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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-004904-35 | EudraCT Number |
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The study will compare the difference between lanreotide Autogel and placebo on progression free survival in patients who have an endocrine tumour in the pancreas or intestines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lanreotide (Autogel formulation) | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lanreotide (Autogel formulation) | Drug | 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | Time from randomization to first documentation of disease progression, or death. Disease progression centrally assessed using Response Evaluation Criteria in Solid Tumours (RECIST) v1.0 | From randomisation up to the last tumour assessment (scheduled at 96 weeks). Radiological scans were performed every 12 weeks during the first year and every 24 weeks during the second year |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Alive & Without Disease Progression | Percentage of patients still ongoing (or completing at Week 96) without centrally assessed disease progression or death at Weeks 48 and 96. | Week 48 & 96 |
| Pharmacokinetic Profile of Lanreotide |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director, Endocrinology | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Outpatient Cancer Center | Los Angeles | California | 90048 | United States | ||
| University of Iowa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25014687 | Result | Caplin ME, Pavel M, Cwikla JB, Phan AT, Raderer M, Sedlackova E, Cadiot G, Wolin EM, Capdevila J, Wall L, Rindi G, Langley A, Martinez S, Blumberg J, Ruszniewski P; CLARINET Investigators. Lanreotide in metastatic enteropancreatic neuroendocrine tumors. N Engl J Med. 2014 Jul 17;371(3):224-33. doi: 10.1056/NEJMoa1316158. | |
| 33052555 |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants.
Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.
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Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
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264 subjects were screened at 48 investigational sites in 14 countries (Austria, Belgium, Czech Republic, Denmark, France, Germany, India, Italy, Poland, Slovakia, Spain, Sweden, United Kingdom and the United States of America). 204 subjects were randomised to receive study treatment in the Intent to treat (ITT) population.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lanreotide (Autogel Formulation) | 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks. |
| FG001 | Placebo | Placebo: Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
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| Placebo | Drug | Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks. |
|
Pharmacokinetic Profile of Lanreotide assessed by mean serum concentration at specified timepoints |
| Week 4, 12, 24, 36, 48, 72, 96 |
| Change in the Global Health Status Quality of Life Assessment | Transformed scores from European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire responses (QLQ)-C30. Questionnaire response scores range from 0 to 100. Higher scores indicate best possible Quality of Life. | Week 12 to Week 96 (last visit) |
| Percentage of Patients With a Greater Than or Equal to 50% Decrease in Plasma Chromogranin A (CgA) Levels | Week 12 to Week 96 (last visit) |
| Percentage of Patients Still Alive Based on Available Overall Survival Data | Overall survival defined as the time from randomisation to death due to any cause. Subjects were followed for overall survival beyond study completion/withdrawal via annual telephone contact until the last subject completed the study. | Randomisation to death or last visit, up to 321 weeks |
| Iowa City |
| Iowa |
| 52242 |
| United States |
| The John Hopkins Hospital | Baltimore | Maryland | 21287-4606 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| Providence Portland Medical Center | Portland | Oregon | 97213 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030-4009 | United States |
| University of Wisconsin School of Medicine and Public Health | Madison | Wisconsin | 53792-5666 | United States |
| University Hospital | Vienna | Austria |
| UZ Antwerpen | Antwerp | Belgium |
| UCL Saint Luc | Brussels | Belgium |
| UZ Gent | Ghent | Belgium |
| Fakultni nemocnice Na | Bulovce | Prague | Czechia |
| Fekultni nemocnice Olomouc | Olomouc | Czechia |
| General faculty | Prague | Czechia |
| Sygehus Hospital | Aarhus | Denmark |
| Rigshospitalet | Copenhagen | Denmark |
| Hôpital A. Paré | Boulogne-Billancourt | 92100 | France |
| Hôpital Beaujon | Clichy | 92118 | France |
| CAC Oscar Lambret | Lille | 59020 | France |
| Hôpital Edouard Herriot | Lyon | 69437 | France |
| CHU la Timone | Marseille | 13385 | France |
| Hôpital R. Debré | Reims | 51092 | France |
| CHI Frejus St Raphael | Saint-Raphaël | 83300 | France |
| Hôpital Rangueil | Toulouse | 31059 | France |
| Unité de gastro enterologie IGR | Villejuif | 94805 | France |
| Charite Hospital | Berlin | Germany |
| University Hospital | Erlangen | Germany |
| University Hospital | Lübeck | Germany |
| Gutenberg University Hospital | Mainz | Germany |
| University Hospital | München | Germany |
| Lukas Hospital | Neuss | Germany |
| Global Hospital | Hyderabad | India |
| Tata Memorial Hospital | Mumbai | India |
| Centro di Refierimiento Oncologica | Aviano | Italy |
| Azienda Malpighi | Bologna | Italy |
| INSCT | Milan | Italy |
| University of Naples | Naples | Italy |
| Hospital S. Chiara | Pisa | Italy |
| Azienda San Giovanni Battista | Torino | Italy |
| UMC Gronigen | Gronigen | Netherlands |
| Erasmu MC | Rotterdam | Netherlands |
| UMC Utrecht | Utrecht | Netherlands |
| Centrum Onkologii-Instytut im. Marii Sklodowskiej - Curie, oddzial w Gliwicach, Zaklad Medycyny Nuklearnej i Endokrynologii Onkologicznej ul. | Gliwice | Poland |
| Katedra i Klinika Endokrynologii Przemiany Materii i Chorob Wewnetrznych Uniwersytetu Medycznego w Poznaniu | Poznan | Poland |
| Samodzielny Publiczny Centralny Szpital Kliniczny, Katedra i Klinika Chorob Wewnetrznych I Endokrynologii ul. Banacha 1 a | Warsaw | Poland |
| Szpital Bielanski im. Ks. Jerzego Popieluszki, Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Klinika Endokrynologii Centrum Medycznego Ksztalcenia Podyplomowego | Warsaw | Poland |
| Zaklad Diagnosttyki Radiologicznej, Centralny Szpital Klincny, Ministrerstwa Spraw Wewnetrznych i Administratracji w Warzawie | Warsaw | Poland |
| Silesian Medical University | Zabrze | Poland |
| Narodny onkologicky ustav, Bratislava | Slovakia | Slovakia |
| Vychodoslovensky onkologicky ustav, Rastislavova | Slovakia | Slovakia |
| Hospital Vall d'Hebron | Barcelona | Spain |
| Institut Catala Oncologia | Barcelona | Spain |
| Hospital G. Maranon | Madrid | Spain |
| Hospital La Paz | Madrid | Spain |
| Hospital Nuestra Senora de la Candelaria | Santa Cruz de Tenerife | Spain |
| Sahlgrenska Hospital | Gothenburg | Sweden |
| Karolinska University Hospital | Stockholm | Sweden |
| University Hospital | Uppsala | Sweden |
| Basingstoke and North Hampshire Hospital | Basingstoke | United Kingdom |
| Royal Victoria Hospital | Belfast | United Kingdom |
| University Hospital Wales | Cardiff | United Kingdom |
| Western General Hospital | Edinburgh | United Kingdom |
| Beatson West of Scotland Cancer Centre | Glasgow | United Kingdom |
| St James Hospital | Leeds | United Kingdom |
| Leicester Royal Infirmary | Leicester | United Kingdom |
| Royal Free Hospital | London | United Kingdom |
| St Bartholomew's Hospital | London | United Kingdom |
| QMC | Nottingham | United Kingdom |
| Churchill Hospital | Oxford | United Kingdom |
| Royal Hallamshire Hospital | Sheffield | United Kingdom |
| Caplin ME, Pavel M, Phan AT, Cwikla JB, Sedlackova E, Thanh XT, Wolin EM, Ruszniewski P; CLARINET Investigators. Lanreotide autogel/depot in advanced enteropancreatic neuroendocrine tumours: final results of the CLARINET open-label extension study. Endocrine. 2021 Feb;71(2):502-513. doi: 10.1007/s12020-020-02475-2. Epub 2020 Oct 14. |
| 25408662 | Derived | Lybaert W, Van Hul E, Woestenborghs H. Long-term disease control of a pancreatic neuroendocrine tumor with lanreotide autogel((R)): a case report. Case Rep Oncol. 2014 Sep 26;7(3):673-80. doi: 10.1159/000368207. eCollection 2014 Sep. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Analysis based on intent-to-treat (ITT) population comprised of 204 subjects.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Lanreotide (Autogel Formulation) | 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks. |
| BG001 | Placebo | Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Time since diagnosis | Time relative to baseline visit (Week 1). | Mean | Standard Deviation | months |
| ||||||||||||||
| Neuroendocrine tumour (NET) origin | Primary tumour characteristics. | Number | participants |
| |||||||||||||||
| Chromogranin A | Chromogranin A is an NET marker. ULN: upper limit of normal. | Number | participants |
|
| 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 | Progression-Free Survival (PFS) | Time from randomization to first documentation of disease progression, or death. Disease progression centrally assessed using Response Evaluation Criteria in Solid Tumours (RECIST) v1.0 | Analysis based on the intent-to-treat (ITT) population which comprised 204 randomised subjects. | Posted | Median | 95% Confidence Interval | Weeks | From randomisation up to the last tumour assessment (scheduled at 96 weeks). Radiological scans were performed every 12 weeks during the first year and every 24 weeks during the second year |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Alive & Without Disease Progression | Percentage of patients still ongoing (or completing at Week 96) without centrally assessed disease progression or death at Weeks 48 and 96. | Analysis based on the intent-to-treat (ITT) population which comprised 204 randomised subjects. | Posted | Number | Percentage of participants | Week 48 & 96 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetic Profile of Lanreotide | Pharmacokinetic Profile of Lanreotide assessed by mean serum concentration at specified timepoints | Analysis based on the intent-to-treat (ITT) population which comprised 101 randomised subjects who received lanreotide | Posted | Mean | Standard Deviation | ng/mL | Week 4, 12, 24, 36, 48, 72, 96 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in the Global Health Status Quality of Life Assessment | Transformed scores from European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire responses (QLQ)-C30. Questionnaire response scores range from 0 to 100. Higher scores indicate best possible Quality of Life. | Analysis based on the intent-to-treat (ITT) population which comprised 193 randomised subjects with valid assessment. | Posted | Least Squares Mean | Standard Error | score on a scale | Week 12 to Week 96 (last visit) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With a Greater Than or Equal to 50% Decrease in Plasma Chromogranin A (CgA) Levels | Analysis based on the subgroup of subjects with an elevated plasma CgA values. Subjects with a gastrinoma were excluded from the analysis. | Posted | Number | percentage of participants | Week 12 to Week 96 (last visit) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Still Alive Based on Available Overall Survival Data | Overall survival defined as the time from randomisation to death due to any cause. Subjects were followed for overall survival beyond study completion/withdrawal via annual telephone contact until the last subject completed the study. | Analysis based on the intent-to-treat (ITT) population which comprised 204 randomised subjects. | Posted | Number | percentage of participants | Randomisation to death or last visit, up to 321 weeks |
|
|
Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lanreotide (Autogel Formulation) | 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks. | 25 | 101 | 88 | 101 | ||
| EG001 | Placebo | Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks. | 32 | 103 | 92 | 103 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Anastomotic ulcer | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Aortic valve stenosis | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Bile duct stenosis | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Biliary fistula | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
| |
| Bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Diverticulum | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Endometrial adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hepatic necrosis | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Infected dermal cyst | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
| |
| Orchitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Peptic ulcer | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Toxic nodular goitre | Endocrine disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Vena cava thrombosis | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pancreatic enzymes decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director Endocrinology | Ipsen | clinical.trials@ipsen.com | clinical.trials@ipsen.com |
| ID | Term |
|---|---|
| C060347 | lanreotide |
Not provided
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Midgut |
|
| Hindgut |
|
| Unknown/Other |
|
| 1-2 × ULN |
|
| >2 × ULN |
|
| Unknown |
|
|
|
|
|
|