Trial Outcomes & Findings for Study to Assess the Efficacy of an Extended Injection Interval Schedule of Lanreotide Autogel in Acromegalic Subjects (NCT NCT00701363)
NCT ID: NCT00701363
Last Updated: 2019-01-29
Results Overview
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)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
124 participants
Primary outcome timeframe
At week 48 (End of Study)
Results posted on
2019-01-29
Participant Flow
Study initiation date: 06-Oct-2008. Study completion date: 20-May-2013. Screened subjects were 128 and screen failure subjects were 4. Subjects treated were 124 and subjects withdrawn early were 17. Subjects completed the study were 107.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Screening (Pre-assignment) Phase
STARTED
|
128
|
0
|
0
|
0
|
|
Screening (Pre-assignment) Phase
COMPLETED
|
124
|
0
|
0
|
0
|
|
Screening (Pre-assignment) Phase
NOT COMPLETED
|
4
|
0
|
0
|
0
|
|
Treatment Phase 1
STARTED
|
124
|
0
|
0
|
0
|
|
Treatment Phase 1
COMPLETED
|
109
|
0
|
0
|
0
|
|
Treatment Phase 1
NOT COMPLETED
|
15
|
0
|
0
|
0
|
|
Treatment Phase 2
STARTED
|
0
|
13
|
70
|
26
|
|
Treatment Phase 2
COMPLETED
|
0
|
13
|
68
|
26
|
|
Treatment Phase 2
NOT COMPLETED
|
0
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Screening (Pre-assignment) Phase
Does not meet entry Criteria
|
4
|
0
|
0
|
0
|
|
Treatment Phase 1
Does not meet entry Criteria
|
1
|
0
|
0
|
0
|
|
Treatment Phase 1
Adverse Event
|
7
|
0
|
0
|
0
|
|
Treatment Phase 1
Protocol Violation
|
1
|
0
|
0
|
0
|
|
Treatment Phase 1
Withdrawal by Subject
|
5
|
0
|
0
|
0
|
|
Treatment Phase 1
Lack of Efficacy
|
1
|
0
|
0
|
0
|
|
Treatment Phase 2
Adverse Event
|
0
|
0
|
1
|
0
|
|
Treatment Phase 2
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study to Assess the Efficacy of an Extended Injection Interval Schedule of Lanreotide Autogel in Acromegalic Subjects
Baseline characteristics by cohort
| Measure |
Phase 1: Lanreotide Autogel 120 mg
n=15 Participants
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.
|
Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks
n=13 Participants
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.
|
Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks
n=70 Participants
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.
|
Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks
n=26 Participants
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.
|
Total
n=124 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
55.2 years
STANDARD_DEVIATION 15.3 • n=5 Participants
|
55.0 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
53.2 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
57.0 years
STANDARD_DEVIATION 9.8 • n=4 Participants
|
55.4 years
STANDARD_DEVIATION 10.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
78 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
|
Region of Enrollment
Russian Federation
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
12 participants
n=5 Participants
|
4 participants
n=4 Participants
|
20 participants
n=21 Participants
|
|
Region of Enrollment
Korea, Republic of
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
4 participants
n=4 Participants
|
17 participants
n=21 Participants
|
|
Region of Enrollment
Brazil
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
12 participants
n=5 Participants
|
1 participants
n=4 Participants
|
15 participants
n=21 Participants
|
|
Region of Enrollment
Serbia
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
2 participants
n=4 Participants
|
15 participants
n=21 Participants
|
|
Region of Enrollment
France
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
9 participants
n=5 Participants
|
4 participants
n=4 Participants
|
14 participants
n=21 Participants
|
|
Region of Enrollment
Poland
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
8 participants
n=5 Participants
|
2 participants
n=4 Participants
|
12 participants
n=21 Participants
|
|
Region of Enrollment
Latvia
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
7 participants
n=5 Participants
|
2 participants
n=4 Participants
|
10 participants
n=21 Participants
|
|
Region of Enrollment
Greece
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
4 participants
n=4 Participants
|
9 participants
n=21 Participants
|
|
Region of Enrollment
Sweden
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
0 participants
n=4 Participants
|
4 participants
n=21 Participants
|
|
Region of Enrollment
Finland
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
3 participants
n=21 Participants
|
|
Region of Enrollment
Denmark
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Region of Enrollment
Norway
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Region of Enrollment
Romania
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Region of Enrollment
Netherlands
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Body Mass Index (BMI)
|
28.4 kg/m^2
STANDARD_DEVIATION 2.9 • n=5 Participants
|
29.2 kg/m^2
STANDARD_DEVIATION 4.1 • n=7 Participants
|
29.5 kg/m^2
STANDARD_DEVIATION 6.5 • n=5 Participants
|
27.0 kg/m^2
STANDARD_DEVIATION 4.3 • n=4 Participants
|
28.8 kg/m^2
STANDARD_DEVIATION 5.6 • n=21 Participants
|
PRIMARY outcome
Timeframe: At week 48 (End of Study)Population: 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
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)
Outcome measures
| Measure |
Overall Study
n=124 Participants
|
Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks
|
Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks
|
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.
|
Overall Study
|
|---|---|---|---|---|---|
|
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)
Intention-to-Treat (n=124)
|
75.8 Percentage of subjects
Interval 68.3 to 83.3
|
—
|
—
|
—
|
—
|
|
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)
Modified Intention-to-Treat (n=109)
|
86.2 Percentage of subjects
Interval 79.8 to 92.7
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At week 24Population: ITT population. n = Number of subjects at the visit.
The criterion for a subject is satisfied if he has a normalised IGF-1 level (age and sex adjusted) at week 24.
Outcome measures
| Measure |
Overall Study
n=124 Participants
|
Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks
|
Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks
|
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.
|
Overall Study
|
|---|---|---|---|---|---|
|
Percentage of Subjects With Normalised IGF-1 Levels (Age and Sex Adjusted)
Intention-to-Treat (n=124)
|
88.7 Percentage of subjects
Interval 83.1 to 94.3
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Normalised IGF-1 Levels (Age and Sex Adjusted)
Modified Intention-to-Treat (n=109)
|
100 Percentage of subjects
Interval 100.0 to 100.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During phase 2 of the study (up to week 48)Population: ITT population. n = Number of subjects at the visit.
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.
Outcome measures
| Measure |
Overall Study
n=124 Participants
|
Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks
|
Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks
|
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.
|
Overall Study
|
|---|---|---|---|---|---|
|
Percentage of Subjects Having Maintained an Injection Interval of Six Weeks or Increasing Their Injection Interval to Eight Weeks
Intention-to-Treat (n=124)
|
78.2 Percentage of subjects
Interval 71.0 to 85.5
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects Having Maintained an Injection Interval of Six Weeks or Increasing Their Injection Interval to Eight Weeks
Modified Intention-to-Treat (n=109)
|
88.1 Percentage of subjects
Interval 82.0 to 94.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At week 48Population: ITT population. n = Number of subjects at the visit.
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.
Outcome measures
| Measure |
Overall Study
n=124 Participants
|
Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks
|
Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks
|
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.
|
Overall Study
|
|---|---|---|---|---|---|
|
Percentage of Subjects Who Extend Their Injection Interval to Eight Weeks During Phase 2 of the Study, Whilst Maintaining Normalised IGF-1 Levels
Intention-to-Treat (n=124)
|
20.2 Percentage of subjects
Interval 13.1 to 27.2
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects Who Extend Their Injection Interval to Eight Weeks During Phase 2 of the Study, Whilst Maintaining Normalised IGF-1 Levels
Modified Intention-to-Treat (n=109)
|
22.9 Percentage of subjects
Interval 15.0 to 30.8
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (visit 1) and week 48Population: 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.
IGF-1 change from Baseline to Week 48 = Mean IGF-1 level at Week 48 - Mean IGF-1 level at Baseline
Outcome measures
| Measure |
Overall Study
n=12 Participants
|
Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks
n=67 Participants
|
Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks
n=25 Participants
|
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.
|
Overall Study
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in IGF-1 Values [Expressed as % of Upper Limit of Normal (ULN)], Overall and by Injection Interval
|
-1.70 Percentage of ULN
Standard Deviation 18.55
|
5.74 Percentage of ULN
Standard Deviation 30.48
|
-4.33 Percentage of ULN
Standard Deviation 28.14
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (visit 1)Population: 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.
Outcome measures
| Measure |
Overall Study
n=12 Participants
|
Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks
n=67 Participants
|
Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks
n=25 Participants
|
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.
|
Overall Study
|
|---|---|---|---|---|---|
|
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
|
98.69 Percentage of ULN
Interval 89.4 to 108.0
|
67.75 Percentage of ULN
Interval 60.4 to 75.1
|
51.30 Percentage of ULN
Interval 41.1 to 61.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (visit 1)Population: 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.
Outcome measures
| Measure |
Overall Study
n=122 Participants
|
Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks
|
Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks
|
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.
|
Overall Study
|
|---|---|---|---|---|---|
|
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
Uncontrolled IGF-1 levels at Week 24 (n=14)
|
95.92 Percentage of ULN
Interval 50.3 to 141.5
|
—
|
—
|
—
|
—
|
|
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
Normalized IGF-1 levels at Week 24 (A+B+C) (n=108)
|
67.49 Percentage of ULN
Interval 61.8 to 73.2
|
—
|
—
|
—
|
—
|
|
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
Difference in Mean Baseline
|
28.43 Percentage of ULN
Interval 6.83 to 50.03
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At baseline, week 24 and week 48Population: 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
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).
Outcome measures
| Measure |
Overall Study
n=15 Participants
|
Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks
n=13 Participants
|
Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks
n=70 Participants
|
Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks
n=26 Participants
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.
|
Overall Study
|
|---|---|---|---|---|---|
|
Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia)
Baseline - Headache
|
2.73 Units on a scale
Standard Deviation 2.71
|
2.15 Units on a scale
Standard Deviation 1.72
|
1.80 Units on a scale
Standard Deviation 1.73
|
2.04 Units on a scale
Standard Deviation 2.11
|
—
|
|
Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia)
Baseline - Excessive perspiration
|
2.80 Units on a scale
Standard Deviation 2.93
|
1.92 Units on a scale
Standard Deviation 2.50
|
2.41 Units on a scale
Standard Deviation 2.18
|
2.08 Units on a scale
Standard Deviation 2.21
|
—
|
|
Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia)
Baseline - Fatigue
|
3.40 Units on a scale
Standard Deviation 2.85
|
4.23 Units on a scale
Standard Deviation 1.48
|
3.27 Units on a scale
Standard Deviation 2.36
|
3.31 Units on a scale
Standard Deviation 2.63
|
—
|
|
Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia)
Baseline - Soft tissue swelling
|
1.13 Units on a scale
Standard Deviation 1.77
|
2.77 Units on a scale
Standard Deviation 2.20
|
1.81 Units on a scale
Standard Deviation 2.02
|
1.42 Units on a scale
Standard Deviation 1.88
|
—
|
|
Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia)
Baseline - Arthralgia
|
2.73 Units on a scale
Standard Deviation 3.17
|
3.46 Units on a scale
Standard Deviation 2.30
|
3.13 Units on a scale
Standard Deviation 2.42
|
4.42 Units on a scale
Standard Deviation 2.35
|
—
|
|
Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia)
Week 24 - Headache
|
2.67 Units on a scale
Standard Deviation 1.53
|
1.38 Units on a scale
Standard Deviation 1.45
|
1.93 Units on a scale
Standard Deviation 1.90
|
2.04 Units on a scale
Standard Deviation 1.90
|
—
|
|
Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia)
Week 24 - Excessive perspiration
|
2.00 Units on a scale
Standard Deviation 2.00
|
2.08 Units on a scale
Standard Deviation 2.02
|
2.25 Units on a scale
Standard Deviation 2.21
|
2.64 Units on a scale
Standard Deviation 2.34
|
—
|
|
Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia)
Week 24 - Fatigue
|
2.33 Units on a scale
Standard Deviation 1.53
|
3.85 Units on a scale
Standard Deviation 1.86
|
3.36 Units on a scale
Standard Deviation 2.56
|
4.08 Units on a scale
Standard Deviation 2.40
|
—
|
|
Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia)
Week 24 - Soft tissue swelling
|
1.33 Units on a scale
Standard Deviation 1.53
|
2.46 Units on a scale
Standard Deviation 1.90
|
1.71 Units on a scale
Standard Deviation 2.17
|
1.76 Units on a scale
Standard Deviation 2.13
|
—
|
|
Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia)
Week 24 - Arthralgia
|
2.00 Units on a scale
Standard Deviation 2.65
|
3.62 Units on a scale
Standard Deviation 2.79
|
3.09 Units on a scale
Standard Deviation 2.66
|
3.68 Units on a scale
Standard Deviation 2.53
|
—
|
|
Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia)
Week 48 - Headache
|
NA Units on a scale
Standard Deviation NA
Phase 1 was up to Week 24 only
|
1.77 Units on a scale
Standard Deviation 1.92
|
2.32 Units on a scale
Standard Deviation 2.22
|
2.62 Units on a scale
Standard Deviation 2.08
|
—
|
|
Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia)
Week 48 - Excessive perspiration
|
NA Units on a scale
Standard Deviation NA
Phase 1 was up to Week 24 only
|
2.31 Units on a scale
Standard Deviation 2.02
|
2.50 Units on a scale
Standard Deviation 2.13
|
2.50 Units on a scale
Standard Deviation 2.40
|
—
|
|
Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia)
Week 48 - Fatigue
|
NA Units on a scale
Standard Deviation NA
Phase 1 was up to Week 24 only
|
3.77 Units on a scale
Standard Deviation 2.55
|
3.16 Units on a scale
Standard Deviation 2.32
|
3.92 Units on a scale
Standard Deviation 2.17
|
—
|
|
Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia)
Week 48 - Soft tissue swelling
|
NA Units on a scale
Standard Deviation NA
Phase 1 was up to Week 24 only
|
2.85 Units on a scale
Standard Deviation 2.08
|
2.10 Units on a scale
Standard Deviation 2.39
|
1.62 Units on a scale
Standard Deviation 2.02
|
—
|
|
Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia)
Week 48 - Arthralgia
|
NA Units on a scale
Standard Deviation NA
Phase 1 was up to Week 24 only
|
3.46 Units on a scale
Standard Deviation 2.57
|
3.60 Units on a scale
Standard Deviation 2.60
|
4.04 Units on a scale
Standard Deviation 2.24
|
—
|
SECONDARY outcome
Timeframe: At weeks 24 and 48Population: 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
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.
Outcome measures
| Measure |
Overall Study
n=11 Participants
|
Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks
n=9 Participants
|
Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks
n=55 Participants
|
Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks
n=21 Participants
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.
|
Overall Study
n=96 Participants
|
|---|---|---|---|---|---|
|
Mean Changes From Baseline in Quality of Life Scores (AcroQoL)
At week 24 (n=1, 9, 55, 21, and 86)
|
21.59 Units on a scale
Standard Deviation NA
Not applicable as there is only One subject.
|
-2.15 Units on a scale
Standard Deviation 9.58
|
-0.27 Units on a scale
Standard Deviation 11.73
|
-0.84 Units on a scale
Standard Deviation 11.00
|
-0.35 Units on a scale
Standard Deviation 11.43
|
|
Mean Changes From Baseline in Quality of Life Scores (AcroQoL)
At week 48 (n=0, 9, 53, 21, and 83)
|
NA Units on a scale
Standard Deviation NA
Phase 1 was up to Week 24 only.
|
1.31 Units on a scale
Standard Deviation 10.67
|
-1.32 Units on a scale
Standard Deviation 10.17
|
-1.52 Units on a scale
Standard Deviation 10.22
|
-1.08 Units on a scale
Standard Deviation 10.15
|
SECONDARY outcome
Timeframe: At weeks 24 and 48Population: 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.
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.
Outcome measures
| Measure |
Overall Study
n=15 Participants
|
Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks
n=13 Participants
|
Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks
n=70 Participants
|
Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks
n=26 Participants
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.
|
Overall Study
n=124 Participants
|
|---|---|---|---|---|---|
|
Mean Changes From Baseline in Quality of Life Scores (SF-36)
At week 24 (n=3, 13, 70, 26, and 112)
|
-0.66 Units on a scale
Standard Deviation 39.14
|
4.91 Units on a scale
Standard Deviation 22.64
|
1.79 Units on a scale
Standard Deviation 13.54
|
-2.75 Units on a scale
Standard Deviation 14.87
|
1.03 Units on a scale
Standard Deviation 15.89
|
|
Mean Changes From Baseline in Quality of Life Scores (SF-36)
At week 48 (n=0, 13, 68, 26, and 107)
|
NA Units on a scale
Standard Deviation NA
Phase 1 was up to Week 24 only.
|
4.96 Units on a scale
Standard Deviation 20.35
|
-0.61 Units on a scale
Standard Deviation 12.09
|
-0.62 Units on a scale
Standard Deviation 14.76
|
0.06 Units on a scale
Standard Deviation 13.93
|
SECONDARY outcome
Timeframe: At week 48 (End of Study)Population: MITT population. n = Number of subjects at the visit. 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.
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.
Outcome measures
| Measure |
Overall Study
n=85 Participants
|
Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks
|
Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks
|
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.
|
Overall Study
|
|---|---|---|---|---|---|
|
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
Phase I / Group A (n=9)
|
44.4 Percentage of subjects
Interval 12.0 to 76.9
|
—
|
—
|
—
|
—
|
|
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
Phase I / Group B (n=55)
|
47.2 Percentage of subjects
Interval 33.7 to 60.6
|
—
|
—
|
—
|
—
|
|
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
Phase I / Group C (n=21)
|
38.1 Percentage of subjects
Interval 17.3 to 58.9
|
—
|
—
|
—
|
—
|
|
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
Overall study (n=85)
|
44.6 Percentage of subjects
Interval 33.9 to 55.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At weeks 24 and 48Population: ITT population. n = Number of subjects at the visit. 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.
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).
Outcome measures
| Measure |
Overall Study
n=88 Participants
|
Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks
|
Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks
|
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.
|
Overall Study
|
|---|---|---|---|---|---|
|
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
Week 24: Phase I / Group A (n=8)
|
0.43 Correlation coefficient
Interval -0.42 to 0.86
|
—
|
—
|
—
|
—
|
|
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
Week 24: Phase I / Group B (n=55)
|
-0.02 Correlation coefficient
Interval -0.28 to 0.25
|
—
|
—
|
—
|
—
|
|
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
Week 24: Phase I / Group C (n=21)
|
-0.41 Correlation coefficient
Interval -0.71 to 0.04
|
—
|
—
|
—
|
—
|
|
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
Week 24: Overall study (n=85)
|
-0.01 Correlation coefficient
Interval -0.23 to 0.2
|
—
|
—
|
—
|
—
|
|
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
Week 48: Phase I / Group A (n=8)
|
0.69 Correlation coefficient
Interval -0.08 to 0.93
|
—
|
—
|
—
|
—
|
|
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
Week 48: Phase I / Group B (n=53)
|
-0.06 Correlation coefficient
Interval -0.32 to 0.22
|
—
|
—
|
—
|
—
|
|
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
Week 48: Phase I / Group C (n=21)
|
-0.09 Correlation coefficient
Interval -0.5 to 0.35
|
—
|
—
|
—
|
—
|
|
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
Week 48: Overall study (n=82)
|
-0.01 Correlation coefficient
Interval -0.22 to 0.21
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Baseline, week 24 and week 48Population: 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.
Outcome measures
| Measure |
Overall Study
n=15 Participants
|
Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks
n=13 Participants
|
Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks
n=70 Participants
|
Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks
n=26 Participants
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.
|
Overall Study
n=124 Participants
|
|---|---|---|---|---|---|
|
Serum Growth Hormone (GH) Levels
MITT - Week 48 (n=0, 13, 68, 26, and 107)
|
NA ng/mL
Standard Deviation NA
Phase 1 was up to week 24 only and was not part of MITT 'NA' for Phase I only group for the MITT
|
0.69 ng/mL
Standard Deviation 0.31
|
0.99 ng/mL
Standard Deviation 0.99
|
0.83 ng/mL
Standard Deviation 0.69
|
0.92 ng/mL
Standard Deviation 0.87
|
|
Serum Growth Hormone (GH) Levels
ITT - Baseline (n=15, 13, 70, 26, and 124)
|
1.04 ng/mL
Standard Deviation 1.02
|
0.92 ng/mL
Standard Deviation 0.68
|
0.92 ng/mL
Standard Deviation 1.16
|
1.08 ng/mL
Standard Deviation 1.17
|
0.97 ng/mL
Standard Deviation 1.09
|
|
Serum Growth Hormone (GH) Levels
ITT - Week 24 (n=3, 13, 70, 26, and 112)
|
4.89 ng/mL
Standard Deviation 7.42
|
0.90 ng/mL
Standard Deviation 0.41
|
0.95 ng/mL
Standard Deviation 0.89
|
0.67 ng/mL
Standard Deviation 0.55
|
0.99 ng/mL
Standard Deviation 1.42
|
|
Serum Growth Hormone (GH) Levels
ITT - Week 48 (n=0, 13, 68, 26, and 107)
|
NA ng/mL
Standard Deviation NA
Phase 1 was up to week 24
|
0.69 ng/mL
Standard Deviation 0.31
|
0.99 ng/mL
Standard Deviation 0.99
|
0.83 ng/mL
Standard Deviation 0.69
|
0.92 ng/mL
Standard Deviation 0.87
|
|
Serum Growth Hormone (GH) Levels
MITT - Baseline (n=0, 13, 70, 26, and 109)
|
NA ng/mL
Standard Deviation NA
Phase 1 was up to week 24 only and was not part of MITT 'NA' for Phase I only group for the MITT
|
0.92 ng/mL
Standard Deviation 0.68
|
0.92 ng/mL
Standard Deviation 1.16
|
1.08 ng/mL
Standard Deviation 1.17
|
0.96 ng/mL
Standard Deviation 1.11
|
|
Serum Growth Hormone (GH) Levels
MITT - Week 24 (n=0, 13, 70, 26, and 109)
|
NA ng/mL
Standard Deviation NA
Phase 1 was up to week 24 only and was not part of MITT 'NA' for Phase I only group for the MITT
|
0.90 ng/mL
Standard Deviation 0.41
|
0.95 ng/mL
Standard Deviation 0.89
|
0.67 ng/mL
Standard Deviation 0.55
|
0.88 ng/mL
Standard Deviation 0.78
|
SECONDARY outcome
Timeframe: At weeks 24 and 48Population: n = Number of subjects at the visit.
Outcome measures
| Measure |
Overall Study
n=124 Participants
|
Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks
|
Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks
|
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.
|
Overall Study
|
|---|---|---|---|---|---|
|
Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL
ITT: Week 24 - Phase I only (n=15)
|
66.7 Percentage of subjects
Interval 13.3 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL
ITT: Week 24 - Phase I / Group A (n=13)
|
100.0 Percentage of subjects
Interval 100.0 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL
ITT: Week 24 - Phase I / Group B (n=70)
|
91.4 Percentage of subjects
Interval 84.9 to 98.0
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL
ITT: Week 24 - Phase I / Group C (n=26)
|
100.0 Percentage of subjects
Interval 100.0 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL
ITT: Week 24 - Overall study (n=124)
|
93.8 Percentage of subjects
Interval 89.3 to 98.2
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL
ITT: Week 48 - Phase I / Group A (n=13)
|
100.0 Percentage of subjects
Interval 100.0 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL
ITT: Week 48 - Phase I / Group B (n=70)
|
92.6 Percentage of subjects
Interval 86.4 to 98.9
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL
ITT: Week 48 - Phase I / Group C (n=26)
|
96.2 Percentage of subjects
Interval 88.8 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL
ITT: Week 48 - Overall study (n=124)
|
94.4 Percentage of subjects
Interval 90.0 to 98.8
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL
MITT: Week 24 - Phase I / Group A (n=13)
|
100.0 Percentage of subjects
Interval 100.0 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL
MITT: Week 24 - Phase I / Group B (n=70)
|
91.4 Percentage of subjects
Interval 84.9 to 98.0
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL
MITT: Week 24 - Phase I / Group C (n=26)
|
100.0 Percentage of subjects
Interval 100.0 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL
MITT: Week 24 - Overall study (n=109)
|
94.5 Percentage of subjects
Interval 90.2 to 98.8
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL
MITT: Week 48 - Phase I / Group A (n=13)
|
100.0 Percentage of subjects
Interval 100.0 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL
MITT: Week 48 - Phase I / Group B (n=70)
|
92.6 Percentage of subjects
Interval 86.4 to 98.9
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL
MITT: Week 48 - Phase I / Group C (n=26)
|
96.2 Percentage of subjects
Interval 88.8 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL
MITT: Week 48 - Overall study (n=109)
|
94.4 Percentage of subjects
Interval 90.0 to 98.8
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At weeks 24 and 48Population: ITT population. n = Number of subjects at the visit. Lan: Lanreotide W: Week Inj: Injection Wks: Weeks Phs: Phase Grp: Group evy: every
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).
Outcome measures
| Measure |
Overall Study
n=124 Participants
|
Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks
|
Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks
|
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.
|
Overall Study
|
|---|---|---|---|---|---|
|
Subject Treatment Schedule Preference
W24:Oct-LAR IM inj evy 4 wks Phs 1 only (n=15)
|
20 Percentage of subjects
|
—
|
—
|
—
|
—
|
|
Subject Treatment Schedule Preference
W24:Lan Autogel inj evy 6 wks Phs 1 only (n=15)
|
80 Percentage of subjects
|
—
|
—
|
—
|
—
|
|
Subject Treatment Schedule Preference
W24:Oct-LAR IM inj evy 4 wks Phs 1/Grp A(n=13)
|
7.7 Percentage of subjects
|
—
|
—
|
—
|
—
|
|
Subject Treatment Schedule Preference
W24:Lan Autogel inj evy 6 wks Phs 1/Grp A(n=13)
|
92.3 Percentage of subjects
|
—
|
—
|
—
|
—
|
|
Subject Treatment Schedule Preference
W24:Oct-LAR IM inj evy 4 wks Phs 1/Grp B(n=70)
|
10.3 Percentage of subjects
|
—
|
—
|
—
|
—
|
|
Subject Treatment Schedule Preference
W24:Lan Autogel inj evy 6 wks Phs 1/Grp B(n=70)
|
85.3 Percentage of subjects
|
—
|
—
|
—
|
—
|
|
Subject Treatment Schedule Preference
W24:Non precised Phs 1/Grp B (n=70)
|
4.4 Percentage of subjects
|
—
|
—
|
—
|
—
|
|
Subject Treatment Schedule Preference
W24:Oct-LAR IM inj evy 4 wks Phs 1/Grp C(n=26)
|
3.8 Percentage of subjects
|
—
|
—
|
—
|
—
|
|
Subject Treatment Schedule Preference
W24:Lan Autogel inj every 6 wks Phs 1/Grp C(n=26)
|
96.2 Percentage of subjects
|
—
|
—
|
—
|
—
|
|
Subject Treatment Schedule Preference
W 24:Oct-LAR IM inj evy 4 wks-Overall study(n=124)
|
8.9 Percentage of subjects
|
—
|
—
|
—
|
—
|
|
Subject Treatment Schedule Preference
W24:Lan Autogel inj evy 6 wks-Overall study(n=124)
|
88.4 Percentage of subjects
|
—
|
—
|
—
|
—
|
|
Subject Treatment Schedule Preference
W 24: Non precised - Overall study (n=124)
|
2.7 Percentage of subjects
|
—
|
—
|
—
|
—
|
|
Subject Treatment Schedule Preference
W48:Oct-LAR IM inj evy 4 wks Phs 1/Grp A(n=13)
|
15.4 Percentage of subjects
|
—
|
—
|
—
|
—
|
|
Subject Treatment Schedule Preference
W48:Lan Autogel inj evy 6 wks Phs 1/Grp A(n=13)
|
76.9 Percentage of subjects
|
—
|
—
|
—
|
—
|
|
Subject Treatment Schedule Preference
W48:Non precised Phs 1/Grp A (n=13)
|
7.7 Percentage of subjects
|
—
|
—
|
—
|
—
|
|
Subject Treatment Schedule Preference
W48:Oct-LAR IM inj evy 4 wks Phs 1/Grp B(n=70)
|
14.7 Percentage of subjects
|
—
|
—
|
—
|
—
|
|
Subject Treatment Schedule Preference
W48:Lan Autogel inj evy 4 wks Phs 1/Grp B(n=70)
|
1.5 Percentage of subjects
|
—
|
—
|
—
|
—
|
|
Subject Treatment Schedule Preference
W48:Lan Autogel inj evy 6 wks Phs 1/Grp B(n=70)
|
77.9 Percentage of subjects
|
—
|
—
|
—
|
—
|
|
Subject Treatment Schedule Preference
W48:Non precised Phs 1/Grp B (n=70)
|
5.9 Percentage of subjects
|
—
|
—
|
—
|
—
|
|
Subject Treatment Schedule Preference
W48:Oct-LAR IM inj evy 4 wks Phs 1/Grp C(n=26)
|
7.7 Percentage of subjects
|
—
|
—
|
—
|
—
|
|
Subject Treatment Schedule Preference
W48:Lan Autogel inj evy 8 wks Phs 1/Grp C(n=26)
|
92.3 Percentage of subjects
|
—
|
—
|
—
|
—
|
|
Subject Treatment Schedule Preference
W48:Oct-LAR IM inj evy 4 wks-Overall study(n=124)
|
13.1 Percentage of subjects
|
—
|
—
|
—
|
—
|
|
Subject Treatment Schedule Preference
W48:Lan Autogel inj evy 4 wks-Overall study(n=124)
|
10.3 Percentage of subjects
|
—
|
—
|
—
|
—
|
|
Subject Treatment Schedule Preference
W48:Lan Autogel inj evy 6 wks-Overall study(n=124)
|
49.5 Percentage of subjects
|
—
|
—
|
—
|
—
|
|
Subject Treatment Schedule Preference
W48:Lan Autogel inj evy 8 wks-Overall study(n=124)
|
22.4 Percentage of subjects
|
—
|
—
|
—
|
—
|
|
Subject Treatment Schedule Preference
W48:Non precised-Overall study (n=124)
|
4.7 Percentage of subjects
|
—
|
—
|
—
|
—
|
Adverse Events
Phase 1: Lanreotide Autogel 120 mg
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks
Serious events: 4 serious events
Other events: 48 other events
Deaths: 0 deaths
Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1: Lanreotide Autogel 120 mg
n=15 participants at risk
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.
|
Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks
n=13 participants at risk
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.
|
Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks
n=70 participants at risk
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.
|
Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks
n=26 participants at risk
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.
|
|---|---|---|---|---|
|
General disorders
Asthenia
|
6.7%
1/15 • Number of events 1 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
General disorders
Chest Pain
|
6.7%
1/15 • Number of events 1 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
3.8%
1/26 • Number of events 1 • Up to week 48
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
6.7%
1/15 • Number of events 1 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
1/15 • Number of events 1 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/15 • Up to week 48
|
7.7%
1/13 • Number of events 1 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.7%
1/15 • Number of events 1 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
6.7%
1/15 • Number of events 1 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Nervous system disorders
Dizziness
|
6.7%
1/15 • Number of events 1 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Cardiac disorders
Arrhythmia
|
6.7%
1/15 • Number of events 1 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
1/15 • Number of events 1 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • Number of events 1 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Pregnancy, puerperium and perinatal conditions
Abortion
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
3.8%
1/26 • Number of events 1 • Up to week 48
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Vascular disorders
Varicose vein
|
0.00%
0/15 • Up to week 48
|
7.7%
1/13 • Number of events 1 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
Other adverse events
| Measure |
Phase 1: Lanreotide Autogel 120 mg
n=15 participants at risk
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.
|
Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks
n=13 participants at risk
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.
|
Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks
n=70 participants at risk
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.
|
Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks
n=26 participants at risk
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.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
15.7%
11/70 • Number of events 21 • Up to week 48
|
3.8%
1/26 • Number of events 4 • Up to week 48
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
6.7%
1/15 • Number of events 1 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
8.6%
6/70 • Number of events 7 • Up to week 48
|
11.5%
3/26 • Number of events 3 • Up to week 48
|
|
General disorders
Injection site pain
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
8.6%
6/70 • Number of events 15 • Up to week 48
|
7.7%
2/26 • Number of events 7 • Up to week 48
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
5.7%
4/70 • Number of events 8 • Up to week 48
|
7.7%
2/26 • Number of events 4 • Up to week 48
|
|
Gastrointestinal disorders
Flatulence
|
13.3%
2/15 • Number of events 2 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
2.9%
2/70 • Number of events 2 • Up to week 48
|
3.8%
1/26 • Number of events 1 • Up to week 48
|
|
Metabolism and nutrition disorders
Impaired fasting glucose
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
7.1%
5/70 • Number of events 5 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 3 • Up to week 48
|
11.5%
3/26 • Number of events 3 • Up to week 48
|
|
General disorders
Application site pain
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
4.3%
3/70 • Number of events 4 • Up to week 48
|
3.8%
1/26 • Number of events 1 • Up to week 48
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
6.7%
1/15 • Number of events 1 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
2.9%
2/70 • Number of events 2 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Nervous system disorders
Dizziness
|
13.3%
2/15 • Number of events 2 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.7%
1/15 • Number of events 1 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
2.9%
2/70 • Number of events 2 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • Number of events 1 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
3.8%
1/26 • Number of events 1 • Up to week 48
|
|
Gastrointestinal disorders
Constipation
|
13.3%
2/15 • Number of events 2 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
General disorders
Injection site induration
|
6.7%
1/15 • Number of events 1 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 2 • Up to week 48
|
7.7%
2/26 • Number of events 2 • Up to week 48
|
|
General disorders
Nodule
|
6.7%
1/15 • Number of events 2 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 3 • Up to week 48
|
3.8%
1/26 • Number of events 2 • Up to week 48
|
|
General disorders
Fatigue
|
6.7%
1/15 • Number of events 2 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
General disorders
Malaise
|
6.7%
1/15 • Number of events 1 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.7%
1/15 • Number of events 1 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
6.7%
1/15 • Number of events 1 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Infections and infestations
Sinusitis
|
6.7%
1/15 • Number of events 1 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Nervous system disorders
Headache
|
6.7%
1/15 • Number of events 1 • Up to week 48
|
15.4%
2/13 • Number of events 2 • Up to week 48
|
2.9%
2/70 • Number of events 2 • Up to week 48
|
7.7%
2/26 • Number of events 5 • Up to week 48
|
|
Nervous system disorders
Migraine
|
6.7%
1/15 • Number of events 3 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
3.8%
1/26 • Number of events 1 • Up to week 48
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.7%
1/15 • Number of events 1 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.7%
1/15 • Number of events 1 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
3.8%
1/26 • Number of events 1 • Up to week 48
|
|
Renal and urinary disorders
Calculus ureteric
|
6.7%
1/15 • Number of events 1 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Renal and urinary disorders
Haematuria
|
6.7%
1/15 • Number of events 1 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
1/15 • Number of events 1 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
6.7%
1/15 • Number of events 1 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Investigations
Low density lipoprotein increased
|
6.7%
1/15 • Number of events 1 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Investigations
Transaminases increased
|
6.7%
1/15 • Number of events 1 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Psychiatric disorders
Stress
|
6.7%
1/15 • Number of events 1 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Blood and lymphatic system disorders
Bicytopenia
|
6.7%
1/15 • Number of events 1 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Endocrine disorders
Hypothyroidism
|
6.7%
1/15 • Number of events 1 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/15 • Up to week 48
|
7.7%
1/13 • Number of events 1 • Up to week 48
|
2.9%
2/70 • Number of events 2 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
General disorders
Feeling cold
|
0.00%
0/15 • Up to week 48
|
7.7%
1/13 • Number of events 1 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Metabolism and nutrition disorders
Podagra
|
0.00%
0/15 • Up to week 48
|
7.7%
1/13 • Number of events 2 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/15 • Up to week 48
|
7.7%
1/13 • Number of events 1 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Hepatobiliary disorders
Cholelithiasis
|
6.7%
1/15 • Number of events 2 • Up to week 48
|
15.4%
2/13 • Number of events 3 • Up to week 48
|
10.0%
7/70 • Number of events 7 • Up to week 48
|
15.4%
4/26 • Number of events 5 • Up to week 48
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.00%
0/15 • Up to week 48
|
15.4%
2/13 • Number of events 2 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
3.8%
1/26 • Number of events 1 • Up to week 48
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/15 • Up to week 48
|
7.7%
1/13 • Number of events 1 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/15 • Up to week 48
|
15.4%
2/13 • Number of events 3 • Up to week 48
|
4.3%
3/70 • Number of events 3 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/15 • Up to week 48
|
7.7%
1/13 • Number of events 1 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/15 • Up to week 48
|
7.7%
1/13 • Number of events 1 • Up to week 48
|
4.3%
3/70 • Number of events 5 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/15 • Up to week 48
|
15.4%
2/13 • Number of events 2 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/15 • Up to week 48
|
7.7%
1/13 • Number of events 1 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/15 • Up to week 48
|
7.7%
1/13 • Number of events 1 • Up to week 48
|
2.9%
2/70 • Number of events 2 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Vascular disorders
Hypertension
|
6.7%
1/15 • Number of events 1 • Up to week 48
|
7.7%
1/13 • Number of events 1 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
7.7%
2/26 • Number of events 2 • Up to week 48
|
|
Vascular disorders
Hypotension
|
0.00%
0/15 • Up to week 48
|
7.7%
1/13 • Number of events 1 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/15 • Up to week 48
|
7.7%
1/13 • Number of events 1 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Respiratory, thoracic and mediastinal disorders
Nasal disorder
|
0.00%
0/15 • Up to week 48
|
7.7%
1/13 • Number of events 1 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/15 • Up to week 48
|
7.7%
1/13 • Number of events 1 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Investigations
High density lipoprotein increased
|
0.00%
0/15 • Up to week 48
|
7.7%
1/13 • Number of events 1 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/15 • Up to week 48
|
7.7%
1/13 • Number of events 1 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/15 • Up to week 48
|
7.7%
1/13 • Number of events 1 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/15 • Up to week 48
|
7.7%
1/13 • Number of events 1 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Endocrine disorders
Goitre
|
0.00%
0/15 • Up to week 48
|
7.7%
1/13 • Number of events 1 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
3.8%
1/26 • Number of events 1 • Up to week 48
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/15 • Up to week 48
|
7.7%
1/13 • Number of events 1 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/15 • Up to week 48
|
7.7%
1/13 • Number of events 1 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 3 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Gastrointestinal disorders
Gingivitis
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
3.8%
1/26 • Number of events 1 • Up to week 48
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
3.8%
1/26 • Number of events 1 • Up to week 48
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Gastrointestinal disorders
Steatorrhoea
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
3.8%
1/26 • Number of events 7 • Up to week 48
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
General disorders
Influenza like illness
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
2.9%
2/70 • Number of events 4 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
General disorders
Injection site nodule
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
3.8%
1/26 • Number of events 1 • Up to week 48
|
|
General disorders
Pyrexia
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
3.8%
1/26 • Number of events 1 • Up to week 48
|
|
General disorders
Asthenia
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
General disorders
Chest pain
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
3.8%
1/26 • Number of events 1 • Up to week 48
|
|
General disorders
Facial pain
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
General disorders
Injection site haematoma
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
General disorders
Injection site swelling
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
3.8%
1/26 • Number of events 2 • Up to week 48
|
|
General disorders
Medical device pain
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
General disorders
Oedema peripheral
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
General disorders
Thirst
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
2.9%
2/70 • Number of events 2 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate contr
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
3.8%
1/26 • Number of events 1 • Up to week 48
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
3.8%
1/26 • Number of events 1 • Up to week 48
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
4.3%
3/70 • Number of events 5 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
3.8%
1/26 • Number of events 1 • Up to week 48
|
|
Infections and infestations
Bronchitis
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
3.8%
1/26 • Number of events 1 • Up to week 48
|
|
Infections and infestations
Cervicitis
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
3.8%
1/26 • Number of events 1 • Up to week 48
|
|
Infections and infestations
Dengue fever
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Infections and infestations
Fungal infection
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 2 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Infections and infestations
Furuncle
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 2 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Infections and infestations
Influenza
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Infections and infestations
Rhinitis
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
3.8%
1/26 • Number of events 1 • Up to week 48
|
|
Infections and infestations
Viral infection
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
3.8%
1/26 • Number of events 1 • Up to week 48
|
|
Nervous system disorders
Intercostal neuralgia
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Nervous system disorders
Sciatica
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
3.8%
1/26 • Number of events 1 • Up to week 48
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Skin and subcutaneous tissue disorders
Increased tendency to bruise
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
3.8%
1/26 • Number of events 1 • Up to week 48
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
3.8%
1/26 • Number of events 1 • Up to week 48
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 2 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Skin and subcutaneous tissue disorders
Seborrhoea
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
3.8%
1/26 • Number of events 1 • Up to week 48
|
|
Vascular disorders
Flushing
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Vascular disorders
Lymphangiectasia
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
3.8%
1/26 • Number of events 1 • Up to week 48
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
3.8%
1/26 • Number of events 2 • Up to week 48
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
3.8%
1/26 • Number of events 1 • Up to week 48
|
|
Renal and urinary disorders
Nephrocalcinosis
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
3.8%
1/26 • Number of events 1 • Up to week 48
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Investigations
Blood pressure systolic decreased
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
3.8%
1/26 • Number of events 1 • Up to week 48
|
|
Investigations
Weight decreased
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Psychiatric disorders
Depression
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
3.8%
1/26 • Number of events 1 • Up to week 48
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Endocrine disorders
Hypogonadism
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Eye disorders
Diplopia
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
3.8%
1/26 • Number of events 1 • Up to week 48
|
|
Eye disorders
Eye swelling
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
3.8%
1/26 • Number of events 1 • Up to week 48
|
|
Eye disorders
Presbyopia
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
3.8%
1/26 • Number of events 1 • Up to week 48
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
3.8%
1/26 • Number of events 1 • Up to week 48
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of liver
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyoma
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
3.8%
1/26 • Number of events 1 • Up to week 48
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
3.8%
1/26 • Number of events 1 • Up to week 48
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Eye disorders
Cataract cortical
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
6.7%
1/15 • Number of events 1 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
0.00%
0/70 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/15 • Up to week 48
|
0.00%
0/13 • Up to week 48
|
1.4%
1/70 • Number of events 1 • Up to week 48
|
0.00%
0/26 • Up to week 48
|
Additional Information
Medical Director, Clinical Endocrinology and Metabolism
Ipsen
Phone: [email protected]
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place