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This study will be conducted to support the registration of the lanreotide Autogel 120 mg formulation in China for the treatment of GEP-NETs and treatment of clinical symptoms of NETs.
The study will include a screening period of up to 4 weeks followed by a 48-week intervention period. After completion of the main study period, five participants will continue in a self/partner injection cohort with lanreotide Autogel 120 mg every 28 days for 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lanreotide Autogel 120 mg | Other | Subjects will be treated with lanreotide Autogel® 120mg, every 28 days (+/- 3 days). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lanreotide autogel | Drug | Administered as deep subcutaneous (SC) injections |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Benefit Rate (CBR) of Tumour Response Assessed by Blinded Independent Central Review (BICR) at Week 24 | 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. | RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) by BICR Within Weeks 24 and 48 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Sciences | Beijing | Beijing Municipality | 100021 | China | ||
| Beijing Cancer Hospital |
Where patient data can be anonymised, Ipsen will share all individual participant data that underlie the results reported in the published journal article with qualified researchers who provide a valid research question. Study documents, such as the study protocol and clinical study report, are not always available.
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Data are available beginning 6 months and ending 5 years after the publication of the findings in a journal; after this time, only raw data may be available.
Proposals should be submitted to DataSharing@ipsen.com and will be assessed by a scientific review board.
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Main Intervention Period |
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| Independent Injection Period |
|
The Intention-To-Treat (ITT) analysis set included all participants who received at least 1 dose of study intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Lanreotide Autogel 120 mg | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinical Benefit Rate (CBR) of Tumour Response Assessed by Blinded Independent Central Review (BICR) at Week 24 | 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. | The ITT analysis set included all participants who received at least 1 dose of study intervention. | Posted | Number | 95% Confidence Interval | percentage of participants | RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24 |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Main Intervention Period: Lanreotide Autogel 120 mg | All participants received a fixed dose of lanreotide autogel 120 mg SC injection every 28 days up to 48 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Ipsen | see email | clinical.trials@ipsen.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 17, 2021 | Oct 31, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 17, 2023 | Oct 31, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C535650 | Gastro-enteropancreatic neuroendocrine tumor |
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| RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24 and 48 |
| Overall Survival (OS) at the End of the Main Intervention Period | 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. | RECIST assessments performed at baseline (within 28 days before start of study intervention) and Week 48 (end of the main intervention period) |
| Time to Progression (TTP) During Main Intervention Period | 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. | RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 12, 24, 36 and 48 |
| Percentage of Participants Alive and Without Tumour Progressive at Weeks 24 and 48 | 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. | RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24 and 48 |
| Clinical Benefit Rate Assessed by BICR at Week 48 | 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. | RECIST assessments performed at baseline (within 28 days before start of study intervention) and Week 48 |
| Overall Response Rate (ORR) at Weeks 24 and 48 | 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. | RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24 and 48 |
| Disease Control Rate (DCR) at Weeks 24 and 48 | 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. | RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24 and 48 |
| Number of Participants With Neuroendocrine Tumours (NET)-Related Clinical Symptoms at Weeks 24 and 48 | 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. | Weeks 24 and 48 |
| Change From Baseline in Plasma Chromogranin A (CgA) at Weeks 12, 24, 36 and 48 | 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. | Baseline (within 28 days before start of study intervention) and Weeks 12, 24, 36 and 48 |
| Change From Baseline in 5-Hydroxyindoleacetic Acid (5-HIAA) at Weeks 12, 24, 36 and 48 | Urine samples were collected to measure 5-HIAA. | Baseline (within 28 days before start of study intervention) and Weeks 12, 24, 36 and 48 |
| Change From Baseline in Quality of Life (QoL) Assessment at Weeks 12, 24, 36 and 48 | 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. | Baseline (within 28 days before start of study intervention) and Weeks 12, 24, 36 and 48 |
| Beijing |
| Beijing Municipality |
| 100142 |
| China |
| Peking University Third Hospital | Beijing | Beijing Municipality | 100191 | China |
| The First Affiliated Hospital, Sun Yat-Sen University | Guangzhou | Guangdong | 510080 | China |
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | 150081 | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450052 | China |
| Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology | Wuhan | Hubei | 430030 | China |
| Qilu Hospital Of Shandong University | Jinan | Shandong | 250012 | China |
| Zhongshan Hospital Affiliated to Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
| Fudan University Shanghai Cancer Centre | Shanghai | Shanghai Municipality | 200433 | China |
| The First Affiliated Hospital Of Xi'an Jiaotong University | Xi’an | Shanxi | 710061 | China |
| West China Hospital of Sichuan University | Chengdu | Sichuan | 610041 | China |
| The second affiliated hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310009 | China |
| The First Affiliated Hospital of College of Medicine, Zhejiang University | Hangzhou | Zhejiang | 310058 | China |
| Refused study visit |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| OG000 | Lanreotide Autogel 120 mg | 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. |
|
|
| Secondary | Progression Free Survival (PFS) by BICR Within Weeks 24 and 48 | 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. | The ITT analysis set included all participants who received at least 1 dose of study intervention. | Posted | Median | 95% Confidence Interval | weeks | RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24 and 48 |
|
|
|
| Secondary | Overall Survival (OS) at the End of the Main Intervention Period | 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. | The ITT analysis set included all participants who received at least 1 dose of study intervention. | Posted | Median | 95% Confidence Interval | weeks | RECIST assessments performed at baseline (within 28 days before start of study intervention) and Week 48 (end of the main intervention period) |
|
|
|
| Secondary | Time to Progression (TTP) During Main Intervention Period | 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. | The ITT analysis set included all participants who received at least 1 dose of study intervention. | Posted | Median | 95% Confidence Interval | weeks | RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 12, 24, 36 and 48 |
|
|
|
| Secondary | Percentage of Participants Alive and Without Tumour Progressive at Weeks 24 and 48 | 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. | The ITT analysis set included all participants who received at least 1 dose of study intervention. | Posted | Number | 95% Confidence Interval | percentage of participants | RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24 and 48 |
|
|
|
| Secondary | Clinical Benefit Rate Assessed by BICR at Week 48 | 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. | The ITT analysis set included all participants who received at least 1 dose of study intervention. | Posted | Number | 95% Confidence Interval | percentage of participants | RECIST assessments performed at baseline (within 28 days before start of study intervention) and Week 48 |
|
|
|
| Secondary | Overall Response Rate (ORR) at Weeks 24 and 48 | 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. | The ITT analysis set included all participants who received at least 1 dose of study intervention. | Posted | Number | 95% Confidence Interval | percentage of participants | RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24 and 48 |
|
|
|
| Secondary | Disease Control Rate (DCR) at Weeks 24 and 48 | 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. | The ITT analysis set included all participants who received at least 1 dose of study intervention. | Posted | Number | 95% Confidence Interval | percentage of participants | RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24 and 48 |
|
|
|
| Secondary | Number of Participants With Neuroendocrine Tumours (NET)-Related Clinical Symptoms at Weeks 24 and 48 | 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. | The ITT analysis set included all participants who received at least 1 dose of study intervention. | Posted | Count of Participants | Participants | No | Weeks 24 and 48 |
|
|
|
| Secondary | Change From Baseline in Plasma Chromogranin A (CgA) at Weeks 12, 24, 36 and 48 | 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. | The ITT analysis set included all participants who received at least 1 dose of study intervention. | Posted | Mean | Standard Deviation | microgram per liter | Baseline (within 28 days before start of study intervention) and Weeks 12, 24, 36 and 48 |
|
|
|
| Secondary | Change From Baseline in 5-Hydroxyindoleacetic Acid (5-HIAA) at Weeks 12, 24, 36 and 48 | Urine samples were collected to measure 5-HIAA. | The ITT analysis set included all participants who received at least 1 dose of study intervention. | Posted | Mean | Standard Deviation | milligram per liter | Baseline (within 28 days before start of study intervention) and Weeks 12, 24, 36 and 48 |
|
|
|
| Secondary | Change From Baseline in Quality of Life (QoL) Assessment at Weeks 12, 24, 36 and 48 | 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. | The ITT analysis set included all participants who received at least 1 dose of study intervention. | Posted | Mean | Standard Deviation | units on a scale | Baseline (within 28 days before start of study intervention) and Weeks 12, 24, 36 and 48 |
|
|
|
| 2 |
| 43 |
| 4 |
| 43 |
| 43 |
| 43 |
| EG001 | Independent Injection Period: Lanreotide Autogel 120 mg | Eligible participants received a fixed dose of lanreotide autogel 120 mg SC injection every 28 days for 24 weeks. | 0 | 5 | 0 | 5 | 2 | 5 |
| Ileus | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Bilirubin conjugated increased | Investigations | MedDRA 25.1 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Glycosylated haemoglobin increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Red blood cell count decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 25.1 | Systematic Assessment |
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| Injection site nodule | General disorders | MedDRA 25.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
|
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| Grade 4 |
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| Grade 5 |
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| Missing |
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| Week 48: Diarrhea |
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| Week 24: Hypertension |
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| Week 48: Hypertension |
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| Week 24: Nodal tachycardia |
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| Week 48: Nodal tachycardia |
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| Week 36 |
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| Week 48 |
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| Week 36 |
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| Week 48 |
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| Week 36 |
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| Week 48 |
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