Study to Assess the Efficacy of an Extended Injection Int... | NCT00701363

ID	Type	Description	Link
2007-005838-37	EudraCT Number

Label	Type	Description	Intervention Names
Lanreotide Autogel 120 mg	Experimental		Drug: Lanreotide Autogel 120 mg

Name	Type	Description	Arm Group Labels	Other Names
Lanreotide Autogel 120 mg	Drug	120mg, injections every 6 weeks, then depending on IGF-1 results at Week 24	Lanreotide Autogel 120 mg

Measure	Description	Time Frame
Percentage of Subjects Having Maintained Their Injection Interval Schedule of Six Weeks or Increased Their Injection Interval to Eight Weeks Whilst Keeping Their Normalised Insulin Growth Factor (IGF-1) Levels (Age and Sex Adjusted)	A subject was responder if he maintained his injection interval schedule of 6 weeks or increased his injection interval to eight weeks whilst keeping his normalised IGF-1 level (age and sex adjusted) at the end of the study (Week 48)	At week 48 (End of Study)

Measure	Description	Time Frame
Percentage of Subjects With Normalised IGF-1 Levels (Age and Sex Adjusted)	The criterion for a subject is satisfied if he has a normalised IGF-1 level (age and sex adjusted) at week 24.	At week 24
Percentage of Subjects Having Maintained an Injection Interval of Six Weeks or Increasing Their Injection Interval to Eight Weeks

Name	Affiliation	Role
Ipsen Medical Director	Ipsen	Study Director

ID	Title	Description
FG000	Phase 1: Lanreotide Autogel 120 mg	Subjects in phase 1 received 5 injections of Lanreotide Autogel 120 mg subcutaneously (SC) at baseline and weeks 6, 12, 18 and 24. Baseline and week 24 injections were administered in the investigational centre, whereas the patient could receive weeks 6, 12 and 18 injections at home as part of the subject's normal medical care, completing details of the injection in the diary cards provided.

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

Percentage of Subjects Having Maintained Their Injection Interval Schedule of Six Weeks or Increased Their Injection Interval to Eight Weeks Whilst Keeping Their Normalised Insulin Growth Factor (IGF-1) Levels (Age and Sex Adjusted)

A subject was responder if he maintained his injection interval schedule of 6 weeks or increased his injection interval to eight weeks whilst keeping his normalised IGF-1 level (age and sex adjusted) at the end of the study (Week 48)

Intention to Treat (ITT) population: All patients having received ≥1 study drug dose. Modified ITT (MITT) population: All subjects in the ITT population for whom group allocation was performed (included in Phase 2).

n = Number of subjects at the visit

Posted

Number

95% Confidence Interval

Percentage of subjects

At week 48 (End of Study)

ID	Title	Description
OG000	Overall Study

Units	Counts
Participants	OG000124

Title

Denominators

Categories

Intention-to-Treat (n=124)

Title	Measurements
	OG00075.8(68.3 to 83.3)

Modified Intention-to-Treat (n=109)

Title	Measurements
	OG00086.2(79.8 to 92.7)

Secondary

Percentage of Subjects With Normalised IGF-1 Levels (Age and Sex Adjusted)

The criterion for a subject is satisfied if he has a normalised IGF-1 level (age and sex adjusted) at week 24.

ITT population. n = Number of subjects at the visit.

Posted

Number

95% Confidence Interval

Percentage of subjects

At week 24

ID	Title	Description
OG000	Overall Study

Units	Counts
Participants	OG000124

Title

Secondary

Percentage of Subjects Having Maintained an Injection Interval of Six Weeks or Increasing Their Injection Interval to Eight Weeks

The criterion for a subject is satisfied if he maintained an injection interval of six weeks or increasing his injection interval to eight weeks during Phase 2 of the study.

ITT population. n = Number of subjects at the visit.

Posted

Number

95% Confidence Interval

Percentage of subjects

During phase 2 of the study (up to week 48)

ID	Title	Description
OG000	Overall Study

Units	Counts
Participants	OG000124

Secondary

Percentage of Subjects Who Extend Their Injection Interval to Eight Weeks During Phase 2 of the Study, Whilst Maintaining Normalised IGF-1 Levels

The criterion for a subject is satisfied if he extended his injection interval to eight weeks during Phase 2 of the study, whilst maintaining normalised IGF-1 levels at Week 48.

ITT population. n = Number of subjects at the visit.

Posted

Number

95% Confidence Interval

Percentage of subjects

At week 48

ID	Title	Description
OG000	Overall Study

Units	Counts
Participants	OG000124

Secondary

Mean Change From Baseline in IGF-1 Values [Expressed as % of Upper Limit of Normal (ULN)], Overall and by Injection Interval

IGF-1 change from Baseline to Week 48 = Mean IGF-1 level at Week 48 - Mean IGF-1 level at Baseline

MITT population. One subject (Group B) had missing IGF-1 value at Week 48. One subject (Group A) had missing IGF-1 value at Baseline.

Posted

Mean

Standard Deviation

Percentage of ULN

Baseline (visit 1) and week 48

ID	Title	Description
OG000	Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks
OG001	Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks
OG002	Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks

Units	Counts
Participants	OG000

Secondary

Treatment Group (A, B or C) Mean Baseline IGF-1 Levels (Expressed as % of ULN) in Subjects Who Maintained Normalised IGF-1 Values at Week 48. Comparisons Will be Made as Follows: A Versus B, A Versus C, A Versus (B+C) and B Versus C

MITT population.

One subject in Group A had missing IGF-1 value at baseline. One subject in Group B had missing IGF-1 value at week 48 and two subjects did not attend week 48 (early withdrawal). One subject in Group C had missing IGF-1 value at week 48.

Posted

Mean

95% Confidence Interval

Percentage of ULN

Baseline (visit 1)

ID	Title	Description
OG000	Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks
OG001	Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks
OG002	Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks

Units	Counts
Participants	OG000

Secondary

Mean Baseline IGF-1 Levels (Expressed as % of ULN) in All Groups (A, B and C) Versus Mean Baseline IGF-1 Levels (Expressed as % of ULN) in Subjects With Uncontrolled IGF-1 Levels at Week 24

ITT population. n = Number of subjects at the visit.

These subjects entered in phase 2

One subject was not included in this analysis because IGF-1 was lower than 130% at week 24 but not in the second phase and one subject in group A had missing IGF-1 value at baseline.

Posted

Mean

95% Confidence Interval

Percentage of ULN

Baseline (visit 1)

ID	Title	Description
OG000	Overall Study

Units	Counts
Participants	OG000122

Secondary

Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia)

Acromegaly symptoms were assessed by the patients using the Patient Assessed Acromegaly Symptom Questionnaire (PASQ) scale ranging from 0 (No symptoms) to 8 (Severe, incapacitating symptoms).

ITT population.

Number of Participants Analyzed:

Phase 1 in week 24: 3

Phase 2 (Group A) in week 24: 13

Phase 2 (Group B) in week 24: 69

Phase 2 (Group C) in week 24: 25

Phase 2 (Group A) in week 48: 13

Phase 2 (Group B) in week 48: 68

Phase 2 (Group C) in week 48: 26

NA = Not Applicable

Posted

Mean

Standard Deviation

Units on a scale

At baseline, week 24 and week 48

ID	Title	Description
OG000	Phase 1 Only: Lanreotide Autogel 120 mg	Only 15 subjects participated only in phase 1 and did not move on to phase 2. The other entered in phase 2 according to IGF-1 level. Subjects in phase 1 received 5 injections of Lanreotide Autogel 120 mg subcutaneously (SC) at baseline and weeks 6, 12, 18 and 24. Baseline and week 24 injections were administered in the investigational centre, whereas the patient could receive weeks 6, 12 and 18 injections at home as part of the subject's normal medical care, completing details of the injection in the diary cards provided.
OG001	Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks	Subjects with IGF-1 levels >100% to ≤130% of ULN at week 24 were assigned to group A. These subjects received 5 injections of Lanreotide Autogel 120 mg at 4-week intervals from week 24 up to week 48.

Secondary

Mean Changes From Baseline in Quality of Life Scores (AcroQoL)

AcroQoL score groups 22 components: Eight physical, Seven psychological appearance and Seven psychological personal relations, adjusted to a scale of 100, where a score of 100 corresponds to the best possible QoL and 0 to the worst.

ITT population n = Number of subjects at the visit. Phase 1 only: These subjects participated only in phase 1 & did not move onto phase 2.

Only subjects from countries having a validated translation of the AcroQoL questionnaire (The Netherlands, Denmark, Sweden, France, Greece, Poland, South Korea, Brazil, Russia, Norway and Romania) were included

Posted

Mean

Standard Deviation

Units on a scale

At weeks 24 and 48

ID	Title	Description
OG000	Phase 1 Only: Lanreotide Autogel 120 mg
OG001	Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks
OG002	Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks
OG003	Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks
OG004	Overall Study

Secondary

Mean Changes From Baseline in Quality of Life Scores (SF-36)

Short Form-36 questionnaire (SF-36) score comprises eight components: Physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health on a scale of 100, where a score of 100 corresponds to the best possible QoL and 0 to the worst.

ITT population. n = Number of subjects at the visit. Phase 1 only: These 15 subjects participated only in phase 1 and did not move on to phase 2.

Posted

Mean

Standard Deviation

Units on a scale

At weeks 24 and 48

ID	Title	Description
OG000	Phase 1 Only: Lanreotide Autogel 120 mg
OG001	Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks
OG002	Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks
OG003	Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks
OG004	Overall Study

Secondary

Percentage of Subjects With Normalized IGF-1 Levels (Age and Sex Adjusted), Without Any Worsening of the AcroQoL Change Score Between Inclusion and Week 48

The criterion for a subject is satisfied if he had a IGF-1 level (age and sex adjusted) without any worsening of the AcroQoL change score between Inclusion and Week 48.

MITT population. n = Number of subjects at the visit.

Posted

Number

95% Confidence Interval

Percentage of subjects

At week 48 (End of Study)

ID	Title	Description
OG000	Overall Study

Units	Counts
Participants	OG000

Secondary

Correlation Between the Changes From Baseline in Quality of Life (AcroQoL) With the Corresponding Changes in IGF-1 Level (Expressed as % of ULN) at Each Visit

AcroQoL change from Baseline to Week 24 (48) = AcroQoL at Week 24 (48) - AcroQoL at Baseline.

IGF-1 change from Baseline to Week 24 (48) = IGF-1 at Week 24 (48) - IGF-1 at Baseline.

Correlation presented is a Spearman correlation (non parametric).

ITT population. n = Number of subjects at the visit.

Posted

Number

95% Confidence Interval

Correlation coefficient

At weeks 24 and 48

ID	Title	Description
OG000	Overall Study

Units	Counts
Participants	OG000

Secondary

Serum Growth Hormone (GH) Levels

ITT population. n = Number of subjects at the visit.

Phase 1 only: These 15 subjects participated only in phase 1 and did not move on to phase 2.

Posted

Mean

Standard Deviation

ng/mL

At Baseline, week 24 and week 48

ID	Title	Description
OG000	Phase 1 Only: Lanreotide Autogel 120 mg
OG001	Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks
OG002	Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks
OG003	Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks
OG004	Overall Study

Units	Counts
Participants

Secondary

Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL

n = Number of subjects at the visit.

Posted

Number

95% Confidence Interval

Percentage of subjects

At weeks 24 and 48

ID	Title	Description
OG000	Overall Study	Lanreotide Autogel 120 mg injections every 6 weeks, then depending on IGF-1 results at Week 24

Units	Counts
Participants	OG000124

Title	Denominators

Secondary

Subject Treatment Schedule Preference

At week 24, the preference assessed between Octreotide Long Acting Repeatable intramuscular injection (Oct-LAR IM) every 4 weeks and Lanreotide Autogel 120 mg subcutaneous injection (SC) every 6 weeks.

At week 48, the preference is assessed between Oct-LAR IM every 4 weeks and Lanreotide Autogel 120 mg SC either injected every 4, 6 or 8 weeks (as injected during Phase II of the study).

ITT population. n = Number of subjects at the visit.

Lan: Lanreotide

W: Week

Inj: Injection

Wks: Weeks

Phs: Phase

Grp: Group

evy: every

Posted

Number

Percentage of subjects

At weeks 24 and 48

ID	Title	Description
OG000	Overall Study

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG00221 events11 affected70 at risk EG0034 events1 affected26 at risk
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected13 at risk EG0027 events6 affected70 at risk EG003
Injection site pain	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG00215 events6 affected70 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0028 events4 affected70 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0002 events2 affected15 at risk EG0010 events0 affected13 at risk EG0022 events2 affected70 at risk EG003
Impaired fasting glucose	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0025 events5 affected70 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0023 events1 affected70 at risk EG003
Application site pain	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0024 events3 affected70 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected13 at risk EG0022 events2 affected70 at risk EG003
Dizziness	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0002 events2 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected13 at risk EG0022 events2 affected70 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0002 events2 affected15 at risk EG0010 events0 affected13 at risk EG0020 events0 affected70 at risk EG003
Injection site induration	General disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected13 at risk EG0022 events1 affected70 at risk EG003
Nodule	General disorders	MedDRA 13.0	Systematic Assessment	EG0002 events1 affected15 at risk EG0010 events0 affected13 at risk EG0023 events1 affected70 at risk EG003
Fatigue	General disorders	MedDRA 13.0	Systematic Assessment	EG0002 events1 affected15 at risk EG0010 events0 affected13 at risk EG0020 events0 affected70 at risk EG003
Malaise	General disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected13 at risk EG0020 events0 affected70 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected13 at risk EG0020 events0 affected70 at risk EG003
Sinusitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected13 at risk EG0020 events0 affected70 at risk EG003
Headache	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0012 events2 affected13 at risk EG0022 events2 affected70 at risk EG003
Migraine	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0003 events1 affected15 at risk EG0010 events0 affected13 at risk EG0020 events0 affected70 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected13 at risk EG0020 events0 affected70 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003
Calculus ureteric	Renal and urinary disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected13 at risk EG0020 events0 affected70 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected13 at risk EG0020 events0 affected70 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected13 at risk EG0020 events0 affected70 at risk EG003
Low density lipoprotein increased	Investigations	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected13 at risk EG0020 events0 affected70 at risk EG003
Transaminases increased	Investigations	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected13 at risk EG0020 events0 affected70 at risk EG003
Stress	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected13 at risk EG0020 events0 affected70 at risk EG003
Bicytopenia	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected13 at risk EG0020 events0 affected70 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected13 at risk EG0020 events0 affected70 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected13 at risk EG0022 events2 affected70 at risk EG003
Feeling cold	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected13 at risk EG0020 events0 affected70 at risk EG003
Podagra	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0012 events1 affected13 at risk EG0020 events0 affected70 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected13 at risk EG0020 events0 affected70 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 13.0	Systematic Assessment	EG0002 events1 affected15 at risk EG0013 events2 affected13 at risk EG0027 events7 affected70 at risk EG003
Gallbladder polyp	Hepatobiliary disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0012 events2 affected13 at risk EG0020 events0 affected70 at risk EG003
Hepatomegaly	Hepatobiliary disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected13 at risk EG0021 events1 affected70 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0013 events2 affected13 at risk EG0023 events3 affected70 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected13 at risk EG0020 events0 affected70 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected13 at risk EG0025 events3 affected70 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0012 events2 affected13 at risk EG0020 events0 affected70 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected13 at risk EG0020 events0 affected70 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected13 at risk EG0022 events2 affected70 at risk EG003
Hypertension	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0011 events1 affected13 at risk EG0021 events1 affected70 at risk EG003
Hypotension	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected13 at risk EG0021 events1 affected70 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected13 at risk EG0020 events0 affected70 at risk EG003
Nasal disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected13 at risk EG0020 events0 affected70 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected13 at risk EG0020 events0 affected70 at risk EG003
High density lipoprotein increased	Investigations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected13 at risk EG0020 events0 affected70 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected13 at risk EG0021 events1 affected70 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected13 at risk EG0020 events0 affected70 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected13 at risk EG0020 events0 affected70 at risk EG003
Goitre	Endocrine disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected13 at risk EG0020 events0 affected70 at risk EG003
Visual acuity reduced	Eye disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected13 at risk EG0020 events0 affected70 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0011 events1 affected13 at risk EG0020 events0 affected70 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0023 events1 affected70 at risk EG003
Dental caries	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003
Gingivitis	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0020 events0 affected70 at risk EG003
Hiatus hernia	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0020 events0 affected70 at risk EG003
Proctitis	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003
Steatorrhoea	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0020 events0 affected70 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003
Influenza like illness	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0024 events2 affected70 at risk EG003
Injection site nodule	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003
Pyrexia	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003
Asthenia	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003
Chest pain	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0020 events0 affected70 at risk EG003
Facial pain	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003
Injection site haematoma	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003
Injection site swelling	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0020 events0 affected70 at risk EG003
Medical device pain	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003
Oedema peripheral	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003
Thirst	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0022 events2 affected70 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003
Diabetes mellitus inadequate contr	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003
Fluid retention	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0020 events0 affected70 at risk EG003
Hepatic cyst	Hepatobiliary disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0020 events0 affected70 at risk EG003
Hepatic steatosis	Hepatobiliary disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0025 events3 affected70 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003
Bronchitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0020 events0 affected70 at risk EG003
Cervicitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0020 events0 affected70 at risk EG003
Dengue fever	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003
Fungal infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0022 events1 affected70 at risk EG003
Furuncle	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0022 events1 affected70 at risk EG003
Gastrointestinal viral infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003
Influenza	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003
Pulpitis dental	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003
Rhinitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0020 events0 affected70 at risk EG003
Viral infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003
Carotid artery stenosis	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0020 events0 affected70 at risk EG003
Intercostal neuralgia	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003
Sciatica	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0020 events0 affected70 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003
Increased tendency to bruise	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0020 events0 affected70 at risk EG003
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0020 events0 affected70 at risk EG003
Rosacea	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0022 events1 affected70 at risk EG003
Seborrhoea	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003
Swelling face	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0020 events0 affected70 at risk EG003
Flushing	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003
Lymphangiectasia	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0020 events0 affected70 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003
Renal cyst	Renal and urinary disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003
Nephrocalcinosis	Renal and urinary disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0020 events0 affected70 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003
Blood pressure systolic decreased	Investigations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0020 events0 affected70 at risk EG003
Weight decreased	Investigations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003
Depression	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0020 events0 affected70 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003
Hypogonadism	Endocrine disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003
Diplopia	Eye disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0020 events0 affected70 at risk EG003
Eye swelling	Eye disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0020 events0 affected70 at risk EG003
Presbyopia	Eye disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0020 events0 affected70 at risk EG003
Sinus bradycardia	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003
Haemangioma of liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003
Leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0020 events0 affected70 at risk EG003
Menorrhagia	Reproductive system and breast disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0020 events0 affected70 at risk EG003
Metrorrhagia	Reproductive system and breast disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003
Cataract cortical	Eye disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected15 at risk EG0010 events0 affected13 at risk EG0020 events0 affected70 at risk EG003
Alcoholism	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected15 at risk EG0010 events0 affected13 at risk EG0021 events1 affected70 at risk EG003

ID	Term
D001849	Bone Diseases, Endocrine
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D006964	Hyperpituitarism
D010900	Pituitary Diseases
D007027	Hypothalamic Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D004700	Endocrine System Diseases

ID	Title	Description
BG000	Phase 1: Lanreotide Autogel 120 mg	Subjects in phase 1 received 5 injections of Lanreotide Autogel 120 mg subcutaneously (SC) at baseline and weeks 6, 12, 18 and 24. Baseline and week 24 injections were administered in the investigational centre, whereas the patient could receive weeks 6, 12 and 18 injections at home as part of the subject's normal medical care, completing details of the injection in the diary cards provided.
BG001	Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks	Subjects with IGF-1 levels >100% to ≤130% of ULN at week 24 were assigned to group A. These subjects received 5 injections of Lanreotide Autogel 120 mg at 4-week intervals from week 24 up to week 48.
BG002	Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks	Subjects with IGF-1 levels >50% to ≤100% of ULN at week 24 were assigned to group B. These subjects received 3 injections of Lanreotide Autogel 120 mg at 6-week intervals from week 24 up to week 48.
BG003	Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks	Subjects with IGF-1 levels ≤50% of ULN at week 24 were assigned to group C. These subjects received 2 injections of Lanreotide Autogel 120 mg at 8-week intervals from week 24 up to week 48.
BG004	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Phase 1: Lanreotide Autogel 120 mg	Subjects in phase 1 received 5 injections of Lanreotide Autogel 120 mg subcutaneously (SC) at baseline and weeks 6, 12, 18 and 24. Baseline and week 24 injections were administered in the investigational centre, whereas the patient could receive weeks 6, 12 and 18 injections at home as part of the subject's normal medical care, completing details of the injection in the diary cards provided.	3	15	12	15
EG001	Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks	Subjects with IGF-1 levels >100% to ≤130% of ULN at week 24 were assigned to group A. These subjects received 5 injections of Lanreotide Autogel 120 mg at 4-week intervals from week 24 up to week 48.	2	13	10	13
EG002	Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks	Subjects with IGF-1 levels >50% to ≤100% of ULN at week 24 were assigned to group B. These subjects received 3 injections of Lanreotide Autogel 120 mg at 6-week intervals from week 24 up to week 48.	4	70	48	70
EG003	Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks	Subjects with IGF-1 levels ≤50% of ULN at week 24 were assigned to group C. These subjects received 2 injections of Lanreotide Autogel 120 mg at 8-week intervals from week 24 up to week 48.	2	26	20	26