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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT 2010-022273-34 | Registry Identifier | EudraCT | |
| 2010-022273-34 |
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This is a multi-centric, open-label study evaluating the efficacy and safety of RAD001 in patients with advanced (stage IV) Lung Cancer (Large Cell) with neuroendocrine differentiation treated with a combination of RAD001 with paclitaxel and carboplatin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RAD001 plus paclitaxel/carboplatin | Experimental | Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RAD001 | Drug | Participants started RAD001 treatment with a dose of 5 mg/day once daily. A dose decrease to 5 mg every other day was allowed if tolerability issues arose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Progression-free | Tumors were assessed according to Response Evaluation Criteria in Solid tumors (RECIST) to determine progression-free status. Complete response (CR): disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response (PR): > 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions; Stable disease (SD): neither sufficient shrinkage to qualify for response or sufficient increase to qualify for progressive disease in target lesions, with response or stable disease observed in non-target lesions, and no new lesions; Progressive disease (PD): > 20% increase in the sum of longest diameters of target lesions compared to smallest sum longest diameter recorded. In addition, the sum must also demonstrate an absolute increase of at least 5mm. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Progression-free | Tumors were assessed according to Response Evaluation Criteria in Solid tumors (RECIST) to determine progression-free status. Complete response (CR) is disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response (PR) is > 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions; Stable disease (SD) is neither sufficient shrinkage to qualify for response or sufficient increase to qualify for progressive disease in target lesions, with response or stable disease observed in non-target lesions, and no new lesions; and Progressive disease (PD is: > 20% increase in the sum of longest diameters of target lesions compared to smallest sum longest diameter recorded. In addition, the sum must also demonstrate an absolute increase of at least 5mm. |
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Inclusion Criteria:
Patients who give a written informed consent obtained according to local guidelines
Histologically confirmed diagnosis of stage IV lung cancer of LC-NEC type according to WHO classification:
World Health organisation (WHO) performance status grade ≤ 1
measurable disease
Adequate bone marrow function
Adequate liver function
Adequate renal function
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Berlin | 13125 | Germany | |||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28535181 | Derived | Christopoulos P, Engel-Riedel W, Grohe C, Kropf-Sanchen C, von Pawel J, Gutz S, Kollmeier J, Eberhardt W, Ukena D, Baum V, Nimmrich I, Sieder C, Schnabel PA, Serke M, Thomas M. Everolimus with paclitaxel and carboplatin as first-line treatment for metastatic large-cell neuroendocrine lung carcinoma: a multicenter phase II trial. Ann Oncol. 2017 Aug 1;28(8):1898-1902. doi: 10.1093/annonc/mdx268. |
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This was an open-label, single arm study.
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| ID | Title | Description |
|---|---|---|
| FG000 | RAD001 Plus Paclitaxel/Carboplatin | Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Paclitaxel | Drug | Paclitaxel was started at doses of 175 mg/m². Dose reductions of Paclitaxel to 135 mg/m2 was permitted if tolerability issues arose. |
|
| Carboplatin | Drug | Carboplatin was started at doses of Area under the Curve 5 (AUC 5). Dose reductions of carboplatin to AUC 4 was permitted if tolerability issues arose. |
|
| 6 months |
| Percentage of Participants With Overall Response Rate (ORR) | ORR was defined as is the proportion of participants with a best overall response of CR or PR. CR is disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response. PR is > 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions. | 3 months |
| Percentage of Participants With Disease Control Rate (DCR) | DCR was defined as is the percentage of participants with a best overall response of CR or PR or SD. Complete response (CR) is disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response (PR) is > 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions; Stable disease (SD) is neither sufficient shrinkage to qualify for response or sufficient increase to qualify for progressive disease in target lesions, with response or stable disease observed in non-target lesions, and no new lesions; and Progressive disease (PD is: > 20% increase in the sum of longest diameters of target lesions compared to smallest sum longest diameter recorded. In addition, the sum must also demonstrate an absolute increase of at least 5mm. | 3 months |
| Progression Free Survival (PFS) | PFS was defined as the time from the date of start of treatment to date of event defined as the first documented progression or death due to any cause. | 6 months |
| Overall Survival (OS) | OS was defined as the time from date of start of treatment to date of death due to any cause. | 12 months |
| Bremen |
| 28177 |
| Germany |
| Novartis Investigative Site | Cologne | 51109 | Germany |
| Novartis Investigative Site | Essen | 45147 | Germany |
| Novartis Investigative Site | Gauting | 82131 | Germany |
| Novartis Investigative Site | Heidelberg | 69120 | Germany |
| Novartis Investigative Site | Hemer | 58675 | Germany |
| Novartis Investigative Site | Leipzig | 04177 | Germany |
| Novartis Investigative Site | Ulm | 89081 | Germany |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | RAD001 Plus Paclitaxel/Carboplatin | Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation. |
| 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 |
|
| 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 Progression-free | Tumors were assessed according to Response Evaluation Criteria in Solid tumors (RECIST) to determine progression-free status. Complete response (CR): disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response (PR): > 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions; Stable disease (SD): neither sufficient shrinkage to qualify for response or sufficient increase to qualify for progressive disease in target lesions, with response or stable disease observed in non-target lesions, and no new lesions; Progressive disease (PD): > 20% increase in the sum of longest diameters of target lesions compared to smallest sum longest diameter recorded. In addition, the sum must also demonstrate an absolute increase of at least 5mm. | All participants were included in the analysis. | Posted | Number | Percentage of participants | 3 months |
|
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Progression-free | Tumors were assessed according to Response Evaluation Criteria in Solid tumors (RECIST) to determine progression-free status. Complete response (CR) is disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response (PR) is > 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions; Stable disease (SD) is neither sufficient shrinkage to qualify for response or sufficient increase to qualify for progressive disease in target lesions, with response or stable disease observed in non-target lesions, and no new lesions; and Progressive disease (PD is: > 20% increase in the sum of longest diameters of target lesions compared to smallest sum longest diameter recorded. In addition, the sum must also demonstrate an absolute increase of at least 5mm. | All participants were included in the analysis. | Posted | Number | Percentage of participants | 6 months |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Overall Response Rate (ORR) | ORR was defined as is the proportion of participants with a best overall response of CR or PR. CR is disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response. PR is > 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions. | All participants were included in the analysis. | Posted | Number | Percentage of participants | 3 months |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Disease Control Rate (DCR) | DCR was defined as is the percentage of participants with a best overall response of CR or PR or SD. Complete response (CR) is disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response (PR) is > 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions; Stable disease (SD) is neither sufficient shrinkage to qualify for response or sufficient increase to qualify for progressive disease in target lesions, with response or stable disease observed in non-target lesions, and no new lesions; and Progressive disease (PD is: > 20% increase in the sum of longest diameters of target lesions compared to smallest sum longest diameter recorded. In addition, the sum must also demonstrate an absolute increase of at least 5mm. | All participants were included in the analysis. | Posted | Number | Percentage of participants | 3 months |
|
| |||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) | PFS was defined as the time from the date of start of treatment to date of event defined as the first documented progression or death due to any cause. | All participants were included in the analysis. | Posted | Median | 95% Confidence Interval | Days | 6 months |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined as the time from date of start of treatment to date of death due to any cause. | All participants were included in the analysis. | Posted | Median | 95% Confidence Interval | Days | 12 months |
|
|
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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 | RAD001 Plus Paclitaxel/Carboplatin | Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation. | 28 | 49 | 43 | 49 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| COLITIS | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| GASTRITIS | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA | Systematic Assessment |
| |
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA | Systematic Assessment |
| |
| MULTI-ORGAN FAILURE | General disorders | MedDRA | Systematic Assessment |
| |
| PAIN | General disorders | MedDRA | Systematic Assessment |
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| ACUTE HEPATIC FAILURE | Hepatobiliary disorders | MedDRA | Systematic Assessment |
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| HEPATOMEGALY | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| CLOSTRIDIAL INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
| |
| EMPYEMA | Infections and infestations | MedDRA | Systematic Assessment |
| |
| EPIDIDYMITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
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| PNEUMONIA | Infections and infestations | MedDRA | Systematic Assessment |
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| PYOPNEUMOTHORAX | Infections and infestations | MedDRA | Systematic Assessment |
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| SEPSIS | Infections and infestations | MedDRA | Systematic Assessment |
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| SINUSITIS | Infections and infestations | MedDRA | Systematic Assessment |
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| C-REACTIVE PROTEIN INCREASED | Investigations | MedDRA | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| PAIN IN JAW | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| SPINAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| BENIGN NEOPLASM OF THYROID GLAND | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| BRONCHIAL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| MALIGNANT NEOPLASM PROGRESSION | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| METASTASES TO CENTRAL NERVOUS SYSTEM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| PARANEOPLASTIC SYNDROME | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| SCIATICA | Nervous system disorders | MedDRA | Systematic Assessment |
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| VOCAL CORD PARESIS | Nervous system disorders | MedDRA | Systematic Assessment |
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| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| VISUAL IMPAIRMENT | Eye disorders | MedDRA | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| DYSPHAGIA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA | Systematic Assessment |
| |
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA | Systematic Assessment |
| |
| MUCOSAL INFLAMMATION | General disorders | MedDRA | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA | Systematic Assessment |
| |
| PAIN | General disorders | MedDRA | Systematic Assessment |
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| PERIPHERAL SWELLING | General disorders | MedDRA | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA | Systematic Assessment |
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| INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA | Systematic Assessment |
| |
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA | Systematic Assessment |
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| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| GROWING PAINS | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA | Systematic Assessment |
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| HYPOAESTHESIA | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| POLYNEUROPATHY | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA | Systematic Assessment |
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| SLEEP DISORDER | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| DYSPHONIA | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| NIGHT SWEATS | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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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 (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis | 862-778-8300 |
| ID | Term |
|---|---|
| D018287 | Carcinoma, Large Cell |
| D018358 | Neuroendocrine Tumors |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000068338 | Everolimus |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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