Trial Outcomes & Findings for An Open-label, Multi-center, Expanded Access Study of Everolimus in Participants With Advanced Neuroendocrine Tumors (NETs) (Core Study) and an Extension Study to the Open-label, Multi-center, Expanded Access Study of Everolimus in Patients With Advanced NETs (E1) (NCT NCT01595009)
NCT ID: NCT01595009
Last Updated: 2018-11-29
Results Overview
The number of participants with AEs, SAEs and deaths were assessed.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
246 participants
Primary outcome timeframe
from the day of first treatment up to 19 months
Results posted on
2018-11-29
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
Lung NET (E1)
Participants with NETs of a lung origin received Everolimus 10 mg orally once daily until documented tumor progression, unacceptable toxicity or any other reason.
|
GI NET (E1)
Participants with NETs of a GI origin received Everolimus 10 mg orally once daily until documented tumor progression, unacceptable toxicity or any other reason.
|
|---|---|---|---|---|
|
Core
STARTED
|
126
|
120
|
0
|
0
|
|
Core
COMPLETED
|
0
|
0
|
0
|
0
|
|
Core
NOT COMPLETED
|
126
|
120
|
0
|
0
|
|
Extension
STARTED
|
0
|
0
|
4
|
11
|
|
Extension
COMPLETED
|
0
|
0
|
0
|
0
|
|
Extension
NOT COMPLETED
|
0
|
0
|
4
|
11
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
Lung NET (E1)
Participants with NETs of a lung origin received Everolimus 10 mg orally once daily until documented tumor progression, unacceptable toxicity or any other reason.
|
GI NET (E1)
Participants with NETs of a GI origin received Everolimus 10 mg orally once daily until documented tumor progression, unacceptable toxicity or any other reason.
|
|---|---|---|---|---|
|
Core
Patients completed per protocol
|
85
|
44
|
0
|
0
|
|
Core
Adverse Event
|
19
|
23
|
0
|
0
|
|
Core
Disease progression
|
14
|
26
|
0
|
0
|
|
Core
Withdrawal by Subject
|
4
|
17
|
0
|
0
|
|
Core
Death
|
3
|
6
|
0
|
0
|
|
Core
Lost to Follow-up
|
1
|
2
|
0
|
0
|
|
Core
Protocol deviation
|
0
|
1
|
0
|
0
|
|
Core
Administrative problems
|
0
|
1
|
0
|
0
|
|
Extension
Administrative problems
|
0
|
0
|
0
|
1
|
|
Extension
Patients completed per protocol
|
0
|
0
|
0
|
2
|
|
Extension
Disease progression
|
0
|
0
|
4
|
7
|
|
Extension
Adverse Event
|
0
|
0
|
0
|
1
|
Baseline Characteristics
An Open-label, Multi-center, Expanded Access Study of Everolimus in Participants With Advanced Neuroendocrine Tumors (NETs) (Core Study) and an Extension Study to the Open-label, Multi-center, Expanded Access Study of Everolimus in Patients With Advanced NETs (E1)
Baseline characteristics by cohort
| Measure |
pNET (Core)
n=126 Participants
Participants with NETs of a pancreatic origin received Everolimus 10 mg orally once daily until documented tumor progression, unacceptable toxicity or any other reason.
|
Non-pNET (Core)
n=120 Participants
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.
|
Total
n=246 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.3 years
STANDARD_DEVIATION 13.04 • n=5 Participants
|
64.4 years
STANDARD_DEVIATION 9.28 • n=7 Participants
|
61.8 years
STANDARD_DEVIATION 11.62 • n=5 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: from the day of first treatment up to 19 monthsPopulation: 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.
The number of participants with AEs, SAEs and deaths were assessed.
Outcome measures
| Measure |
pNET (Core)
n=123 Participants
Participants with NETs of a pancreatic origin received Everolimus 10 mg orally once daily until documented tumor progression, unacceptable toxicity or any other reason.
|
Non-pNET (Core)
n=117 Participants
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.
|
|---|---|---|
|
Number and Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths (Core)
Adverse events
|
90 Participants
|
109 Participants
|
|
Number and Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths (Core)
Serious adverse events
|
25 Participants
|
59 Participants
|
|
Number and Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths (Core)
Deaths
|
5 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: from the first day of treatment in the extension up to 4 yearsPopulation: 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.
The number of participants with AEs, SAEs and deaths were assessed.
Outcome measures
| Measure |
pNET (Core)
n=4 Participants
Participants with NETs of a pancreatic origin received Everolimus 10 mg orally once daily until documented tumor progression, unacceptable toxicity or any other reason.
|
Non-pNET (Core)
n=11 Participants
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.
|
|---|---|---|
|
Number and Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths During the Extension Phase (E1)
AEs
|
4 Participants
|
11 Participants
|
|
Number and Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths During the Extension Phase (E1)
SAEs
|
1 Participants
|
4 Participants
|
|
Number and Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths During the Extension Phase (E1)
Deaths
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: from the day of first treatment up to 19 monthsPopulation: The full analysis set, which consisted of all participants who received at least one dose, was analyzed.
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.
Outcome measures
| Measure |
pNET (Core)
n=126 Participants
Participants with NETs of a pancreatic origin received Everolimus 10 mg orally once daily until documented tumor progression, unacceptable toxicity or any other reason.
|
Non-pNET (Core)
n=120 Participants
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.
|
|---|---|---|
|
Investigator-assessed Progression Free Survival (PFS) (Core)
|
7.62 Months
Interval 5.52 to 7.62
|
10.78 Months
Interval 8.77 to
Upper limit of the 95% confidence interval was not estimable because there were too few participants at this time point.
|
SECONDARY outcome
Timeframe: Baseline, weeks 4, 8, 20, 32, 44, and end of treatment (EOT) up to week 82Population: 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.
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.
Outcome measures
| Measure |
pNET (Core)
n=126 Participants
Participants with NETs of a pancreatic origin received Everolimus 10 mg orally once daily until documented tumor progression, unacceptable toxicity or any other reason.
|
Non-pNET (Core)
n=120 Participants
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.
|
|---|---|---|
|
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
|
21.37 units on a scale
Standard Deviation 28.084
|
|
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
|
60.53 units on a scale
Standard Deviation 21.497
|
|
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
|
58.91 units on a scale
Standard Deviation 20.622
|
|
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
|
56.59 units on a scale
Standard Deviation 20.417
|
|
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
|
59.65 units on a scale
Standard Deviation 17.663
|
|
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
|
56.20 units on a scale
Standard Deviation 20.297
|
|
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
|
57.74 units on a scale
Standard Deviation 25.205
|
|
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
|
48.86 units on a scale
Standard Deviation 27.823
|
|
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 20.850
|
72.97 units on a scale
Standard Deviation 22.938
|
|
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 22.380
|
68.62 units on a scale
Standard Deviation 23.648
|
|
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 25.810
|
67.48 units on a scale
Standard Deviation 24.973
|
|
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
|
73.71 units on a scale
Standard Deviation 21.351
|
|
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
|
71.62 units on a scale
Standard Deviation 23.729
|
|
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
|
76.19 units on a scale
Standard Deviation 22.602
|
|
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
|
60.94 units on a scale
Standard Deviation 28.037
|
|
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
|
67.27 units on a scale
Standard Deviation 32.397
|
|
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
|
62.25 units on a scale
Standard Deviation 30.483
|
|
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
|
58.14 units on a scale
Standard Deviation 31.460
|
|
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
|
58.33 units on a scale
Standard Deviation 29.129
|
|
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
|
55.26 units on a scale
Standard Deviation 35.325
|
|
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
|
66.67 units on a scale
Standard Deviation 26.954
|
|
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
|
49.13 units on a scale
Standard Deviation 33.212
|
|
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 22.650
|
67.20 units on a scale
Standard Deviation 22.988
|
|
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
|
66.69 units on a scale
Standard Deviation 25.380
|
|
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 24.730
|
64.02 units on a scale
Standard Deviation 26.640
|
|
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
|
63.16 units on a scale
Standard Deviation 27.456
|
|
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
|
61.11 units on a scale
Standard Deviation 28.184
|
|
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
|
65.67 units on a scale
Standard Deviation 31.059
|
|
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
|
57.63 units on a scale
Standard Deviation 25.841
|
|
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 19.630
|
80.61 units on a scale
Standard Deviation 23.842
|
|
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 20.050
|
78.80 units on a scale
Standard Deviation 23.708
|
|
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
|
76.33 units on a scale
Standard Deviation 27.418
|
|
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
|
78.65 units on a scale
Standard Deviation 23.307
|
|
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
|
75.21 units on a scale
Standard Deviation 24.445
|
|
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
|
84.52 units on a scale
Standard Deviation 20.111
|
|
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
|
73.46 units on a scale
Standard Deviation 24.522
|
|
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
|
67.42 units on a scale
Standard Deviation 28.989
|
|
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
|
67.80 units on a scale
Standard Deviation 30.093
|
|
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
|
65.31 units on a scale
Standard Deviation 29.396
|
|
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
|
66.07 units on a scale
Standard Deviation 29.977
|
|
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
|
66.24 units on a scale
Standard Deviation 32.329
|
|
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 0.000
|
72.62 units on a scale
Standard Deviation 31.082
|
|
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
|
52.89 units on a scale
Standard Deviation 33.933
|
|
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
|
42.39 units on a scale
Standard Deviation 28.534
|
|
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
|
43.58 units on a scale
Standard Deviation 28.035
|
|
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
|
48.86 units on a scale
Standard Deviation 29.878
|
|
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 18.430
|
44.44 units on a scale
Standard Deviation 27.698
|
|
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
|
48.72 units on a scale
Standard Deviation 29.575
|
|
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
|
38.89 units on a scale
Standard Deviation 26.777
|
|
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
|
56.49 units on a scale
Standard Deviation 30.474
|
|
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
|
9.46 units on a scale
Standard Deviation 17.353
|
|
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
|
7.43 units on a scale
Standard Deviation 14.995
|
|
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
|
10.34 units on a scale
Standard Deviation 18.015
|
|
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
|
6.14 units on a scale
Standard Deviation 12.048
|
|
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
|
5.98 units on a scale
Standard Deviation 11.139
|
|
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
|
4.76 units on a scale
Standard Deviation 10.187
|
|
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
|
15.80 units on a scale
Standard Deviation 27.023
|
|
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
|
31.21 units on a scale
Standard Deviation 31.535
|
|
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
|
30.88 units on a scale
Standard Deviation 29.796
|
|
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
|
37.55 units on a scale
Standard Deviation 32.372
|
|
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
|
33.33 units on a scale
Standard Deviation 32.581
|
|
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
|
34.62 units on a scale
Standard Deviation 32.977
|
|
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
|
26.19 units on a scale
Standard Deviation 30.462
|
|
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
|
43.90 units on a scale
Standard Deviation 33.362
|
|
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
|
24.32 units on a scale
Standard Deviation 29.110
|
|
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
|
26.14 units on a scale
Standard Deviation 28.388
|
|
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
|
29.12 units on a scale
Standard Deviation 31.665
|
|
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
|
28.07 units on a scale
Standard Deviation 30.072
|
|
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
|
35.90 units on a scale
Standard Deviation 31.885
|
|
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
|
21.43 units on a scale
Standard Deviation 28.063
|
|
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
|
33.77 units on a scale
Standard Deviation 30.824
|
|
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
|
28.18 units on a scale
Standard Deviation 32.929
|
|
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
|
32.36 units on a scale
Standard Deviation 30.769
|
|
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
|
29.02 units on a scale
Standard Deviation 28.540
|
|
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
|
35.09 units on a scale
Standard Deviation 32.380
|
|
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
|
33.33 units on a scale
Standard Deviation 32.880
|
|
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
|
28.57 units on a scale
Standard Deviation 36.648
|
|
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
|
34.63 units on a scale
Standard Deviation 32.643
|
|
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
|
18.62 units on a scale
Standard Deviation 29.365
|
|
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
|
21.90 units on a scale
Standard Deviation 29.849
|
|
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
|
25.67 units on a scale
Standard Deviation 31.623
|
|
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
|
20.47 units on a scale
Standard Deviation 27.998
|
|
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
|
23.93 units on a scale
Standard Deviation 30.540
|
|
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
|
26.19 units on a scale
Standard Deviation 29.753
|
|
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
|
33.77 units on a scale
Standard Deviation 37.906
|
|
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
|
13.21 units on a scale
Standard Deviation 27.072
|
|
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
|
11.33 units on a scale
Standard Deviation 24.501
|
|
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
|
7.58 units on a scale
Standard Deviation 22.447
|
|
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
|
8.77 units on a scale
Standard Deviation 21.387
|
|
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 0.000
|
4.27 units on a scale
Standard Deviation 13.636
|
|
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 0.000
|
2.38 units on a scale
Standard Deviation 8.909
|
|
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
|
10.39 units on a scale
Standard Deviation 23.107
|
|
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
|
36.67 units on a scale
Standard Deviation 38.828
|
|
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
|
38.19 units on a scale
Standard Deviation 36.577
|
|
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
|
42.42 units on a scale
Standard Deviation 39.708
|
|
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
|
31.58 units on a scale
Standard Deviation 29.828
|
|
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
|
40.17 units on a scale
Standard Deviation 36.015
|
|
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
|
40.48 units on a scale
Standard Deviation 37.390
|
|
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
|
39.04 units on a scale
Standard Deviation 38.639
|
|
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
|
16.52 units on a scale
Standard Deviation 25.770
|
|
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
|
16.67 units on a scale
Standard Deviation 27.010
|
|
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
|
16.86 units on a scale
Standard Deviation 24.837
|
|
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
|
19.88 units on a scale
Standard Deviation 27.357
|
|
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
|
19.05 units on a scale
Standard Deviation 25.198
|
|
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
|
27.63 units on a scale
Standard Deviation 30.496
|
SECONDARY outcome
Timeframe: Baseline, weeks 4, 8, 20, 32, 44, and end of treatment (EOT) up to week 82Population: 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.
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.
Outcome measures
| Measure |
pNET (Core)
n=126 Participants
Participants with NETs of a pancreatic origin received Everolimus 10 mg orally once daily until documented tumor progression, unacceptable toxicity or any other reason.
|
Non-pNET (Core)
n=120 Participants
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.
|
|---|---|---|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Endocrine, Baseline
|
12.99 units on a scale
Standard Deviation 20.372
|
23.52 units on a scale
Standard Deviation 23.771
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Endocrine, week 4
|
13.21 units on a scale
Standard Deviation 17.440
|
17.85 units on a scale
Standard Deviation 21.403
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Endocrine, week 8
|
13.47 units on a scale
Standard Deviation 17.293
|
16.79 units on a scale
Standard Deviation 20.216
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Endocrine, week 20
|
12.50 units on a scale
Standard Deviation 12.511
|
15.87 units on a scale
Standard Deviation 21.067
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Endocrine, week 32
|
16.67 units on a scale
Standard Deviation 14.344
|
13.74 units on a scale
Standard Deviation 17.978
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Endocrine, week 44
|
0.00 units on a scale
Standard Deviation NA
Standard deviation does not apply when n = 1.
|
7.14 units on a scale
Standard Deviation 11.202
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Endocrine, EOT up to week 82
|
9.49 units on a scale
Standard Deviation 15.627
|
15.20 units on a scale
Standard Deviation 18.755
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
G.I., Baseline
|
23.69 units on a scale
Standard Deviation 20.183
|
26.19 units on a scale
Standard Deviation 21.328
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
G.I., week 4
|
23.02 units on a scale
Standard Deviation 20.488
|
23.39 units on a scale
Standard Deviation 18.958
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
G.I., week 8
|
22.34 units on a scale
Standard Deviation 18.398
|
27.53 units on a scale
Standard Deviation 21.341
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
G.I., week 20
|
25.63 units on a scale
Standard Deviation 14.056
|
22.31 units on a scale
Standard Deviation 18.837
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
G.I., week 32
|
25.00 units on a scale
Standard Deviation 11.386
|
26.84 units on a scale
Standard Deviation 19.879
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
G.I., week 44
|
0.00 units on a scale
Standard Deviation NA
Standard deviation does not apply when n = 1.
|
20.95 units on a scale
Standard Deviation 16.714
|
|
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
|
30.48 units on a scale
Standard Deviation 24.484
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Treatment, baseline
|
9.26 units on a scale
Standard Deviation 11.675
|
18.44 units on a scale
Standard Deviation 19.374
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Treatment, week 4
|
17.72 units on a scale
Standard Deviation 15.337
|
22.22 units on a scale
Standard Deviation 20.077
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Treatment, week 8
|
16.18 units on a scale
Standard Deviation 19.528
|
20.27 units on a scale
Standard Deviation 17.283
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Treatment, week 20
|
28.70 units on a scale
Standard Deviation 21.493
|
19.74 units on a scale
Standard Deviation 19.755
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Treatment, week 32
|
27.78 units on a scale
Standard Deviation 7.857
|
24.49 units on a scale
Standard Deviation 23.684
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Treatment, week 44
|
16.67 units on a scale
Standard Deviation NA
Standard deviation does not apply when n = 1.
|
18.18 units on a scale
Standard Deviation 18.936
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Treatment, EOT up to week 82
|
22.06 units on a scale
Standard Deviation 21.705
|
24.81 units on a scale
Standard Deviation 21.735
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Social function, Baseline
|
39.56 units on a scale
Standard Deviation 23.721
|
47.42 units on a scale
Standard Deviation 25.726
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Social function, week 4
|
36.52 units on a scale
Standard Deviation 26.294
|
45.28 units on a scale
Standard Deviation 27.483
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Social function, week 8
|
38.35 units on a scale
Standard Deviation 23.629
|
46.49 units on a scale
Standard Deviation 26.265
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Social function, week 20
|
40.28 units on a scale
Standard Deviation 14.472
|
42.66 units on a scale
Standard Deviation 25.648
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Social function, week 32
|
38.89 units on a scale
Standard Deviation 14.344
|
48.54 units on a scale
Standard Deviation 23.735
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Social function, week 44
|
33.33 units on a scale
Standard Deviation NA
Standard deviation does not apply when n = 1.
|
40.08 units on a scale
Standard Deviation 26.165
|
|
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
|
54.22 units on a scale
Standard Deviation 28.428
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Disease-related worries, Baseline
|
43.10 units on a scale
Standard Deviation 25.599
|
53.94 units on a scale
Standard Deviation 27.664
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Disease-related worries, week 4
|
39.20 units on a scale
Standard Deviation 28.562
|
46.33 units on a scale
Standard Deviation 28.165
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Disease-related worries, week 8
|
40.56 units on a scale
Standard Deviation 28.183
|
47.32 units on a scale
Standard Deviation 28.541
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Disease-related worries, week 20
|
37.50 units on a scale
Standard Deviation 8.267
|
46.83 units on a scale
Standard Deviation 32.096
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Disease-related worries, week 32
|
38.89 units on a scale
Standard Deviation 11.111
|
53.51 units on a scale
Standard Deviation 27.137
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Disease-related worries, week 44
|
33.33 units on a scale
Standard Deviation NA
Standard deviation does not apply when n=1.
|
44.05 units on a scale
Standard Deviation 32.647
|
|
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
|
55.04 units on a scale
Standard Deviation 31.667
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Muscle/bone pain, Baseline
|
26.67 units on a scale
Standard Deviation 33.347
|
29.66 units on a scale
Standard Deviation 31.210
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Muscle/bone pain, week 4
|
24.07 units on a scale
Standard Deviation 29.966
|
33.00 units on a scale
Standard Deviation 31.956
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Muscle/bone pain, week 8
|
31.18 units on a scale
Standard Deviation 34.357
|
33.33 units on a scale
Standard Deviation 33.524
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Muscle/bone pain, week 20
|
41.67 units on a scale
Standard Deviation 15.430
|
34.52 units on a scale
Standard Deviation 33.614
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Muscle/bone pain, week 32
|
50.00 units on a scale
Standard Deviation 19.245
|
40.35 units on a scale
Standard Deviation 34.795
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Muscle/bone pain, week 44
|
33.33 units on a scale
Standard Deviation NA
Standard deviation does not apply when n=1.
|
26.19 units on a scale
Standard Deviation 26.726
|
|
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
|
40.89 units on a scale
Standard Deviation 33.141
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Sexual function, Baseline
|
35.46 units on a scale
Standard Deviation 32.899
|
39.32 units on a scale
Standard Deviation 40.468
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Sexual function, week 4
|
21.05 units on a scale
Standard Deviation 26.191
|
40.89 units on a scale
Standard Deviation 40.483
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Sexual function, week 8
|
28.79 units on a scale
Standard Deviation 33.007
|
43.92 units on a scale
Standard Deviation 40.083
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Sexual function, week 20
|
33.33 units on a scale
Standard Deviation 33.333
|
38.10 units on a scale
Standard Deviation 39.724
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Sexual function, week 32
|
11.11 units on a scale
Standard Deviation 19.245
|
29.17 units on a scale
Standard Deviation 35.864
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Sexual function, week 44
|
—
|
47.62 units on a scale
Standard Deviation 46.576
|
|
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
|
48.94 units on a scale
Standard Deviation 43.323
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Communication function, Baseline
|
7.58 units on a scale
Standard Deviation 16.325
|
9.88 units on a scale
Standard Deviation 22.904
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Communication function, week 4
|
8.18 units on a scale
Standard Deviation 17.179
|
6.46 units on a scale
Standard Deviation 15.626
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Communication function, week 8
|
12.22 units on a scale
Standard Deviation 18.535
|
9.69 units on a scale
Standard Deviation 19.714
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Communication function, week 20
|
14.29 units on a scale
Standard Deviation 17.817
|
10.30 units on a scale
Standard Deviation 19.108
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Communication function, week 32
|
8.33 units on a scale
Standard Deviation 16.667
|
7.89 units on a scale
Standard Deviation 19.658
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Communication function, week 44
|
0.00 units on a scale
Standard Deviation NA
Standard deviation does not apply when n=1.
|
4.76 units on a scale
Standard Deviation 12.105
|
|
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
|
12.61 units on a scale
Standard Deviation 23.214
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Body image, Baseline
|
15.90 units on a scale
Standard Deviation 28.932
|
22.43 units on a scale
Standard Deviation 34.195
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Body image, week 4
|
15.09 units on a scale
Standard Deviation 27.399
|
22.79 units on a scale
Standard Deviation 31.239
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Body image, week 8
|
21.51 units on a scale
Standard Deviation 27.953
|
26.10 units on a scale
Standard Deviation 31.256
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Body image, week 20
|
16.67 units on a scale
Standard Deviation 17.817
|
30.30 units on a scale
Standard Deviation 34.708
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Body image, week 32
|
0.00 units on a scale
Standard Deviation 0.000
|
28.83 units on a scale
Standard Deviation 33.483
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Body image, week 44
|
0.00 units on a scale
Standard Deviation NA
Standard deviation does not apply when n=1.
|
30.95 units on a scale
Standard Deviation 27.625
|
|
Mean EORTC QLQ-G.I. NET21 Score (Core)
Body image, EOT up to week 82
|
23.02 units on a scale
Standard Deviation 32.500
|
34.70 units on a scale
Standard Deviation 37.449
|
SECONDARY outcome
Timeframe: Baseline, weeks 4, 8, 20, 32, 44, and end of treatment (EOT) up to week 82Population: The full analysis set, which consisted of all participants who received at least one dose of everolimus, was analyzed.
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.
Outcome measures
| Measure |
pNET (Core)
n=126 Participants
Participants with NETs of a pancreatic origin received Everolimus 10 mg orally once daily until documented tumor progression, unacceptable toxicity or any other reason.
|
Non-pNET (Core)
n=120 Participants
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.
|
|---|---|---|
|
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
|
76 Participants
|
|
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
|
35 Participants
|
|
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
|
1 Participants
|
|
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
|
102 Participants
|
|
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
|
10 Participants
|
|
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
|
—
|
|
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
|
60 Participants
|
|
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
|
46 Participants
|
|
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
|
6 Participants
|
|
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
|
40 Participants
|
|
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
|
66 Participants
|
|
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
|
7 Participants
|
|
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
|
53 Participants
|
|
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
|
54 Participants
|
|
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
|
6 Participants
|
|
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
|
66 Participants
|
|
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
|
37 Participants
|
|
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
|
1 Participants
|
|
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
|
86 Participants
|
|
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
|
16 Participants
|
|
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
|
2 Participants
|
|
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
|
55 Participants
|
|
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
|
42 Participants
|
|
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
|
7 Participants
|
|
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
|
30 Participants
|
|
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
|
64 Participants
|
|
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
|
8 Participants
|
|
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
|
57 Participants
|
|
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
|
43 Participants
|
|
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
|
3 Participants
|
|
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
|
45 Participants
|
|
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
|
37 Participants
|
|
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
|
3 Participants
|
|
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
|
70 Participants
|
|
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
|
15 Participants
|
|
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
|
1 Participants
|
|
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
|
40 Participants
|
|
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
|
41 Participants
|
|
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
|
5 Participants
|
|
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
|
25 Participants
|
|
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
|
52 Participants
|
|
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
|
10 Participants
|
|
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
|
38 Participants
|
|
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
|
41 Participants
|
|
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
|
8 Participants
|
|
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
|
37 Participants
|
|
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
|
17 Participants
|
|
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
|
|
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
|
49 Participants
|
|
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
|
6 Participants
|
|
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
|
30 Participants
|
|
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
|
22 Participants
|
|
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
|
2 Participants
|
|
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
|
19 Participants
|
|
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
|
34 Participants
|
|
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
|
2 Participants
|
|
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
|
27 Participants
|
|
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
|
23 Participants
|
|
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
|
5 Participants
|
|
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
|
25 Participants
|
|
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
|
12 Participants
|
|
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
|
|
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
|
32 Participants
|
|
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
|
|
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
|
|
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
|
22 Participants
|
|
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
|
14 Participants
|
|
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
|
|
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
|
10 Participants
|
|
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
|
27 Participants
|
|
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
|
|
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
|
20 Participants
|
|
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
|
14 Participants
|
|
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
|
|
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
|
9 Participants
|
|
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
|
4 Participants
|
|
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
|
|
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
|
12 Participants
|
|
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
|
|
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
|
|
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
|
7 Participants
|
|
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
|
|
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
|
8 Participants
|
|
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
|
7 Participants
|
|
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
|
6 Participants
|
|
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
|
|
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
|
42 Participants
|
|
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
|
31 Participants
|
|
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
|
4 Participants
|
|
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
|
56 Participants
|
|
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
|
19 Participants
|
|
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
|
1 Participants
|
|
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
|
29 Participants
|
|
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
|
36 Participants
|
|
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
|
11 Participants
|
|
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
|
18 Participants
|
|
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
|
48 Participants
|
|
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
|
11 Participants
|
|
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
|
31 Participants
|
|
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
|
40 Participants
|
|
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
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline, weeks 4, 8, 20, 32, 44, and end of treatment (EOT) up to week 82Population: 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.
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.
Outcome measures
| Measure |
pNET (Core)
n=126 Participants
Participants with NETs of a pancreatic origin received Everolimus 10 mg orally once daily until documented tumor progression, unacceptable toxicity or any other reason.
|
Non-pNET (Core)
n=120 Participants
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.
|
|---|---|---|
|
Mean EQ-5D Visual Analogue Scale (VAS) Score (Core)
Baseline
|
68.8 units on a scale
Standard Deviation 19.90
|
63.9 units on a scale
Standard Deviation 19.09
|
|
Mean EQ-5D Visual Analogue Scale (VAS) Score (Core)
Week 4
|
69.3 units on a scale
Standard Deviation 18.06
|
63.8 units on a scale
Standard Deviation 18.78
|
|
Mean EQ-5D Visual Analogue Scale (VAS) Score (Core)
Week 8
|
64.6 units on a scale
Standard Deviation 21.77
|
61.2 units on a scale
Standard Deviation 18.65
|
|
Mean EQ-5D Visual Analogue Scale (VAS) Score (Core)
Week 20
|
67.4 units on a scale
Standard Deviation 19.58
|
64.6 units on a scale
Standard Deviation 15.51
|
|
Mean EQ-5D Visual Analogue Scale (VAS) Score (Core)
Week 32
|
42.6 units on a scale
Standard Deviation 24.67
|
62.0 units on a scale
Standard Deviation 17.65
|
|
Mean EQ-5D Visual Analogue Scale (VAS) Score (Core)
Week 44
|
66.7 units on a scale
Standard Deviation 15.28
|
68.6 units on a scale
Standard Deviation 18.71
|
|
Mean EQ-5D Visual Analogue Scale (VAS) Score (Core)
EOT up to Week 82
|
66.5 units on a scale
Standard Deviation 20.64
|
55.3 units on a scale
Standard Deviation 23.02
|
SECONDARY outcome
Timeframe: from the start of treatment, every 12 weeks for the first year and then every 6 months up to 19 monthsPopulation: The full analysis set, which consisted of all participants who received at least one dose, was analyzed.
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.
Outcome measures
| Measure |
pNET (Core)
n=126 Participants
Participants with NETs of a pancreatic origin received Everolimus 10 mg orally once daily until documented tumor progression, unacceptable toxicity or any other reason.
|
Non-pNET (Core)
n=120 Participants
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.
|
|---|---|---|
|
Investigator-assessed Best Overall Response (Core)
Progressive disease (PD)
|
9 Participants
|
8 Participants
|
|
Investigator-assessed Best Overall Response (Core)
Unknown
|
41 Participants
|
27 Participants
|
|
Investigator-assessed Best Overall Response (Core)
Partial response (PR)
|
2 Participants
|
1 Participants
|
|
Investigator-assessed Best Overall Response (Core)
Stable disease (SD)
|
74 Participants
|
84 Participants
|
|
Investigator-assessed Best Overall Response (Core)
Objective response rate (complete response or PR)
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: from first date of treatment in the extension up to 4 yearsPopulation: The full analysis set, which consisted of all participants who received at least one dose of everolimus during the extension, was analyzed
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.
Outcome measures
| Measure |
pNET (Core)
n=4 Participants
Participants with NETs of a pancreatic origin received Everolimus 10 mg orally once daily until documented tumor progression, unacceptable toxicity or any other reason.
|
Non-pNET (Core)
n=11 Participants
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.
|
|---|---|---|
|
Investigator-assessed Progression Free Survival (PFS) (E1)
|
159 Days
Interval 10.0 to 1074.0
|
655 Days
Interval 9.0 to
The upper limit of the 95% confidence interval was not estimable since there were too few number of participants at this time point.
|
SECONDARY outcome
Timeframe: baseline, every 12 weeks and up to 4 yearsPopulation: 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.
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.
Outcome measures
| Measure |
pNET (Core)
n=1 Participants
Participants with NETs of a pancreatic origin received Everolimus 10 mg orally once daily until documented tumor progression, unacceptable toxicity or any other reason.
|
Non-pNET (Core)
n=6 Participants
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.
|
|---|---|---|
|
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 NA
Standard deviation does not apply when n=1.
|
-0.00 score on a scale
Standard Deviation 11.785
|
|
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
Standard Deviation NA
Standard deviation does not apply when n=1.
|
0.00 score on a scale
Standard Deviation 7.303
|
|
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
Standard Deviation NA
Standard deviation does not apply when n=1.
|
5.56 score on a scale
Standard Deviation 22.771
|
|
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
Standard Deviation NA
Standard deviation does not apply when n=1.
|
-1.85 score on a scale
Standard Deviation 17.003
|
|
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
Standard Deviation NA
Standard deviation does not apply when n=1.
|
-16.67 score on a scale
Standard Deviation 21.082
|
|
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
Standard Deviation NA
Standard deviation does not apply when n=1.
|
-8.33 score on a scale
Standard Deviation 9.129
|
|
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
Standard Deviation NA
Standard deviation does not apply when n=1.
|
-3.70 score on a scale
Standard Deviation 22.951
|
|
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 NA
Standard deviation does not apply when n=1.
|
0.00 score on a scale
Standard Deviation 18.257
|
|
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
Standard Deviation NA
Standard deviation does not apply when n=1.
|
16.67 score on a scale
Standard Deviation 27.889
|
|
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
Standard Deviation NA
Standard deviation does not apply when n=1.
|
-5.56 score on a scale
Standard Deviation 13.608
|
|
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
Standard Deviation NA
Standard deviation does not apply when n=1.
|
11.11 score on a scale
Standard Deviation 17.213
|
|
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 NA
Standard deviation does not apply when n=1.
|
0.00 score on a scale
Standard Deviation 21.082
|
|
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
Standard Deviation NA
Standard deviation does not apply when n=1.
|
5.56 score on a scale
Standard Deviation 25.092
|
|
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
Standard Deviation NA
Standard deviation does not apply when n=1.
|
-16.67 score on a scale
Standard Deviation 45.947
|
|
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
Standard Deviation NA
Standard deviation does not apply when n=1.
|
16.67 score on a scale
Standard Deviation 18.257
|
SECONDARY outcome
Timeframe: baseline, every 12 weeks and up to 4 yearsPopulation: 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.
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.
Outcome measures
| Measure |
pNET (Core)
n=4 Participants
Participants with NETs of a pancreatic origin received Everolimus 10 mg orally once daily until documented tumor progression, unacceptable toxicity or any other reason.
|
Non-pNET (Core)
n=11 Participants
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.
|
|---|---|---|
|
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
Standard Deviation NA
Standard deviation does not apply when n=1.
|
7.41 units on a scale
Standard Deviation 22.951
|
|
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
Standard Deviation NA
Standard deviation does not apply when n=1.
|
-0.93 units on a scale
Standard Deviation 7.384
|
|
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
|
|
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
Standard Deviation NA
Standard deviation does not apply when n=1.
|
11.11 units on a scale
Standard Deviation 17.213
|
|
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
Standard Deviation NA
Standard deviation does not apply when n=1.
|
5.56 units on a scale
Standard Deviation 18.257
|
|
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
Standard Deviation NA
Standard deviation does not apply when n=1.
|
14.44 units on a scale
Standard Deviation 23.633
|
|
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
Standard Deviation NA
Standard deviation does not apply when n=1.
|
5.56 units on a scale
Standard Deviation 12.423
|
|
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
|
|
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 NA
Standard deviation does not apply when n=1.
|
0.00 units on a scale
Standard Deviation 21.082
|
SECONDARY outcome
Timeframe: baseline, every 12 weeks and up to 4 yearsPopulation: 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.
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.
Outcome measures
| Measure |
pNET (Core)
n=1 Participants
Participants with NETs of a pancreatic origin received Everolimus 10 mg orally once daily until documented tumor progression, unacceptable toxicity or any other reason.
|
Non-pNET (Core)
n=6 Participants
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.
|
|---|---|---|
|
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
Standard Deviation NA
Standard deviation does not apply when n=1.
|
-8.58 units on a scale
Standard Deviation 13.302
|
|
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
Standard Deviation NA
Standard deviation does not apply when n=1.
|
-4.17 units on a scale
Standard Deviation 21.479
|
SECONDARY outcome
Timeframe: from the start of treatment, every 12 weeks for the first year and then every 6 months up to 4 yearsPopulation: The full analysis set, which consisted of all participants who received at least one dose of everolimus during the extension, was analyzed
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.
Outcome measures
| Measure |
pNET (Core)
n=4 Participants
Participants with NETs of a pancreatic origin received Everolimus 10 mg orally once daily until documented tumor progression, unacceptable toxicity or any other reason.
|
Non-pNET (Core)
n=11 Participants
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.
|
|---|---|---|
|
Investigator-assessed Best Overall Response During the Extension Phase (E1)
Complete response
|
0 Participants
|
0 Participants
|
|
Investigator-assessed Best Overall Response During the Extension Phase (E1)
Partial response
|
0 Participants
|
1 Participants
|
|
Investigator-assessed Best Overall Response During the Extension Phase (E1)
Stable disease
|
2 Participants
|
7 Participants
|
|
Investigator-assessed Best Overall Response During the Extension Phase (E1)
Progressive disease
|
2 Participants
|
3 Participants
|
|
Investigator-assessed Best Overall Response During the Extension Phase (E1)
Unknown
|
0 Participants
|
0 Participants
|
Adverse Events
pNET (Core)
Serious events: 25 serious events
Other events: 73 other events
Deaths: 0 deaths
Non-pNET (Core)
Serious events: 59 serious events
Other events: 89 other events
Deaths: 0 deaths
Lung NET (E1)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
GI NET (E1)
Serious events: 4 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
pNET (Core)
n=123 participants at risk
pNET (Core)
|
Non-pNET (Core)
n=117 participants at risk
Non-pNET (Core)
|
Lung NET (E1)
n=4 participants at risk
Lung NET (E1)
|
GI NET (E1)
n=11 participants at risk
GI NET (E1)
|
|---|---|---|---|---|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
1.7%
2/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Infections and infestations
Abscess limb
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Infections and infestations
Cystitis
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
3/123 • up to 19 month for the core and up to 4 years for the extension
|
3.4%
4/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Gastrointestinal disorders
Dysphagia
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Gastrointestinal disorders
Ileitis
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
1.7%
2/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Gastrointestinal disorders
Stomatitis
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
1.7%
2/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Gastrointestinal disorders
Tongue oedema
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
1.7%
2/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Gastrointestinal disorders
Vomiting
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
General disorders
Asthenia
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
General disorders
Chills
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
General disorders
Death
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
General disorders
Device occlusion
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
General disorders
Euthanasia
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
General disorders
Fatigue
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
4.3%
5/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
General disorders
General physical health deterioration
|
1.6%
2/123 • up to 19 month for the core and up to 4 years for the extension
|
6.0%
7/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
General disorders
Impaired healing
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
General disorders
Multi-organ failure
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
General disorders
Oedema
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
General disorders
Oedema peripheral
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
General disorders
Pyrexia
|
1.6%
2/123 • up to 19 month for the core and up to 4 years for the extension
|
2.6%
3/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Hepatobiliary disorders
Cholangitis
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Hepatobiliary disorders
Cholecystocholangitis
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Infections and infestations
Gastrointestinal infection
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Infections and infestations
Infection
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Infections and infestations
Peritonitis
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
1.7%
2/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Infections and infestations
Pneumonia
|
1.6%
2/123 • up to 19 month for the core and up to 4 years for the extension
|
5.1%
6/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Infections and infestations
Pyelonephritis acute
|
1.6%
2/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Infections and infestations
Sepsis
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Infections and infestations
Septic shock
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Infections and infestations
Sinusitis
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Infections and infestations
Upper respiratory tract infection
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Infections and infestations
Urinary tract infection
|
1.6%
2/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Injury, poisoning and procedural complications
Limb traumatic amputation
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Investigations
Antineutrophil cytoplasmic antibody increased
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Investigations
Blood cholesterol increased
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Investigations
Blood uric acid increased
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Investigations
C-reactive protein increased
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Investigations
Weight decreased
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
1.7%
2/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Investigations
White blood cell count increased
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.6%
2/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Musculoskeletal and connective tissue disorders
Hypercreatinaemia
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to pancreas
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
1.7%
2/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vipoma
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Nervous system disorders
Hypoglycaemic seizure
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Psychiatric disorders
Depression
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Psychiatric disorders
Major depression
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Renal and urinary disorders
Renal failure acute
|
2.4%
3/123 • up to 19 month for the core and up to 4 years for the extension
|
1.7%
2/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
25.0%
1/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
1.7%
2/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Blood and lymphatic system disorders
Anaemia
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
2.6%
3/117 • up to 19 month for the core and up to 4 years for the extension
|
25.0%
1/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Blood and lymphatic system disorders
Haemoglobinaemia
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Cardiac disorders
Cardiac failure
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
1.7%
2/117 • up to 19 month for the core and up to 4 years for the extension
|
25.0%
1/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Eye disorders
Retinal vascular thrombosis
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Gastrointestinal disorders
Abdominal pain
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
4.3%
5/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Gastrointestinal disorders
Ascites
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
Other adverse events
| Measure |
pNET (Core)
n=123 participants at risk
pNET (Core)
|
Non-pNET (Core)
n=117 participants at risk
Non-pNET (Core)
|
Lung NET (E1)
n=4 participants at risk
Lung NET (E1)
|
GI NET (E1)
n=11 participants at risk
GI NET (E1)
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.7%
7/123 • up to 19 month for the core and up to 4 years for the extension
|
8.5%
10/117 • up to 19 month for the core and up to 4 years for the extension
|
25.0%
1/4 • up to 19 month for the core and up to 4 years for the extension
|
27.3%
3/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.8%
12/123 • up to 19 month for the core and up to 4 years for the extension
|
4.3%
5/117 • up to 19 month for the core and up to 4 years for the extension
|
25.0%
1/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Eye disorders
Cataract
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Eye disorders
Eyelid oedema
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Gastrointestinal disorders
Abdominal pain
|
3.3%
4/123 • up to 19 month for the core and up to 4 years for the extension
|
8.5%
10/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
45.5%
5/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.4%
3/123 • up to 19 month for the core and up to 4 years for the extension
|
3.4%
4/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Gastrointestinal disorders
Bowel movement irregularity
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
25.0%
1/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
3.4%
4/117 • up to 19 month for the core and up to 4 years for the extension
|
50.0%
2/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Gastrointestinal disorders
Diarrhoea
|
8.1%
10/123 • up to 19 month for the core and up to 4 years for the extension
|
29.1%
34/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
27.3%
3/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Gastrointestinal disorders
Dry mouth
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
18.2%
2/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
50.0%
2/4 • up to 19 month for the core and up to 4 years for the extension
|
27.3%
3/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
25.0%
1/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Gastrointestinal disorders
Mouth ulceration
|
1.6%
2/123 • up to 19 month for the core and up to 4 years for the extension
|
1.7%
2/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Gastrointestinal disorders
Nausea
|
8.1%
10/123 • up to 19 month for the core and up to 4 years for the extension
|
8.5%
10/117 • up to 19 month for the core and up to 4 years for the extension
|
25.0%
1/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Gastrointestinal disorders
Stomatitis
|
8.9%
11/123 • up to 19 month for the core and up to 4 years for the extension
|
11.1%
13/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
18.2%
2/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
2/123 • up to 19 month for the core and up to 4 years for the extension
|
4.3%
5/117 • up to 19 month for the core and up to 4 years for the extension
|
25.0%
1/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
General disorders
Asthenia
|
9.8%
12/123 • up to 19 month for the core and up to 4 years for the extension
|
5.1%
6/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
General disorders
Chest pain
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
General disorders
Fatigue
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
11.1%
13/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
27.3%
3/11 • up to 19 month for the core and up to 4 years for the extension
|
|
General disorders
Generalised oedema
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
General disorders
Inflammation
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
General disorders
Injection site reaction
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
General disorders
Mucosal inflammation
|
9.8%
12/123 • up to 19 month for the core and up to 4 years for the extension
|
4.3%
5/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
General disorders
Oedema
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
2.6%
3/117 • up to 19 month for the core and up to 4 years for the extension
|
25.0%
1/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
General disorders
Oedema peripheral
|
4.1%
5/123 • up to 19 month for the core and up to 4 years for the extension
|
12.8%
15/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
36.4%
4/11 • up to 19 month for the core and up to 4 years for the extension
|
|
General disorders
Peripheral swelling
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
General disorders
Pyrexia
|
6.5%
8/123 • up to 19 month for the core and up to 4 years for the extension
|
4.3%
5/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
18.2%
2/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Infections and infestations
Bronchitis
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
1.7%
2/117 • up to 19 month for the core and up to 4 years for the extension
|
50.0%
2/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Infections and infestations
Cystitis
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
18.2%
2/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Infections and infestations
Erysipelas
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
1.7%
2/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
18.2%
2/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Infections and infestations
Laryngitis
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
25.0%
1/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Infections and infestations
Nasopharyngitis
|
1.6%
2/123 • up to 19 month for the core and up to 4 years for the extension
|
4.3%
5/117 • up to 19 month for the core and up to 4 years for the extension
|
50.0%
2/4 • up to 19 month for the core and up to 4 years for the extension
|
45.5%
5/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Infections and infestations
Paronychia
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
2.6%
3/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
18.2%
2/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
25.0%
1/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
3.4%
4/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Infections and infestations
Rhinitis
|
1.6%
2/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Infections and infestations
Sinusitis
|
1.6%
2/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Infections and infestations
Urinary tract infection
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
4.3%
5/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
18.2%
2/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
25.0%
1/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
18.2%
2/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Investigations
Blood creatinine increased
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
18.2%
2/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Investigations
Blood glucose increased
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Investigations
Blood uric acid increased
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Investigations
Weight decreased
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
2.6%
3/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
18.2%
2/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.9%
6/123 • up to 19 month for the core and up to 4 years for the extension
|
7.7%
9/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
1.7%
2/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
2.4%
3/123 • up to 19 month for the core and up to 4 years for the extension
|
4.3%
5/117 • up to 19 month for the core and up to 4 years for the extension
|
25.0%
1/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
10.6%
13/123 • up to 19 month for the core and up to 4 years for the extension
|
5.1%
6/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
25.0%
1/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
2.4%
3/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.6%
2/123 • up to 19 month for the core and up to 4 years for the extension
|
5.1%
6/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.6%
2/123 • up to 19 month for the core and up to 4 years for the extension
|
1.7%
2/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
18.2%
2/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
5.1%
6/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
36.4%
4/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
2.6%
3/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
18.2%
2/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Nervous system disorders
Headache
|
3.3%
4/123 • up to 19 month for the core and up to 4 years for the extension
|
7.7%
9/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Psychiatric disorders
Depression
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
2.6%
3/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
25.0%
1/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
25.0%
1/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Renal and urinary disorders
Renal cyst haemorrhage
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.4%
3/123 • up to 19 month for the core and up to 4 years for the extension
|
5.1%
6/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
18.2%
2/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.1%
5/123 • up to 19 month for the core and up to 4 years for the extension
|
5.1%
6/117 • up to 19 month for the core and up to 4 years for the extension
|
25.0%
1/4 • up to 19 month for the core and up to 4 years for the extension
|
18.2%
2/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.6%
2/123 • up to 19 month for the core and up to 4 years for the extension
|
2.6%
3/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
18.2%
2/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
18.2%
2/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
2.4%
3/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
25.0%
1/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Skin and subcutaneous tissue disorders
Hair growth abnormal
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Skin and subcutaneous tissue disorders
Nail dystrophy
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
18.2%
2/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
18.2%
2/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Skin and subcutaneous tissue disorders
Panniculitis
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
25.0%
1/4 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Skin and subcutaneous tissue disorders
Pityriasis rosea
|
0.00%
0/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
3.4%
4/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.3%
9/123 • up to 19 month for the core and up to 4 years for the extension
|
6.0%
7/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
18.2%
2/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Vascular disorders
Haematoma
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Vascular disorders
Hypertension
|
4.1%
5/123 • up to 19 month for the core and up to 4 years for the extension
|
5.1%
6/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
45.5%
5/11 • up to 19 month for the core and up to 4 years for the extension
|
|
Vascular disorders
Hypotension
|
0.81%
1/123 • up to 19 month for the core and up to 4 years for the extension
|
0.85%
1/117 • up to 19 month for the core and up to 4 years for the extension
|
0.00%
0/4 • up to 19 month for the core and up to 4 years for the extension
|
9.1%
1/11 • up to 19 month for the core and up to 4 years for the extension
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-1873
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER