32.38 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Global health status/QOL, Baseline | 60.53 units on a scale | Standard Deviation 21.497 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Global health status/QOL, Week 8 | 56.59 units on a scale | Standard Deviation 20.417 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Global health status/QOL,Week 20 | 59.65 units on a scale | Standard Deviation 17.663 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Global health status/QOL, Week 32 | 56.20 units on a scale | Standard Deviation 20.297 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Insomnia, week 32 | 33.33 units on a scale | Standard Deviation 32.88 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Insomnia, week 48 | 28.57 units on a scale | Standard Deviation 36.648 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Global health status/QOL, Week 44 | 57.74 units on a scale | Standard Deviation 25.205 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Insomnia, EOT up o week 82 | 34.63 units on a scale | Standard Deviation 32.643 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Appetite loss, Baseline | 18.62 units on a scale | Standard Deviation 29.365 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Appetitie loss, week 4 | 21.90 units on a scale | Standard Deviation 29.849 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Global health status/QOL, EOT up to Week 82 | 48.86 units on a scale | Standard Deviation 27.823 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Physical functioning, Baseline | 72.97 units on a scale | Standard Deviation 22.938 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Physical functioning, week 4 | 68.62 units on a scale | Standard Deviation 23.648 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Appetitie loss, week 8 | 25.67 units on a scale | Standard Deviation 31.623 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Physical functioning, week 8 | 67.48 units on a scale | Standard Deviation 24.973 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Appetitie loss, week 24 | 20.47 units on a scale | Standard Deviation 27.998 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Physical functioning, week 20 | 73.71 units on a scale | Standard Deviation 21.351 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Physical functioning, week 32 | 71.62 units on a scale | Standard Deviation 23.729 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Appetitie loss, week 36 | 23.93 units on a scale | Standard Deviation 30.54 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Appetitie loss, week 44 | 26.19 units on a scale | Standard Deviation 29.753 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Physical functioning, week 44 | 76.19 units on a scale | Standard Deviation 22.602 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Appetitie loss, EOT up to week 82 | 33.77 units on a scale | Standard Deviation 37.906 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Constipation, Baseline | 13.21 units on a scale | Standard Deviation 27.072 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Constipation, week 4 | 11.33 units on a scale | Standard Deviation 24.501 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Physical functioning, EOT up to week 82 | 60.94 units on a scale | Standard Deviation 28.037 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Role functioning, Baseline | 67.27 units on a scale | Standard Deviation 32.397 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Role functioning, week 4 | 62.25 units on a scale | Standard Deviation 30.483 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Role functioning, week 8 | 58.14 units on a scale | Standard Deviation 31.46 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Role functioning, week 20 | 58.33 units on a scale | Standard Deviation 29.129 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Role functioning, week 32 | 55.26 units on a scale | Standard Deviation 35.325 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Role functioning, week 44 | 66.67 units on a scale | Standard Deviation 26.954 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Emotional functioning, Baseline | 67.20 units on a scale | Standard Deviation 22.988 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Emotional functioning, week 4 | 66.69 units on a scale | Standard Deviation 25.38 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Emotional functioning, week 8 | 64.02 units on a scale | Standard Deviation 26.64 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Emotional functioning, week 32 | 61.11 units on a scale | Standard Deviation 28.184 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Emotional functioning, week 44 | 65.67 units on a scale | Standard Deviation 31.059 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Emotional functioning, EOT up to week 82 | 57.63 units on a scale | Standard Deviation 25.841 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Cognitive functioning, Baseline | 80.61 units on a scale | Standard Deviation 23.842 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Cognitive functioning, week 4 | 78.80 units on a scale | Standard Deviation 23.708 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Cognitive functioning, week 8 | 76.33 units on a scale | Standard Deviation 27.418 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Cognitive functioning, week 20 | 78.65 units on a scale | Standard Deviation 23.307 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Cognitive functioning, week 32 | 75.21 units on a scale | Standard Deviation 24.445 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Cognitive functioning, week 44 | 84.52 units on a scale | Standard Deviation 20.111 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Cognitive functioning, EOT up to week 82 | 73.46 units on a scale | Standard Deviation 24.522 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Social functioning, Baseline | 67.42 units on a scale | Standard Deviation 28.989 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Social functioning, week 4 | 67.80 units on a scale | Standard Deviation 30.093 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Social functioning, week 8 | 65.31 units on a scale | Standard Deviation 29.396 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Social functioning, week 20 | 66.07 units on a scale | Standard Deviation 29.977 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Social functioning, week 32 | 66.24 units on a scale | Standard Deviation 32.329 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Social functioning, week 44 | 72.62 units on a scale | Standard Deviation 31.082 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Social functioning, EOT up to week 82 | 52.89 units on a scale | Standard Deviation 33.933 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Constipation, week 8 | 7.58 units on a scale | Standard Deviation 22.447 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Fatigue, baseline | 42.39 units on a scale | Standard Deviation 28.534 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Fatigue, week 4 | 43.58 units on a scale | Standard Deviation 28.035 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Fatigue, week 32 | 48.72 units on a scale | Standard Deviation 29.575 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Fatigue, week 44 | 38.89 units on a scale | Standard Deviation 26.777 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Fatigue, EOT up to week 82 | 56.49 units on a scale | Standard Deviation 30.474 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Nausea and vomiting, Baseline | 9.46 units on a scale | Standard Deviation 17.353 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Nausea and vomiting, week 4 | 7.43 units on a scale | Standard Deviation 14.995 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Nausea and vomiting, week 8 | 10.34 units on a scale | Standard Deviation 18.015 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Constipation, week 20 | 8.77 units on a scale | Standard Deviation 21.387 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Constipation, week 32 | 4.27 units on a scale | Standard Deviation 13.636 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Constipation, week 44 | 2.38 units on a scale | Standard Deviation 8.909 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Constipation, EOT up to week 82 | 10.39 units on a scale | Standard Deviation 23.107 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Diarrhea, Baseline | 36.67 units on a scale | Standard Deviation 38.828 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Diarrhea, week 4 | 38.19 units on a scale | Standard Deviation 36.577 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Nausea and vomiting, week 32 | 5.98 units on a scale | Standard Deviation 11.139 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Nausea and vomiting, week 44 | 4.76 units on a scale | Standard Deviation 10.187 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Nausea and vomiting, EOT up to week 82 | 15.80 units on a scale | Standard Deviation 27.023 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Diarrhea, week 8 | 42.42 units on a scale | Standard Deviation 39.708 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Diarrhea, week 20 | 31.58 units on a scale | Standard Deviation 29.828 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Pain, Baseline | 31.21 units on a scale | Standard Deviation 31.535 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Pain, week 4 | 30.88 units on a scale | Standard Deviation 29.796 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Pain, week 8 | 37.55 units on a scale | Standard Deviation 32.372 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Pain, week 20 | 33.33 units on a scale | Standard Deviation 32.581 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Diarrhea, week 32 | 40.17 units on a scale | Standard Deviation 36.015 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Diarrhea, week 44 | 40.48 units on a scale | Standard Deviation 37.39 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Diarrhea, EOT up to week 82 | 39.04 units on a scale | Standard Deviation 38.639 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Financial difficulties, Baseline | 16.52 units on a scale | Standard Deviation 25.77 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Financial difficulties, week 4 | 16.67 units on a scale | Standard Deviation 27.01 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Financial difficulties, week 8 | 16.86 units on a scale | Standard Deviation 24.837 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Financial difficulties, week 20 | 19.88 units on a scale | Standard Deviation 27.357 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Financial difficulties, week 32 | 21.37 units on a scale | Standard Deviation 28.084 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Financial difficulties, week 44 | 19.05 units on a scale | Standard Deviation 25.198 |
| Non-pNET (Core) | Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core) | Global health status/QOL, Week 4 | 58.91 units on a scale | Standard Deviation 20.622 |
Secondary
Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core)
The EQ-5D is divided into two distinct sections. The first section includes one item addressing each of five dimensions (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression). Patients rate each of these items from no problem, some problem, or extreme problem. A composite health index is then defined by combining the levels for each dimension. The second section of the questionnaire measures self-rated (global) health status utilizing a vertically oriented visual analogue scale where 100 represents the best possible health state and 0 represents the worst possible health state. Respondents are asked to rate their current health by placing a mark along this continuum. The scores from each section are then transformed into a single health utility score. Overall scores range from 0 to 1 with lower scores representing a higher level of dysfunction.
Time frame: Baseline, weeks 4, 8, 20, 32, 44, and end of treatment (EOT) up to week 82
Population: The full analysis set, which consisted of all participants who received at least one dose of everolimus, was analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 20, Self-care, Some problem | 4 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Baseline, Mobility, No problem | 84 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Baseline, Mobility, Some problem | 31 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Baseline, Mobility, Extreme problem | 2 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Baseline, Self-care, No problem | 100 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Baseline, Self-care, Some problem | 15 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Baseline, Self-care, Extreme problem | 2 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Baseline, Usual activities, No problem | 71 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Baseline, Usual activities, Some problem | 43 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Baseline, Usual actvities, Extreme problem | 4 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Baseline, Pain/Discomfort, No problem | 59 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Baseline, Pain/discomfort, Some problem | 52 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Baseline, Pain/discomfort, Extreme problem | 6 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Baseline, Anxiety/depression, No problem | 65 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Baseline, Anxiety/depression, Some problem | 47 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Baseline, Anxiety/depression, Extreme problem | 5 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 4, Mobility, No problem | 72 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 4, Mobility, Some problem | 27 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 4, Mobility, Extreme problem | 2 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 4, Self-care, No problem | 89 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 4, Self-care, Some problem | 10 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 4, Self-care, Extreme problem | 3 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 4, Usual activities, No problem | 66 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 4, Usual activities, Some problem | 31 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 4, Usual activities, Extreme problem | 4 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 4, Pain/discomfort, No problem | 39 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 4, Pain/discomfort, Some problem | 58 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 4, Pain/discomfort, Extreme problem | 3 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 4, Anxiety/depression, No problem | 54 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 4, Anxiety depression, Some problem | 46 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 4, Anxiety/depression, Extreme problem | 1 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 8, Mobility, No problem | 48 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 8, Mobility, Some problem | 24 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 8, Mobility, Extreme problem | 2 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 8, Self-care, No problem | 61 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 8, Self-care, Some problem | 7 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 8, Self-care, Extreme problem | 6 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 8, Usual activities, No problem | 46 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 8, Usual activities, Some problem | 23 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 8, Usual activties, Extreme problem | 4 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 8, Pain/discomfort, No problem | 34 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 8, Pain/discomfort, Some problem | 32 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 8, Pain/discomfort, Extreme problem | 7 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 8, Anxiety/depression, No problem | 43 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 8, Anxiety/depression, Some problem | 30 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 8, Anxiety/depression, Extreme problem | 1 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 20, Mobility, No problem | 26 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 20, Mobility, Some problem | 3 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 20, Self-care, No problem | 25 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 20, Usual activities, No problem | 18 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 20 Usual activities, Some problem | 10 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 20, Usual activities, Extreme problem | 1 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 20, Pain/discomfort, No problem | 12 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 20, Pain/discomfort, Some problem | 16 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 20, Pain/discomfort, Extreme problem | 1 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 20, Anxiety/depression, No problem | 16 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 20, Anxiety/depression, Some problem | 12 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 20, Anxiety/depression, Extreme problem | 1 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 32, Mobility, No problem | 3 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 32, Mobility, Some problem | 2 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 32, Self-care, No problem | 5 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 32, Usual activities, No problem | 4 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 32, Usual activities, Some problem | 1 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 32, Pain/discomfort, No problem | 1 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 32, Pain/discomfort, Some problem | 4 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 32, Anxiety/depression, No problem | 4 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 32, Anxiety/depression, Some problem | 1 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 44, Mobility, No problem | 2 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 44, Mobility, Some problem | 1 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 44, Self-care, No problem | 3 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 44, usual activities, Some problem | 3 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 44, Pain/discomfort, Some problem | 3 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 44, Anxiry/depression, No problem | 1 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 44, Anxiety/depression, Some problem | 2 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | EOT up to Week 82, Mobility, No problem | 59 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | EOT up to Week 82, Mobility, Some problem | 23 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | EOT up to Week 82, Mobility, Extreme problem | 4 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | EOT up to Week 82, Self-care, No problem | 69 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | EOT up to Week 82, Self-care, Some problem | 12 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | EOT up to Week 82, Self-care, Extreme problem | 2 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | EOT up toWeek 82, Usual activities, No problem | 54 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | EOT up to Week 82, Usual activities, Some problem | 24 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | EOT up to Week 82, Usual activities, Extreme prob. | 5 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | EOT up to Week 82, Pain/discomfort, No problem | 43 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | EOT up to Week 82, Pain/discomfort, Some problem | 36 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | EOT up to Week 82, Pain/discomfort, Extreme prob. | 5 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | EOT up to Week 82, Anxiety/depression, No problem | 48 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | EOT up to Week 82, Anxiety/depression, Some prob. | 33 Participants |
| pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | EOT up toWeek 82, Anxiety/depression, Extreme prob | 3 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 8, Anxiety/depression, Extreme problem | 8 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 44, Self-care, No problem | 12 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 20, Mobility, No problem | 37 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 44, Self-care, Some problem | 2 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 20, Mobility, Some problem | 17 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 20, Mobility, Extreme problem | 1 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 44, Usual activities, No problem | 6 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 20, Self-care, No problem | 49 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 20, Self-care, Some problem | 6 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | EOT up to Week 82, Self-care, Extreme problem | 1 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 20, Usual activities, No problem | 30 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 44, usual activities, Some problem | 7 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 20 Usual activities, Some problem | 22 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Baseline, Mobility, No problem | 76 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 44, Pain/discomfort, No problem | 6 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Baseline, Mobility, Some problem | 35 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 20, Usual activities, Extreme problem | 2 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Baseline, Mobility, Extreme problem | 1 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | EOT up to Week 82, Pain/discomfort, Some problem | 48 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Baseline, Self-care, No problem | 102 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 20, Pain/discomfort, No problem | 19 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Baseline, Self-care, Some problem | 10 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 44, Pain/discomfort, Some problem | 8 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 20, Pain/discomfort, Some problem | 34 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Baseline, Usual activities, No problem | 60 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | EOT up toWeek 82, Usual activities, No problem | 29 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Baseline, Usual activities, Some problem | 46 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 20, Pain/discomfort, Extreme problem | 2 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Baseline, Usual actvities, Extreme problem | 6 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 44, Anxiry/depression, No problem | 7 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Baseline, Pain/Discomfort, No problem | 40 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 20, Anxiety/depression, No problem | 27 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Baseline, Pain/discomfort, Some problem | 66 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | EOT up toWeek 82, Anxiety/depression, Extreme prob | 6 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Baseline, Pain/discomfort, Extreme problem | 7 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 20, Anxiety/depression, Some problem | 23 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Baseline, Anxiety/depression, No problem | 53 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 44, Anxiety/depression, Some problem | 6 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Baseline, Anxiety/depression, Some problem | 54 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 20, Anxiety/depression, Extreme problem | 5 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Baseline, Anxiety/depression, Extreme problem | 6 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 44, Anxiety/depression, Extreme problem | 1 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 4, Mobility, No problem | 66 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 32, Mobility, No problem | 25 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 4, Mobility, Some problem | 37 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | EOT up to Week 82, Usual activities, Some problem | 36 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 4, Mobility, Extreme problem | 1 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 32, Mobility, Some problem | 12 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 4, Self-care, No problem | 86 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 32, Mobility, Extreme problem | 2 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 4, Self-care, Some problem | 16 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | EOT up to Week 82, Mobility, No problem | 42 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 4, Self-care, Extreme problem | 2 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 32, Self-care, No problem | 32 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 4, Usual activities, No problem | 55 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 32, Self-care, Some problem | 3 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 4, Usual activities, Some problem | 42 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 32, Self-care, Extreme problem | 2 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 4, Usual activities, Extreme problem | 7 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | EOT up to Week 82, Pain/discomfort, Extreme prob. | 11 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 4, Pain/discomfort, No problem | 30 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 32, Usual activities, No problem | 22 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 4, Pain/discomfort, Some problem | 64 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | EOT up to Week 82, Mobility, Some problem | 31 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 4, Pain/discomfort, Extreme problem | 8 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 32, Usual activities, Some problem | 14 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 4, Anxiety/depression, No problem | 57 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 32, Usual activities, Extreme problem | 3 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 4, Anxiety depression, Some problem | 43 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | EOT up to Week 82, Usual activities, Extreme prob. | 11 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 4, Anxiety/depression, Extreme problem | 3 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 32, Pain/discomfort, No problem | 10 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 8, Mobility, No problem | 45 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | EOT up to Week 82, Mobility, Extreme problem | 4 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 8, Mobility, Some problem | 37 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 32, Pain/discomfort, Some problem | 27 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 8, Mobility, Extreme problem | 3 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 32, Pain/discomfort, Extreme problem | 2 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 8, Self-care, No problem | 70 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | EOT up to Week 82, Anxiety/depression, Some prob. | 40 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 8, Self-care, Some problem | 15 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 32, Anxiety/depression, No problem | 20 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 8, Self-care, Extreme problem | 1 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | EOT up to Week 82, Self-care, No problem | 56 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 8, Usual activities, No problem | 40 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 32, Anxiety/depression, Some problem | 14 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 8, Usual activities, Some problem | 41 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 32, Anxiety/depression, Extreme problem | 5 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 8, Usual activties, Extreme problem | 5 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | EOT up to Week 82, Pain/discomfort, No problem | 18 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 8, Pain/discomfort, No problem | 25 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 44, Mobility, No problem | 9 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 8, Pain/discomfort, Some problem | 52 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | EOT up to Week 82, Self-care, Some problem | 19 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 8, Pain/discomfort, Extreme problem | 10 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 44, Mobility, Some problem | 4 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 8, Anxiety/depression, No problem | 38 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 44, Mobility, Extreme problem | 1 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | Week 8, Anxiety/depression, Some problem | 41 Participants |
| Non-pNET (Core) | Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core) | EOT up to Week 82, Anxiety/depression, No problem | 31 Participants |