Efficacy and Safety Study in Pancreatic or Midgut Neuroen... | NCT02651987

ID	Type	Description	Link
2014-005607-24	EudraCT Number

Label	Type	Description	Intervention Names
Lanreotide Autogel®	Experimental	One subcutaneous (SC) injection of lanreotide Autogel® 120mg every 14 days until disease progression or death or unacceptable toxicity or tolerability.	Drug: Lanreotide autogel 120 mg

Name	Type	Description	Arm Group Labels	Other Names
Lanreotide autogel 120 mg	Drug		Lanreotide Autogel®

Measure	Description	Time Frame
Median Progression Free Survival (PFS)	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.	From Day 1 up to Week 60 for the panNET cohort and Week 103 for the midgut NET cohort

Measure	Description	Time Frame
Median Time to Progression	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.

Name	Affiliation	Role
Ipsen Medical Director	Ipsen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Erasme Hospital		Brussels		1070	Belgium
Cliniques Unversitaires Saint Luc

ID	Title	Description
FG000	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.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 9, 2017	Oct 15, 2020

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Median Progression Free Survival (PFS)

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.

The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.

Posted

Median

95% Confidence Interval

months

From Day 1 up to Week 60 for the panNET cohort and Week 103 for the midgut NET cohort

ID	Title	Description
OG000	PanNET Cohort	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.
OG001	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.

Units	Counts
Participants	OG00048 OG00151

Title

Denominators

Categories

Title	Measurements
	OG0005.6(5.5 to 8.3) OG0018.3(5.6 to 11.1)

Secondary

Median Time to Progression

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.

The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.

Posted

Median

95% Confidence Interval

months

From Day 1 up to Week 60 for the panNET cohort and Week 103 for the midgut NET cohort

ID	Title	Description
OG000	PanNET Cohort	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.
OG001	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.

Secondary

Percentage of Subjects Alive and Progression Free

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.

The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.

Posted

Number

95% Confidence Interval

percentage of subjects

Weeks 12, 24, 36, 48, 60 (for both cohorts) and Weeks 72, 84 and 96 (for midgut NET cohort)

ID	Title	Description
OG000	PanNET Cohort	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.
OG001	Midgut NET Cohort

Secondary

Overall Survival

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.

The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.

Posted

Median

95% Confidence Interval

months

From Day 1 up to Week 60 for the panNET cohort and Week 103 for the midgut NET cohort

ID	Title	Description
OG000	PanNET Cohort	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
OG001	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.

Secondary

Objective Response Rate (ORR)

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.

The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.

Posted

Number

95% Confidence Interval

percentage of subjects

Weeks 12, 24, 36, 48, 60 (for both cohorts) and Weeks 72, 84, and 96 (for midgut cohort)

ID	Title	Description
OG000	PanNET Cohort	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.
OG001	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.

Secondary

Disease Control Rate (DCR)

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.

The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.

Posted

Number

95% Confidence Interval

percentage of subjects

Weeks 24 and 48

ID	Title	Description
OG000	PanNET Cohort	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.
OG001	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.

Secondary

Best Overall Response Rate

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.

The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.

Posted

Number

95% Confidence Interval

percentage of subjects

From Day 1 up to Week 60 for the panNET cohort and Week 103 for the midgut NET cohort

ID	Title	Description
OG000	PanNET Cohort	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.
OG001	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.

Secondary

Median Duration of Stable Disease

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.

The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.

Posted

Median

95% Confidence Interval

months

From Day 1 up to Week 60 for the panNET cohort and Week 103 for the midgut NET cohort

ID	Title	Description
OG000	PanNET Cohort	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.
OG001	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.

Secondary

Factors Associated With PFS

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 \

The FAS included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.

Posted

Number

95% Confidence Interval

Hazard Ratio

Screening/Baseline (Day 1)

ID	Title	Description
OG000	PanNET Cohort	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.

Secondary

Mean Change From Baseline in Number of Stools and Flushing Episodes

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.

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.

Posted

Mean

Standard Deviation

episodes

Baseline (Day 1), Weeks 8,12, 48 and end of study (approximately 64 weeks for panNET cohort and 108 weeks for midgut NET cohort)

ID	Title	Description
OG000	PanNET Cohort	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.
OG001	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.

Secondary

Mean Change From Baseline in QoL Measured Using EORTC, QLQ-C30 v3.0 (Global Health Status Sub-score)

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.

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.

Posted

Mean

Standard Deviation

score on a scale

Baseline (Day 1) and end of study (approximately 64 weeks for panNET cohort and 108 weeks for midgut NET (and overall) cohort)

ID	Title	Description
OG000	PanNET Cohort	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.

Secondary

Mean Change From Baseline in EQ-5D-5L v1.0 Questionnaire (Descriptive System)

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.

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.

Posted

Mean

Standard Deviation

Index value

Baseline (Day 1) and end of study (approximately 64 weeks for panNET cohort and 108 weeks for midgut NET (and overall) cohort)

ID	Title	Description
OG000	PanNET Cohort	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.

Secondary

Mean Change From Baseline in EQ-5D-5L v1.0 Questionnaire (VAS)

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.

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.

Posted

Mean

Standard Deviation

score on a scale

Baseline (Day 1) and end of study (approximately 64 weeks for panNET cohort and 108 weeks for midgut NET (and overall) cohort)

ID	Title	Description
OG000	PanNET Cohort	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.
OG001	Midgut NET Cohort

Secondary

Mean Change From Baseline in QoL Questionnaire Gastrointestinal Neuroendocrine Tumour 21 (QLQ-GI.NET21; 2006)

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.

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.

Posted

Mean

Standard Deviation

score on a scale

Baseline (Day 1) and end of study (approximately 64 weeks for panNET cohort and 108 weeks for midgut NET (and overall) cohort)

ID	Title	Description
OG000	PanNET Cohort	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.

Secondary

Mean Change From Baseline in Nonspecific Tumour Biomarkers

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.

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.

Posted

Mean

Standard Deviation

xULN

Baseline (Day 1) and end of study (approximately 64 weeks for panNET cohort and 108 weeks for midgut NET cohort)

ID	Title	Description
OG000	PanNET Cohort	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.
OG001

Secondary

Mean Change From Baseline in PanNet Specific Tumour Biomarkers: Pancreatic Polypeptide, Gastrin

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.

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.

Posted

Mean

Standard Deviation

pmol/L

Baseline (Day 1) and end of study (approximately 64 weeks)

ID	Title	Description
OG000	PanNET Cohort	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.

Units	Counts
Participants

Secondary

Mean Change From Baseline in PanNet Specific Tumour Biomarkers: Glucagon

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.

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.

Posted

Mean

Standard Deviation

ng/L

Baseline (Day 1) and end of study (approximately 64 weeks)

ID	Title	Description
OG000	PanNET Cohort	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.

Units	Counts
Participants

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lymphopenia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0010 events0 affected51 at risk EG0021 events1 affected99 at risk
Monocytopenia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0010 events0 affected51 at risk EG0021 events1 affected99 at risk
Arrhythmia	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0010 events0 affected51 at risk EG0021 events1 affected99 at risk
Cardiac failure	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0012 events1 affected51 at risk EG0022 events1 affected99 at risk
Heart valve incompetence	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Palpitations	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0010 events0 affected51 at risk EG0021 events1 affected99 at risk
Right ventricular failure	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Tachycardia	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0010 events0 affected51 at risk EG0021 events1 affected99 at risk
Tricuspid valve disease	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Deafness	Ear and labyrinth disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0010 events0 affected51 at risk EG0021 events1 affected99 at risk
Deafness unilateral	Ear and labyrinth disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0010 events0 affected51 at risk EG0021 events1 affected99 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0010 events0 affected51 at risk EG0021 events1 affected99 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0012 events1 affected51 at risk EG0022 events1 affected99 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0010 events0 affected51 at risk EG0021 events1 affected99 at risk
Diplopia	Eye disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Dry eye	Eye disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Eye pain	Eye disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Eye pruritus	Eye disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Glaucoma	Eye disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Ocular hyperaemia	Eye disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0012 events2 affected51 at risk EG0022 events2 affected99 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0017 events6 affected51 at risk EG0027 events6 affected99 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG00013 events7 affected48 at risk EG00116 events12 affected51 at risk EG00229 events19 affected99 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0011 events1 affected51 at risk EG0022 events2 affected99 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected48 at risk EG0017 events6 affected51 at risk EG0029 events8 affected99 at risk
Anal incontinence	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0010 events0 affected51 at risk EG0021 events1 affected99 at risk
Anorectal discomfort	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Ascites	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0012 events2 affected51 at risk EG0022 events2 affected99 at risk
Constipation	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0003 events2 affected48 at risk EG0013 events2 affected51 at risk EG0026 events4 affected99 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG00020 events14 affected48 at risk EG00135 events27 affected51 at risk EG00255 events41 affected99 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0010 events0 affected51 at risk EG0021 events1 affected99 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0013 events2 affected51 at risk EG0023 events2 affected99 at risk
Faeces discoloured	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Flatulence	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0018 events6 affected51 at risk EG0029 events7 affected99 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0012 events2 affected51 at risk EG0023 events3 affected99 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0010 events0 affected51 at risk EG0021 events1 affected99 at risk
Gingival pain	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0011 events1 affected51 at risk EG0022 events2 affected99 at risk
Glossodynia	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0010 events0 affected51 at risk EG0021 events1 affected99 at risk
Hernial eventration	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Nausea	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0005 events5 affected48 at risk EG0019 events6 affected51 at risk EG00214 events11 affected99 at risk
Oral pain	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Pancreatic failure	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Proctalgia	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Steatorrhoea	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected48 at risk EG0013 events3 affected51 at risk EG0025 events5 affected99 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0011 events1 affected51 at risk EG0022 events2 affected99 at risk
Toothache	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0010 events0 affected51 at risk EG0021 events1 affected99 at risk
Vomiting	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0009 events6 affected48 at risk EG0014 events4 affected51 at risk EG00213 events10 affected99 at risk
Asthenia	General disorders	MedDRA 22.0	Systematic Assessment	EG00024 events4 affected48 at risk EG0015 events4 affected51 at risk EG00229 events8 affected99 at risk
Chest pain	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0013 events3 affected51 at risk EG0023 events3 affected99 at risk
Fatigue	General disorders	MedDRA 22.0	Systematic Assessment	EG0008 events7 affected48 at risk EG00111 events8 affected51 at risk EG00219 events15 affected99 at risk
Gait disturbance	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Hunger	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Influenza like illness	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0013 events3 affected51 at risk EG0024 events4 affected99 at risk
Injection site bruising	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0010 events0 affected51 at risk EG0021 events1 affected99 at risk
Injection site pain	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Malaise	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0012 events2 affected51 at risk EG0023 events3 affected99 at risk
Medical device site pain	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0010 events0 affected51 at risk EG0021 events1 affected99 at risk
Oedema peripheral	General disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected48 at risk EG0012 events2 affected51 at risk EG0024 events4 affected99 at risk
Pain	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Peripheral swelling	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0013 events3 affected51 at risk EG0023 events3 affected99 at risk
Polyp	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Pyrexia	General disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected48 at risk EG0015 events2 affected51 at risk EG0027 events4 affected99 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0013 events3 affected51 at risk EG0023 events3 affected99 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Liver injury	Hepatobiliary disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0010 events0 affected51 at risk EG0021 events1 affected99 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Bronchitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Carbuncle	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Cystitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected48 at risk EG0011 events1 affected51 at risk EG0023 events3 affected99 at risk
Cystitis bacterial	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Diverticulitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0012 events2 affected51 at risk EG0022 events2 affected99 at risk
Folliculitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Herpes zoster	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0012 events2 affected51 at risk EG0022 events2 affected99 at risk
Influenza	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected48 at risk EG0016 events3 affected51 at risk EG0028 events5 affected99 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0002 events1 affected48 at risk EG0013 events3 affected51 at risk EG0025 events4 affected99 at risk
Nasopharyngitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0007 events7 affected48 at risk EG0016 events5 affected51 at risk EG00213 events12 affected99 at risk
Respiratory tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Tonsillitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0010 events0 affected51 at risk EG0021 events1 affected99 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Urinary tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0006 events4 affected48 at risk EG0011 events1 affected51 at risk EG0027 events5 affected99 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Incision site pain	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0012 events2 affected51 at risk EG0022 events2 affected99 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0010 events0 affected51 at risk EG0021 events1 affected99 at risk
Radiation skin injury	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0010 events0 affected51 at risk EG0021 events1 affected99 at risk
Alanine aminotransferase increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0012 events2 affected51 at risk EG0023 events3 affected99 at risk
Aspartate aminotransferase abnormal	Investigations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0010 events0 affected51 at risk EG0021 events1 affected99 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0011 events1 affected51 at risk EG0022 events2 affected99 at risk
Bacterial test positive	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0003 events3 affected48 at risk EG0011 events1 affected51 at risk EG0024 events4 affected99 at risk
Blood bilirubin increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0012 events2 affected51 at risk EG0022 events2 affected99 at risk
Blood chromogranin A increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Blood creatinine increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0010 events0 affected51 at risk EG0021 events1 affected99 at risk
Blood glucose decreased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Blood glucose increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0011 events1 affected51 at risk EG0022 events2 affected99 at risk
Blood potassium increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0010 events0 affected51 at risk EG0021 events1 affected99 at risk
Blood triglycerides increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Blood urea increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0011 events1 affected51 at risk EG0022 events2 affected99 at risk
Blood urine present	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
C-reactive protein increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Gamma-glutamyltransferase abnormal	Investigations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0010 events0 affected51 at risk EG0021 events1 affected99 at risk
Gamma-glutamyltransferase decreased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0012 events2 affected51 at risk EG0023 events3 affected99 at risk
Glycosylated haemoglobin increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0010 events0 affected51 at risk EG0021 events1 affected99 at risk
Lymphocyte count decreased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Neutrophil count decreased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Platelet count decreased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Specific gravity urine increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0010 events0 affected51 at risk EG0021 events1 affected99 at risk
Urine ketone body present	Investigations	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected48 at risk EG0010 events0 affected51 at risk EG0022 events2 affected99 at risk
Weight decreased	Investigations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0012 events2 affected51 at risk EG0023 events3 affected99 at risk
Carbohydrate intolerance	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0010 events0 affected51 at risk EG0021 events1 affected99 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0005 events5 affected48 at risk EG0012 events2 affected51 at risk EG0027 events7 affected99 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0011 events1 affected51 at risk EG0022 events2 affected99 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0012 events2 affected51 at risk EG0022 events2 affected99 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0010 events0 affected51 at risk EG0021 events1 affected99 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0010 events0 affected51 at risk EG0021 events1 affected99 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0012 events2 affected51 at risk EG0023 events3 affected99 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0003 events1 affected48 at risk EG0011 events1 affected51 at risk EG0024 events2 affected99 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0010 events0 affected51 at risk EG0021 events1 affected99 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0011 events1 affected51 at risk EG0022 events2 affected99 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0017 events5 affected51 at risk EG0027 events5 affected99 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected48 at risk EG0012 events2 affected51 at risk EG0024 events4 affected99 at risk
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0010 events0 affected51 at risk EG0021 events1 affected99 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0015 events3 affected51 at risk EG0025 events3 affected99 at risk
Mobility decreased	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0010 events0 affected51 at risk EG0021 events1 affected99 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0013 events2 affected51 at risk EG0024 events3 affected99 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0011 events1 affected51 at risk EG0022 events2 affected99 at risk
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0012 events2 affected51 at risk EG0023 events3 affected99 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0012 events1 affected51 at risk EG0022 events1 affected99 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0012 events2 affected51 at risk EG0022 events2 affected99 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0011 events1 affected51 at risk EG0022 events2 affected99 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected48 at risk EG0012 events1 affected51 at risk EG0024 events3 affected99 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0012 events1 affected51 at risk EG0022 events1 affected99 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0012 events2 affected51 at risk EG0023 events3 affected99 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Ageusia	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0010 events0 affected51 at risk EG0021 events1 affected99 at risk
Aphasia	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0012 events1 affected51 at risk EG0022 events1 affected99 at risk
Balance disorder	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Dizziness	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0003 events3 affected48 at risk EG0017 events5 affected51 at risk EG00210 events8 affected99 at risk
Dizziness postural	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Head discomfort	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Headache	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0003 events3 affected48 at risk EG0015 events4 affected51 at risk EG0028 events7 affected99 at risk
Lethargy	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0011 events1 affected51 at risk EG0022 events2 affected99 at risk
Poor quality sleep	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0011 events1 affected51 at risk EG0022 events2 affected99 at risk
Presyncope	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0012 events2 affected51 at risk EG0022 events2 affected99 at risk
Sciatica	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0012 events2 affected51 at risk EG0022 events2 affected99 at risk
Syncope	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0010 events0 affected51 at risk EG0021 events1 affected99 at risk
Taste disorder	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0010 events0 affected51 at risk EG0021 events1 affected99 at risk
Tremor	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0012 events2 affected51 at risk EG0023 events3 affected99 at risk
Acrophobia	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Confusional state	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Insomnia	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected48 at risk EG0010 events0 affected51 at risk EG0022 events2 affected99 at risk
Mood altered	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0010 events0 affected51 at risk EG0021 events1 affected99 at risk
Panic attack	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Sleep disorder	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0012 events2 affected51 at risk EG0022 events2 affected99 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Dysuria	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0012 events2 affected51 at risk EG0022 events2 affected99 at risk
Haematuria	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0012 events2 affected51 at risk EG0023 events3 affected99 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Gynaecomastia	Reproductive system and breast disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0010 events0 affected51 at risk EG0021 events1 affected99 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0003 events3 affected48 at risk EG0013 events3 affected51 at risk EG0026 events6 affected99 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0010 events0 affected51 at risk EG0021 events1 affected99 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0015 events4 affected51 at risk EG0025 events4 affected99 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0012 events2 affected51 at risk EG0023 events3 affected99 at risk
Increased upper airway secretion	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0012 events2 affected51 at risk EG0022 events2 affected99 at risk
Orthopnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Sputum discoloured	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0012 events2 affected51 at risk EG0022 events2 affected99 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0010 events0 affected51 at risk EG0021 events1 affected99 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Photosensitivity reaction	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0010 events0 affected51 at risk EG0021 events1 affected99 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0014 events3 affected51 at risk EG0025 events4 affected99 at risk
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0011 events1 affected51 at risk EG0022 events2 affected99 at risk
Skin fissures	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Skin irritation	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0012 events2 affected51 at risk EG0022 events2 affected99 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Injection	Surgical and medical procedures	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Flushing	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected48 at risk EG00114 events9 affected51 at risk EG00216 events11 affected99 at risk
Haematoma	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Hot flush	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG00114 events2 affected51 at risk EG00214 events2 affected99 at risk
Hypertension	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected48 at risk EG0019 events9 affected51 at risk EG00211 events11 affected99 at risk
Peripheral venous disease	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected48 at risk EG0011 events1 affected51 at risk EG0021 events1 affected99 at risk
Venous thrombosis limb	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0010 events0 affected51 at risk EG0021 events1 affected99 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected48 at risk EG0011 events1 affected51 at risk EG0022 events2 affected99 at risk

ID	Title	Description
BG000	PanNET 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 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.
BG001	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.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	PanNET Cohort	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.	1	48	5	48	41	48
EG001	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.	3	51	13	51	47	51
EG002	Overall Subjects	All subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.	4	99	18	99	88	99