Trial Outcomes & Findings for Study to Assess the Efficacy and Safety of Lanreotide Autogel® in Chinese Participants With GEP-NETs (NCT NCT04852679)
NCT ID: NCT04852679
Last Updated: 2024-10-01
Results Overview
The CBR was defined as the percentage of participants with a best overall response of confirmed complete response (CR), confirmed partial response (PR), or continued stable disease (SD) until the time of assessment according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria v1.1. The CR was defined as disappearance of all target lesions. The PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. The SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum longest diameter since the treatment started.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
43 participants
Primary outcome timeframe
RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24
Results posted on
2024-10-01
Participant Flow
This Phase 3 single-arm, open-label study was conducted in chinese adult participants with unresectable, locally advanced or metastatic Grade 1 or 2 gastroenteropancreatic neuroendocrine tumours (GEP-NETs) at 14 investigational sites in China between 24 May 2021 and 13 January 2023.
This study consisted of a screening period (up to 4 weeks), followed by a 48-week main intervention period and then a 24-week independent injection period. A total of 43 participants were treated in this study.
Participant milestones
| Measure |
Lanreotide Autogel 120 Milligram (mg)
All participants received a fixed dose of lanreotide autogel 120 mg subcutaneous (SC) injection every 28 days up to 48 weeks during the main intervention period. After completion of the main intervention period, eligible participants entered an independent injection period to receive lanreotide autogel 120 mg SC injection every 28 days for 24 weeks.
|
|---|---|
|
Main Intervention Period
STARTED
|
43
|
|
Main Intervention Period
Study Intervention Completion at Week 24
|
28
|
|
Main Intervention Period
COMPLETED
|
22
|
|
Main Intervention Period
NOT COMPLETED
|
21
|
|
Independent Injection Period
STARTED
|
5
|
|
Independent Injection Period
COMPLETED
|
4
|
|
Independent Injection Period
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Lanreotide Autogel 120 Milligram (mg)
All participants received a fixed dose of lanreotide autogel 120 mg subcutaneous (SC) injection every 28 days up to 48 weeks during the main intervention period. After completion of the main intervention period, eligible participants entered an independent injection period to receive lanreotide autogel 120 mg SC injection every 28 days for 24 weeks.
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|---|---|
|
Main Intervention Period
Withdrawal by Subject
|
3
|
|
Main Intervention Period
Adverse Event
|
1
|
|
Main Intervention Period
Progressive Disease
|
16
|
|
Main Intervention Period
Refused study visit
|
1
|
|
Independent Injection Period
Missed study visit
|
1
|
Baseline Characteristics
Study to Assess the Efficacy and Safety of Lanreotide Autogel® in Chinese Participants With GEP-NETs
Baseline characteristics by cohort
| Measure |
Lanreotide Autogel 120 mg
n=43 Participants
All participants received a fixed dose of lanreotide autogel 120 mg SC injection every 28 days up to 48 weeks during the main intervention period. After completion of the main intervention period, eligible participants entered an independent injection period to receive lanreotide autogel 120 mg SC injection every 28 days for 24 weeks.
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|---|---|
|
Age, Continuous
|
51.8 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24Population: The ITT analysis set included all participants who received at least 1 dose of study intervention.
The CBR was defined as the percentage of participants with a best overall response of confirmed complete response (CR), confirmed partial response (PR), or continued stable disease (SD) until the time of assessment according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria v1.1. The CR was defined as disappearance of all target lesions. The PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. The SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum longest diameter since the treatment started.
Outcome measures
| Measure |
Lanreotide Autogel 120 mg
n=43 Participants
All participants received a fixed dose of lanreotide autogel 120 mg SC injection every 28 days up to 48 weeks during the main intervention period. After completion of the main intervention period, eligible participants entered an independent injection period to receive lanreotide autogel 120 mg SC injection every 28 days for 24 weeks.
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|---|---|
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Clinical Benefit Rate (CBR) of Tumour Response Assessed by Blinded Independent Central Review (BICR) at Week 24
|
62.79 percentage of participants
Interval 46.7 to 77.0
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SECONDARY outcome
Timeframe: RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24 and 48Population: The ITT analysis set included all participants who received at least 1 dose of study intervention.
The PFS was defined as the time from the first administration of study intervention to the date of the first documented PD measured using RECIST criteria v1.1 and confirmed by BICR, or death from any cause, whichever comes first. The PFS was estimated using the Kaplan-Meier method. The PD was defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Lanreotide Autogel 120 mg
n=43 Participants
All participants received a fixed dose of lanreotide autogel 120 mg SC injection every 28 days up to 48 weeks during the main intervention period. After completion of the main intervention period, eligible participants entered an independent injection period to receive lanreotide autogel 120 mg SC injection every 28 days for 24 weeks.
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|---|---|
|
Progression Free Survival (PFS) by BICR Within Weeks 24 and 48
Week 24
|
NA weeks
Interval 24.1 to
Medium and upper limit of confidence interval (CI) could not be determined as too few survival events during the 24 weeks study duration.
|
|
Progression Free Survival (PFS) by BICR Within Weeks 24 and 48
Week 48
|
NA weeks
Interval 36.1 to
Medium and upper limit of CI could not be determined as too few survival events during the main intervention period.
|
SECONDARY outcome
Timeframe: RECIST assessments performed at baseline (within 28 days before start of study intervention) and Week 48 (end of the main intervention period)Population: The ITT analysis set included all participants who received at least 1 dose of study intervention.
The OS was defined as the time from the first administration of study intervention to the date of death from any cause. The OS was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Lanreotide Autogel 120 mg
n=43 Participants
All participants received a fixed dose of lanreotide autogel 120 mg SC injection every 28 days up to 48 weeks during the main intervention period. After completion of the main intervention period, eligible participants entered an independent injection period to receive lanreotide autogel 120 mg SC injection every 28 days for 24 weeks.
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|---|---|
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Overall Survival (OS) at the End of the Main Intervention Period
|
NA weeks
The results could not be determined as too few death events during the main intervention period.
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SECONDARY outcome
Timeframe: RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 12, 24, 36 and 48Population: The ITT analysis set included all participants who received at least 1 dose of study intervention.
The TTP was defined as the time from the first administration of study intervention to the date of the first documented PD, or clinical progression confirmed by the investigator. The TTP was assessed by BICR and estimated using the Kaplan-Meier method. The PD was defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Lanreotide Autogel 120 mg
n=43 Participants
All participants received a fixed dose of lanreotide autogel 120 mg SC injection every 28 days up to 48 weeks during the main intervention period. After completion of the main intervention period, eligible participants entered an independent injection period to receive lanreotide autogel 120 mg SC injection every 28 days for 24 weeks.
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|---|---|
|
Time to Progression (TTP) During Main Intervention Period
|
NA weeks
Interval 48.0 to
Medium and upper limit of CI could not be determined as too few progression events during the main intervention period.
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SECONDARY outcome
Timeframe: RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24 and 48Population: The ITT analysis set included all participants who received at least 1 dose of study intervention.
Percentage of participants who were alive and progression free per RECIST v1.1 using BICR assessments at 24 and 48 weeks after first dose of study intervention were reported. The PFS was estimated using the Kaplan-Meier method. The PD was defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Lanreotide Autogel 120 mg
n=43 Participants
All participants received a fixed dose of lanreotide autogel 120 mg SC injection every 28 days up to 48 weeks during the main intervention period. After completion of the main intervention period, eligible participants entered an independent injection period to receive lanreotide autogel 120 mg SC injection every 28 days for 24 weeks.
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|---|---|
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Percentage of Participants Alive and Without Tumour Progressive at Weeks 24 and 48
Week 24
|
77.4 percentage of participants
Interval 59.6 to 88.1
|
|
Percentage of Participants Alive and Without Tumour Progressive at Weeks 24 and 48
Week 48
|
59.0 percentage of participants
Interval 36.1 to 76.1
|
SECONDARY outcome
Timeframe: RECIST assessments performed at baseline (within 28 days before start of study intervention) and Week 48Population: The ITT analysis set included all participants who received at least 1 dose of study intervention.
The CBR was defined as the percentage of participants with a best overall response of confirmed CR, confirmed PR, or continued SD until the time of assessment according to RECIST criteria v1.1. The CR was defined as disappearance of all target lesions. The PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. The SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started.
Outcome measures
| Measure |
Lanreotide Autogel 120 mg
n=43 Participants
All participants received a fixed dose of lanreotide autogel 120 mg SC injection every 28 days up to 48 weeks during the main intervention period. After completion of the main intervention period, eligible participants entered an independent injection period to receive lanreotide autogel 120 mg SC injection every 28 days for 24 weeks.
|
|---|---|
|
Clinical Benefit Rate Assessed by BICR at Week 48
|
58.1 percentage of participants
Interval 42.1 to 73.0
|
SECONDARY outcome
Timeframe: RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24 and 48Population: The ITT analysis set included all participants who received at least 1 dose of study intervention.
The ORR was defined as the percentage of participants with a best overall response of confirmed CR or confirmed PR. The CR was defined as disappearance of all target lesions. The PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter.
Outcome measures
| Measure |
Lanreotide Autogel 120 mg
n=43 Participants
All participants received a fixed dose of lanreotide autogel 120 mg SC injection every 28 days up to 48 weeks during the main intervention period. After completion of the main intervention period, eligible participants entered an independent injection period to receive lanreotide autogel 120 mg SC injection every 28 days for 24 weeks.
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|---|---|
|
Overall Response Rate (ORR) at Weeks 24 and 48
Week 24
|
0 percentage of participants
Interval 0.0 to 8.2
|
|
Overall Response Rate (ORR) at Weeks 24 and 48
Week 48
|
7.0 percentage of participants
Interval 1.5 to 19.1
|
SECONDARY outcome
Timeframe: RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24 and 48Population: The ITT analysis set included all participants who received at least 1 dose of study intervention.
The DCR was defined as the percentage of participants with a best overall response of confirmed CR, confirmed PR or SD. The CR was defined as disappearance of all target lesions. The PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. The SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started.
Outcome measures
| Measure |
Lanreotide Autogel 120 mg
n=43 Participants
All participants received a fixed dose of lanreotide autogel 120 mg SC injection every 28 days up to 48 weeks during the main intervention period. After completion of the main intervention period, eligible participants entered an independent injection period to receive lanreotide autogel 120 mg SC injection every 28 days for 24 weeks.
|
|---|---|
|
Disease Control Rate (DCR) at Weeks 24 and 48
Week 24
|
69.8 percentage of participants
Interval 53.9 to 82.8
|
|
Disease Control Rate (DCR) at Weeks 24 and 48
Week 48
|
69.8 percentage of participants
Interval 53.9 to 82.8
|
SECONDARY outcome
Timeframe: Weeks 24 and 48Population: The ITT analysis set included all participants who received at least 1 dose of study intervention.
The presence or absence of endocrine symptoms of NETs (example; flushing, diarrhoea, abdominal pain, weakness, heartburn, nausea, vomiting, sweating, tremor, palpitation, or erythema) were assessed by the investigator at screening. In participants with symptoms of NETs at screening, a baseline assessment of the symptoms experienced in the last 4 weeks was performed by questioning before study intervention administration at Day 1. These symptoms were recorded in the case report form and severity graded upon National Cancer Institute Common Terminology Criteria for Adverse Events. Where, Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death.
Outcome measures
| Measure |
Lanreotide Autogel 120 mg
n=43 Participants
All participants received a fixed dose of lanreotide autogel 120 mg SC injection every 28 days up to 48 weeks during the main intervention period. After completion of the main intervention period, eligible participants entered an independent injection period to receive lanreotide autogel 120 mg SC injection every 28 days for 24 weeks.
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|---|---|
|
Number of Participants With Neuroendocrine Tumours (NET)-Related Clinical Symptoms at Weeks 24 and 48
Week 24: Nodal tachycardia · Grade 2
|
0 Participants
|
|
Number of Participants With Neuroendocrine Tumours (NET)-Related Clinical Symptoms at Weeks 24 and 48
Week 24: Nodal tachycardia · Grade 3
|
0 Participants
|
|
Number of Participants With Neuroendocrine Tumours (NET)-Related Clinical Symptoms at Weeks 24 and 48
Week 24: Nodal tachycardia · Grade 4
|
0 Participants
|
|
Number of Participants With Neuroendocrine Tumours (NET)-Related Clinical Symptoms at Weeks 24 and 48
Week 24: Nodal tachycardia · Grade 5
|
0 Participants
|
|
Number of Participants With Neuroendocrine Tumours (NET)-Related Clinical Symptoms at Weeks 24 and 48
Week 24: Nodal tachycardia · Missing
|
43 Participants
|
|
Number of Participants With Neuroendocrine Tumours (NET)-Related Clinical Symptoms at Weeks 24 and 48
Week 48: Nodal tachycardia · Grade 1
|
0 Participants
|
|
Number of Participants With Neuroendocrine Tumours (NET)-Related Clinical Symptoms at Weeks 24 and 48
Week 48: Nodal tachycardia · Grade 2
|
0 Participants
|
|
Number of Participants With Neuroendocrine Tumours (NET)-Related Clinical Symptoms at Weeks 24 and 48
Week 24: Diarrhea · Grade 1
|
0 Participants
|
|
Number of Participants With Neuroendocrine Tumours (NET)-Related Clinical Symptoms at Weeks 24 and 48
Week 24: Diarrhea · Grade 2
|
0 Participants
|
|
Number of Participants With Neuroendocrine Tumours (NET)-Related Clinical Symptoms at Weeks 24 and 48
Week 24: Diarrhea · Grade 3
|
0 Participants
|
|
Number of Participants With Neuroendocrine Tumours (NET)-Related Clinical Symptoms at Weeks 24 and 48
Week 24: Diarrhea · Grade 4
|
0 Participants
|
|
Number of Participants With Neuroendocrine Tumours (NET)-Related Clinical Symptoms at Weeks 24 and 48
Week 24: Diarrhea · Grade 5
|
0 Participants
|
|
Number of Participants With Neuroendocrine Tumours (NET)-Related Clinical Symptoms at Weeks 24 and 48
Week 24: Diarrhea · Missing
|
43 Participants
|
|
Number of Participants With Neuroendocrine Tumours (NET)-Related Clinical Symptoms at Weeks 24 and 48
Week 48: Diarrhea · Grade 1
|
0 Participants
|
|
Number of Participants With Neuroendocrine Tumours (NET)-Related Clinical Symptoms at Weeks 24 and 48
Week 48: Diarrhea · Grade 2
|
0 Participants
|
|
Number of Participants With Neuroendocrine Tumours (NET)-Related Clinical Symptoms at Weeks 24 and 48
Week 48: Diarrhea · Grade 3
|
0 Participants
|
|
Number of Participants With Neuroendocrine Tumours (NET)-Related Clinical Symptoms at Weeks 24 and 48
Week 48: Diarrhea · Grade 4
|
0 Participants
|
|
Number of Participants With Neuroendocrine Tumours (NET)-Related Clinical Symptoms at Weeks 24 and 48
Week 48: Diarrhea · Grade 5
|
0 Participants
|
|
Number of Participants With Neuroendocrine Tumours (NET)-Related Clinical Symptoms at Weeks 24 and 48
Week 48: Diarrhea · Missing
|
43 Participants
|
|
Number of Participants With Neuroendocrine Tumours (NET)-Related Clinical Symptoms at Weeks 24 and 48
Week 24: Hypertension · Grade 1
|
1 Participants
|
|
Number of Participants With Neuroendocrine Tumours (NET)-Related Clinical Symptoms at Weeks 24 and 48
Week 24: Hypertension · Grade 2
|
0 Participants
|
|
Number of Participants With Neuroendocrine Tumours (NET)-Related Clinical Symptoms at Weeks 24 and 48
Week 24: Hypertension · Grade 3
|
0 Participants
|
|
Number of Participants With Neuroendocrine Tumours (NET)-Related Clinical Symptoms at Weeks 24 and 48
Week 24: Hypertension · Grade 4
|
0 Participants
|
|
Number of Participants With Neuroendocrine Tumours (NET)-Related Clinical Symptoms at Weeks 24 and 48
Week 24: Hypertension · Grade 5
|
0 Participants
|
|
Number of Participants With Neuroendocrine Tumours (NET)-Related Clinical Symptoms at Weeks 24 and 48
Week 24: Hypertension · Missing
|
42 Participants
|
|
Number of Participants With Neuroendocrine Tumours (NET)-Related Clinical Symptoms at Weeks 24 and 48
Week 48: Hypertension · Grade 1
|
0 Participants
|
|
Number of Participants With Neuroendocrine Tumours (NET)-Related Clinical Symptoms at Weeks 24 and 48
Week 48: Hypertension · Grade 2
|
0 Participants
|
|
Number of Participants With Neuroendocrine Tumours (NET)-Related Clinical Symptoms at Weeks 24 and 48
Week 48: Hypertension · Grade 3
|
0 Participants
|
|
Number of Participants With Neuroendocrine Tumours (NET)-Related Clinical Symptoms at Weeks 24 and 48
Week 48: Hypertension · Grade 4
|
0 Participants
|
|
Number of Participants With Neuroendocrine Tumours (NET)-Related Clinical Symptoms at Weeks 24 and 48
Week 48: Hypertension · Grade 5
|
0 Participants
|
|
Number of Participants With Neuroendocrine Tumours (NET)-Related Clinical Symptoms at Weeks 24 and 48
Week 48: Hypertension · Missing
|
43 Participants
|
|
Number of Participants With Neuroendocrine Tumours (NET)-Related Clinical Symptoms at Weeks 24 and 48
Week 24: Nodal tachycardia · Grade 1
|
0 Participants
|
|
Number of Participants With Neuroendocrine Tumours (NET)-Related Clinical Symptoms at Weeks 24 and 48
Week 48: Nodal tachycardia · Grade 3
|
0 Participants
|
|
Number of Participants With Neuroendocrine Tumours (NET)-Related Clinical Symptoms at Weeks 24 and 48
Week 48: Nodal tachycardia · Grade 4
|
0 Participants
|
|
Number of Participants With Neuroendocrine Tumours (NET)-Related Clinical Symptoms at Weeks 24 and 48
Week 48: Nodal tachycardia · Grade 5
|
0 Participants
|
|
Number of Participants With Neuroendocrine Tumours (NET)-Related Clinical Symptoms at Weeks 24 and 48
Week 48: Nodal tachycardia · Missing
|
43 Participants
|
SECONDARY outcome
Timeframe: Baseline (within 28 days before start of study intervention) and Weeks 12, 24, 36 and 48Population: The ITT analysis set included all participants who received at least 1 dose of study intervention.
The CgA determination was useful for staging, prognosis and follow up, since the serum concentration correlated to the tumour mass. Blood samples were collected to measure circulating CgA.
Outcome measures
| Measure |
Lanreotide Autogel 120 mg
n=36 Participants
All participants received a fixed dose of lanreotide autogel 120 mg SC injection every 28 days up to 48 weeks during the main intervention period. After completion of the main intervention period, eligible participants entered an independent injection period to receive lanreotide autogel 120 mg SC injection every 28 days for 24 weeks.
|
|---|---|
|
Change From Baseline in Plasma Chromogranin A (CgA) at Weeks 12, 24, 36 and 48
Week 12
|
-35.7305 microgram per liter
Standard Deviation 105.1477
|
|
Change From Baseline in Plasma Chromogranin A (CgA) at Weeks 12, 24, 36 and 48
Week 24
|
-46.2278 microgram per liter
Standard Deviation 126.1348
|
|
Change From Baseline in Plasma Chromogranin A (CgA) at Weeks 12, 24, 36 and 48
Week 36
|
-51.8435 microgram per liter
Standard Deviation 125.4386
|
|
Change From Baseline in Plasma Chromogranin A (CgA) at Weeks 12, 24, 36 and 48
Week 48
|
-30.8557 microgram per liter
Standard Deviation 134.5523
|
SECONDARY outcome
Timeframe: Baseline (within 28 days before start of study intervention) and Weeks 12, 24, 36 and 48Population: The ITT analysis set included all participants who received at least 1 dose of study intervention.
Urine samples were collected to measure 5-HIAA.
Outcome measures
| Measure |
Lanreotide Autogel 120 mg
n=36 Participants
All participants received a fixed dose of lanreotide autogel 120 mg SC injection every 28 days up to 48 weeks during the main intervention period. After completion of the main intervention period, eligible participants entered an independent injection period to receive lanreotide autogel 120 mg SC injection every 28 days for 24 weeks.
|
|---|---|
|
Change From Baseline in 5-Hydroxyindoleacetic Acid (5-HIAA) at Weeks 12, 24, 36 and 48
Week 12
|
-0.5495 milligram per liter
Standard Deviation 0.9598
|
|
Change From Baseline in 5-Hydroxyindoleacetic Acid (5-HIAA) at Weeks 12, 24, 36 and 48
Week 24
|
-1.1965 milligram per liter
Standard Deviation 4.5374
|
|
Change From Baseline in 5-Hydroxyindoleacetic Acid (5-HIAA) at Weeks 12, 24, 36 and 48
Week 36
|
-0.0837 milligram per liter
Standard Deviation 1.6261
|
|
Change From Baseline in 5-Hydroxyindoleacetic Acid (5-HIAA) at Weeks 12, 24, 36 and 48
Week 48
|
-1.3129 milligram per liter
Standard Deviation 6.3055
|
SECONDARY outcome
Timeframe: Baseline (within 28 days before start of study intervention) and Weeks 12, 24, 36 and 48Population: The ITT analysis set included all participants who received at least 1 dose of study intervention.
The European Organization for Research and Treatment of Cancer QoL Questionnaire for Cancer participants contains 30 single items. For questions 1 to 28, score ranges from 1 to 4 where, 1= not at all, 2= a little, 3= quite a bit and 4= very much. Global health status/QoL contains questions 29 and 30 and score ranges from 1 to 7, where 1= very poor and 7= excellent. Total score ranges from 0 (poor) to 100 (excellent). Higher score indicates a high QoL.
Outcome measures
| Measure |
Lanreotide Autogel 120 mg
n=36 Participants
All participants received a fixed dose of lanreotide autogel 120 mg SC injection every 28 days up to 48 weeks during the main intervention period. After completion of the main intervention period, eligible participants entered an independent injection period to receive lanreotide autogel 120 mg SC injection every 28 days for 24 weeks.
|
|---|---|
|
Change From Baseline in Quality of Life (QoL) Assessment at Weeks 12, 24, 36 and 48
Week 12
|
3.0 units on a scale
Standard Deviation 16.0
|
|
Change From Baseline in Quality of Life (QoL) Assessment at Weeks 12, 24, 36 and 48
Week 24
|
-4.0 units on a scale
Standard Deviation 18.2
|
|
Change From Baseline in Quality of Life (QoL) Assessment at Weeks 12, 24, 36 and 48
Week 36
|
-9.4 units on a scale
Standard Deviation 16.5
|
|
Change From Baseline in Quality of Life (QoL) Assessment at Weeks 12, 24, 36 and 48
Week 48
|
-13.8 units on a scale
Standard Deviation 19.0
|
Adverse Events
Main Intervention Period: Lanreotide Autogel 120 mg
Serious events: 4 serious events
Other events: 43 other events
Deaths: 2 deaths
Independent Injection Period: Lanreotide Autogel 120 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Main Intervention Period: Lanreotide Autogel 120 mg
n=43 participants at risk
All participants received a fixed dose of lanreotide autogel 120 mg SC injection every 28 days up to 48 weeks.
|
Independent Injection Period: Lanreotide Autogel 120 mg
n=5 participants at risk
Eligible participants received a fixed dose of lanreotide autogel 120 mg SC injection every 28 days for 24 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
2.3%
1/43 • Number of events 1 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
0.00%
0/5 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
|
Gastrointestinal disorders
Ileus
|
2.3%
1/43 • Number of events 1 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
0.00%
0/5 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
2.3%
1/43 • Number of events 1 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
0.00%
0/5 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
|
Investigations
Alanine aminotransferase increased
|
2.3%
1/43 • Number of events 1 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
0.00%
0/5 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
|
Investigations
Aspartate aminotransferase increased
|
2.3%
1/43 • Number of events 1 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
0.00%
0/5 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.3%
1/43 • Number of events 1 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
0.00%
0/5 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
Other adverse events
| Measure |
Main Intervention Period: Lanreotide Autogel 120 mg
n=43 participants at risk
All participants received a fixed dose of lanreotide autogel 120 mg SC injection every 28 days up to 48 weeks.
|
Independent Injection Period: Lanreotide Autogel 120 mg
n=5 participants at risk
Eligible participants received a fixed dose of lanreotide autogel 120 mg SC injection every 28 days for 24 weeks.
|
|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
20.9%
9/43 • Number of events 10 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
0.00%
0/5 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
|
Investigations
Bilirubin conjugated increased
|
18.6%
8/43 • Number of events 8 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
0.00%
0/5 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
|
Investigations
Blood bilirubin increased
|
18.6%
8/43 • Number of events 9 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
0.00%
0/5 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
|
Investigations
Weight decreased
|
18.6%
8/43 • Number of events 10 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
0.00%
0/5 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
|
Investigations
Blood glucose increased
|
16.3%
7/43 • Number of events 7 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
0.00%
0/5 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
|
Investigations
White blood cell count decreased
|
14.0%
6/43 • Number of events 8 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
0.00%
0/5 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
|
Investigations
Glycosylated haemoglobin increased
|
11.6%
5/43 • Number of events 5 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
20.0%
1/5 • Number of events 1 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
9.3%
4/43 • Number of events 4 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
0.00%
0/5 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
|
Investigations
Weight increased
|
9.3%
4/43 • Number of events 4 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
0.00%
0/5 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
|
Investigations
Aspartate aminotransferase increased
|
7.0%
3/43 • Number of events 5 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
0.00%
0/5 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
|
Investigations
Blood lactate dehydrogenase increased
|
7.0%
3/43 • Number of events 3 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
0.00%
0/5 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
|
Investigations
Blood urea increased
|
7.0%
3/43 • Number of events 4 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
0.00%
0/5 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
|
Investigations
Neutrophil count decreased
|
7.0%
3/43 • Number of events 3 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
20.0%
1/5 • Number of events 1 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
|
Investigations
Red blood cell count decreased
|
7.0%
3/43 • Number of events 3 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
0.00%
0/5 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
41.9%
18/43 • Number of events 32 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
0.00%
0/5 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
16.3%
7/43 • Number of events 8 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
0.00%
0/5 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
|
Gastrointestinal disorders
Constipation
|
14.0%
6/43 • Number of events 8 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
0.00%
0/5 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
|
Gastrointestinal disorders
Abdominal distension
|
11.6%
5/43 • Number of events 6 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
0.00%
0/5 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.6%
5/43 • Number of events 5 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
0.00%
0/5 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.0%
3/43 • Number of events 4 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
0.00%
0/5 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
|
Gastrointestinal disorders
Nausea
|
7.0%
3/43 • Number of events 4 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
0.00%
0/5 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
|
Gastrointestinal disorders
Vomiting
|
7.0%
3/43 • Number of events 3 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
0.00%
0/5 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
|
General disorders
Fatigue
|
16.3%
7/43 • Number of events 8 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
0.00%
0/5 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
|
General disorders
Injection site nodule
|
11.6%
5/43 • Number of events 5 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
0.00%
0/5 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
|
Infections and infestations
Urinary tract infection
|
11.6%
5/43 • Number of events 6 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
0.00%
0/5 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
|
Hepatobiliary disorders
Cholelithiasis
|
9.3%
4/43 • Number of events 4 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
0.00%
0/5 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
9.3%
4/43 • Number of events 4 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
0.00%
0/5 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/43 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
20.0%
1/5 • Number of events 1 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/43 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
20.0%
1/5 • Number of events 1 • Main intervention period: Treatment-emergent adverse events (TEAEs) were reported from first injection of study intervention up to Week 48, approximately 48 weeks. Independent injection period: TEAEs were reported from Week 48 to end of study or 4 weeks after last injection of study intervention, approximately 28 weeks.
Main intervention period: The safety set included all participants who received at least 1 dose of study intervention. Independent injection period: The independent injection set included all participants who received the study intervention by independent injection. A TEAE is defined as any adverse event that is not occurred prior to the first dose of study intervention or occurred prior to the first dose of study intervention but the intensity increased during the active phase of the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place