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Efficacy and Safety Study in Pancreatic or Midgut Neuroendocrine Tumours Having Progressed Radiologically While Previously Treated With Lanreotide Autogel® 120 mg (CLARINET FORTE)

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ClinicalTrials.gov Identifier: NCT02651987
Recruitment Status : Completed
First Posted : January 11, 2016
Results First Posted : December 30, 2020
Last Update Posted : December 30, 2020
Sponsor:
Information provided by (Responsible Party):
Ipsen

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Pancreatic Tumours
Midgut Neuroendocrine Tumours
Intervention Drug: Lanreotide autogel 120 mg
Enrollment 99
Recruitment Details Subjects with well differentiated, metastatic or locally advanced, unresectable, pancreatic or midgut neuroendocrine tumours (NETs) and who had radiologically documented disease progression as per Response Evaluation Criteria in Solid Tumours (RECIST) v1.0 whilst receiving treatment with lanreotide Autogel® 120mg, every 28 days for at least 24 weeks were enrolled into this study in 25 centres across 10 countries.
Pre-assignment Details Subjects who had centrally reviewed, radiologically documented disease progression within 24 months prior to enrolment and whilst receiving treatment with lanreotide Autogel® 120 mg, administered every 28 days for at least 24 weeks, were recruited into one of two cohorts based on the primary location of NET (i.e. pancreatic NET [panNET] or midgut NET cohort).
Arm/Group Title Pancreatic NET (panNET) Cohort Midgut NET Cohort
Hide Arm/Group Description Subjects were treated with lanreotide Autogel® 120 mg, administered as deep subcutaneous (SC) injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 48 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 48 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (progressive disease [PD] or death) in the panNET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability. Subjects were treated with lanreotide Autogel® 120 mg, administered as deep SC injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 96 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 96 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (PD or death) in the midgut NET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability.
Period Title: Overall Study
Started 48 51
Completed 43 46
Not Completed 5 5
Reason Not Completed
Adverse Event             2             2
Consent Withdrawn             2             0
Local PD             0             2
Investigator Decision             1             1
Arm/Group Title PanNET Cohort Midgut NET Cohort Total
Hide Arm/Group Description Subjects were treated with lanreotide Autogel® 120 mg, administered as deep SC injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 48 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 48 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (PD or death) in the panNET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability. Subjects were treated with lanreotide Autogel® 120 mg, administered as deep SC injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 96 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 96 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (PD or death) in the midgut NET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability. Total of all reporting groups
Overall Number of Baseline Participants 48 51 99
Hide Baseline Analysis Population Description
The full analysis set (FAS) included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 48 participants 51 participants 99 participants
63.3  (10.6) 67.1  (8.2) 65.2  (9.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 51 participants 99 participants
Female
28
  58.3%
22
  43.1%
50
  50.5%
Male
20
  41.7%
29
  56.9%
49
  49.5%
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 36 participants 38 participants 74 participants
Asian
0
   0.0%
1
   2.6%
1
   1.4%
White
35
  97.2%
37
  97.4%
72
  97.3%
Other
1
   2.8%
0
   0.0%
1
   1.4%
[1]
Measure Analysis Population Description: French local regulation does not allow the collection of race and therefore French subjects are not included in this baseline measure.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Netherlands Number Analyzed 48 participants 51 participants 99 participants
1 3 4
Belgium Number Analyzed 48 participants 51 participants 99 participants
3 2 5
Ireland Number Analyzed 48 participants 51 participants 99 participants
2 0 2
Denmark Number Analyzed 48 participants 51 participants 99 participants
1 2 3
Poland Number Analyzed 48 participants 51 participants 99 participants
12 10 22
Italy Number Analyzed 48 participants 51 participants 99 participants
2 6 8
United Kingdom Number Analyzed 48 participants 51 participants 99 participants
6 9 15
France Number Analyzed 48 participants 51 participants 99 participants
12 13 25
Germany Number Analyzed 48 participants 51 participants 99 participants
8 3 11
Spain Number Analyzed 48 participants 51 participants 99 participants
1 3 4
Quality of Life (QoL) Questionnaire Core 30 (QLQ-C30) Score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 46 participants 50 participants 96 participants
68.12  (19.74) 67.83  (20.76) 67.97  (20.17)
[1]
Measure Description: QoL was measured Using European Organisation Into the Research and Treatment of Cancer (EORTC), QLQ-C30 v3.0. The global health status sub-score was assessed using the last 2 questions which represented subject's assessment of overall health & QoL. Each question was coded on a 7-point scale (1=very poor to 7=excellent). The sub-score was transformed to range from 0-100, with a high score for global health status representing a high QoL.
[2]
Measure Analysis Population Description: Only subjects who had a QLQ-C30 measure at baseline are included.
EuroQoL 5 Dimensions, 5 Levels (EQ-5D-5L) v1.0 Questionnaire Descriptive System Score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 45 participants 45 participants 90 participants
0.82  (0.17) 0.83  (0.14) 0.83  (0.15)
[1]
Measure Description: The EQ-5D-5L descriptive system comprised the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 5 levels: no problems, slight problems, moderate problems, severe problems, extreme problems. The EQ-5D-5L health states, defined by the EQ-5D-5L descriptive system, was converted into a single index value with scores ranging from 0 (no problems) to 1 (extreme problems).
[2]
Measure Analysis Population Description: Only subjects with a EQ-5D-5L index value at baseline are included.
EQ-5D-5L Visual Analogue Scale (VAS) Score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 47 participants 44 participants 91 participants
75.02  (17.93) 70.45  (14.93) 72.81  (16.62)
[1]
Measure Description: The EQ-5D-5L VAS recorded the subject's self-rated health on a vertical VAS which is numbered from 0 (worst health state) to 100 (best health state).
[2]
Measure Analysis Population Description: Only subjects with a EQ-5D-5L VAS score at baseline are included.
QoL Questionnaire Gastrointestinal Neuroendocrine Tumour 21 (QLQ-GI.NET21) Score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Endocrine Symptoms Number Analyzed 45 participants 49 participants 94 participants
16.54  (22.30) 19.73  (22.82) 18.20  (22.51)
Gastrointestinal Symptoms Number Analyzed 45 participants 49 participants 94 participants
21.70  (20.01) 22.04  (17.17) 21.88  (18.48)
Treatment Related Symptoms Number Analyzed 32 participants 32 participants 64 participants
11.63  (13.11) 11.46  (13.75) 11.55  (13.33)
Social Function Number Analyzed 45 participants 49 participants 94 participants
32.84  (24.18) 35.03  (24.33) 33.98  (24.15)
Disease Related Worries Number Analyzed 45 participants 49 participants 94 participants
44.44  (29.96) 44.22  (25.83) 44.33  (27.74)
Muscle/Bone Pain Number Analyzed 44 participants 48 participants 92 participants
26.52  (30.99) 25.69  (30.16) 26.09  (30.39)
Sexual Function Number Analyzed 31 participants 28 participants 59 participants
22.58  (30.29) 17.86  (27.94) 20.34  (29.04)
Information/Communication Function Number Analyzed 45 participants 48 participants 93 participants
3.70  (12.76) 4.17  (11.14) 3.94  (11.89)
Body Image Number Analyzed 44 participants 45 participants 89 participants
10.61  (23.60) 15.56  (28.95) 13.11  (26.41)
[1]
Measure Description: The EORTC QLQ-GI.NET21 module comprised 21 questions that used a 4-point scale (1 = Not at all, 2 = A little, 3 = Quite a bit, 4 = Very much) to evaluate 3 defined multi-item symptom scales (endocrine, gastrointestinal and treatment related side effects), 2 single item symptoms (bone/muscle pain and concern about weight loss), 2 psychosocial scales (social function and disease-related worries) and 2 single items (sexuality and communication). Answers were converted on a grading scale and then individual sub-scores transformed to range from 0 to 100 with a higher score = more or worse problems.
[2]
Measure Analysis Population Description: Only subjects who had a QLQ GI.NET21 measure at baseline are included.
Categories of Proliferation index Ki67  
Measure Type: Number
Unit of measure:  Participants
≥10% Number Analyzed 48 participants 51 participants 99 participants
7 4 11
<10% Number Analyzed 48 participants 51 participants 99 participants
41 46 87
Missing Number Analyzed 48 participants 51 participants 99 participants
0 1 1
Tumour grading (according to WHO 2010 classification)   [1] 
Measure Type: Number
Unit of measure:  Participants
Grade 1 Number Analyzed 48 participants 51 participants 99 participants
12 29 41
Grade 2 Number Analyzed 48 participants 51 participants 99 participants
36 22 58
[1]
Measure Description: According to the 2010 WHO classification, Grade 1 NET is defined as <=2% Ki-67 labelling index; and Grade 2 NET is defined as 3-20% Ki-67 labelling index. Grade 2 is considered to have a worse outcome.
Hepatic tumour load  
Measure Type: Number
Unit of measure:  Participants
>25% Number Analyzed 48 participants 51 participants 99 participants
7 9 16
≤25% Number Analyzed 48 participants 51 participants 99 participants
41 42 83
1.Primary Outcome
Title Median Progression Free Survival (PFS)
Hide Description PFS was defined as the time from first injection of lanreotide Autogel® 120 mg every 14 days to progression or death. Disease progression was assessed by tumour response evaluation according to RECIST v1.0, every 12 weeks, measured by independent central review using the same imaging technique (computed tomography [CT] scan or magnetic resonance imaging [MRI]) for each subject throughout the study. The median PFS time was estimated using the Kaplan Meier method for each cohort.
Time Frame From Day 1 up to Week 60 for the panNET cohort and Week 103 for the midgut NET cohort
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
Arm/Group Title PanNET Cohort Midgut NET Cohort
Hide Arm/Group Description:
Subjects were treated with lanreotide Autogel® 120 mg, administered as SC injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 48 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 48 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (PD or death) in the panNET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability.
Subjects were treated with lanreotide Autogel® 120 mg, administered as deep SC injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 96 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 96 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (PD or death) in the midgut NET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability.
Overall Number of Participants Analyzed 48 51
Median (95% Confidence Interval)
Unit of Measure: months
5.6
(5.5 to 8.3)
8.3
(5.6 to 11.1)
2.Secondary Outcome
Title Median Time to Progression
Hide Description Time to Progression was defined as time from first injection of lanreotide Autogel® 120 mg every 14 days to progression. Disease progression was assessed by tumour response evaluation according to RECIST v1.0, every 12 weeks, measured by independent central review using the same imaging technique (CT scan or MRI) for each subject throughout the study. Median time to progression was estimated using the Kaplan Meier method for each cohort.
Time Frame From Day 1 up to Week 60 for the panNET cohort and Week 103 for the midgut NET cohort
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
Arm/Group Title PanNET Cohort Midgut NET Cohort
Hide Arm/Group Description:
Subjects were treated with lanreotide Autogel® 120 mg, administered as SC injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 48 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 48 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (PD or death) in the panNET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability.
Subjects were treated with lanreotide Autogel® 120 mg, administered as deep SC injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 96 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 96 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (PD or death) in the midgut NET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability.
Overall Number of Participants Analyzed 48 51
Median (95% Confidence Interval)
Unit of Measure: months
5.6
(5.5 to 8.3)
8.7
(8.3 to 13.9)
3.Secondary Outcome
Title Percentage of Subjects Alive and Progression Free
Hide Description The percentage of subjects alive and progression-free was assessed throughout the study up to Week 60 for the panNET cohort and Week 96 for the midgut cohort. Disease progression was assessed by tumour response evaluation according to RECIST v1.0, every 12 weeks measured by independent central review using the same imaging technique (CT scan or MRI) for each subject throughout the study. The percentage of subjects alive and progression free was estimated using the Kaplan Meier method for each cohort.
Time Frame Weeks 12, 24, 36, 48, 60 (for both cohorts) and Weeks 72, 84 and 96 (for midgut NET cohort)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
Arm/Group Title PanNET Cohort Midgut NET Cohort
Hide Arm/Group Description:
Subjects were treated with lanreotide Autogel® 120 mg, administered as SC injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 48 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 48 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (PD or death) in the panNET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability.
Subjects were treated with lanreotide Autogel® 120 mg, administered as deep SC injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 96 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 96 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (PD or death) in the midgut NET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability.
Overall Number of Participants Analyzed 48 51
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
Week 12 Number Analyzed 48 participants 51 participants
93.3
(80.7 to 97.8)
91.8
(79.7 to 96.9)
Week 24 Number Analyzed 48 participants 51 participants
64.4
(48.7 to 76.5)
65.3
(50.3 to 76.8)
Week 36 Number Analyzed 48 participants 51 participants
37.8
(23.9 to 51.6)
59.2
(44.2 to 71.4)
Week 48 Number Analyzed 48 participants 51 participants
28.5
(16.2 to 42.1)
38.3
(24.8 to 51.6)
Week 60 Number Analyzed 48 participants 51 participants
20.7
(9.0 to 35.7)
36.1
(22.9 to 49.5)
Week 72 Number Analyzed 0 participants 51 participants
29.8
(17.6 to 42.9)
Week 84 Number Analyzed 0 participants 51 participants
27.5
(15.7 to 40.5)
Week 96 Number Analyzed 0 participants 51 participants
25.2
(13.9 to 38.1)
4.Secondary Outcome
Title Overall Survival
Hide Description Overall survival was defined as the time in months from the first injection of lanreotide Autogel® 120 mg every 14 days to death due to any cause. Median overall survival was estimated using the Kaplan Meier method for each cohort.
Time Frame From Day 1 up to Week 60 for the panNET cohort and Week 103 for the midgut NET cohort
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
Arm/Group Title PanNET Cohort Midgut NET Cohort
Hide Arm/Group Description:
Subjects were treated with lanreotide Autogel® 120 mg, administered as SC injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 48 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 48 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (PD or death) in the panNET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability
Subjects were treated with lanreotide Autogel® 120 mg, administered as deep SC injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 96 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 96 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (PD or death) in the midgut NET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability.
Overall Number of Participants Analyzed 48 51
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
The median overall survival from the Kaplan Meier model was not reached for this cohort.
5.Secondary Outcome
Title Objective Response Rate (ORR)
Hide Description The ORR was defined as the percentage of subjects who achieve either complete response (CR) or partial response (PR) according to RECIST v1.0 criteria. ORR was evaluated every 12 weeks and results are presented for each cohort.
Time Frame Weeks 12, 24, 36, 48, 60 (for both cohorts) and Weeks 72, 84, and 96 (for midgut cohort)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
Arm/Group Title PanNET Cohort Midgut NET Cohort
Hide Arm/Group Description:
Subjects were treated with lanreotide Autogel® 120 mg, administered as SC injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 48 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 48 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (PD or death) in the panNET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability.
Subjects were treated with lanreotide Autogel® 120 mg, administered as deep SC injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 96 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 96 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (PD or death) in the midgut NET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability.
Overall Number of Participants Analyzed 48 51
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
Week 12 Number Analyzed 48 participants 51 participants
0.0
(0.0 to 7.4)
0.0
(0.0 to 7.0)
Week 24 Number Analyzed 48 participants 51 participants
0.0
(0.0 to 7.4)
0.0
(0.0 to 7.0)
Week 36 Number Analyzed 48 participants 51 participants
0.0
(0.0 to 7.4)
0.0
(0.0 to 7.0)
Week 48 Number Analyzed 48 participants 51 participants
0.0
(0.0 to 7.4)
0.0
(0.0 to 7.0)
Week 60 Number Analyzed 48 participants 51 participants
0.0
(0.0 to 7.4)
2.0
(0.0 to 10.4)
Week 72 Number Analyzed 0 participants 51 participants
3.9
(0.5 to 13.5)
Week 84 Number Analyzed 0 participants 51 participants
2.0
(0.0 to 10.4)
Week 96 Number Analyzed 0 participants 51 participants
2.0
(0.0 to 10.4)
6.Secondary Outcome
Title Disease Control Rate (DCR)
Hide Description The DCR was defined as the percentage of subjects who achieved CR plus PR plus Stable Disease (SD), evaluated according to RECIST v1.0 criteria. The DCR at Weeks 24 and 48 is presented for each cohort.
Time Frame Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
Arm/Group Title PanNET Cohort Midgut NET Cohort
Hide Arm/Group Description:
Subjects were treated with lanreotide Autogel® 120 mg, administered as SC injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 48 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 48 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (PD or death) in the panNET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability.
Subjects were treated with lanreotide Autogel® 120 mg, administered as deep SC injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 96 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 96 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (PD or death) in the midgut NET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability.
Overall Number of Participants Analyzed 48 51
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
Week 24
43.8
(29.5 to 58.8)
58.8
(44.2 to 72.4)
Week 48
22.9
(12.0 to 37.3)
33.3
(20.8 to 47.9)
7.Secondary Outcome
Title Best Overall Response Rate
Hide Description Best overall response was defined as the best response recorded from the initiation of treatment until disease progression, according to RECIST v1.0 evaluation. The percentage of subjects in each response category and those who were non-evaluable (i.e. with no tumour assessment after the start of study treatment) throughout the study are presented for each cohort.
Time Frame From Day 1 up to Week 60 for the panNET cohort and Week 103 for the midgut NET cohort
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
Arm/Group Title PanNET Cohort Midgut NET Cohort
Hide Arm/Group Description:
Subjects were treated with lanreotide Autogel® 120 mg, administered as SC injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 48 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 48 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (PD or death) in the panNET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability.
Subjects were treated with lanreotide Autogel® 120 mg, administered as deep SC injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 96 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 96 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (PD or death) in the midgut NET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability.
Overall Number of Participants Analyzed 48 51
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
CR
0.0
(0.0 to 7.4)
0.0
(0.0 to 7.0)
PR
0.0
(0.0 to 7.4)
3.9
(0.5 to 13.5)
SD
66.7
(51.6 to 79.6)
68.6
(54.1 to 80.9)
PD
31.3
(18.7 to 46.3)
23.5
(12.8 to 37.5)
Not evaluable
0.0
(0.0 to 7.4)
2.0
(0.0 to 10.4)
8.Secondary Outcome
Title Median Duration of Stable Disease
Hide Description Median duration of SD was the time from first injection of lanreotide Autogel® 120 mg every 14 days until the first occurrence of PD by central assessment. Disease progression was assessed by tumour response evaluation according to RECIST v1.0, every 12 weeks, measured using the same imaging technique (CT scan or MRI) for each subject throughout the study. Median duration of stable disease was estimated using the Kaplan Meier method for each cohort.
Time Frame From Day 1 up to Week 60 for the panNET cohort and Week 103 for the midgut NET cohort
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
Arm/Group Title PanNET Cohort Midgut NET Cohort
Hide Arm/Group Description:
Subjects were treated with lanreotide Autogel® 120 mg, administered as SC injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 48 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 48 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (PD or death) in the panNET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability.
Subjects were treated with lanreotide Autogel® 120 mg, administered as deep SC injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 96 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 96 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (PD or death) in the midgut NET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability.
Overall Number of Participants Analyzed 48 51
Median (95% Confidence Interval)
Unit of Measure: months
8.3
(8.0 to 13.8)
13.8 [1] 
(8.6 to NA)
[1]
95% confidence interval upper limit could not be calculated as an insufficient number of events were observed.
9.Secondary Outcome
Title Factors Associated With PFS
Hide Description

A univariate cox proportional hazards model was used to assess whether the following factors were associated with PFS:

  • Hepatic tumour load: >25% versus reference ≤25%
  • Tumour Grade: Grade 2 versus reference Grade 1,
  • Previous surgery of the primary tumour: No versus reference Yes,
  • Proliferation index Ki67: ≥10% versus reference <10%
  • Duration of treatment with lanreotide Autogel® 120 mg every 28 days by category: ≥median value versus reference <median value,
  • Age by category: ≥65 years versus reference <65 years,
  • Time from diagnosis to study entry by category: ≥3 years versus reference <3 years,
  • Time interval between the two CT scans (pre-screening/screening): ≥12 months versus reference <12 months and
  • Symptoms (diarrhoea or flushing at baseline): No versus reference Yes.

Each factor was assessed for its importance in the Cox model for PFS in a univariate fashion.

Time Frame Screening/Baseline (Day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
Arm/Group Title PanNET Cohort Midgut NET Cohort
Hide Arm/Group Description:
Subjects were treated with lanreotide Autogel® 120 mg, administered as SC injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 48 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 48 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (PD or death) in the panNET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability.
Subjects were treated with lanreotide Autogel® 120 mg, administered as deep SC injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 96 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 96 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (PD or death) in the midgut NET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability.
Overall Number of Participants Analyzed 48 51
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Hazard Ratio
Hepatic tumour load: >25% Vs ≤25% Number Analyzed 48 participants 51 participants
0.96
(0.40 to 2.32)
1.54
(0.70 to 3.40)
Tumour Grade: 2 Vs 1 Number Analyzed 48 participants 51 participants
0.68
(0.32 to 1.45)
0.90
(0.46 to 1.77)
Previous surgery: No Vs Yes Number Analyzed 48 participants 51 participants
1.04
(0.53 to 2.04)
2.14
(0.83 to 5.52)
Ki67: ≥10% Vs <10% Number Analyzed 48 participants 50 participants
3.60
(1.39 to 9.32)
2.26
(0.67 to 7.60)
Duration of treatment with lanreotide Autogel® 120 mg every 28 days: ≥median Vs <median Number Analyzed 48 participants 51 participants
0.68
(0.34 to 1.34)
0.76
(0.40 to 1.47)
Age: ≥65 years Vs <65 years Number Analyzed 48 participants 51 participants
1.55
(0.79 to 3.06)
1.15
(0.58 to 2.31)
Time from diagnosis: ≥3 years Vs <3 years Number Analyzed 48 participants 51 participants
0.49
(0.25 to 0.96)
0.94
(0.49 to 1.82)
Time between CT scans: ≥12 months Vs <12 months Number Analyzed 48 participants 51 participants
0.47
(0.24 to 0.94)
0.72
(0.37 to 1.39)
Symptoms: No Vs Yes Number Analyzed 48 participants 50 participants
2.55
(0.89 to 7.28)
1.32
(0.68 to 2.56)
10.Secondary Outcome
Title Mean Change From Baseline in Number of Stools and Flushing Episodes
Hide Description Symptom control was measured by the total number of stools (diarrhoea) and flushing episodes during the 7 days prior to the visit, reported orally by the subject to the investigator. The mean change from baseline in number of stools and flushing episodes reported at each visit is presented for each cohort.
Time Frame Baseline (Day 1), Weeks 8,12, 48 and end of study (approximately 64 weeks for panNET cohort and 108 weeks for midgut NET cohort)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study. Numbers analysed at each time point correspond to the number of subjects reporting episodes in the 7 days prior to the visit.
Arm/Group Title PanNET Cohort Midgut NET Cohort
Hide Arm/Group Description:
Subjects were treated with lanreotide Autogel® 120 mg, administered as SC injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 48 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 48 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (PD or death) in the panNET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability.
Subjects were treated with lanreotide Autogel® 120 mg, administered as deep SC injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 96 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 96 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (PD or death) in the midgut NET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability.
Overall Number of Participants Analyzed 48 51
Mean (Standard Deviation)
Unit of Measure: episodes
Stools - Week 8 Number Analyzed 5 participants 13 participants
1.0  (5.5) -1.0  (8.2)
Stools - Week 12 Number Analyzed 5 participants 13 participants
-1.2  (7.9) 0.7  (2.5)
Stools - Week 48 Number Analyzed 2 participants 5 participants
-1.0  (0.0) 3.4  (4.8)
Stools - End of Study Number Analyzed 4 participants 5 participants
0.5  (5.4) -1.2  (12.2)
Flushing - Week 8 Number Analyzed 3 participants 9 participants
0.7  (2.1) -3.3  (8.3)
Flushing - Week 12 Number Analyzed 2 participants 6 participants
-1.0  (0.0) 1.5  (10.0)
Flushing - Week 48 Number Analyzed 2 participants 2 participants
-1.0  (0.0) -1.5  (2.1)
Flushing - End of Study Number Analyzed 2 participants 4 participants
0.0  (1.4) -0.5  (6.2)
11.Secondary Outcome
Title Mean Change From Baseline in QoL Measured Using EORTC, QLQ-C30 v3.0 (Global Health Status Sub-score)
Hide Description

Subjects were instructed to complete the 30 questions in the EORTC-QLQ-C30 v3.0 questionnaire at baseline and every 12 weeks throughout the study.

The global health status sub-score was assessed using the last 2 questions which represented subject's assessment of overall health & QoL. Each question was coded on a 7-point scale (1=very poor to 7=excellent). The sub-score was transformed to range from 0-100, with a high score for global health status representing a high QoL. The mean change from baseline in the transformed global health status are presented for the end of study/early withdrawal visit, with a positive change indicating an improvement in QoL.

Time Frame Baseline (Day 1) and end of study (approximately 64 weeks for panNET cohort and 108 weeks for midgut NET (and overall) cohort)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study. Only subjects with data available for analysis are presented.
Arm/Group Title PanNET Cohort Midgut NET Cohort Overall
Hide Arm/Group Description:
Subjects were treated with lanreotide Autogel® 120 mg, administered as SC injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 48 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 48 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (PD or death) in the panNET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability.
Subjects were treated with lanreotide Autogel® 120 mg, administered as deep SC injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 96 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 96 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (PD or death) in the midgut NET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability.
All subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
Overall Number of Participants Analyzed 22 25 47
Mean (Standard Deviation)
Unit of Measure: score on a scale
-0.38  (15.32) -1.33  (17.13) -0.89  (16.14)
12.Secondary Outcome
Title Mean Change From Baseline in EQ-5D-5L v1.0 Questionnaire (Descriptive System)
Hide Description

Subjects were instructed to complete the EQ-5D-5L descriptive system at baseline and every 12 weeks throughout the study.

The EQ-5D-5L descriptive system comprised the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 5 levels: no problems, slight problems, moderate problems, severe problems, extreme problems. The EQ-5D-5L health states, defined by the EQ-5D-5L descriptive system, was converted into a single index value with scores ranging from 0 (no problems) to 1 (extreme problems). The mean change from baseline at the end of study/early withdrawal visit is presented with a positive change from baseline in the index values indicating a worsening of symptoms.

Time Frame Baseline (Day 1) and end of study (approximately 64 weeks for panNET cohort and 108 weeks for midgut NET (and overall) cohort)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study. Only subjects with data available for analysis are presented.
Arm/Group Title PanNET Cohort Midgut NET Cohort Overall
Hide Arm/Group Description:
Subjects were treated with lanreotide Autogel® 120 mg, administered as SC injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 48 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 48 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (PD or death) in the panNET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability.
Subjects were treated with lanreotide Autogel® 120 mg, administered as deep SC injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 96 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 96 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (PD or death) in the midgut NET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability.
All subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
Overall Number of Participants Analyzed 22 21 43
Mean (Standard Deviation)
Unit of Measure: Index value
-0.04  (0.12) 0.00  (0.11) -0.02  (0.12)
13.Secondary Outcome
Title Mean Change From Baseline in EQ-5D-5L v1.0 Questionnaire (VAS)
Hide Description Subjects were instructed to complete the EQ-5D-5L VAS at baseline and every 12 weeks throughout the study. The EQ-5D-5L VAS recorded the subject's self-rated health on a vertical VAS which is numbered from 0 (worst health state) to 100 (best health state). The mean change from baseline at the end of study/early withdrawal visit is presented with a positive change in the VAS indicating an improvement in symptoms.
Time Frame Baseline (Day 1) and end of study (approximately 64 weeks for panNET cohort and 108 weeks for midgut NET (and overall) cohort)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study. Only subjects with data available for analysis are presented.
Arm/Group Title PanNET Cohort Midgut NET Cohort Overall
Hide Arm/Group Description:
Subjects were treated with lanreotide Autogel® 120 mg, administered as SC injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 48 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 48 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (PD or death) in the panNET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability.
Subjects were treated with lanreotide Autogel® 120 mg, administered as deep SC injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 96 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 96 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (PD or death) in the midgut NET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability.
All subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
Overall Number of Participants Analyzed 21 21 42
Mean (Standard Deviation)
Unit of Measure: score on a scale
-1.90  (14.80) -1.76  (9.34) -1.83  (12.22)
14.Secondary Outcome
Title Mean Change From Baseline in QoL Questionnaire Gastrointestinal Neuroendocrine Tumour 21 (QLQ-GI.NET21; 2006)
Hide Description Subjects were asked to complete the EORTC QLQ-GI.NET21 module which comprised 21 questions that used a 4-point scale (1 = Not at all, 2 = A little, 3 = Quite a bit, 4 = Very much) to evaluate 3 defined multi-item symptom scales (endocrine, gastrointestinal and treatment related side effects), 2 single item symptoms (bone/muscle pain and concern about weight loss), 2 psychosocial scales (social function and disease-related worries) and 2 other single items (sexuality and communication). Answers were converted into grading scale, with values between 0 and 100. Each individual sub-score was transformed to range from 0 to 100. The mean change from baseline at the end of study/early withdrawal visit is presented with a higher score representing more or worse problems.
Time Frame Baseline (Day 1) and end of study (approximately 64 weeks for panNET cohort and 108 weeks for midgut NET (and overall) cohort)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study. Only subjects with data available for analysis are presented.
Arm/Group Title PanNET Cohort Midgut NET Cohort Overall
Hide Arm/Group Description:
Subjects were treated with lanreotide Autogel® 120 mg, administered as SC injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 48 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 48 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (PD or death) in the panNET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability.
Subjects were treated with lanreotide Autogel® 120 mg, administered as deep SC injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 96 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 96 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (PD or death) in the midgut NET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability.
All subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
Overall Number of Participants Analyzed 48 51 99
Mean (Standard Deviation)
Unit of Measure: score on a scale
Endocrine Symptoms Number Analyzed 21 participants 24 participants 45 participants
-0.53  (11.37) -5.09  (17.33) -2.96  (14.87)
Gastrointestinal Symptoms Number Analyzed 21 participants 24 participants 45 participants
-3.49  (14.24) -2.78  (15.96) -3.11  (15.02)
Treatment Related Symptoms Number Analyzed 15 participants 16 participants 31 participants
5.93  (15.64) -3.47  (14.47) 1.08  (15.54)
Social Function Number Analyzed 21 participants 24 participants 45 participants
-0.79  (13.41) -9.49  (18.20) -5.43  (16.56)
Disease Related Worries Number Analyzed 21 participants 24 participants 45 participants
3.17  (15.47) -0.93  (27.40) 0.99  (22.48)
Muscle/Bone Pain Number Analyzed 20 participants 24 participants 44 participants
-1.67  (33.29) 0.00  (36.78) -0.76  (34.84)
Sexual Function Number Analyzed 14 participants 12 participants 26 participants
2.38  (15.82) -2.78  (26.43) 0.00  (21.08)
Information/Communication Function Number Analyzed 21 participants 23 participants 44 participants
7.94  (29.64) -2.90  (9.60) 2.27  (22.04)
Body Image Number Analyzed 20 participants 22 participants 42 participants
0.00  (15.29) -7.58  (28.97) -3.97  (23.52)
15.Secondary Outcome
Title Mean Change From Baseline in Nonspecific Tumour Biomarkers
Hide Description Nonspecific tumour peptide biomarkers (chromogranin A [CgA], neuron specific enolase [NSE] and plasma/urinary 5-hydroxyindoleacetic acid [5-HIAA]) were evaluated in both pancreas and midgut subjects at baseline and Week 12 and every 12 weeks thereafter. At all scheduled visits, except baseline, plasma/urinary 5-HIAA was only performed in subjects with symptoms of carcinoid syndrome (diarrhoea and/or flushing) or if urinary 5-HIAA was elevated (above upper limit of normal [ULN]) at baseline. Mean change from baseline values were normalised by the ULN (xULN) and are presented for each cohort.
Time Frame Baseline (Day 1) and end of study (approximately 64 weeks for panNET cohort and 108 weeks for midgut NET cohort)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study. Only subjects with data available for analysis are presented.
Arm/Group Title PanNET Cohort Midgut NET Cohort
Hide Arm/Group Description:
Subjects were treated with lanreotide Autogel® 120 mg, administered as SC injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 48 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 48 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (PD or death) in the panNET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability.
Subjects were treated with lanreotide Autogel® 120 mg, administered as deep SC injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 96 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 96 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (PD or death) in the midgut NET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability.
Overall Number of Participants Analyzed 48 51
Mean (Standard Deviation)
Unit of Measure: xULN
CgA Number Analyzed 22 participants 24 participants
0.205  (1.258) 0.370  (1.843)
NSE Number Analyzed 15 participants 10 participants
0.03  (1.00) -0.49  (1.86)
Plasma 5-HIAA Number Analyzed 20 participants 17 participants
-0.42  (1.44) 3.90  (7.39)
16.Secondary Outcome
Title Mean Change From Baseline in PanNet Specific Tumour Biomarkers: Pancreatic Polypeptide, Gastrin
Hide Description PanNET specific tumour peptide biomarkers were evaluated in pancreas subjects at baseline. Only the tumour biomarkers that were above normal range at baseline were evaluated every 12 weeks thereafter and at the end of study visit. The mean change from baseline values in picomole/liter (pmol/L) are presented for the end of study visit.
Time Frame Baseline (Day 1) and end of study (approximately 64 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study. Only subjects in the panNET cohort with data available for analysis are presented.
Arm/Group Title PanNET Cohort
Hide Arm/Group Description:
Subjects were treated with lanreotide Autogel® 120 mg, administered as SC injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 48 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 48 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (PD or death) in the panNET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability.
Overall Number of Participants Analyzed 48
Mean (Standard Deviation)
Unit of Measure: pmol/L
Pancreatic Polypeptide Number Analyzed 3 participants
82.7  (146.7)
Gastrin Number Analyzed 4 participants
-9.8  (70.7)
17.Secondary Outcome
Title Mean Change From Baseline in PanNet Specific Tumour Biomarkers: Glucagon
Hide Description PanNET specific tumour peptide biomarkers were evaluated in pancreas subjects at baseline. Only the tumour biomarkers that were above normal range at baseline were evaluated every 12 weeks thereafter and at the end of study visit. The mean change from baseline values in nanograms (ng)/L are presented for the end of study visit.
Time Frame Baseline (Day 1) and end of study (approximately 64 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study. Only subjects in panNET cohort with data available for analysis are presented.
Arm/Group Title PanNET Cohort
Hide Arm/Group Description:
Subjects were treated with lanreotide Autogel® 120 mg, administered as SC injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 48 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 48 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (PD or death) in the panNET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability.
Overall Number of Participants Analyzed 4
Mean (Standard Deviation)
Unit of Measure: ng/L
5.5  (36.4)
Time Frame Treatment emergent adverse events were recorded from the first dose of lanreotide Autogel® 120 mg on Day 1 until 28 days after the last treatment. Overall time frame of up to a maximum of 64 weeks for panNET cohort and 108 weeks for midgut NET (and overall) cohort.
Adverse Event Reporting Description The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
 
Arm/Group Title PanNET Cohort Midgut NET Cohort Overall Subjects
Hide Arm/Group Description Subjects were treated with lanreotide Autogel® 120 mg, administered as SC injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 48 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 48 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (PD or death) in the panNET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability. Subjects were treated with lanreotide Autogel® 120 mg, administered as deep SC injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 96 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 96 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (PD or death) in the midgut NET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability. All subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
All-Cause Mortality
PanNET Cohort Midgut NET Cohort Overall Subjects
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/48 (2.08%)      3/51 (5.88%)      4/99 (4.04%)    
Hide Serious Adverse Events
PanNET Cohort Midgut NET Cohort Overall Subjects
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/48 (10.42%)      13/51 (25.49%)      18/99 (18.18%)    
Cardiac disorders       
Cardiac failure  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Pulseless electrical activity  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Gastrointestinal disorders       
Abdominal pain  1  0/48 (0.00%)  0 1/51 (1.96%)  2 1/99 (1.01%)  2
Diarrhoea  1  1/48 (2.08%)  1 0/51 (0.00%)  0 1/99 (1.01%)  1
Intestinal obstruction  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
General disorders       
Asthenia  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Chest pain  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
General physical health deterioration  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Immune system disorders       
Anaphylactic reaction  1  1/48 (2.08%)  1 0/51 (0.00%)  0 1/99 (1.01%)  1
Infections and infestations       
Peritonitis  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Viral infection  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Injury, poisoning and procedural complications       
Craniocerebral injury  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Fall  1  1/48 (2.08%)  1 0/51 (0.00%)  0 1/99 (1.01%)  1
Spinal fracture  1  1/48 (2.08%)  1 0/51 (0.00%)  0 1/99 (1.01%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Bone neoplasm  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Breast cancer  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Nervous system disorders       
Spinal cord compression  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Syncope  1  1/48 (2.08%)  1 0/51 (0.00%)  0 1/99 (1.01%)  1
Respiratory, thoracic and mediastinal disorders       
Pulmonary embolism  1  1/48 (2.08%)  1 2/51 (3.92%)  3 3/99 (3.03%)  4
Vascular disorders       
Hypotension  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
1
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PanNET Cohort Midgut NET Cohort Overall Subjects
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   41/48 (85.42%)      47/51 (92.16%)      88/99 (88.89%)    
Blood and lymphatic system disorders       
Lymphopenia  1  1/48 (2.08%)  1 0/51 (0.00%)  0 1/99 (1.01%)  1
Monocytopenia  1  1/48 (2.08%)  1 0/51 (0.00%)  0 1/99 (1.01%)  1
Cardiac disorders       
Arrhythmia  1  1/48 (2.08%)  1 0/51 (0.00%)  0 1/99 (1.01%)  1
Cardiac failure  1  0/48 (0.00%)  0 1/51 (1.96%)  2 1/99 (1.01%)  2
Heart valve incompetence  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Palpitations  1  1/48 (2.08%)  1 0/51 (0.00%)  0 1/99 (1.01%)  1
Right ventricular failure  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Tachycardia  1  1/48 (2.08%)  1 0/51 (0.00%)  0 1/99 (1.01%)  1
Tricuspid valve disease  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Ear and labyrinth disorders       
Deafness  1  1/48 (2.08%)  1 0/51 (0.00%)  0 1/99 (1.01%)  1
Deafness unilateral  1  1/48 (2.08%)  1 0/51 (0.00%)  0 1/99 (1.01%)  1
Ear pain  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Hypoacusis  1  1/48 (2.08%)  1 0/51 (0.00%)  0 1/99 (1.01%)  1
Vertigo  1  0/48 (0.00%)  0 1/51 (1.96%)  2 1/99 (1.01%)  2
Vertigo positional  1  1/48 (2.08%)  1 0/51 (0.00%)  0 1/99 (1.01%)  1
Eye disorders       
Diplopia  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Dry eye  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Eye pain  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Eye pruritus  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Glaucoma  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Ocular hyperaemia  1  0/48 (0.00%)  0 2/51 (3.92%)  2 2/99 (2.02%)  2
Gastrointestinal disorders       
Abdominal discomfort  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Abdominal distension  1  0/48 (0.00%)  0 6/51 (11.76%)  7 6/99 (6.06%)  7
Abdominal pain  1  7/48 (14.58%)  13 12/51 (23.53%)  16 19/99 (19.19%)  29
Abdominal pain lower  1  1/48 (2.08%)  1 1/51 (1.96%)  1 2/99 (2.02%)  2
Abdominal pain upper  1  2/48 (4.17%)  2 6/51 (11.76%)  7 8/99 (8.08%)  9
Anal incontinence  1  1/48 (2.08%)  1 0/51 (0.00%)  0 1/99 (1.01%)  1
Anorectal discomfort  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Ascites  1  0/48 (0.00%)  0 2/51 (3.92%)  2 2/99 (2.02%)  2
Constipation  1  2/48 (4.17%)  3 2/51 (3.92%)  3 4/99 (4.04%)  6
Diarrhoea  1  14/48 (29.17%)  20 27/51 (52.94%)  35 41/99 (41.41%)  55
Dry mouth  1  1/48 (2.08%)  1 0/51 (0.00%)  0 1/99 (1.01%)  1
Dyspepsia  1  0/48 (0.00%)  0 2/51 (3.92%)  3 2/99 (2.02%)  3
Faeces discoloured  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Flatulence  1  1/48 (2.08%)  1 6/51 (11.76%)  8 7/99 (7.07%)  9
Gastrooesophageal reflux disease  1  1/48 (2.08%)  1 2/51 (3.92%)  2 3/99 (3.03%)  3
Gingival bleeding  1  1/48 (2.08%)  1 0/51 (0.00%)  0 1/99 (1.01%)  1
Gingival pain  1  1/48 (2.08%)  1 1/51 (1.96%)  1 2/99 (2.02%)  2
Glossodynia  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Haematochezia  1  1/48 (2.08%)  1 0/51 (0.00%)  0 1/99 (1.01%)  1
Hernial eventration  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Inguinal hernia  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Nausea  1  5/48 (10.42%)  5 6/51 (11.76%)  9 11/99 (11.11%)  14
Oral pain  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Pancreatic failure  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Proctalgia  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Steatorrhoea  1  2/48 (4.17%)  2 3/51 (5.88%)  3 5/99 (5.05%)  5
Stomatitis  1  1/48 (2.08%)  1 1/51 (1.96%)  1 2/99 (2.02%)  2
Toothache  1  1/48 (2.08%)  1 0/51 (0.00%)  0 1/99 (1.01%)  1
Vomiting  1  6/48 (12.50%)  9 4/51 (7.84%)  4 10/99 (10.10%)  13
Haemorrhoids  1  1/48 (2.08%)  1 1/51 (1.96%)  1 2/99 (2.02%)  2
General disorders       
Asthenia  1  4/48 (8.33%)  24 4/51 (7.84%)  5 8/99 (8.08%)  29
Chest pain  1  0/48 (0.00%)  0 3/51 (5.88%)  3 3/99 (3.03%)  3
Fatigue  1  7/48 (14.58%)  8 8/51 (15.69%)  11 15/99 (15.15%)  19
Gait disturbance  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Hunger  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Influenza like illness  1  1/48 (2.08%)  1 3/51 (5.88%)  3 4/99 (4.04%)  4
Injection site bruising  1  1/48 (2.08%)  1 0/51 (0.00%)  0 1/99 (1.01%)  1
Injection site pain  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Malaise  1  1/48 (2.08%)  1 2/51 (3.92%)  2 3/99 (3.03%)  3
Medical device site pain  1  1/48 (2.08%)  1 0/51 (0.00%)  0 1/99 (1.01%)  1
Oedema peripheral  1  2/48 (4.17%)  2 2/51 (3.92%)  2 4/99 (4.04%)  4
Pain  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Peripheral swelling  1  0/48 (0.00%)  0 3/51 (5.88%)  3 3/99 (3.03%)  3
Polyp  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Pyrexia  1  2/48 (4.17%)  2 2/51 (3.92%)  5 4/99 (4.04%)  7
Hepatobiliary disorders       
Bile duct stone  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Cholelithiasis  1  0/48 (0.00%)  0 3/51 (5.88%)  3 3/99 (3.03%)  3
Hepatic failure  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Liver injury  1  1/48 (2.08%)  1 0/51 (0.00%)  0 1/99 (1.01%)  1
Immune system disorders       
Drug hypersensitivity  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Infections and infestations       
Bronchitis  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Carbuncle  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Cystitis  1  2/48 (4.17%)  2 1/51 (1.96%)  1 3/99 (3.03%)  3
Cystitis bacterial  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Diverticulitis  1  0/48 (0.00%)  0 2/51 (3.92%)  2 2/99 (2.02%)  2
Folliculitis  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Herpes zoster  1  0/48 (0.00%)  0 2/51 (3.92%)  2 2/99 (2.02%)  2
Influenza  1  2/48 (4.17%)  2 3/51 (5.88%)  6 5/99 (5.05%)  8
Lower respiratory tract infection  1  1/48 (2.08%)  2 3/51 (5.88%)  3 4/99 (4.04%)  5
Nasopharyngitis  1  7/48 (14.58%)  7 5/51 (9.80%)  6 12/99 (12.12%)  13
Respiratory tract infection  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Tonsillitis  1  1/48 (2.08%)  1 0/51 (0.00%)  0 1/99 (1.01%)  1
Upper respiratory tract infection  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Urinary tract infection  1  4/48 (8.33%)  6 1/51 (1.96%)  1 5/99 (5.05%)  7
Injury, poisoning and procedural complications       
Fall  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Incision site pain  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Incisional hernia  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Ligament sprain  1  0/48 (0.00%)  0 2/51 (3.92%)  2 2/99 (2.02%)  2
Muscle strain  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Post procedural complication  1  1/48 (2.08%)  1 0/51 (0.00%)  0 1/99 (1.01%)  1
Radiation skin injury  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Skin abrasion  1  1/48 (2.08%)  1 0/51 (0.00%)  0 1/99 (1.01%)  1
Investigations       
Alanine aminotransferase increased  1  1/48 (2.08%)  1 2/51 (3.92%)  2 3/99 (3.03%)  3
Aspartate aminotransferase abnormal  1  1/48 (2.08%)  1 0/51 (0.00%)  0 1/99 (1.01%)  1
Aspartate aminotransferase increased  1  1/48 (2.08%)  1 1/51 (1.96%)  1 2/99 (2.02%)  2
Bacterial test positive  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Blood alkaline phosphatase increased  1  3/48 (6.25%)  3 1/51 (1.96%)  1 4/99 (4.04%)  4
Blood bilirubin increased  1  0/48 (0.00%)  0 2/51 (3.92%)  2 2/99 (2.02%)  2
Blood chromogranin A increased  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Blood creatinine increased  1  1/48 (2.08%)  1 0/51 (0.00%)  0 1/99 (1.01%)  1
Blood glucose decreased  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Blood glucose increased  1  1/48 (2.08%)  1 1/51 (1.96%)  1 2/99 (2.02%)  2
Blood potassium increased  1  1/48 (2.08%)  1 0/51 (0.00%)  0 1/99 (1.01%)  1
Blood triglycerides increased  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Blood urea increased  1  1/48 (2.08%)  1 1/51 (1.96%)  1 2/99 (2.02%)  2
Blood urine present  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
C-reactive protein increased  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Gamma-glutamyltransferase abnormal  1  1/48 (2.08%)  1 0/51 (0.00%)  0 1/99 (1.01%)  1
Gamma-glutamyltransferase decreased  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Gamma-glutamyltransferase increased  1  1/48 (2.08%)  1 2/51 (3.92%)  2 3/99 (3.03%)  3
Glycosylated haemoglobin increased  1  1/48 (2.08%)  1 0/51 (0.00%)  0 1/99 (1.01%)  1
Lymphocyte count decreased  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Neutrophil count decreased  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Platelet count decreased  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Specific gravity urine increased  1  1/48 (2.08%)  1 0/51 (0.00%)  0 1/99 (1.01%)  1
Urine ketone body present  1  2/48 (4.17%)  2 0/51 (0.00%)  0 2/99 (2.02%)  2
Weight decreased  1  1/48 (2.08%)  1 2/51 (3.92%)  2 3/99 (3.03%)  3
Metabolism and nutrition disorders       
Carbohydrate intolerance  1  1/48 (2.08%)  1 0/51 (0.00%)  0 1/99 (1.01%)  1
Decreased appetite  1  5/48 (10.42%)  5 2/51 (3.92%)  2 7/99 (7.07%)  7
Hypercholesterolaemia  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Hyperglycaemia  1  1/48 (2.08%)  1 1/51 (1.96%)  1 2/99 (2.02%)  2
Hyperkalaemia  1  0/48 (0.00%)  0 2/51 (3.92%)  2 2/99 (2.02%)  2
Hypernatraemia  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Hypertriglyceridaemia  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Hyperuricaemia  1  1/48 (2.08%)  1 0/51 (0.00%)  0 1/99 (1.01%)  1
Hypoalbuminaemia  1  1/48 (2.08%)  1 0/51 (0.00%)  0 1/99 (1.01%)  1
Hypocalcaemia  1  1/48 (2.08%)  1 2/51 (3.92%)  2 3/99 (3.03%)  3
Hypoglycaemia  1  1/48 (2.08%)  3 1/51 (1.96%)  1 2/99 (2.02%)  4
Hypokalaemia  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Hyponatraemia  1  1/48 (2.08%)  1 0/51 (0.00%)  0 1/99 (1.01%)  1
Malnutrition  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Vitamin D deficiency  1  1/48 (2.08%)  1 1/51 (1.96%)  1 2/99 (2.02%)  2
Musculoskeletal and connective tissue disorders       
Arthralgia  1  0/48 (0.00%)  0 5/51 (9.80%)  7 5/99 (5.05%)  7
Back pain  1  2/48 (4.17%)  2 2/51 (3.92%)  2 4/99 (4.04%)  4
Exostosis  1  1/48 (2.08%)  1 0/51 (0.00%)  0 1/99 (1.01%)  1
Flank pain  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Intervertebral disc degeneration  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Intervertebral disc protrusion  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Joint swelling  1  0/48 (0.00%)  0 3/51 (5.88%)  5 3/99 (3.03%)  5
Mobility decreased  1  1/48 (2.08%)  1 0/51 (0.00%)  0 1/99 (1.01%)  1
Muscle spasms  1  1/48 (2.08%)  1 2/51 (3.92%)  3 3/99 (3.03%)  4
Musculoskeletal chest pain  1  1/48 (2.08%)  1 1/51 (1.96%)  1 2/99 (2.02%)  2
Musculoskeletal discomfort  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Musculoskeletal pain  1  1/48 (2.08%)  1 2/51 (3.92%)  2 3/99 (3.03%)  3
Myalgia  1  0/48 (0.00%)  0 1/51 (1.96%)  2 1/99 (1.01%)  2
Neck pain  1  0/48 (0.00%)  0 2/51 (3.92%)  2 2/99 (2.02%)  2
Osteoarthritis  1  1/48 (2.08%)  1 1/51 (1.96%)  1 2/99 (2.02%)  2
Osteoporosis  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Pain in extremity  1  2/48 (4.17%)  2 1/51 (1.96%)  2 3/99 (3.03%)  4
Periarthritis  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Rheumatoid arthritis  1  0/48 (0.00%)  0 1/51 (1.96%)  2 1/99 (1.01%)  2
Spinal pain  1  1/48 (2.08%)  1 2/51 (3.92%)  2 3/99 (3.03%)  3
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Metastases to liver  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Nervous system disorders       
Ageusia  1  1/48 (2.08%)  1 0/51 (0.00%)  0 1/99 (1.01%)  1
Aphasia  1  0/48 (0.00%)  0 1/51 (1.96%)  2 1/99 (1.01%)  2
Balance disorder  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Dizziness  1  3/48 (6.25%)  3 5/51 (9.80%)  7 8/99 (8.08%)  10
Dizziness postural  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Head discomfort  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Headache  1  3/48 (6.25%)  3 4/51 (7.84%)  5 7/99 (7.07%)  8
Lethargy  1  1/48 (2.08%)  1 1/51 (1.96%)  1 2/99 (2.02%)  2
Poor quality sleep  1  1/48 (2.08%)  1 1/51 (1.96%)  1 2/99 (2.02%)  2
Presyncope  1  0/48 (0.00%)  0 2/51 (3.92%)  2 2/99 (2.02%)  2
Sciatica  1  0/48 (0.00%)  0 2/51 (3.92%)  2 2/99 (2.02%)  2
Syncope  1  1/48 (2.08%)  1 0/51 (0.00%)  0 1/99 (1.01%)  1
Taste disorder  1  1/48 (2.08%)  1 0/51 (0.00%)  0 1/99 (1.01%)  1
Tremor  1  1/48 (2.08%)  1 2/51 (3.92%)  2 3/99 (3.03%)  3
Psychiatric disorders       
Acrophobia  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Confusional state  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Insomnia  1  2/48 (4.17%)  2 0/51 (0.00%)  0 2/99 (2.02%)  2
Mood altered  1  1/48 (2.08%)  1 0/51 (0.00%)  0 1/99 (1.01%)  1
Panic attack  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Sleep disorder  1  0/48 (0.00%)  0 2/51 (3.92%)  2 2/99 (2.02%)  2
Renal and urinary disorders       
Chronic kidney disease  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Dysuria  1  0/48 (0.00%)  0 2/51 (3.92%)  2 2/99 (2.02%)  2
Haematuria  1  1/48 (2.08%)  1 2/51 (3.92%)  2 3/99 (3.03%)  3
Urethral stenosis  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Reproductive system and breast disorders       
Gynaecomastia  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Respiratory, thoracic and mediastinal disorders       
Asthma  1  1/48 (2.08%)  1 0/51 (0.00%)  0 1/99 (1.01%)  1
Cough  1  3/48 (6.25%)  3 3/51 (5.88%)  3 6/99 (6.06%)  6
Dysphonia  1  1/48 (2.08%)  1 0/51 (0.00%)  0 1/99 (1.01%)  1
Dyspnoea  1  0/48 (0.00%)  0 4/51 (7.84%)  5 4/99 (4.04%)  5
Dyspnoea exertional  1  1/48 (2.08%)  1 2/51 (3.92%)  2 3/99 (3.03%)  3
Increased upper airway secretion  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Oropharyngeal pain  1  0/48 (0.00%)  0 2/51 (3.92%)  2 2/99 (2.02%)  2
Orthopnoea  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Productive cough  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Sputum discoloured  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Skin and subcutaneous tissue disorders       
Erythema  1  0/48 (0.00%)  0 2/51 (3.92%)  2 2/99 (2.02%)  2
Hyperhidrosis  1  1/48 (2.08%)  1 0/51 (0.00%)  0 1/99 (1.01%)  1
Night sweats  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Photosensitivity reaction  1  1/48 (2.08%)  1 0/51 (0.00%)  0 1/99 (1.01%)  1
Pruritus  1  1/48 (2.08%)  1 3/51 (5.88%)  4 4/99 (4.04%)  5
Pruritus generalised  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Rash  1  1/48 (2.08%)  1 1/51 (1.96%)  1 2/99 (2.02%)  2
Skin fissures  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Skin irritation  1  0/48 (0.00%)  0 2/51 (3.92%)  2 2/99 (2.02%)  2
Urticaria  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Surgical and medical procedures       
Injection  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Vascular disorders       
Deep vein thrombosis  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Flushing  1  2/48 (4.17%)  2 9/51 (17.65%)  14 11/99 (11.11%)  16
Haematoma  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Hot flush  1  0/48 (0.00%)  0 2/51 (3.92%)  14 2/99 (2.02%)  14
Hypertension  1  2/48 (4.17%)  2 9/51 (17.65%)  9 11/99 (11.11%)  11
Peripheral venous disease  1  0/48 (0.00%)  0 1/51 (1.96%)  1 1/99 (1.01%)  1
Venous thrombosis limb  1  1/48 (2.08%)  1 0/51 (0.00%)  0 1/99 (1.01%)  1
1
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ipsen Medical Director
Organization: Ipsen
Phone: see email
EMail: clinical.trials@ipsen.com
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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT02651987    
Other Study ID Numbers: 8-79-52030-326
2014-005607-24 ( EudraCT Number )
First Submitted: December 11, 2015
First Posted: January 11, 2016
Results First Submitted: October 16, 2020
Results First Posted: December 30, 2020
Last Update Posted: December 30, 2020