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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004707-12 | EudraCT Number |
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Study to allow access to everolimus for patients who are on everolimus treatment in a Novartis-sponsored study and are benefiting from the treatment as judged by the investigator
This multi-center, open-label roll-over study aimed to better characterize the long-term safety of everolimus in subjects currently being treated in a Novartis-sponsored studies and who were receiving clinical benefit on the current study treatment as judged by the Investigator.
The study was designed to provide continued treatment with everolimus monotherapy to the subjects. Subjects were allowed to continue combination therapy with Sandostatin LAR® Depot if they were receiving this combination therapy on the parent protocol. Subjects were allowed to continue in this roll-over study until they no longer benefitted from the everolimus treatment as judged by the Investigator, discontinued due to toxicities, subject withdrew consent or lost to follow-up, disease progression, protocol non-compliance, or subject death, whichever occurred first. A subject was considered to have reached end of study when everolimus treatment was permanently discontinued.
As per the original protocol, it was designed to collect only serious adverse events (SAEs) and protocol defined adverse events of special interest (AESIs). However, due to the feedback received from health authorities, the protocol was amended in 2016 (3 years after study was initiated) to collect all AEs (non-serious and serious AEs, and AESIs). The protocol was also amended to include an Investigator assessment of clinical benefit at every visit for remaining subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Everolimus | Experimental | Participants who were receiving everolimus in a Novartis-sponsored study, were not progressing on the current study treatment and were unable to access everolimus treatment outside of a clinical trial. Participants receiving everolimus treatment in combination with Sandostatin LAR Depot on the parent protocol were allowed to continue Sandostatin LAR Depot treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Everolimus | Drug | Everolimus was provided by the investigator in 2.5 mg, 5 mg or 10 mg tablets for daily oral administration. The starting dose of everolimus was the same as the last dose that was given in the parent study. Dose modification thereafter was done at the discretion of the Investigator based upon what is in the subject's best interest. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. All SAEs were captured in safety database from enrollment. Safety data collection was changed in the protocol amendment released in March 2016: AEs and SAEs were captured in the clinical database from protocol amendment release (18 March 2016). Hence, SAEs from both safety database and clinical database are summarized separately. | SAEs collected in safety database from enrollment to end of treatment (EOT) plus 30 days, up to approximately 7.2 years. AEs/SAEs collected in clinical database from protocol amendment date 18 March 2016 to EOT plus 30 days, up to approximately 4.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Clinical Benefit | Percentage of patients with clinical benefit as judged by the investigator. Investigator attestation of continued clinical benefit was collected in clinical database after protocol amendment (release date 18 March 2016). Clinical benefit assessment before protocol amendment was done retrospectively. | After 3 months from enrollment, every 3 months, until end of treatment, assessed up to 7.2 years |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria might apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hematology Oncology Services of Arkansas SC | Little Rock | Arkansas | 72205 | United States | ||
| Rocky Mountain Cancer Centers SC |
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
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There was no screening period. Patients enrolled into trial directly from the parent protocol.
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| ID | Title | Description |
|---|---|---|
| FG000 | Everolimus | Participants who were receiving everolimus in a Novartis-sponsored study |
| FG001 | Everolimus+Sandostatin LAR | Participants who were receiving everolimus in combination with Sandostatin LAR depot in a Novartis-sponsored study |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Mar 18, 2016 | May 17, 2021 |
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| Sandostatin LAR Depot | Drug | Sandostatin LAR Depot was provided by Novartis or by the investigational site considering local regulations. The dose and frequency of Sandostatin LAR Intramuscular injections was the same as the last dose that was given in the parent study. |
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| Greenwood Village |
| Colorado |
| United States |
| Stamford Hospital | Stamford | Connecticut | 06902 | United States |
| H Lee Moffitt Cancer Center and Research Institute SC-2 | Tampa | Florida | 33612 | United States |
| Central Indiana Cancer Centers SC | Indianapolis | Indiana | 46227 | United States |
| Crescent City Research Consortium, LLC SC-3 | Metairie | Louisiana | 70006 | United States |
| Mayo Clinic SC-2 | Rochester | Minnesota | 55905 | United States |
| Washington University School of Medicine Dept of Oncology | St Louis | Missouri | 63110 | United States |
| Nebraska Cancer Specialists Onc Dept | Omaha | Nebraska | 68154 | United States |
| Clinical Research Alliance | Lake Success | New York | 11042 | United States |
| New York University Medical Center SC-4 | New York | New York | 10016 | United States |
| Oregon Health and Science University SC-8 | Portland | Oregon | 97239 | United States |
| Utah Cancer Specialists Utah Cancer (2) | Salt Lake City | Utah | 84106 | United States |
| Novartis Investigative Site | Prague | Czech Republic | 120 00 | Czechia |
| Novartis Investigative Site | Arezzo | AR | 52100 | Italy |
| Novartis Investigative Site | Milan | MI | 20133 | Italy |
| Novartis Investigative Site | Milan | MI | 20141 | Italy |
| Novartis Investigative Site | Groningen | 9713 GZ | Netherlands |
| Novartis Investigative Site | Leningrad Region | Russia | 188663 | Russia |
| Novartis Investigative Site | Seoul | 03080 | South Korea |
| Novartis Investigative Site | Seoul | 03722 | South Korea |
| Novartis Investigative Site | Barcelona | Catalonia | 08035 | Spain |
| Novartis Investigative Site | Bangkok | 10700 | Thailand |
| Novartis Investigative Site | Izmir | 35040 | Turkey (Türkiye) |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Everolimus | Participants who were receiving everolimus in a Novartis-sponsored study |
| BG001 | Everolimus+Sandostatin LAR | Participants who were receiving everolimus in combination with Sandostatin LAR depot in a Novartis-sponsored study |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| 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 |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. All SAEs were captured in safety database from enrollment. Safety data collection was changed in the protocol amendment released in March 2016: AEs and SAEs were captured in the clinical database from protocol amendment release (18 March 2016). Hence, SAEs from both safety database and clinical database are summarized separately. | All subjects who received at least one dose of everolimus after enrolling into the roll-over study. | Posted | Count of Participants | Participants | SAEs collected in safety database from enrollment to end of treatment (EOT) plus 30 days, up to approximately 7.2 years. AEs/SAEs collected in clinical database from protocol amendment date 18 March 2016 to EOT plus 30 days, up to approximately 4.5 years |
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| Secondary | Percentage of Patients With Clinical Benefit | Percentage of patients with clinical benefit as judged by the investigator. Investigator attestation of continued clinical benefit was collected in clinical database after protocol amendment (release date 18 March 2016). Clinical benefit assessment before protocol amendment was done retrospectively. | All participants who remained in the study after protocol amendment (18 March 2016) with at least one assessment reported for the specified endpoint | Posted | Count of Participants | Participants | After 3 months from enrollment, every 3 months, until end of treatment, assessed up to 7.2 years |
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SAEs were collected in safety database from enrollment to end of the treatment (EOT) plus 30 days, up to approximately 7.2 years. Other AEs (Non-serious AEs) were collected in clinical database from protocol amendment date 18 March 2016 to EOT plus 30 days, up to approximately 4.5 years
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. SAEs were collected throughout the study duration in the safety database. Other AEs (Non-serious AEs) were collected after global protocol amendment date 18-Mar-2016 in the clinical database.
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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 | Everolimus | Participants who were receiving everolimus in a Novartis-sponsored study | 1 | 22 | 6 | 22 | 3 | 22 |
| EG001 | Everolimus + Sandostatin LAR | Participants who were receiving everolimus in combination with Sandostatin LAR depot in a Novartis-sponsored study | 2 | 12 | 9 | 12 | 5 | 12 |
| EG002 | All Subjects | All subjects | 3 | 34 | 15 | 34 | 8 | 34 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aplastic anaemia | Blood and lymphatic system disorders | MedDRA (23.0.) | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (23.0.) | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA (23.0.) | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA (23.0.) | Systematic Assessment |
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| Heart valve incompetence | Cardiac disorders | MedDRA (23.0.) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (23.0.) | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA (23.0.) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (23.0.) | Systematic Assessment |
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| Umbilical hernia | Gastrointestinal disorders | MedDRA (23.0.) | Systematic Assessment |
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| Asthenia | General disorders | MedDRA (23.0.) | Systematic Assessment |
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| Jaundice | Hepatobiliary disorders | MedDRA (23.0.) | Systematic Assessment |
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| Clostridium difficile infection | Infections and infestations | MedDRA (23.0.) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (23.0.) | Systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA (23.0.) | Systematic Assessment |
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| Staphylococcal infection | Infections and infestations | MedDRA (23.0.) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (23.0.) | Systematic Assessment |
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| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (23.0.) | Systematic Assessment |
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| Hip fracture | Injury, poisoning and procedural complications | MedDRA (23.0.) | Systematic Assessment |
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| Incisional hernia | Injury, poisoning and procedural complications | MedDRA (23.0.) | Systematic Assessment |
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| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA (23.0.) | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA (23.0.) | Systematic Assessment |
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| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA (23.0.) | Systematic Assessment |
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| Fluid intake reduced | Metabolism and nutrition disorders | MedDRA (23.0.) | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (23.0.) | Systematic Assessment |
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| Malnutrition | Metabolism and nutrition disorders | MedDRA (23.0.) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (23.0.) | Systematic Assessment |
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| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0.) | Systematic Assessment |
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| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0.) | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA (23.0.) | Systematic Assessment |
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| Hepatic encephalopathy | Nervous system disorders | MedDRA (23.0.) | Systematic Assessment |
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| Metabolic encephalopathy | Nervous system disorders | MedDRA (23.0.) | Systematic Assessment |
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| Subarachnoid haemorrhage | Nervous system disorders | MedDRA (23.0.) | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA (23.0.) | Systematic Assessment |
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| Nephropathy | Renal and urinary disorders | MedDRA (23.0.) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0.) | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0.) | Systematic Assessment |
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| Petechiae | Skin and subcutaneous tissue disorders | MedDRA (23.0.) | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA (23.0.) | Systematic Assessment |
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| Haemorrhage | Vascular disorders | MedDRA (23.0.) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (23.0.) | Systematic Assessment |
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| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (23.0.) | Systematic Assessment |
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| Cardiac ventricular thrombosis | Cardiac disorders | MedDRA (23.0.) | Systematic Assessment |
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| Periorbital oedema | Eye disorders | MedDRA (23.0.) | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA (23.0.) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (23.0.) | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA (23.0.) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (23.0.) | Systematic Assessment |
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| Duodenal stenosis | Gastrointestinal disorders | MedDRA (23.0.) | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (23.0.) | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (23.0.) | Systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | MedDRA (23.0.) | Systematic Assessment |
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| Large intestinal obstruction | Gastrointestinal disorders | MedDRA (23.0.) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (23.0.) | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA (23.0.) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (23.0.) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (23.0.) | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA (23.0.) | Systematic Assessment |
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| Pain | General disorders | MedDRA (23.0.) | Systematic Assessment |
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| Clostridium difficile infection | Infections and infestations | MedDRA (23.0.) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (23.0.) | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (23.0.) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (23.0.) | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA (23.0.) | Systematic Assessment |
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| Skin abrasion | Injury, poisoning and procedural complications | MedDRA (23.0.) | Systematic Assessment |
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| Blood chromogranin A increased | Investigations | MedDRA (23.0.) | Systematic Assessment |
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| Blood triglycerides increased | Investigations | MedDRA (23.0.) | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA (23.0.) | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA (23.0.) | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (23.0.) | Systematic Assessment |
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| Vitamin B12 deficiency | Metabolism and nutrition disorders | MedDRA (23.0.) | Systematic Assessment |
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| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA (23.0.) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (23.0.) | Systematic Assessment |
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| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA (23.0.) | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (23.0.) | Systematic Assessment |
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| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA (23.0.) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (23.0.) | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA (23.0.) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (23.0.) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0.) | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0.) | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0.) | Systematic Assessment |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0.) | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (23.0.) | Systematic Assessment |
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| Onychoclasis | Skin and subcutaneous tissue disorders | MedDRA (23.0.) | Systematic Assessment |
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| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (23.0.) | Systematic Assessment |
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The original protocol was designed to collect only SAEs and protocol defined AESIs in the Safety database. The protocol was amended in 2016 (3 years after study was initiated) to include all AEs (non-SAEs, SAEs, and AESIs) to be collected in the clinical database. At the time of amendment release, 32 of the 34 subjects were enrolled and did not have AEs collected in clinical database before protocol amendment, which also amounts to approximately 50% of SAEs not reported in clinical database.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study director | Novartis Pharmaceuticals | 862-778-8300 | novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 9, 2020 | May 17, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D002276 | Carcinoid Tumor |
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D000068338 | Everolimus |
| D015282 | Octreotide |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| AEs (Clinical Database) |
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| Tretament-related AEs (Clinical Database) |
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| SAEs (Clinical Database) |
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| Treatment-related SAEs (Clinical Database) |
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