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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-000077-38 | EudraCT Number |
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| Name | Class |
|---|---|
| Roche Pharma AG | INDUSTRY |
To estimate the difference in efficacy and safety of bevacizumab and RAD001 compared to bevacizumab and interferon alfa-2a for first-line treatment of patients with metastatic carcinoma of the kidney.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bevacizumab, RAD001 (everolimus) | Experimental | Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks |
|
| bevacizumab, interferon alfa-2a (IFN) | Active Comparator | Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RAD001(everolimus) | Drug | 10 mg qd |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) of Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab | Tumor response and disease progression were assessed using response evaluation criteria in solid tumors (RECIST), version 1.0. All target and non-target lesions identified at baseline were assessed using the same method, CT scan with contrast or MRI with contrast, throughout the trial. All scans were reviewed by independent, central radiology. Disease progression was defined as: 1) a 20% increase in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameters of all target lesions recorded at or after baseline or 2) the appearance of a new lesions or 3) the unequivocal progression of non-target lesions overall. | Time from randomization to the date of radiological progressive disease as per independent central review, death from any cause, or last tumor assessment, reported between date of first participant randomized until 31Dec2011, cutoff date. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) Treatment Effect in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab | Overall survival (OS) was defined as the time of randomization to the date of death due to any cause. | Time from randomization to the date of death from any cause, reported between date of first participant randomized and up to 2 years after the last participant randomized (data cutoff: 30Aug2012) |
Not provided
Inclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| Highlands Oncology Group Dept of Highlands Oncology Grp | Fayetteville | Arkansas | 72703 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37146227 | Derived | Aldin A, Besiroglu B, Adams A, Monsef I, Piechotta V, Tomlinson E, Hornbach C, Dressen N, Goldkuhle M, Maisch P, Dahm P, Heidenreich A, Skoetz N. First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 May 4;5(5):CD013798. doi: 10.1002/14651858.CD013798.pub2. | |
| 25851632 |
| Label | URL |
|---|---|
| Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bevacizumab, RAD001 (Everolimus) | Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks. |
| FG001 | Bevacizumab, Interferon Alfa-2a (IFN) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| interferon alfa-2a | Drug | dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 |
|
| bevacizumab | Drug | 10 mg/kg every 2 weeks |
|
| Best Overall Response in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab | Overall response is defined as the number of participants having achieved confirmed Complete Response (CR) + Partial Response (PR). Confirmed CR = at least two determinations of CR at least 4 weeks apart before progression. Confirmed PR = at least two determinations of PR or better at least 4 weeks apart before progression. CR required a disappearance of all target and non-target lesions. PR required at least a 30% decrease in the sum of the longest diameters of all target lesions, taking as a reference the baseline sum of the longest diameters. Disease progression was defined as: 1) a 20% increase in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameters of all target lesions recorded at or after baseline or 2) the appearance of a new lesions or 3) the unequivocal progression of non-target lesions overall. | Time from first participant randomized until 31Dec2011, cutoff date. |
| Response Duration Differences in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab | The duration of response, applied only to participants with best overall response at CR or PR, is defined as the number of days between the date of first documented response (CR or PR) and the date of the event: radiological progression as per central review or death due to underlying cancer, whichever occurs first. If no event, participant is censored at the last adequate assessment. | Time from first documented response date of radiological progressive disease as per independent central review, death due to underlying cancer, or last tumor assessment, reported between date of first participant randomized until 31Dec2011, cut-off date. |
| Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events and Deaths | Participants were monitored for adverse events, serious adverse events and deaths throughout the study. Participants were assessed continuously at each 28-day cycle. | From the first participant randomized until the last patient discontinued the study treatment + 28 days |
| Time to Definitive Deterioration of the Functional Assessment of Cancer Therapy Kidney Symptom Index, Disease Related Symptoms (FKSI-DRS) Risk Score by at Least 2 Score Units | The analysis of this outcome measure was based on the FKSI-DRS scale which is a validated disease-related symptom index containing 9 items that measure symptoms predominantly related to kidney cancer. Each item is scored on a 5-point scale (0 = not at all; 4 = very much). If at least 5 of the 9 questions have been answered, the FKSI-DRS total score is calculated by subtracting nine times the mean of the scores of the answered items from 36. Participants with less than 5 out of the 9 questions answered will have a missing FKSI-DRS total score. The FKSI-DRS total score ranges from 0 (most severe symptoms) to 36 (no symptoms). Definitive deterioration is defined as a decrease by at least 2 units compared to baseline, with no later increase above this threshold observed during the study. A single measure reporting a decrease of at least 2 units was considered definitive only if it is the last one available for the participant. | Time from randomization to the date of definitive deterioration (defined as no later increase above the threshold observed during the study), or date of last assessment, reported between date of first patient randomized until 31Dec2011 |
| Time to Definitive Deterioration of the Global Health Status and the Physical Functioning (PF) Subscale Scores of the European Organization for the Research and Treatment of Cancer (EORTC)-Core Quality of Life Questionnaire (QLQ-C30) by at Least 10% | The EORTC QLQ-C30 contains 30 items. These include five functional scales (physical, role, emotional, social and cognitive functioning), three symptom scales (fatigue, pain, nausea, and vomiting), a global health status/QoL scale, and six single items (dyspnea, diarrhea, constipation, anorexia, insomnia and financial impact). The PF subscale consists of 5 questions each scored from 1 (not at all) to 4 (very much). The score for the PF subscale and global health status range from 0 to 100, with a higher score representing a high level of functioning/high quality of life. Definitive deterioration by at least 10% is defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the course of the study. A single measure reporting a decrease of at least 10% is considered definitive only if it is the last one available for the participant. | Time from randomization to the date of definitive deterioration (defined as no later increase above the threshold observed during the study), or date of last assessment, reported between date of first participant randomized until 31Dec2011 |
| Duration of Exposure of RAD001 in Participants Randomized to the Treatment Combination of RAD001 and Bevacizumab | This outcome measure was assessed continuously. | From the date of the first participant treated until the last patient discontinued the study treatment + 28 days |
| City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(3) |
| Duarte |
| California |
| 91010-3000 |
| United States |
| USC/Kenneth Norris Comprehensive Cancer Center Regulatory Contact 3 | Los Angeles | California | 90053 | United States |
| University of California at Los Angeles Dept. of Hem/Oncology | Los Angeles | California | 90095 | United States |
| Karmanos Cancer Institute Dept.of KarmanosCancerInst (5) | Detroit | Michigan | 48201 | United States |
| Nevada Cancer Institute Dept. of Nevada Cancer (3) | Las Vegas | Nevada | 89135 | United States |
| St. Luke's Hospital and Health Network St. Luke's Cancer Network | Bethlehem | Pennsylvania | United States |
| Las Colinas Hematology Oncology Grapevine | Irving | Texas | 75038 | United States |
| Seattle Cancer Care Alliance Dept. of SCCA | Seattle | Washington | 98105 | United States |
| Novartis Investigative Site | Brussels | 1070 | Belgium |
| Novartis Investigative Site | Brussels | 1200 | Belgium |
| Novartis Investigative Site | Charleroi | 6000 | Belgium |
| Novartis Investigative Site | Kortrijk | 8500 | Belgium |
| Novartis Investigative Site | Leuven | 3000 | Belgium |
| Novartis Investigative Site | Liège | 4000 | Belgium |
| Novartis Investigative Site | Rio de Janeiro | Rio de Janeiro | 20230-130 | Brazil |
| Novartis Investigative Site | Porto Alegre | Rio Grande do Sul | 90560-030 | Brazil |
| Novartis Investigative Site | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Novartis Investigative Site | Ribeirão Preto | São Paulo | 14015-130 | Brazil |
| Novartis Investigative Site | Santo André | São Paulo | 09060-650 | Brazil |
| Novartis Investigative Site | São Paulo | São Paulo | 01246-000 | Brazil |
| Novartis Investigative Site | Olomouc | 775 20 | Czechia |
| Novartis Investigative Site | Prague | 140 00 | Czechia |
| Novartis Investigative Site | Cairo | Egypt | Egypt |
| Novartis Investigative Site | Cairo | Egypt |
| Novartis Investigative Site | Strasbourg | Cedex | 67091 | France |
| Novartis Investigative Site | Suresnes | France | 92150 | France |
| Novartis Investigative Site | Avignon | 84000 | France |
| Novartis Investigative Site | Bordeaux | 33075 | France |
| Novartis Investigative Site | Caen | 14021 | France |
| Novartis Investigative Site | La Roche-sur-Yon | 85925 | France |
| Novartis Investigative Site | Montellier Cedex 5 | 34298 | France |
| Novartis Investigative Site | Nantes | 44202 | France |
| Novartis Investigative Site | Reims | 51100 | France |
| Novartis Investigative Site | Rouen | 76031 | France |
| Novartis Investigative Site | Strasbourg | 67010 | France |
| Novartis Investigative Site | Toulouse | 31059 | France |
| Novartis Investigative Site | Berlin | 10117 | Germany |
| Novartis Investigative Site | Berlin | 13055 | Germany |
| Novartis Investigative Site | Dessau | 06846 | Germany |
| Novartis Investigative Site | Essen | 45122 | Germany |
| Novartis Investigative Site | Frankfurt | 60488 | Germany |
| Novartis Investigative Site | Frankfurt | 60590 | Germany |
| Novartis Investigative Site | Göttingen | 37075 | Germany |
| Novartis Investigative Site | Hamburg | 20246 | Germany |
| Novartis Investigative Site | Hanover | 30625 | Germany |
| Novartis Investigative Site | Heidelberg | 69115 | Germany |
| Novartis Investigative Site | Leipzig | 04109 | Germany |
| Novartis Investigative Site | Mainz | 55131 | Germany |
| Novartis Investigative Site | Tübingen | 72076 | Germany |
| Novartis Investigative Site | Shatin, New Territories | Hong Kong | Hong Kong |
| Novartis Investigative Site | Tuenmen | Hong Kong | Hong Kong |
| Novartis Investigative Site | Budapest | 1086 | Hungary |
| Novartis Investigative Site | Budapest | 1122 | Hungary |
| Novartis Investigative Site | Brescia | BS | 25123 | Italy |
| Novartis Investigative Site | Cremona | CR | 26100 | Italy |
| Novartis Investigative Site | Catanzaro | CZ | 88100 | Italy |
| Novartis Investigative Site | Florence | FI | 50134 | Italy |
| Novartis Investigative Site | Milan | MI | 20133 | Italy |
| Novartis Investigative Site | Modena | MO | 41100 | Italy |
| Novartis Investigative Site | Perugia | PG | 06129 | Italy |
| Novartis Investigative Site | Aviano | PN | 33081 | Italy |
| Novartis Investigative Site | Pavia | PV | 27100 | Italy |
| Novartis Investigative Site | Roma | RM | 00128 | Italy |
| Novartis Investigative Site | Roma | RM | 00152 | Italy |
| Novartis Investigative Site | Trento | TN | 38100 | Italy |
| Novartis Investigative Site | Negrar | VR | 37024 | Italy |
| Novartis Investigative Site | Naples | 80131 | Italy |
| Novartis Investigative Site | Leiden | Netherlands | 2333 ZA | Netherlands |
| Novartis Investigative Site | Moscow | Moscow | 115478 | Russia |
| Novartis Investigative Site | Obninsk | Russia | 249036 | Russia |
| Novartis Investigative Site | Moscow | 125284 | Russia |
| Novartis Investigative Site | Saint Petersburg | 191104 | Russia |
| Novartis Investigative Site | Saint Petersburg | 197758 | Russia |
| Novartis Investigative Site | Singapore | Singapore | 258500 | Singapore |
| Novartis Investigative Site | Johannesburg | 2196 | South Africa |
| Novartis Investigative Site | Pretoria | 0001 | South Africa |
| Novartis Investigative Site | Pretoria | 0044 | South Africa |
| Novartis Investigative Site | Goyang-si | Gyeonggi-do | 03722 | South Korea |
| Novartis Investigative Site | Seoul | Korea | 06351 | South Korea |
| Novartis Investigative Site | Daegu | 705-703 | South Korea |
| Novartis Investigative Site | Seoul | 136-705 | South Korea |
| Novartis Investigative Site | Taegu | 700 -721 | South Korea |
| Novartis Investigative Site | Jaén | Andalusia | 23007 | Spain |
| Novartis Investigative Site | Barcelona | Barcelona | 08041 | Spain |
| Novartis Investigative Site | Santander | Cantabria | 39008 | Spain |
| Novartis Investigative Site | Madrid | Madrid | 28034 | Spain |
| Novartis Investigative Site | Madrid | Madrid | 28041 | Spain |
| Novartis Investigative Site | Zaragoza | Zaragoza | 50009 | Spain |
| Novartis Investigative Site | Santander | 39008 | Spain |
| Novartis Investigative Site | Bern | Switzerland | 3010 | Switzerland |
| Novartis Investigative Site | Chur | 7000 | Switzerland |
| Novartis Investigative Site | Taichung | Taiwan | 40705 | Taiwan |
| Novartis Investigative Site | Taipei | Taiwan | 10002 | Taiwan |
| Novartis Investigative Site | Taipei | Taiwan | 114 | Taiwan |
| Novartis Investigative Site | Taipei | Taiwan, ROC | 112 | Taiwan |
| Novartis Investigative Site | Linkou District | 33305 | Taiwan |
| Novartis Investigative Site | Bangkok | 10330 | Thailand |
| Novartis Investigative Site | Songkhla | 90110 | Thailand |
| Novartis Investigative Site | Adana | Turkey | 01330 | Turkey (Türkiye) |
| Novartis Investigative Site | Ankara | Turkey | 06100 | Turkey (Türkiye) |
| Novartis Investigative Site | Bursa | Turkey | 16059 | Turkey (Türkiye) |
| Novartis Investigative Site | Altunizade | 34662 | Turkey (Türkiye) |
| Novartis Investigative Site | Antalya | 07070 | Turkey (Türkiye) |
| Novartis Investigative Site | Balcova / Izmir | 35340 | Turkey (Türkiye) |
| Novartis Investigative Site | Mecidiyekoy/Istanbul | 34394 | Turkey (Türkiye) |
| Novartis Investigative Site | Northwood | Middlesex | HA6 2RN | United Kingdom |
| Novartis Investigative Site | Glasgow | G12 0YN | United Kingdom |
| Novartis Investigative Site | Southampton | SO16 6YD | United Kingdom |
| Ravaud A, Barrios CH, Alekseev B, Tay MH, Agarwala SS, Yalcin S, Lin CC, Roman L, Shkolnik M, Anak O, Gogov S, Pelov D, Louveau AL, Melichar B. RECORD-2: phase II randomized study of everolimus and bevacizumab versus interferon alpha-2a and bevacizumab as first-line therapy in patients with metastatic renal cell carcinoma. Ann Oncol. 2015 Jul;26(7):1378-84. doi: 10.1093/annonc/mdv170. Epub 2015 Apr 7. |
Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
| Full Analysis Set |
|
| Safety Set |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Bevacizumab, RAD001 (Everolimus) | Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks. |
| BG001 | Bevacizumab, Interferon Alfa-2a (IFN) | Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 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 |
|
| 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) of Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab | Tumor response and disease progression were assessed using response evaluation criteria in solid tumors (RECIST), version 1.0. All target and non-target lesions identified at baseline were assessed using the same method, CT scan with contrast or MRI with contrast, throughout the trial. All scans were reviewed by independent, central radiology. Disease progression was defined as: 1) a 20% increase in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameters of all target lesions recorded at or after baseline or 2) the appearance of a new lesions or 3) the unequivocal progression of non-target lesions overall. | Full Analysis Set: This set consists of all randomized participants. | Posted | Median | 95% Confidence Interval | Months | Time from randomization to the date of radiological progressive disease as per independent central review, death from any cause, or last tumor assessment, reported between date of first participant randomized until 31Dec2011, cutoff date. |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) Treatment Effect in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab | Overall survival (OS) was defined as the time of randomization to the date of death due to any cause. | Full Analysis Set: This set consists of all randomized participants. | Posted | Median | 95% Confidence Interval | Months | Time from randomization to the date of death from any cause, reported between date of first participant randomized and up to 2 years after the last participant randomized (data cutoff: 30Aug2012) |
|
| |||||||||||||||||||||||||||||
| Secondary | Best Overall Response in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab | Overall response is defined as the number of participants having achieved confirmed Complete Response (CR) + Partial Response (PR). Confirmed CR = at least two determinations of CR at least 4 weeks apart before progression. Confirmed PR = at least two determinations of PR or better at least 4 weeks apart before progression. CR required a disappearance of all target and non-target lesions. PR required at least a 30% decrease in the sum of the longest diameters of all target lesions, taking as a reference the baseline sum of the longest diameters. Disease progression was defined as: 1) a 20% increase in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameters of all target lesions recorded at or after baseline or 2) the appearance of a new lesions or 3) the unequivocal progression of non-target lesions overall. | Full Analysis Set: This set consists of all randomized participants. | Posted | Number | Number of participants | Time from first participant randomized until 31Dec2011, cutoff date. |
| |||||||||||||||||||||||||||||||
| Secondary | Response Duration Differences in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab | The duration of response, applied only to participants with best overall response at CR or PR, is defined as the number of days between the date of first documented response (CR or PR) and the date of the event: radiological progression as per central review or death due to underlying cancer, whichever occurs first. If no event, participant is censored at the last adequate assessment. | A subset of participants from the full analysis set were analyzed. The full analysis set consists of all randomized participants. the subset includes participants who were complete responders or partial responders. | Posted | Median | 95% Confidence Interval | Months | Time from first documented response date of radiological progressive disease as per independent central review, death due to underlying cancer, or last tumor assessment, reported between date of first participant randomized until 31Dec2011, cut-off date. |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events and Deaths | Participants were monitored for adverse events, serious adverse events and deaths throughout the study. Participants were assessed continuously at each 28-day cycle. | Safety Set: The safety set included all participants who received at least one dose of study drug (everolimus, bevacizumab or IFN) and had a valid post-baseline assessment. No AE or occurrence of death, noted at assessment, constitutes a valid post-baseline safety assessment. | Posted | Number | Participants | From the first participant randomized until the last patient discontinued the study treatment + 28 days |
|
| ||||||||||||||||||||||||||||||
| Secondary | Time to Definitive Deterioration of the Functional Assessment of Cancer Therapy Kidney Symptom Index, Disease Related Symptoms (FKSI-DRS) Risk Score by at Least 2 Score Units | The analysis of this outcome measure was based on the FKSI-DRS scale which is a validated disease-related symptom index containing 9 items that measure symptoms predominantly related to kidney cancer. Each item is scored on a 5-point scale (0 = not at all; 4 = very much). If at least 5 of the 9 questions have been answered, the FKSI-DRS total score is calculated by subtracting nine times the mean of the scores of the answered items from 36. Participants with less than 5 out of the 9 questions answered will have a missing FKSI-DRS total score. The FKSI-DRS total score ranges from 0 (most severe symptoms) to 36 (no symptoms). Definitive deterioration is defined as a decrease by at least 2 units compared to baseline, with no later increase above this threshold observed during the study. A single measure reporting a decrease of at least 2 units was considered definitive only if it is the last one available for the participant. | Full Analysis Set: This set consists of all randomized participants. | Posted | Median | 95% Confidence Interval | Months | Time from randomization to the date of definitive deterioration (defined as no later increase above the threshold observed during the study), or date of last assessment, reported between date of first patient randomized until 31Dec2011 |
| ||||||||||||||||||||||||||||||
| Secondary | Time to Definitive Deterioration of the Global Health Status and the Physical Functioning (PF) Subscale Scores of the European Organization for the Research and Treatment of Cancer (EORTC)-Core Quality of Life Questionnaire (QLQ-C30) by at Least 10% | The EORTC QLQ-C30 contains 30 items. These include five functional scales (physical, role, emotional, social and cognitive functioning), three symptom scales (fatigue, pain, nausea, and vomiting), a global health status/QoL scale, and six single items (dyspnea, diarrhea, constipation, anorexia, insomnia and financial impact). The PF subscale consists of 5 questions each scored from 1 (not at all) to 4 (very much). The score for the PF subscale and global health status range from 0 to 100, with a higher score representing a high level of functioning/high quality of life. Definitive deterioration by at least 10% is defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the course of the study. A single measure reporting a decrease of at least 10% is considered definitive only if it is the last one available for the participant. | Full Analysis Set: This set consists of all randomized participants. | Posted | Median | 95% Confidence Interval | Months | Time from randomization to the date of definitive deterioration (defined as no later increase above the threshold observed during the study), or date of last assessment, reported between date of first participant randomized until 31Dec2011 |
| ||||||||||||||||||||||||||||||
| Secondary | Duration of Exposure of RAD001 in Participants Randomized to the Treatment Combination of RAD001 and Bevacizumab | This outcome measure was assessed continuously. | Safety Set: The safety set included all participants who received at least one dose of study drug (everolimus, bevacizumab or IFN) and had a valid post-baseline assessment. No AE or occurrence of death, noted at assessment, constitutes a valid post-baseline safety assessment. | Posted | Median | Full Range | weeks | From the date of the first participant treated until the last patient discontinued the study treatment + 28 days |
|
|
Not provided
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 | Bevacizumab, RAD001 (Everolimus) | Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks. | 79 | 180 | 173 | 180 | ||
| EG001 | Bevacizumab, Interferon Alfa-2a (IFN) | Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks. | 76 | 181 | 179 | 181 |
| 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 |
| |
| LYMPHADENOPATHY MEDIASTINAL | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| ANGINA PECTORIS | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| CARDIAC ARREST | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| CARDIAC FAILURE ACUTE | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| TACHYCARDIA | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| VENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| DEAFNESS | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| TINNITUS | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| ANAL FISSURE | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| ANAL FISTULA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| ASCITES | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| COLITIS | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| DYSPHAGIA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| ENTERITIS | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| FLATULENCE | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| GASTRIC FISTULA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| GASTRIC ULCER | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| GASTRIC ULCER HAEMORRHAGE | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| GASTRITIS | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| HAEMORRHOIDAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| INTESTINAL ISCHAEMIA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| MOUTH HAEMORRHAGE | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| PANCREATITIS | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| PANCREATITIS CHRONIC | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| PROCTITIS | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| RECTAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| RETROPERITONEUM CYST | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| SIGMOIDITIS | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| TOOTHACHE | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| UPPER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA | Systematic Assessment |
| |
| DISEASE PROGRESSION | General disorders | MedDRA | Systematic Assessment |
| |
| DRUG INEFFECTIVE | General disorders | MedDRA | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA | Systematic Assessment |
| |
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA | Systematic Assessment |
| |
| GENERALISED OEDEMA | General disorders | MedDRA | Systematic Assessment |
| |
| HYPERPYREXIA | General disorders | MedDRA | Systematic Assessment |
| |
| MULTI-ORGAN FAILURE | General disorders | MedDRA | Systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA | Systematic Assessment |
| |
| PERFORMANCE STATUS DECREASED | General disorders | MedDRA | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA | Systematic Assessment |
| |
| SUDDEN DEATH | General disorders | MedDRA | Systematic Assessment |
| |
| BILE DUCT OBSTRUCTION | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| CHOLESTASIS | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| HEPATOTOXICITY | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| JAUNDICE | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| ANAL ABSCESS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| BRONCHOPNEUMONIA | Infections and infestations | MedDRA | Systematic Assessment |
| |
| ESCHERICHIA URINARY TRACT INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
| |
| INJECTION SITE INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
| |
| LARYNGITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| LUNG INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
| |
| MYELITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| NECROTISING FASCIITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| OSTEOMYELITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| PHARYNGITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA | Systematic Assessment |
| |
| PYELONEPHRITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| SEPTIC SHOCK | Infections and infestations | MedDRA | Systematic Assessment |
| |
| SINUSITIS BACTERIAL | Infections and infestations | MedDRA | Systematic Assessment |
| |
| TONSILLITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| TUBERCULOSIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
| |
| ALCOHOL POISONING | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| CEMENT EMBOLISM | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| CRANIOCEREBRAL INJURY | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| FRACTURE | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| HEPATIC HAEMATOMA | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| INCISIONAL HERNIA | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| LACERATION | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| SPINAL COMPRESSION FRACTURE | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| SUBDURAL HAEMATOMA | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| TOXICITY TO VARIOUS AGENTS | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| VASCULAR PSEUDOANEURYSM | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| BLOOD CREATINE INCREASED | Investigations | MedDRA | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA | Systematic Assessment |
| |
| EJECTION FRACTION DECREASED | Investigations | MedDRA | Systematic Assessment |
| |
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | MedDRA | Systematic Assessment |
| |
| HAEMOGLOBIN DECREASED | Investigations | MedDRA | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA | Systematic Assessment |
| |
| CACHEXIA | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| DIABETES MELLITUS INADEQUATE CONTROL | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| HYPERCALCAEMIA | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| HYPERVOLAEMIA | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| HYPOALBUMINAEMIA | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| HYPOGLYCAEMIA | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| METABOLIC ACIDOSIS | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| BONE LOSS | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| GROIN PAIN | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| PATHOLOGICAL FRACTURE | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| ROTATOR CUFF SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| CANCER PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| INTESTINAL ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| MALIGNANT NEOPLASM PROGRESSION | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| METASTASES TO BONE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| PROSTATE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| CEREBRAL INFARCTION | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| CEREBRAL ISCHAEMIA | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| COMA | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| CONVULSION | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| ENCEPHALOPATHY | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| EPILEPSY | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| HAEMORRHAGE INTRACRANIAL | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| SPINAL CORD COMPRESSION | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| ACUTE PSYCHOSIS | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| DELIRIUM | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| MENTAL STATUS CHANGES | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| SOPOR | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| BLADDER DILATATION | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| NEPHROTIC SYNDROME | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| OLIGURIA | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| PROTEINURIA | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| RENAL COLIC | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| RENAL FAILURE ACUTE | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| RENAL IMPAIRMENT | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| TUBULOINTERSTITIAL NEPHRITIS | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| URINARY RETENTION | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| MENORRHAGIA | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| TESTICULAR PAIN | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| ACUTE PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| ATELECTASIS | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| BRONCHOSPASM | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| EMPHYSEMA | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| PNEUMONIA ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| SLEEP APNOEA SYNDROME | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| ACCELERATED HYPERTENSION | Vascular disorders | MedDRA | Systematic Assessment |
| |
| CIRCULATORY COLLAPSE | Vascular disorders | MedDRA | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA | Systematic Assessment |
| |
| HYPERTENSIVE CRISIS | Vascular disorders | MedDRA | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA | Systematic Assessment |
| |
| HYPOVOLAEMIC SHOCK | Vascular disorders | MedDRA | Systematic Assessment |
| |
| THROMBOSIS | Vascular 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 |
| |
| LYMPHOPENIA | 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 |
| |
| TACHYCARDIA | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| GINGIVAL BLEEDING | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| MOUTH ULCERATION | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| TOOTHACHE | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA | Systematic Assessment |
| |
| MALAISE | General disorders | MedDRA | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA | Systematic Assessment |
| |
| GINGIVITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA | Systematic Assessment |
| |
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | MedDRA | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| HYPERCHOLESTEROLAEMIA | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| HYPERTRIGLYCERIDAEMIA | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| HYPERURICAEMIA | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| DYSURIA | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| PROTEINURIA | Renal and urinary 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 |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| DERMATITIS | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| DERMATITIS ACNEIFORM | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA | Systematic Assessment |
|
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 Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D000230 | Adenocarcinoma |
| D002292 | Carcinoma, Renal Cell |
| D000072662 | Margins of Excision |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D065308 | Morphological and Microscopic Findings |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068338 | Everolimus |
| D000077190 | Interferon alpha-2 |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D016898 | Interferon-alpha |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
|
|
|
|
|
|
| Participants |
|
|
| OG001 |
| Bevacizumab, Interferon Alfa-2a (IFN) |
Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks. |
|
|
| OG001 | Bevacizumab, Interferon Alfa-2a (IFN) | Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks. |
|
|
|