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Assess the Efficacy and Safety of MYL-1402O Compared with Avastin®, in the First-line Treatment of Patients with Stage IV Non-Squamous Non-Small Cell Lung Cancer
MYL-1402O is a monoclonal antibody currently being developed by Mylan GmbH, as a proposed biosimilar to European Union and US licensed Avastin (hereafter referred to as Avastin), which is approved as first line treatment in combination with carboplatin and paclitaxel (CP) for patients with Stage IV unresectable, recurrent or metastatic nsNSCLC. This randomized equivalence study is designed to meet the global regulatory requirement for approval of a biosimilar product. For this study, both MYL-1402O and Avastin are considered investigational medicinal products (IMP).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MYL-1402O | Experimental | Patients will begin Period 1 receiving bevacizumab combination therapy (MYL-1402O15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV) on Day 0 of Cycle 1 for up to 6 cycles of therapy. Each cycle will consist of 3 weeks (21 days ± 3 days) and a cycle will start with the administration of bevacizumab (as MYL-1402O ). In Period 2, eligible patients will continue to receive bevacizumab ( MYL- 1402O) every 3 weeks as monotherapy. |
|
| Avastin | Active Comparator | Patients will begin Period 1 receiving bevacizumab combination therapy ( Avastin15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV) on Day 0 of Cycle 1 for up to 6 cycles of therapy. Each cycle will consist of 3 weeks (21 days ± 3 days) and a cycle will start with the administration of bevacizumab (as Avastin). In Period 2, eligible patients will continue to receive bevacizumab (Avastin) every 3 weeks as monotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab as MYL-1402O | Biological | Bevacizumab as MYL-1402O 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Efficacy Analysis of Overall Response Rate ( ORR) of MYL-1402O as Compared to Avastin | The primary efficacy endpoint Overall Response Rate (ORR) will be based on best tumor responses as assessed by an independent review at any time point during the first 18 weeks, and assessed according to RECIST 1.1. The primary efficacy analysis is based on the ratio of the MYL-1402O ORR to the Avastin ORR at Week 18 based on the Intent to Treat ( ITT) set of patients. | 18 weeks after first dosing per patient |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tazeen A Idris, MD | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grodno Clinical Regional Hospital | Grodno | Hrodzenskaya Voblasts | 230017 | Belarus | ||
| Mogilev Regional Oncology Dispensary |
A total of 1016 patients were screened; 345 patients were screen failures. Most common reasons for screen failures were; 57=met exclusion criteria tumor location in contact with major vessels, 46= withdrew consent; 37= patients who have brain metastasis which was treated and stable at the time of signing ICF and 36= patients did not have at least 1 measurable lesion as defined by RECIST 1.1.
671 subjects enrolled at 89 sites across Eastern Europe, Russia, Asia Pacific, South East Asia.
Date of first patient randomized: 21 Jan 2017 Date of last patient randomized: 31 Jan 2019
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| ID | Title | Description |
|---|---|---|
| FG000 | MYL-1402O | Patients will begin Period 1 receiving bevacizumab combination therapy (MYL-1402O15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV) on Day 0 of Cycle 1 for up to 6 cycles of therapy. Each cycle will consist of 3 weeks (21 days ± 3 days) and a cycle will start with the administration of bevacizumab (as MYL-1402O ). In Period 2, eligible patients will continue to receive bevacizumab ( MYL- 1402O) every 3 weeks as monotherapy. Bevacizumab as MYL-1402O: Bevacizumab as MYL-1402O 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
|
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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 | Feb 19, 2019 | Dec 23, 2020 |
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Multicenter, Double-Blind, Randomized, Parallel-Group
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Double blind
| Bevacizumab as Avastin | Biological | Bevacizumab as Avastin 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV |
|
| Minsk |
| Minsk Oblast |
| 220013 |
| Belarus |
| Babruysk Interregional Oncological Dispensary | Babruysk | 213825 | Belarus |
| State Institution NN Alexandrov Republican Scientific and Practical Centre of Oncology And Medical R | Minsk | 223040 | Belarus |
| Grodno Clinical Regional Hospital | Mogilev | 212018 | Belarus |
| Clinical Hospital Mostar | Mostar | Bosnia and Herzegovina |
| Clinical Center University of Sarajevo | Sarajevo | 71000 | Bosnia and Herzegovina |
| Javna zdravstvena ustanova bolnica Trebinje | Trebinje | 89101 | Bosnia and Herzegovina |
| County Hospital Zenica | Zenica | Bosnia and Herzegovina |
| Complex Oncology Center-Veliko Tarnovo | Veliko Tarnovo | 5000 | Bulgaria |
| Complex Oncology Center - Vratsa EOOD | Vratsa | 30001 | Bulgaria |
| Clinical Hospital Centre Osijek | Osijek | 31000 | Croatia |
| General Hospital Sibenik | Šibenik | 22000 | Croatia |
| Clinical Hospital Center Zagreb - PPDS | Zagreb | 10000 | Croatia |
| Research Institute of Clinical Medicine | Tbilisi | 112 | Georgia |
| LTD High Technology Medical Center University Clinic | Tbilisi | 144 | Georgia |
| Orszagos Koranyi Pulmonologiai Intezet | Budapest | Hungary |
| Semmelweis Egyetem | Budapest | Hungary |
| Debreceni Egyetem Klinikai Kozpont | Debrecen | Hungary |
| Veszprem Megyei Tudogyogyintezet | Farkasgyepü | Hungary |
| Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktató Kórház | Miskolc | Hungary |
| City Cancer Center | Vijayawada | Andhra Pradesh | 520002 | India |
| Mahatma Gandhi Medical College and Hospital | Visakhapatnam | Andhra Pradesh | 530017 | India |
| Regional Cancer Centre Indira Gandhi Institute of Medical Sciences | Patna | Bihar | 800014 | India |
| HCG Cancer Center | Ahmedabad | Gujarat | 380060 | India |
| Shree Giriraj Multispeciality Hospital | Rajkot | Gujarat | 360005 | India |
| Synexus Affiliate - Apple Hospital | Surat | Gujarat | 395002 | India |
| Unique Hospital - Multispeciality & Research Institute | Surat | Gujarat | 395002 | India |
| Aadhar Health Institute | Hisar | Haryana | 125001 | India |
| BGS Global Hospital | Bangalore | Karnataka | 560060 | India |
| Sri Venkateshwara Hospital | Bangalore | Karnataka | 560068 | India |
| Shetty's Hospital | Bengaluru | Karnataka | 560068 | India |
| Amravati Cancer Foundation Sujan Surgical and Cancer Hospital | Amravati | Maharashtra | 444606 | India |
| United CIIGMA Institute of Medical Sciences Pvt.Ltd. | Aurangabad | Maharashtra | 431005 | India |
| Seth Nandlal Dhoot Hospital | Aurangabad | Maharashtra | 431210 | India |
| Government Medical College | Nagpur | Maharashtra | 440003 | India |
| Curie Manavata Cancer Centre | Nashik | Maharashtra | 422004 | India |
| Ruby Hall Clinic | Pune | Maharashtra | 411001 | India |
| Acharya Tulsi Regional Cancer Institute and Research Centre | Bikaner | Rajasthan | 334003 | India |
| Malpani Multispecialty Hospital | Jaipur | Rajasthan | 302013 | India |
| Institute of Respiratory Diseases (Chest and TB Hospital) | Jaipur | Rajasthan | 302016 | India |
| Apex Hospital | Jaipur | Rajasthan | 302017 | India |
| Bhagwan Mahaveer Cancer Hospital and Research Centre | Jaipur | Rajasthan | 302017 | India |
| Rajiv Gandhi Government General Hospital | Chennai | Tamil Nadu | 600003 | India |
| Meenakshi Mission Hospital and Research Center | Madurai | Tamil Nadu | 625107 | India |
| Shatabdi Superspeciality Hospital | Lucknow | Uttar Pradesh | 226003 | India |
| Chittaranjan National Cancer Institute | Kolkata | West Bengal | 700026 | India |
| KLES Dr Prabhakar Kore Hospital and Medical Research Centre | Belagāve | 590010 | India |
| Prince Aly Khan Hospital Mumbai | Mumbai | 400010 | India |
| Jaslok Hospital and Research Centre | Mumbai | 400026 | India |
| Sahyadri Speciality Hospital | Pune | 411004 | India |
| Kailash Cancer Hospital and Research Centre | Vadodara | 391760 | India |
| Ospedale Felice Lotti De Pontedera | Pontedera | 56025 | Italy |
| Philippine General Hospital | Manila | National Capital Region | 1000 | Philippines |
| Cardinal Santos Medical Center | San Juan City | National Capital Region | 1502 | Philippines |
| Med-Polonia Sp. z o.o. | Poznan | 60-693 | Poland |
| Radomskie Centrum Onkologii | Radom | 26-600 | Poland |
| Medisprof SRL | Cluj-Napoca | Cluj | 400641 | Romania |
| Ploiesti Municipal Hospital | Ploieşti | Prahova | 100337 | Romania |
| Spitalul Judetean de Urgenta Sf. Pantelimon Focsani | Focşani | Vrancea | 620165 | Romania |
| Elias Emergency University Hospital | Bucharest | 11461 | Romania |
| Prof. Dr. Alexandru Trestioreanu Oncologic Institute | Bucharest | 22328 | Romania |
| Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Constanta | Constanța | 900591 | Romania |
| Oncology Center Sfantul Nectarie | Craiova | Romania |
| Arkhangelsk Regional Clinical Oncology Dispensary | Arkhangelsk | 163045 | Russia |
| Chelyabinsk Regional Clinical Oncology Dispensary | Chelyabinsk | 454087 | Russia |
| Kaluga Regional Oncology Dispensary | Kaluga | 248007 | Russia |
| Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic | Kazan' | 420029 | Russia |
| Kursk Regional Oncology Centre | Kursk | 305524 | Russia |
| Vitamed | Moscow | 129515 | Russia |
| City Clinical Hospital #1 | Novosibirsk | 630047 | Russia |
| Clinical Oncology Dispensary | Omsk | 644013 | Russia |
| Stavropol Regional Clinical Oncology Centre Pyatigorsk Affiliate | Pyatigorsk | 357502 | Russia |
| Ryazan State Medical University n.a. I.P. Pavlov | Ryazan | 390011 | Russia |
| Research Institute of Phtisio-pneumology | Saint Petersburg | 191036 | Russia |
| Leningrad Regional Clinical Hospital | Saint Petersburg | 194291 | Russia |
| Railway Clinical Hospital JSC RZhD | Saint Petersburg | 195271 | Russia |
| Clinical Theoretical and Practical Center of Specialized Kinds of Medical Care | Saint Petersburg | 197758 | Russia |
| Scientific Research Institute of Oncology n.a. N.N. Petrov | Saint Petersburg | 197758 | Russia |
| City Clinical Oncology Dispensary | Saint Petersburg | 198255 | Russia |
| Mordovia State University | Saransk | 430000 | Russia |
| Research Oncology Institute of Tomsk Scientific Center | Tomsk | 634028 | Russia |
| Volgograd Regional Clinical Oncology Dispensary | Volgograd | 400138 | Russia |
| Regional Clinical Oncology Hospital | Yaroslavl | 150040 | Russia |
| Hospital Universitario Vall d'Hebrón - PPDS | Barcelona | 8035 | Spain |
| Hospital Son Llatzer | Palma de Mallorca | 7198 | Spain |
| Kaohsiung Medical University Hospital | Kaohsiung City | 807 | Taiwan |
| E-DA hospital | Kaohsiung City | 82544 | Taiwan |
| Taichung Veterans General Hospital | Taichung | 40705 | Taiwan |
| Mackay Memorial Hospital-Taipei branch | Taipei | 10449 | Taiwan |
| Gazi University Medical Faculty Gazi Hospital | Ankara | 6500 | Turkey (Türkiye) |
| Ege Universitesi Tip Fakultesi Hastanesi | Izmir | 35100 | Turkey (Türkiye) |
| Municipal Institution City Clinical Hospital #4 of Dnipro City Council - PPDS | Dnipropetrovsk | 49102 | Ukraine |
| Municipal Institution SubCarpathian ClinicalOncological Centre | Ivano-Frankivsk | 76018 | Ukraine |
| MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council | Kryvyi Rih | 50048 | Ukraine |
| Municipal non profit enterprise of Sumy Regional Council Sumy Regional Clinical Oncology Dispensary | Sumy | 40022 | Ukraine |
| MNPE Central City Clinical Hospital of Uzhhorod City Council | Uzhhorod | 88000 | Ukraine |
| MI of Zaporizhzhia Regional Council Zaporizhzhia Regional Clinical Oncology Dispensary | Zaporizhzhia | 69040 | Ukraine |
| Bach Mai Hospital | Hanoi | 100000 | Vietnam |
| National Cancer Hospital | Hanoi | 100000 | Vietnam |
| National Lung Hospital | Hanoi | 100000 | Vietnam |
| Cho Ray Hospital | Ho Chi Minh City | 700000 | Vietnam |
| FG001 | Avastin | Patients will begin Period 1 receiving bevacizumab combination therapy ( Avastin15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV) on Day 0 of Cycle 1 for up to 6 cycles of therapy. Each cycle will consist of 3 weeks (21 days ± 3 days) and a cycle will start with the administration of bevacizumab (as Avastin). In Period 2, eligible patients will continue to receive bevacizumab (Avastin) every 3 weeks as monotherapy. Bevacizumab as Avastin: Bevacizumab as Avastin 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Period 2 |
|
|
The primary efficacy endpoint was the ORR as assessed by an independent review during the first 18 Weeks, according to RECIST 1.1. The primary endpoint was analyzed differently to meet the requirements of FDA and EMA. For FDA, the primary efficacy endpoint was based on the ratio of ORRs and for EMA it was based on difference in ORRs.
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| ID | Title | Description |
|---|---|---|
| BG000 | MYL-1402O | Patients will begin Period 1 receiving bevacizumab combination therapy (MYL-1402O15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV) on Day 0 of Cycle 1 for up to 6 cycles of therapy. Each cycle will consist of 3 weeks (21 days ± 3 days) and a cycle will start with the administration of bevacizumab (as MYL-1402O ). In Period 2, eligible patients will continue to receive bevacizumab ( MYL- 1402O) every 3 weeks as monotherapy. Bevacizumab as MYL-1402O: Bevacizumab as MYL-1402O 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV |
| BG001 | Avastin | Patients will begin Period 1 receiving bevacizumab combination therapy ( Avastin15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV) on Day 0 of Cycle 1 for up to 6 cycles of therapy. Each cycle will consist of 3 weeks (21 days ± 3 days) and a cycle will start with the administration of bevacizumab (as Avastin). In Period 2, eligible patients will continue to receive bevacizumab (Avastin) every 3 weeks as monotherapy. Bevacizumab as Avastin: Bevacizumab as Avastin 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV |
| 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, Categorical | 7 patients are Baseline failures (Randomized but Screen failed at Baseline visit) and not dosed. | Count of Participants | Participants |
| |||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Primary Efficacy Analysis of Overall Response Rate ( ORR) of MYL-1402O as Compared to Avastin | The primary efficacy endpoint Overall Response Rate (ORR) will be based on best tumor responses as assessed by an independent review at any time point during the first 18 weeks, and assessed according to RECIST 1.1. The primary efficacy analysis is based on the ratio of the MYL-1402O ORR to the Avastin ORR at Week 18 based on the Intent to Treat ( ITT) set of patients. | The primary efficacy analysis was conducted in the Intent To Treat population (ITT) | Posted | Count of Participants | Participants | 18 weeks after first dosing per patient |
|
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|
|
Active collection period of AEs will be from the time the patient signs the ICF through the Safety Follow Up Visit. Pre-existing diseases or conditions (reported at time of screening) will not be considered AEs unless there is an increase in the frequency or severity, or a change in the quality of the disease or condition. Progression of NSCLC and its consequences will not be collected as an AE even if they lead to hospitalization or meet any other seriousness criteria including death.
The Investigator is responsible for the detection and documentation of events meeting the criteria and definition of an AE or SAE. At each visit, the patient will be allowed time to spontaneously report any issues since the last visit or evaluation. The Investigator will then monitor and/or ask about or evaluate AEs using non-leading questions. Any clinically relevant observations made during the visit are also to be considered AEs.
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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 | MYL-1402O | Patients will begin Period 1 receiving bevacizumab combination therapy (MYL-1402O15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV) on Day 0 of Cycle 1 for up to 6 cycles of therapy. Each cycle will consist of 3 weeks (21 days ± 3 days) and a cycle will start with the administration of bevacizumab (as MYL-1402O ). In Period 2, eligible patients will continue to receive bevacizumab ( MYL- 1402O) every 3 weeks as monotherapy. Bevacizumab as MYL-1402O: Bevacizumab as MYL-1402O 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV | 101 | 335 | 59 | 335 | 311 | 335 |
| EG001 | Avastin | Patients will begin Period 1 receiving bevacizumab combination therapy ( Avastin15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV) on Day 0 of Cycle 1 for up to 6 cycles of therapy. Each cycle will consist of 3 weeks (21 days ± 3 days) and a cycle will start with the administration of bevacizumab (as Avastin). In Period 2, eligible patients will continue to receive bevacizumab (Avastin) every 3 weeks as monotherapy. Bevacizumab as Avastin: Bevacizumab as Avastin 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV | 82 | 329 | 55 | 329 | 304 | 329 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pulmonary Haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Acute Respiratory Distress Syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pulmonary Thrombosis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Infectious Pleural Effusion | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Ear Infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Eye Infection Fungal | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Gastroenteritis Salmonella | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Gastrointestinal Infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Hepatitis C | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Lung Infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Rectal Abscess | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Duodenal Ulcer | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Duodenal Ulcer Haemorrhage | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Gastric Perforation | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Gastric Ulcer Haemorrhage | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Large Intestine Perforation | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Peptic Ulcer Haemorrhage | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Peptic Ulcer Perforation | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Acute Coronary Syndrome | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Angina Unstable | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cardicac Arrest | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cardiac Failure Acute | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cardio-Respiratory Arrest | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| COR Pulmonale Acute | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Coronary Artery disease | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Ventricular Arrhythmia | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Venous Thrombosis | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Impaired Healing | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Multiple Organ Dysfunction Syndrome | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cererovascular accident | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cerebral Small Vessel Ischamic Disease | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cystitis Haemorrhagic | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pyelocalieectasis | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Renal Cyst Ruptured | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Angle Closure Glaucoma | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Femur Fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Platelet Count Decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Pathological Fracture | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Alanine Aminotranferase Increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
|
There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Keri Vaughan, Senior Director | Mylan GmbH | +215.280.2846 | keri.vaughan@viatris.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 21, 2019 | Dec 23, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Lost to Follow-up |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
| Progressive Disease |
|
| Terminated by Sponsor |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Hungary |
|
| Philippines |
|
| Ukraine |
|
| Belarus |
|
| India |
|
| Russia |
|
| Spain |
|
| Vietnam |
|
| Turkey |
|
| Taiwan |
|
| Poland |
|
| Georgia |
|
| Bulgaria |
|
| Bosnia and Herzegovina |
|
| Croatia |
|