Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-02-20 @ 5:39 AM
Study NCT ID:
NCT02596958
Status:
COMPLETED
Last Update Posted:
2016-04-04
First Post:
2015-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy Study of Avastin in Locally Advanced Metastatic or Recurrent Non-small Lung Cancer (NSLC) Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800-821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-LaRoche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to the end of study (median duration of 170.8 days)', 'eventGroups': [{'id': 'EG000', 'title': 'Bevacizumab', 'description': 'Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.', 'otherNumAtRisk': 987, 'otherNumAffected': 851, 'seriousNumAtRisk': 987, 'seriousNumAffected': 110}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 594}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 492}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 311}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 307}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 171}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 102}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 66}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 134}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 68}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 50}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 111}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Palmar-plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 99}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 61}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 56}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 459}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 185}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 99}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}], 'seriousEvents': [{'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 15}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Acquired tracheo-oesophageal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Bronchial haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Oesophagobronchial fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Pleural fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Pulmonary haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 15}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Large intestine perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Gastrointestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Large intestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Splenic infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Cerebral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Malignant neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Metastases to central nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 987, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Adverse Drug Reactions (ADRs), Toxicities, Avastin-Related ADRs, and Serious ADRs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '987', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab', 'description': 'Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.'}], 'classes': [{'title': 'ADRs', 'categories': [{'measurements': [{'value': '88.6', 'groupId': 'OG000'}]}]}, {'title': 'Toxicities', 'categories': [{'measurements': [{'value': '88.2', 'groupId': 'OG000'}]}]}, {'title': 'Avastin-related ADR', 'categories': [{'measurements': [{'value': '27.0', 'groupId': 'OG000'}]}]}, {'title': 'Serious ADR', 'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 74 months', 'description': 'ADRs were defined as any response to a drug which was noxious and unintended, and which occurred at dose normally used related to the pharmacological properties. Serious ADRs were defined as any untoward medical occurrence or effect that at any dose resulted in death or life-threatening conditions or required hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect or medically important condition. Toxicity was defined as an adverse event that had an attribution (the relationship to investigational agent) of possible, probable or definite. Avastin-related ADRs (an adverse event with a possible relationship or a relationship to the treatment with AVASTIN) were due to Avastin. ADRs includes serious as well as non-serious ADRs.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population was defined as all participants included in the observational study, regardless of whether they finished it or not.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Withdrew or Modified Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '987', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab', 'description': 'Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 74 months', 'description': 'Percentage of participants who withdrew treatment or experienced at least 1 dose deviation in relation to the planned Avastin therapy were reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population was defined as all participants included in the observational study, regardless of whether they finished it.'}, {'type': 'SECONDARY', 'title': 'Number of Cycles of Systemic Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '987', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab', 'description': 'Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.'}], 'classes': [{'title': 'Total number of cycles', 'categories': [{'measurements': [{'value': '7.6', 'spread': '7.0', 'groupId': 'OG000'}]}]}, {'title': 'Number of cycles with combination therapy', 'categories': [{'measurements': [{'value': '4.2', 'spread': '1.8', 'groupId': 'OG000'}]}]}, {'title': 'Number of cycles with maintenance therapy', 'categories': [{'measurements': [{'value': '3.4', 'spread': '6.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 74 months', 'description': 'Number of cycles of systemic therapy was the mean number of cycles received by participants in combination therapy with Avastin and chemotherapy and with Avastin monotherapy (maintenance).', 'unitOfMeasure': 'cycles', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population was defined as all participants included in the observational study, regardless of whether they finished it.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Best Tumor Response Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '976', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab', 'description': 'Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.'}], 'classes': [{'title': 'CR', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000'}]}]}, {'title': 'PR', 'categories': [{'measurements': [{'value': '43.3', 'groupId': 'OG000'}]}]}, {'title': 'SD', 'categories': [{'measurements': [{'value': '29.4', 'groupId': 'OG000'}]}]}, {'title': 'PD', 'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000'}]}]}, {'title': 'NE', 'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 74 months', 'description': 'Best tumor response (assessed as per clinical routine of the individual center) was categorized according to the following criteria at the investigator discretion: complete response (CR: commonly defined as disappearance of all target lesions, all non-target lesions, and no new lesion), partial response (PR: commonly defined as at least a 30 percent \\[%\\] decrease in the sum of the longest diameter \\[LD\\] of target lesions, no progression in non-target lesion, and no new lesion), stable disease (SD: commonly defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease \\[PD\\], in addition to no new target lesions). PD: commonly defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started and not evaluable (NE).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population was defined as all participants included in the observational study, regardless of whether they finished it. Here, number of participants analyzed = participants with non-missing tumor response data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Eastern Cooperative Group(ECOG) Performance Status Grades', 'denoms': [{'units': 'Participants', 'counts': [{'value': '806', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab', 'description': 'Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.'}], 'classes': [{'title': 'Grade 0', 'categories': [{'measurements': [{'value': '18.7', 'groupId': 'OG000'}]}]}, {'title': 'Grade 1', 'categories': [{'measurements': [{'value': '50.1', 'groupId': 'OG000'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '23.2', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 74 months', 'description': "ECOG Performance Status measured on-therapy (time between first dose and last dose date with a 30-day lag) assessed participant's performance status on 5 point scale: 0 is equal to (=) fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (greater than \\[\\>\\] 50% of waking hours \\[hrs\\]), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair \\>50% of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population was defined as all participants included in the observational study, regardless of whether they finished it. Here, number of participants analyzed = participants with non-missing tumor response data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Disease Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '976', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab', 'description': 'Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.'}], 'classes': [{'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 74 months', 'description': 'Disease control was defined as having achieved CR (commonly defined as disappearance of all target lesions, all non-target lesions, and no new lesion), PR (commonly defined as at least a 30% decrease in the sum of the LD of target lesions, no progression in non-target lesion, and no new lesion), or SD (commonly defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, in addition to no new target lesions) during the course of observation which were assessed as per investigator discretion. PD: commonly defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started and NE.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population was defined as all participants included in the observational study, regardless of whether they finished it. Here, number of participants analyzed = participants with non-missing tumor response data.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '941', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab', 'description': 'Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000', 'lowerLimit': '7.1', 'upperLimit': '8.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 74 months', 'description': 'PFS was defined as the time (months) between the start of therapy and progression (unequivocal progression of existing non-target lesions) or death. Progression: at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started. PFS was estimated using Kaplan-Meier method.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population was defined as all participants included in the observational study, regardless of whether they finished it. Here, number of participants analyzed = participants with non-missing tumor response data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Died', 'denoms': [{'units': 'Participants', 'counts': [{'value': '975', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab', 'description': 'Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 74 months', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population was defined as all participants included in the observational study, regardless of whether they finished it. Here, number of participants analyzed = participants with non-missing tumor response data.'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '975', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab', 'description': 'Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.4', 'spread': '0.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 74 months', 'description': 'Overall survival was defined as the time (months) between the start of therapy and the date of death.', 'unitOfMeasure': 'months', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population was defined as all participants included in the observational study, regardless of whether they finished it. Here 'number of participants analyzed' = participants assessed for this outcome measure."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bevacizumab', 'description': 'Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current summary of product characteristics (SmPC).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '996'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '996'}]}], 'dropWithdraws': [{'type': 'Serious Adverse Drug Reactions', 'reasons': [{'groupId': 'FG000', 'numSubjects': '44'}]}, {'type': 'Cancer Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '441'}]}, {'type': 'Death From Cancer', 'reasons': [{'groupId': 'FG000', 'numSubjects': '112'}]}, {'type': 'Death From Other Cause', 'reasons': [{'groupId': 'FG000', 'numSubjects': '33'}]}, {'type': 'Refusal of Treatment/Poor Cooperation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '61'}]}, {'type': 'Administrative Reasons/Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '231'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '33'}]}, {'type': 'Missing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '32'}]}, {'type': 'Excluded Due to Second Line Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '987', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Bevacizumab', 'description': 'Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.5', 'spread': '9.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '396', 'groupId': 'BG000'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '590', 'groupId': 'BG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Analysis population was defined as all participants included in the observational study, regardless of whether they finished it or not. Nine hundred and ninety six (996) participants were documented but only 987 participants were included in the analysis population as 9 participants were excluded due to documented second line treatment.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 996}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-07', 'studyFirstSubmitDate': '2015-11-03', 'resultsFirstSubmitDate': '2016-02-05', 'studyFirstSubmitQcDate': '2015-11-03', 'lastUpdatePostDateStruct': {'date': '2016-04-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-02-05', 'studyFirstPostDateStruct': {'date': '2015-11-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Adverse Drug Reactions (ADRs), Toxicities, Avastin-Related ADRs, and Serious ADRs', 'timeFrame': 'Up to 74 months', 'description': 'ADRs were defined as any response to a drug which was noxious and unintended, and which occurred at dose normally used related to the pharmacological properties. Serious ADRs were defined as any untoward medical occurrence or effect that at any dose resulted in death or life-threatening conditions or required hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect or medically important condition. Toxicity was defined as an adverse event that had an attribution (the relationship to investigational agent) of possible, probable or definite. Avastin-related ADRs (an adverse event with a possible relationship or a relationship to the treatment with AVASTIN) were due to Avastin. ADRs includes serious as well as non-serious ADRs.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Withdrew or Modified Treatment', 'timeFrame': 'Up to 74 months', 'description': 'Percentage of participants who withdrew treatment or experienced at least 1 dose deviation in relation to the planned Avastin therapy were reported.'}, {'measure': 'Number of Cycles of Systemic Therapy', 'timeFrame': 'Up to 74 months', 'description': 'Number of cycles of systemic therapy was the mean number of cycles received by participants in combination therapy with Avastin and chemotherapy and with Avastin monotherapy (maintenance).'}, {'measure': 'Percentage of Participants With Best Tumor Response Over Time', 'timeFrame': 'Up to 74 months', 'description': 'Best tumor response (assessed as per clinical routine of the individual center) was categorized according to the following criteria at the investigator discretion: complete response (CR: commonly defined as disappearance of all target lesions, all non-target lesions, and no new lesion), partial response (PR: commonly defined as at least a 30 percent \\[%\\] decrease in the sum of the longest diameter \\[LD\\] of target lesions, no progression in non-target lesion, and no new lesion), stable disease (SD: commonly defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease \\[PD\\], in addition to no new target lesions). PD: commonly defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started and not evaluable (NE).'}, {'measure': 'Percentage of Participants With Eastern Cooperative Group(ECOG) Performance Status Grades', 'timeFrame': 'Up to 74 months', 'description': "ECOG Performance Status measured on-therapy (time between first dose and last dose date with a 30-day lag) assessed participant's performance status on 5 point scale: 0 is equal to (=) fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (greater than \\[\\>\\] 50% of waking hours \\[hrs\\]), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair \\>50% of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead."}, {'measure': 'Percentage of Participants With Disease Control', 'timeFrame': 'Up to 74 months', 'description': 'Disease control was defined as having achieved CR (commonly defined as disappearance of all target lesions, all non-target lesions, and no new lesion), PR (commonly defined as at least a 30% decrease in the sum of the LD of target lesions, no progression in non-target lesion, and no new lesion), or SD (commonly defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, in addition to no new target lesions) during the course of observation which were assessed as per investigator discretion. PD: commonly defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started and NE.'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Up to 74 months', 'description': 'PFS was defined as the time (months) between the start of therapy and progression (unequivocal progression of existing non-target lesions) or death. Progression: at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started. PFS was estimated using Kaplan-Meier method.'}, {'measure': 'Percentage of Participants Who Died', 'timeFrame': 'Up to 74 months'}, {'measure': 'Overall Survival', 'timeFrame': 'Up to 74 months', 'description': 'Overall survival was defined as the time (months) between the start of therapy and the date of death.'}]}, 'conditionsModule': {'conditions': ['Non-Squamous Non-Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '31077164', 'type': 'DERIVED', 'citation': 'Zahn MO, Linck D, Losem C, Gessner C, Metze H, Gaillard VE, Tessen HW. AVAiLABLE NIS - AVASTIN(R) in lung cancer treatment in routine oncology practice in Germany. BMC Cancer. 2019 May 10;19(1):433. doi: 10.1186/s12885-019-5618-0.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this non-interventional study is the collection and documentation of data on safety and efficacy of intravenous (IV) bevacizumab (Avastin) in addition to platinum-based chemotherapy for first-line treatment in participants with unresectable advanced, metastatic or recurrent non-small cell lung cancer (NSCLC) other than predominantly squamous cell histology with focus on adenocarcinoma and elderly patients in daily routine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell and with or without adenocarcinoma histology will be selected.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age greater than or equal to (\\>=) 18 years\n* Histologically confirmed predominantly non-squamous NSCLC that is unresectably advanced, metastatic or recurrent (with or without adenocarcinoma)\n* No contraindications to Avastin® according to the current Summary of Product Characteristics (SmPC) for Avastin®\n* Therapeutic decision for Avastin® as first line treatment in combination with platinum-based chemotherapy was taken individually and independent of the non-interventional trial.\n\nExclusion Criteria:\n\nN/A'}, 'identificationModule': {'nctId': 'NCT02596958', 'briefTitle': 'Safety and Efficacy Study of Avastin in Locally Advanced Metastatic or Recurrent Non-small Lung Cancer (NSLC) Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Available - Avastin in Addition to Platinum-based Chemotherapy is Indicated for First-lime Treatment of Patients With Locally Advanced, Metastatic or Recurrent Non-small Lung Cancer Other Than Predominantly Squamous Cell Histology', 'orgStudyIdInfo': {'id': 'ML21217'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Bevacizumab', 'description': 'Patients will receive six 3-weeks cycle of IV bevacizumab along with platinum-based chemotherapy, followed by maintenance therapy of bevacizumab until progression (approximately 7 months).', 'interventionNames': ['Drug: Bevacizumab']}], 'interventions': [{'name': 'Bevacizumab', 'type': 'DRUG', 'otherNames': ['Avastin'], 'description': 'Six 3-weeks cycle of IV bevacizumab will be administered for approximately 7 months.', 'armGroupLabels': ['Bevacizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38642', 'city': 'Goslar', 'country': 'Germany', 'geoPoint': {'lat': 51.90425, 'lon': 10.42766}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}