Trial Outcomes & Findings for Efficacy and Safety Study in Pancreatic or Midgut Neuroendocrine Tumours Having Progressed Radiologically While Previously Treated With Lanreotide Autogel® 120 mg (NCT NCT02651987)
NCT ID: NCT02651987
Last Updated: 2022-10-03
Results Overview
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.
COMPLETED
PHASE2
99 participants
From Day 1 up to Week 60 for the panNET cohort and Week 103 for the midgut NET cohort
2022-10-03
Participant Flow
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.
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).
Participant milestones
| Measure |
Pancreatic NET (panNET) Cohort
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.
|
Midgut NET Cohort
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 Study
STARTED
|
48
|
51
|
|
Overall Study
COMPLETED
|
43
|
46
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
Pancreatic NET (panNET) Cohort
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.
|
Midgut NET Cohort
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 Study
Adverse Event
|
2
|
2
|
|
Overall Study
Consent Withdrawn
|
2
|
0
|
|
Overall Study
Local PD
|
0
|
2
|
|
Overall Study
Investigator Decision
|
1
|
1
|
Baseline Characteristics
French local regulation does not allow the collection of race and therefore French subjects are not included in this baseline measure.
Baseline characteristics by cohort
| Measure |
PanNET Cohort
n=48 Participants
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.
|
Midgut NET Cohort
n=51 Participants
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
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.3 years
STANDARD_DEVIATION 10.6 • n=48 Participants
|
67.1 years
STANDARD_DEVIATION 8.2 • n=51 Participants
|
65.2 years
STANDARD_DEVIATION 9.6 • n=99 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=48 Participants
|
22 Participants
n=51 Participants
|
50 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=48 Participants
|
29 Participants
n=51 Participants
|
49 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
0 Participants
n=36 Participants • French local regulation does not allow the collection of race and therefore French subjects are not included in this baseline measure.
|
1 Participants
n=38 Participants • French local regulation does not allow the collection of race and therefore French subjects are not included in this baseline measure.
|
1 Participants
n=74 Participants • French local regulation does not allow the collection of race and therefore French subjects are not included in this baseline measure.
|
|
Race/Ethnicity, Customized
Race · White
|
35 Participants
n=36 Participants • French local regulation does not allow the collection of race and therefore French subjects are not included in this baseline measure.
|
37 Participants
n=38 Participants • French local regulation does not allow the collection of race and therefore French subjects are not included in this baseline measure.
|
72 Participants
n=74 Participants • French local regulation does not allow the collection of race and therefore French subjects are not included in this baseline measure.
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=36 Participants • French local regulation does not allow the collection of race and therefore French subjects are not included in this baseline measure.
|
0 Participants
n=38 Participants • French local regulation does not allow the collection of race and therefore French subjects are not included in this baseline measure.
|
1 Participants
n=74 Participants • French local regulation does not allow the collection of race and therefore French subjects are not included in this baseline measure.
|
|
Region of Enrollment
Netherlands
|
1 participants
n=48 Participants
|
3 participants
n=51 Participants
|
4 participants
n=99 Participants
|
|
Region of Enrollment
Belgium
|
3 participants
n=48 Participants
|
2 participants
n=51 Participants
|
5 participants
n=99 Participants
|
|
Region of Enrollment
Ireland
|
2 participants
n=48 Participants
|
0 participants
n=51 Participants
|
2 participants
n=99 Participants
|
|
Region of Enrollment
Denmark
|
1 participants
n=48 Participants
|
2 participants
n=51 Participants
|
3 participants
n=99 Participants
|
|
Region of Enrollment
Poland
|
12 participants
n=48 Participants
|
10 participants
n=51 Participants
|
22 participants
n=99 Participants
|
|
Region of Enrollment
Italy
|
2 participants
n=48 Participants
|
6 participants
n=51 Participants
|
8 participants
n=99 Participants
|
|
Region of Enrollment
United Kingdom
|
6 participants
n=48 Participants
|
9 participants
n=51 Participants
|
15 participants
n=99 Participants
|
|
Region of Enrollment
France
|
12 participants
n=48 Participants
|
13 participants
n=51 Participants
|
25 participants
n=99 Participants
|
|
Region of Enrollment
Germany
|
8 participants
n=48 Participants
|
3 participants
n=51 Participants
|
11 participants
n=99 Participants
|
|
Region of Enrollment
Spain
|
1 participants
n=48 Participants
|
3 participants
n=51 Participants
|
4 participants
n=99 Participants
|
|
Quality of Life (QoL) Questionnaire Core 30 (QLQ-C30) Score
|
68.12 score on a scale
STANDARD_DEVIATION 19.74 • n=46 Participants • Only subjects who had a QLQ-C30 measure at baseline are included.
|
67.83 score on a scale
STANDARD_DEVIATION 20.76 • n=50 Participants • Only subjects who had a QLQ-C30 measure at baseline are included.
|
67.97 score on a scale
STANDARD_DEVIATION 20.17 • n=96 Participants • 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
|
0.82 score on a scale
STANDARD_DEVIATION 0.17 • n=45 Participants • Only subjects with a EQ-5D-5L index value at baseline are included.
|
0.83 score on a scale
STANDARD_DEVIATION 0.14 • n=45 Participants • Only subjects with a EQ-5D-5L index value at baseline are included.
|
0.83 score on a scale
STANDARD_DEVIATION 0.15 • n=90 Participants • Only subjects with a EQ-5D-5L index value at baseline are included.
|
|
EQ-5D-5L Visual Analogue Scale (VAS) Score
|
75.02 score on a scale
STANDARD_DEVIATION 17.93 • n=47 Participants • Only subjects with a EQ-5D-5L VAS score at baseline are included.
|
70.45 score on a scale
STANDARD_DEVIATION 14.93 • n=44 Participants • Only subjects with a EQ-5D-5L VAS score at baseline are included.
|
72.81 score on a scale
STANDARD_DEVIATION 16.62 • n=91 Participants • Only subjects with a EQ-5D-5L VAS score at baseline are included.
|
|
QoL Questionnaire Gastrointestinal Neuroendocrine Tumour 21 (QLQ-GI.NET21) Score
Endocrine Symptoms
|
16.54 score on a scale
STANDARD_DEVIATION 22.30 • n=45 Participants • Only subjects who had a QLQ GI.NET21 measure at baseline are included.
|
19.73 score on a scale
STANDARD_DEVIATION 22.82 • n=49 Participants • Only subjects who had a QLQ GI.NET21 measure at baseline are included.
|
18.20 score on a scale
STANDARD_DEVIATION 22.51 • n=94 Participants • Only subjects who had a QLQ GI.NET21 measure at baseline are included.
|
|
QoL Questionnaire Gastrointestinal Neuroendocrine Tumour 21 (QLQ-GI.NET21) Score
Gastrointestinal Symptoms
|
21.70 score on a scale
STANDARD_DEVIATION 20.01 • n=45 Participants • Only subjects who had a QLQ GI.NET21 measure at baseline are included.
|
22.04 score on a scale
STANDARD_DEVIATION 17.17 • n=49 Participants • Only subjects who had a QLQ GI.NET21 measure at baseline are included.
|
21.88 score on a scale
STANDARD_DEVIATION 18.48 • n=94 Participants • Only subjects who had a QLQ GI.NET21 measure at baseline are included.
|
|
QoL Questionnaire Gastrointestinal Neuroendocrine Tumour 21 (QLQ-GI.NET21) Score
Treatment Related Symptoms
|
11.63 score on a scale
STANDARD_DEVIATION 13.11 • n=32 Participants • Only subjects who had a QLQ GI.NET21 measure at baseline are included.
|
11.46 score on a scale
STANDARD_DEVIATION 13.75 • n=32 Participants • Only subjects who had a QLQ GI.NET21 measure at baseline are included.
|
11.55 score on a scale
STANDARD_DEVIATION 13.33 • n=64 Participants • Only subjects who had a QLQ GI.NET21 measure at baseline are included.
|
|
QoL Questionnaire Gastrointestinal Neuroendocrine Tumour 21 (QLQ-GI.NET21) Score
Social Function
|
32.84 score on a scale
STANDARD_DEVIATION 24.18 • n=45 Participants • Only subjects who had a QLQ GI.NET21 measure at baseline are included.
|
35.03 score on a scale
STANDARD_DEVIATION 24.33 • n=49 Participants • Only subjects who had a QLQ GI.NET21 measure at baseline are included.
|
33.98 score on a scale
STANDARD_DEVIATION 24.15 • n=94 Participants • Only subjects who had a QLQ GI.NET21 measure at baseline are included.
|
|
QoL Questionnaire Gastrointestinal Neuroendocrine Tumour 21 (QLQ-GI.NET21) Score
Disease Related Worries
|
44.44 score on a scale
STANDARD_DEVIATION 29.96 • n=45 Participants • Only subjects who had a QLQ GI.NET21 measure at baseline are included.
|
44.22 score on a scale
STANDARD_DEVIATION 25.83 • n=49 Participants • Only subjects who had a QLQ GI.NET21 measure at baseline are included.
|
44.33 score on a scale
STANDARD_DEVIATION 27.74 • n=94 Participants • Only subjects who had a QLQ GI.NET21 measure at baseline are included.
|
|
QoL Questionnaire Gastrointestinal Neuroendocrine Tumour 21 (QLQ-GI.NET21) Score
Muscle/Bone Pain
|
26.52 score on a scale
STANDARD_DEVIATION 30.99 • n=44 Participants • Only subjects who had a QLQ GI.NET21 measure at baseline are included.
|
25.69 score on a scale
STANDARD_DEVIATION 30.16 • n=48 Participants • Only subjects who had a QLQ GI.NET21 measure at baseline are included.
|
26.09 score on a scale
STANDARD_DEVIATION 30.39 • n=92 Participants • Only subjects who had a QLQ GI.NET21 measure at baseline are included.
|
|
QoL Questionnaire Gastrointestinal Neuroendocrine Tumour 21 (QLQ-GI.NET21) Score
Sexual Function
|
22.58 score on a scale
STANDARD_DEVIATION 30.29 • n=31 Participants • Only subjects who had a QLQ GI.NET21 measure at baseline are included.
|
17.86 score on a scale
STANDARD_DEVIATION 27.94 • n=28 Participants • Only subjects who had a QLQ GI.NET21 measure at baseline are included.
|
20.34 score on a scale
STANDARD_DEVIATION 29.04 • n=59 Participants • Only subjects who had a QLQ GI.NET21 measure at baseline are included.
|
|
QoL Questionnaire Gastrointestinal Neuroendocrine Tumour 21 (QLQ-GI.NET21) Score
Information/Communication Function
|
3.70 score on a scale
STANDARD_DEVIATION 12.76 • n=45 Participants • Only subjects who had a QLQ GI.NET21 measure at baseline are included.
|
4.17 score on a scale
STANDARD_DEVIATION 11.14 • n=48 Participants • Only subjects who had a QLQ GI.NET21 measure at baseline are included.
|
3.94 score on a scale
STANDARD_DEVIATION 11.89 • n=93 Participants • Only subjects who had a QLQ GI.NET21 measure at baseline are included.
|
|
QoL Questionnaire Gastrointestinal Neuroendocrine Tumour 21 (QLQ-GI.NET21) Score
Body Image
|
10.61 score on a scale
STANDARD_DEVIATION 23.60 • n=44 Participants • Only subjects who had a QLQ GI.NET21 measure at baseline are included.
|
15.56 score on a scale
STANDARD_DEVIATION 28.95 • n=45 Participants • Only subjects who had a QLQ GI.NET21 measure at baseline are included.
|
13.11 score on a scale
STANDARD_DEVIATION 26.41 • n=89 Participants • Only subjects who had a QLQ GI.NET21 measure at baseline are included.
|
|
Categories of Proliferation index Ki67
≥10%
|
7 participants
n=48 Participants
|
4 participants
n=51 Participants
|
11 participants
n=99 Participants
|
|
Categories of Proliferation index Ki67
<10%
|
41 participants
n=48 Participants
|
46 participants
n=51 Participants
|
87 participants
n=99 Participants
|
|
Categories of Proliferation index Ki67
Missing
|
0 participants
n=48 Participants
|
1 participants
n=51 Participants
|
1 participants
n=99 Participants
|
|
Tumour grading (according to WHO 2010 classification)
Grade 1
|
12 participants
n=48 Participants
|
29 participants
n=51 Participants
|
41 participants
n=99 Participants
|
|
Tumour grading (according to WHO 2010 classification)
Grade 2
|
36 participants
n=48 Participants
|
22 participants
n=51 Participants
|
58 participants
n=99 Participants
|
|
Hepatic tumour load
>25%
|
7 participants
n=48 Participants
|
9 participants
n=51 Participants
|
16 participants
n=99 Participants
|
|
Hepatic tumour load
≤25%
|
41 participants
n=48 Participants
|
42 participants
n=51 Participants
|
83 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to Week 60 for the panNET cohort and Week 103 for the midgut NET cohortPopulation: The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
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.
Outcome measures
| Measure |
PanNET Cohort
n=48 Participants
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.
|
Midgut NET Cohort
n=51 Participants
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
All subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|---|---|---|---|
|
Median Progression Free Survival (PFS)
|
5.6 months
Interval 5.5 to 8.3
|
8.3 months
Interval 5.6 to 11.1
|
—
|
SECONDARY outcome
Timeframe: From Day 1 up to Week 60 for the panNET cohort and Week 103 for the midgut NET cohortPopulation: The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
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.
Outcome measures
| Measure |
PanNET Cohort
n=48 Participants
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.
|
Midgut NET Cohort
n=51 Participants
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
All subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|---|---|---|---|
|
Median Time to Progression
|
5.6 months
Interval 5.5 to 8.3
|
8.7 months
Interval 8.3 to 13.9
|
—
|
SECONDARY outcome
Timeframe: Weeks 12, 24, 36, 48, 60 (for both cohorts) and Weeks 72, 84 and 96 (for midgut NET cohort)Population: The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
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.
Outcome measures
| Measure |
PanNET Cohort
n=48 Participants
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.
|
Midgut NET Cohort
n=51 Participants
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
All subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|---|---|---|---|
|
Percentage of Subjects Alive and Progression Free
Week 12
|
93.3 percentage of subjects
Interval 80.7 to 97.8
|
91.8 percentage of subjects
Interval 79.7 to 96.9
|
—
|
|
Percentage of Subjects Alive and Progression Free
Week 24
|
64.4 percentage of subjects
Interval 48.7 to 76.5
|
65.3 percentage of subjects
Interval 50.3 to 76.8
|
—
|
|
Percentage of Subjects Alive and Progression Free
Week 36
|
37.8 percentage of subjects
Interval 23.9 to 51.6
|
59.2 percentage of subjects
Interval 44.2 to 71.4
|
—
|
|
Percentage of Subjects Alive and Progression Free
Week 48
|
28.5 percentage of subjects
Interval 16.2 to 42.1
|
38.3 percentage of subjects
Interval 24.8 to 51.6
|
—
|
|
Percentage of Subjects Alive and Progression Free
Week 60
|
20.7 percentage of subjects
Interval 9.0 to 35.7
|
36.1 percentage of subjects
Interval 22.9 to 49.5
|
—
|
|
Percentage of Subjects Alive and Progression Free
Week 72
|
—
|
29.8 percentage of subjects
Interval 17.6 to 42.9
|
—
|
|
Percentage of Subjects Alive and Progression Free
Week 84
|
—
|
27.5 percentage of subjects
Interval 15.7 to 40.5
|
—
|
|
Percentage of Subjects Alive and Progression Free
Week 96
|
—
|
25.2 percentage of subjects
Interval 13.9 to 38.1
|
—
|
SECONDARY outcome
Timeframe: From Day 1 up to Week 60 for the panNET cohort and Week 103 for the midgut NET cohortPopulation: The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
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.
Outcome measures
| Measure |
PanNET Cohort
n=48 Participants
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.
|
Midgut NET Cohort
n=51 Participants
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
All subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|---|---|---|---|
|
Overall Survival
|
NA months
The median overall survival from the Kaplan Meier model was not reached for this cohort.
|
NA months
The median overall survival from the Kaplan Meier model was not reached for this cohort.
|
—
|
SECONDARY outcome
Timeframe: Weeks 12, 24, 36, 48, 60 (for both cohorts) and Weeks 72, 84, and 96 (for midgut cohort)Population: The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
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.
Outcome measures
| Measure |
PanNET Cohort
n=48 Participants
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.
|
Midgut NET Cohort
n=51 Participants
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
All subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|---|---|---|---|
|
Objective Response Rate (ORR)
Week 12
|
0.0 percentage of subjects
Interval 0.0 to 7.4
|
0.0 percentage of subjects
Interval 0.0 to 7.0
|
—
|
|
Objective Response Rate (ORR)
Week 24
|
0.0 percentage of subjects
Interval 0.0 to 7.4
|
0.0 percentage of subjects
Interval 0.0 to 7.0
|
—
|
|
Objective Response Rate (ORR)
Week 36
|
0.0 percentage of subjects
Interval 0.0 to 7.4
|
0.0 percentage of subjects
Interval 0.0 to 7.0
|
—
|
|
Objective Response Rate (ORR)
Week 48
|
0.0 percentage of subjects
Interval 0.0 to 7.4
|
0.0 percentage of subjects
Interval 0.0 to 7.0
|
—
|
|
Objective Response Rate (ORR)
Week 60
|
0.0 percentage of subjects
Interval 0.0 to 7.4
|
2.0 percentage of subjects
Interval 0.0 to 10.4
|
—
|
|
Objective Response Rate (ORR)
Week 72
|
—
|
3.9 percentage of subjects
Interval 0.5 to 13.5
|
—
|
|
Objective Response Rate (ORR)
Week 84
|
—
|
2.0 percentage of subjects
Interval 0.0 to 10.4
|
—
|
|
Objective Response Rate (ORR)
Week 96
|
—
|
2.0 percentage of subjects
Interval 0.0 to 10.4
|
—
|
SECONDARY outcome
Timeframe: Weeks 24 and 48Population: The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
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.
Outcome measures
| Measure |
PanNET Cohort
n=48 Participants
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.
|
Midgut NET Cohort
n=51 Participants
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
All subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|---|---|---|---|
|
Disease Control Rate (DCR)
Week 24
|
43.8 percentage of subjects
Interval 29.5 to 58.8
|
58.8 percentage of subjects
Interval 44.2 to 72.4
|
—
|
|
Disease Control Rate (DCR)
Week 48
|
22.9 percentage of subjects
Interval 12.0 to 37.3
|
33.3 percentage of subjects
Interval 20.8 to 47.9
|
—
|
SECONDARY outcome
Timeframe: From Day 1 up to Week 60 for the panNET cohort and Week 103 for the midgut NET cohortPopulation: The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
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.
Outcome measures
| Measure |
PanNET Cohort
n=48 Participants
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.
|
Midgut NET Cohort
n=51 Participants
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
All subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|---|---|---|---|
|
Best Overall Response Rate
Not evaluable
|
0.0 percentage of subjects
Interval 0.0 to 7.4
|
2.0 percentage of subjects
Interval 0.0 to 10.4
|
—
|
|
Best Overall Response Rate
CR
|
0.0 percentage of subjects
Interval 0.0 to 7.4
|
0.0 percentage of subjects
Interval 0.0 to 7.0
|
—
|
|
Best Overall Response Rate
PR
|
0.0 percentage of subjects
Interval 0.0 to 7.4
|
3.9 percentage of subjects
Interval 0.5 to 13.5
|
—
|
|
Best Overall Response Rate
SD
|
66.7 percentage of subjects
Interval 51.6 to 79.6
|
68.6 percentage of subjects
Interval 54.1 to 80.9
|
—
|
|
Best Overall Response Rate
PD
|
31.3 percentage of subjects
Interval 18.7 to 46.3
|
23.5 percentage of subjects
Interval 12.8 to 37.5
|
—
|
SECONDARY outcome
Timeframe: From Day 1 up to Week 60 for the panNET cohort and Week 103 for the midgut NET cohortPopulation: The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
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.
Outcome measures
| Measure |
PanNET Cohort
n=48 Participants
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.
|
Midgut NET Cohort
n=51 Participants
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
All subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|---|---|---|---|
|
Median Duration of Stable Disease
|
8.3 months
Interval 8.0 to 13.8
|
13.8 months
Interval 8.6 to
95% confidence interval upper limit could not be calculated as an insufficient number of events were observed.
|
—
|
SECONDARY outcome
Timeframe: Screening/Baseline (Day 1)Population: The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
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.
Outcome measures
| Measure |
PanNET Cohort
n=48 Participants
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.
|
Midgut NET Cohort
n=51 Participants
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
All subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|---|---|---|---|
|
Factors Associated With PFS
Ki67: ≥10% Vs <10%
|
3.60 Hazard Ratio
Interval 1.39 to 9.32
|
2.26 Hazard Ratio
Interval 0.67 to 7.6
|
—
|
|
Factors Associated With PFS
Tumour Grade: 2 Vs 1
|
0.68 Hazard Ratio
Interval 0.32 to 1.45
|
0.90 Hazard Ratio
Interval 0.46 to 1.77
|
—
|
|
Factors Associated With PFS
Age: ≥65 years Vs <65 years
|
1.55 Hazard Ratio
Interval 0.79 to 3.06
|
1.15 Hazard Ratio
Interval 0.58 to 2.31
|
—
|
|
Factors Associated With PFS
Hepatic tumour load: >25% Vs ≤25%
|
0.96 Hazard Ratio
Interval 0.4 to 2.32
|
1.54 Hazard Ratio
Interval 0.7 to 3.4
|
—
|
|
Factors Associated With PFS
Previous surgery: No Vs Yes
|
1.04 Hazard Ratio
Interval 0.53 to 2.04
|
2.14 Hazard Ratio
Interval 0.83 to 5.52
|
—
|
|
Factors Associated With PFS
Duration of treatment with lanreotide Autogel® 120 mg every 28 days: ≥median Vs <median
|
0.68 Hazard Ratio
Interval 0.34 to 1.34
|
0.76 Hazard Ratio
Interval 0.4 to 1.47
|
—
|
|
Factors Associated With PFS
Time from diagnosis: ≥3 years Vs <3 years
|
0.49 Hazard Ratio
Interval 0.25 to 0.96
|
0.94 Hazard Ratio
Interval 0.49 to 1.82
|
—
|
|
Factors Associated With PFS
Time between CT scans: ≥12 months Vs <12 months
|
0.47 Hazard Ratio
Interval 0.24 to 0.94
|
0.72 Hazard Ratio
Interval 0.37 to 1.39
|
—
|
|
Factors Associated With PFS
Symptoms: No Vs Yes
|
2.55 Hazard Ratio
Interval 0.89 to 7.28
|
1.32 Hazard Ratio
Interval 0.68 to 2.56
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Weeks 8,12, 48 and end of study (approximately 64 weeks for panNET cohort and 108 weeks for midgut NET cohort)Population: 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.
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.
Outcome measures
| Measure |
PanNET Cohort
n=48 Participants
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.
|
Midgut NET Cohort
n=51 Participants
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
All subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|---|---|---|---|
|
Mean Change From Baseline in Number of Stools and Flushing Episodes
Flushing - Week 48
|
-1.0 episodes
Standard Deviation 0.0
|
-1.5 episodes
Standard Deviation 2.1
|
—
|
|
Mean Change From Baseline in Number of Stools and Flushing Episodes
Stools - Week 8
|
1.0 episodes
Standard Deviation 5.5
|
-1.0 episodes
Standard Deviation 8.2
|
—
|
|
Mean Change From Baseline in Number of Stools and Flushing Episodes
Stools - Week 12
|
-1.2 episodes
Standard Deviation 7.9
|
0.7 episodes
Standard Deviation 2.5
|
—
|
|
Mean Change From Baseline in Number of Stools and Flushing Episodes
Stools - Week 48
|
-1.0 episodes
Standard Deviation 0.0
|
3.4 episodes
Standard Deviation 4.8
|
—
|
|
Mean Change From Baseline in Number of Stools and Flushing Episodes
Stools - End of Study
|
0.5 episodes
Standard Deviation 5.4
|
-1.2 episodes
Standard Deviation 12.2
|
—
|
|
Mean Change From Baseline in Number of Stools and Flushing Episodes
Flushing - Week 8
|
0.7 episodes
Standard Deviation 2.1
|
-3.3 episodes
Standard Deviation 8.3
|
—
|
|
Mean Change From Baseline in Number of Stools and Flushing Episodes
Flushing - Week 12
|
-1.0 episodes
Standard Deviation 0.0
|
1.5 episodes
Standard Deviation 10.0
|
—
|
|
Mean Change From Baseline in Number of Stools and Flushing Episodes
Flushing - End of Study
|
0.0 episodes
Standard Deviation 1.4
|
-0.5 episodes
Standard Deviation 6.2
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and end of study (approximately 64 weeks for panNET cohort and 108 weeks for midgut NET (and overall) cohort)Population: 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.
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.
Outcome measures
| Measure |
PanNET Cohort
n=22 Participants
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.
|
Midgut NET Cohort
n=25 Participants
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
n=47 Participants
All subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|---|---|---|---|
|
Mean Change From Baseline in QoL Measured Using EORTC, QLQ-C30 v3.0 (Global Health Status Sub-score)
|
-0.38 score on a scale
Standard Deviation 15.32
|
-1.33 score on a scale
Standard Deviation 17.13
|
-0.89 score on a scale
Standard Deviation 16.14
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and end of study (approximately 64 weeks for panNET cohort and 108 weeks for midgut NET (and overall) cohort)Population: 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.
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.
Outcome measures
| Measure |
PanNET Cohort
n=22 Participants
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.
|
Midgut NET Cohort
n=21 Participants
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
n=43 Participants
All subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|---|---|---|---|
|
Mean Change From Baseline in EQ-5D-5L v1.0 Questionnaire (Descriptive System)
|
-0.04 Index value
Standard Deviation 0.12
|
0.00 Index value
Standard Deviation 0.11
|
-0.02 Index value
Standard Deviation 0.12
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and end of study (approximately 64 weeks for panNET cohort and 108 weeks for midgut NET (and overall) cohort)Population: 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.
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.
Outcome measures
| Measure |
PanNET Cohort
n=21 Participants
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.
|
Midgut NET Cohort
n=21 Participants
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
n=42 Participants
All subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|---|---|---|---|
|
Mean Change From Baseline in EQ-5D-5L v1.0 Questionnaire (VAS)
|
-1.90 score on a scale
Standard Deviation 14.80
|
-1.76 score on a scale
Standard Deviation 9.34
|
-1.83 score on a scale
Standard Deviation 12.22
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and end of study (approximately 64 weeks for panNET cohort and 108 weeks for midgut NET (and overall) cohort)Population: 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.
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.
Outcome measures
| Measure |
PanNET Cohort
n=48 Participants
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.
|
Midgut NET Cohort
n=51 Participants
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
n=99 Participants
All subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|---|---|---|---|
|
Mean Change From Baseline in QoL Questionnaire Gastrointestinal Neuroendocrine Tumour 21 (QLQ-GI.NET21; 2006)
Endocrine Symptoms
|
-0.53 score on a scale
Standard Deviation 11.37
|
-5.09 score on a scale
Standard Deviation 17.33
|
-2.96 score on a scale
Standard Deviation 14.87
|
|
Mean Change From Baseline in QoL Questionnaire Gastrointestinal Neuroendocrine Tumour 21 (QLQ-GI.NET21; 2006)
Gastrointestinal Symptoms
|
-3.49 score on a scale
Standard Deviation 14.24
|
-2.78 score on a scale
Standard Deviation 15.96
|
-3.11 score on a scale
Standard Deviation 15.02
|
|
Mean Change From Baseline in QoL Questionnaire Gastrointestinal Neuroendocrine Tumour 21 (QLQ-GI.NET21; 2006)
Treatment Related Symptoms
|
5.93 score on a scale
Standard Deviation 15.64
|
-3.47 score on a scale
Standard Deviation 14.47
|
1.08 score on a scale
Standard Deviation 15.54
|
|
Mean Change From Baseline in QoL Questionnaire Gastrointestinal Neuroendocrine Tumour 21 (QLQ-GI.NET21; 2006)
Social Function
|
-0.79 score on a scale
Standard Deviation 13.41
|
-9.49 score on a scale
Standard Deviation 18.20
|
-5.43 score on a scale
Standard Deviation 16.56
|
|
Mean Change From Baseline in QoL Questionnaire Gastrointestinal Neuroendocrine Tumour 21 (QLQ-GI.NET21; 2006)
Disease Related Worries
|
3.17 score on a scale
Standard Deviation 15.47
|
-0.93 score on a scale
Standard Deviation 27.40
|
0.99 score on a scale
Standard Deviation 22.48
|
|
Mean Change From Baseline in QoL Questionnaire Gastrointestinal Neuroendocrine Tumour 21 (QLQ-GI.NET21; 2006)
Muscle/Bone Pain
|
-1.67 score on a scale
Standard Deviation 33.29
|
0.00 score on a scale
Standard Deviation 36.78
|
-0.76 score on a scale
Standard Deviation 34.84
|
|
Mean Change From Baseline in QoL Questionnaire Gastrointestinal Neuroendocrine Tumour 21 (QLQ-GI.NET21; 2006)
Sexual Function
|
2.38 score on a scale
Standard Deviation 15.82
|
-2.78 score on a scale
Standard Deviation 26.43
|
0.00 score on a scale
Standard Deviation 21.08
|
|
Mean Change From Baseline in QoL Questionnaire Gastrointestinal Neuroendocrine Tumour 21 (QLQ-GI.NET21; 2006)
Information/Communication Function
|
7.94 score on a scale
Standard Deviation 29.64
|
-2.90 score on a scale
Standard Deviation 9.60
|
2.27 score on a scale
Standard Deviation 22.04
|
|
Mean Change From Baseline in QoL Questionnaire Gastrointestinal Neuroendocrine Tumour 21 (QLQ-GI.NET21; 2006)
Body Image
|
0.00 score on a scale
Standard Deviation 15.29
|
-7.58 score on a scale
Standard Deviation 28.97
|
-3.97 score on a scale
Standard Deviation 23.52
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and end of study (approximately 64 weeks for panNET cohort and 108 weeks for midgut NET cohort)Population: 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.
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.
Outcome measures
| Measure |
PanNET Cohort
n=48 Participants
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.
|
Midgut NET Cohort
n=51 Participants
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
All subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|---|---|---|---|
|
Mean Change From Baseline in Nonspecific Tumour Biomarkers
CgA
|
0.205 xULN
Standard Deviation 1.258
|
0.370 xULN
Standard Deviation 1.843
|
—
|
|
Mean Change From Baseline in Nonspecific Tumour Biomarkers
NSE
|
0.03 xULN
Standard Deviation 1.00
|
-0.49 xULN
Standard Deviation 1.86
|
—
|
|
Mean Change From Baseline in Nonspecific Tumour Biomarkers
Plasma 5-HIAA
|
-0.42 xULN
Standard Deviation 1.44
|
3.90 xULN
Standard Deviation 7.39
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and end of study (approximately 64 weeks)Population: 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.
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.
Outcome measures
| Measure |
PanNET Cohort
n=48 Participants
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.
|
Midgut NET Cohort
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
All subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|---|---|---|---|
|
Mean Change From Baseline in PanNet Specific Tumour Biomarkers: Pancreatic Polypeptide, Gastrin
Pancreatic Polypeptide
|
82.7 pmol/L
Standard Deviation 146.7
|
—
|
—
|
|
Mean Change From Baseline in PanNet Specific Tumour Biomarkers: Pancreatic Polypeptide, Gastrin
Gastrin
|
-9.8 pmol/L
Standard Deviation 70.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and end of study (approximately 64 weeks)Population: 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.
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.
Outcome measures
| Measure |
PanNET Cohort
n=4 Participants
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.
|
Midgut NET Cohort
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
All subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|---|---|---|---|
|
Mean Change From Baseline in PanNet Specific Tumour Biomarkers: Glucagon
|
5.5 ng/L
Standard Deviation 36.4
|
—
|
—
|
Adverse Events
PanNET Cohort
Midgut NET Cohort
Overall Subjects
Serious adverse events
| Measure |
PanNET Cohort
n=48 participants at risk
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.
|
Midgut NET Cohort
n=51 participants at risk
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 Subjects
n=99 participants at risk
All subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|---|---|---|---|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Cardiac disorders
Pulseless electrical activity
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
0.00%
0/51 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
General disorders
Asthenia
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
General disorders
Chest pain
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
General disorders
General physical health deterioration
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Immune system disorders
Anaphylactic reaction
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
0.00%
0/51 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Infections and infestations
Viral infection
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
0.00%
0/51 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
0.00%
0/51 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone neoplasm
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Nervous system disorders
Syncope
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
0.00%
0/51 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.9%
2/51 • Number of events 3 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.0%
3/99 • Number of events 4 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Vascular disorders
Hypotension
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
Other adverse events
| Measure |
PanNET Cohort
n=48 participants at risk
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.
|
Midgut NET Cohort
n=51 participants at risk
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 Subjects
n=99 participants at risk
All subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
0.00%
0/51 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Blood and lymphatic system disorders
Monocytopenia
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
0.00%
0/51 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Cardiac disorders
Arrhythmia
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
0.00%
0/51 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Cardiac disorders
Heart valve incompetence
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Cardiac disorders
Palpitations
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
0.00%
0/51 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Cardiac disorders
Tachycardia
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
0.00%
0/51 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Cardiac disorders
Tricuspid valve disease
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Ear and labyrinth disorders
Deafness
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
0.00%
0/51 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
0.00%
0/51 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Ear and labyrinth disorders
Hypoacusis
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
0.00%
0/51 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Ear and labyrinth disorders
Vertigo positional
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
0.00%
0/51 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Eye disorders
Diplopia
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Eye disorders
Dry eye
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Eye disorders
Eye pain
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Eye disorders
Glaucoma
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.9%
2/51 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
2/99 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
11.8%
6/51 • Number of events 7 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
6.1%
6/99 • Number of events 7 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
14.6%
7/48 • Number of events 13 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
23.5%
12/51 • Number of events 16 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
19.2%
19/99 • Number of events 29 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
2/99 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.2%
2/48 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
11.8%
6/51 • Number of events 7 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
8.1%
8/99 • Number of events 9 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Gastrointestinal disorders
Anal incontinence
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
0.00%
0/51 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.9%
2/51 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
2/99 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Gastrointestinal disorders
Constipation
|
4.2%
2/48 • Number of events 3 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.9%
2/51 • Number of events 3 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
4.0%
4/99 • Number of events 6 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
29.2%
14/48 • Number of events 20 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
52.9%
27/51 • Number of events 35 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
41.4%
41/99 • Number of events 55 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Gastrointestinal disorders
Dry mouth
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
0.00%
0/51 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.9%
2/51 • Number of events 3 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
2/99 • Number of events 3 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Gastrointestinal disorders
Flatulence
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
11.8%
6/51 • Number of events 8 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
7.1%
7/99 • Number of events 9 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.9%
2/51 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.0%
3/99 • Number of events 3 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Gastrointestinal disorders
Gingival bleeding
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
0.00%
0/51 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Gastrointestinal disorders
Gingival pain
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
2/99 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Gastrointestinal disorders
Haematochezia
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
0.00%
0/51 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Gastrointestinal disorders
Hernial eventration
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Gastrointestinal disorders
Nausea
|
10.4%
5/48 • Number of events 5 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
11.8%
6/51 • Number of events 9 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
11.1%
11/99 • Number of events 14 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Gastrointestinal disorders
Pancreatic failure
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Gastrointestinal disorders
Steatorrhoea
|
4.2%
2/48 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
5.9%
3/51 • Number of events 3 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
5.1%
5/99 • Number of events 5 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Gastrointestinal disorders
Stomatitis
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
2/99 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Gastrointestinal disorders
Toothache
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
0.00%
0/51 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
6/48 • Number of events 9 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
7.8%
4/51 • Number of events 4 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
10.1%
10/99 • Number of events 13 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
General disorders
Asthenia
|
8.3%
4/48 • Number of events 24 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
7.8%
4/51 • Number of events 5 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
8.1%
8/99 • Number of events 29 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
General disorders
Chest pain
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
5.9%
3/51 • Number of events 3 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.0%
3/99 • Number of events 3 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
General disorders
Fatigue
|
14.6%
7/48 • Number of events 8 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
15.7%
8/51 • Number of events 11 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
15.2%
15/99 • Number of events 19 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
General disorders
Gait disturbance
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
General disorders
Hunger
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
General disorders
Influenza like illness
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
5.9%
3/51 • Number of events 3 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
4.0%
4/99 • Number of events 4 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
General disorders
Injection site bruising
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
0.00%
0/51 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
General disorders
Injection site pain
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
General disorders
Malaise
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.9%
2/51 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.0%
3/99 • Number of events 3 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
General disorders
Medical device site pain
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
0.00%
0/51 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
General disorders
Oedema peripheral
|
4.2%
2/48 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.9%
2/51 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
4.0%
4/99 • Number of events 4 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
General disorders
Pain
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
General disorders
Peripheral swelling
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
5.9%
3/51 • Number of events 3 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.0%
3/99 • Number of events 3 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
General disorders
Polyp
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
General disorders
Pyrexia
|
4.2%
2/48 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.9%
2/51 • Number of events 5 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
4.0%
4/99 • Number of events 7 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
5.9%
3/51 • Number of events 3 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.0%
3/99 • Number of events 3 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Hepatobiliary disorders
Liver injury
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
0.00%
0/51 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Infections and infestations
Carbuncle
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Infections and infestations
Cystitis
|
4.2%
2/48 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.0%
3/99 • Number of events 3 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Infections and infestations
Cystitis bacterial
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.9%
2/51 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
2/99 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.9%
2/51 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
2/99 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Infections and infestations
Influenza
|
4.2%
2/48 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
5.9%
3/51 • Number of events 6 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
5.1%
5/99 • Number of events 8 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Infections and infestations
Lower respiratory tract infection
|
2.1%
1/48 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
5.9%
3/51 • Number of events 3 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
4.0%
4/99 • Number of events 5 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Infections and infestations
Nasopharyngitis
|
14.6%
7/48 • Number of events 7 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
9.8%
5/51 • Number of events 6 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
12.1%
12/99 • Number of events 13 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Infections and infestations
Tonsillitis
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
0.00%
0/51 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Infections and infestations
Urinary tract infection
|
8.3%
4/48 • Number of events 6 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
5.1%
5/99 • Number of events 7 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.9%
2/51 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
2/99 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
0.00%
0/51 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
0.00%
0/51 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Investigations
Alanine aminotransferase increased
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.9%
2/51 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.0%
3/99 • Number of events 3 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Investigations
Aspartate aminotransferase abnormal
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
0.00%
0/51 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Investigations
Aspartate aminotransferase increased
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
2/99 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Investigations
Bacterial test positive
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Investigations
Blood alkaline phosphatase increased
|
6.2%
3/48 • Number of events 3 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
4.0%
4/99 • Number of events 4 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.9%
2/51 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
2/99 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Investigations
Blood chromogranin A increased
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Investigations
Blood creatinine increased
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
0.00%
0/51 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Investigations
Blood glucose decreased
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Investigations
Blood glucose increased
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
2/99 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Investigations
Blood potassium increased
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
0.00%
0/51 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Investigations
Blood urea increased
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
2/99 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Investigations
Blood urine present
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Investigations
Gamma-glutamyltransferase abnormal
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
0.00%
0/51 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Investigations
Gamma-glutamyltransferase decreased
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Investigations
Gamma-glutamyltransferase increased
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.9%
2/51 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.0%
3/99 • Number of events 3 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Investigations
Glycosylated haemoglobin increased
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
0.00%
0/51 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Investigations
Platelet count decreased
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Investigations
Specific gravity urine increased
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
0.00%
0/51 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Investigations
Urine ketone body present
|
4.2%
2/48 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
0.00%
0/51 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
2/99 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Investigations
Weight decreased
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.9%
2/51 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.0%
3/99 • Number of events 3 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Metabolism and nutrition disorders
Carbohydrate intolerance
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
0.00%
0/51 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.4%
5/48 • Number of events 5 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.9%
2/51 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
7.1%
7/99 • Number of events 7 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
2/99 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.9%
2/51 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
2/99 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
0.00%
0/51 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
0.00%
0/51 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.9%
2/51 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.0%
3/99 • Number of events 3 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.1%
1/48 • Number of events 3 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
2/99 • Number of events 4 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
0.00%
0/51 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
2/99 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
9.8%
5/51 • Number of events 7 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
5.1%
5/99 • Number of events 7 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.2%
2/48 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.9%
2/51 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
4.0%
4/99 • Number of events 4 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
0.00%
0/51 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
5.9%
3/51 • Number of events 5 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.0%
3/99 • Number of events 5 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
0.00%
0/51 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.9%
2/51 • Number of events 3 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.0%
3/99 • Number of events 4 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
2/99 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.9%
2/51 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.0%
3/99 • Number of events 3 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.9%
2/51 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
2/99 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
2/99 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.2%
2/48 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.0%
3/99 • Number of events 4 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.9%
2/51 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.0%
3/99 • Number of events 3 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Nervous system disorders
Ageusia
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
0.00%
0/51 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Nervous system disorders
Dizziness
|
6.2%
3/48 • Number of events 3 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
9.8%
5/51 • Number of events 7 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
8.1%
8/99 • Number of events 10 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Nervous system disorders
Headache
|
6.2%
3/48 • Number of events 3 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
7.8%
4/51 • Number of events 5 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
7.1%
7/99 • Number of events 8 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Nervous system disorders
Lethargy
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
2/99 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Nervous system disorders
Poor quality sleep
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
2/99 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.9%
2/51 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
2/99 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.9%
2/51 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
2/99 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Nervous system disorders
Syncope
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
0.00%
0/51 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Nervous system disorders
Taste disorder
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
0.00%
0/51 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Nervous system disorders
Tremor
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.9%
2/51 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.0%
3/99 • Number of events 3 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Psychiatric disorders
Acrophobia
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Psychiatric disorders
Insomnia
|
4.2%
2/48 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
0.00%
0/51 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
2/99 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Psychiatric disorders
Mood altered
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
0.00%
0/51 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.9%
2/51 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
2/99 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.9%
2/51 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
2/99 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Renal and urinary disorders
Haematuria
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.9%
2/51 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.0%
3/99 • Number of events 3 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
0.00%
0/51 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
3/48 • Number of events 3 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
5.9%
3/51 • Number of events 3 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
6.1%
6/99 • Number of events 6 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
0.00%
0/51 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
7.8%
4/51 • Number of events 5 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
4.0%
4/99 • Number of events 5 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.9%
2/51 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.0%
3/99 • Number of events 3 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.9%
2/51 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
2/99 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.9%
2/51 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
2/99 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
0.00%
0/51 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
0.00%
0/51 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
5.9%
3/51 • Number of events 4 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
4.0%
4/99 • Number of events 5 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
2/99 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.9%
2/51 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
2/99 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Surgical and medical procedures
Injection
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Vascular disorders
Flushing
|
4.2%
2/48 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
17.6%
9/51 • Number of events 14 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
11.1%
11/99 • Number of events 16 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Vascular disorders
Haematoma
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Vascular disorders
Hot flush
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
3.9%
2/51 • Number of events 14 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
2/99 • Number of events 14 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Vascular disorders
Hypertension
|
4.2%
2/48 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
17.6%
9/51 • Number of events 9 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
11.1%
11/99 • Number of events 11 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Vascular disorders
Peripheral venous disease
|
0.00%
0/48 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Vascular disorders
Venous thrombosis limb
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
0.00%
0/51 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
1.0%
1/99 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|
Gastrointestinal disorders
Haemorrhoids
|
2.1%
1/48 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
1/51 • Number of events 1 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
2.0%
2/99 • Number of events 2 • 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.
The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place