Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2026-02-25 @ 9:48 PM
Study NCT ID:
NCT02304406
Status:
COMPLETED
Last Update Posted:
2019-07-19
First Post:
2014-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Retrospective Epidemiology Study Of ALK Rearrangement In Non-Small Cell Lung Cancer Patients In The Middle East & North Africa
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Not applicable as adverse events was not planned to be collected during the study', 'description': 'Due to the non-interventional nature of the study, adverse events were not collected during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Non-Small Cell Lung Cancer', 'description': 'Tissue samples of participants of MENA previously diagnosed with NSCLC were tested retrospectively for the prevalence of ALK rearrangement.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Prevalence of Anaplastic Lymphoma Kinase (ALK) Rearrangement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Small Cell Lung Cancer', 'description': 'Tissue samples of participants of MENA previously diagnosed with NSCLC were tested retrospectively for the prevalence of ALK rearrangement.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.69', 'groupId': 'OG000', 'lowerLimit': '6.26', 'upperLimit': '11.71'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'Participants with prevalence of ALK rearrangement were positive for ALK: defined as presence of strong granular cytoplasmic staining in tumor cells (any percentage of positive tumor cells).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Gender', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Small Cell Lung Cancer', 'description': 'Tissue samples of participants of MENA previously diagnosed with NSCLC were tested retrospectively for the prevalence of ALK rearrangement.'}], 'classes': [{'title': 'Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000'}]}]}, {'title': 'Female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.1304', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.85', 'ciLowerLimit': '0.80', 'ciUpperLimit': '4.77', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the gender of study participants.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies the participants evaluable at specific categories.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Race', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Small Cell Lung Cancer', 'description': 'Tissue samples of participants of MENA previously diagnosed with NSCLC were tested retrospectively for the prevalence of ALK rearrangement.'}], 'classes': [{'title': 'White /Caucasian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000'}]}]}, {'title': 'Arabic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '388', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000'}]}]}, {'title': 'Others', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.6422', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the race of study participants.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies the participants evaluable at specific categories.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Smoking History', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Small Cell Lung Cancer', 'description': 'Tissue samples of participants of MENA previously diagnosed with NSCLC were tested retrospectively for the prevalence of ALK rearrangement.'}], 'classes': [{'title': 'Never', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000'}]}]}, {'title': 'Current', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000'}]}]}, {'title': 'Ex-smoker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000'}]}]}, {'title': 'Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.9', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.4524', 'groupIds': ['OG000'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the smoking history of study participants as participants who never smoked, current smoker and ex-smoker.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies the participants evaluable at specific categories.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Tumor Histologic Diagnosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Small Cell Lung Cancer', 'description': 'Tissue samples of participants of MENA previously diagnosed with NSCLC were tested retrospectively for the prevalence of ALK rearrangement.'}], 'classes': [{'title': 'Adenocarcinoma: Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '430', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.6', 'groupId': 'OG000'}]}]}, {'title': 'Large cell carcinoma: Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}]}]}, {'title': 'Not specified', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Others', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.9010', 'groupIds': ['OG000'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the diagnosis of tumor histology of study participants.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies the participants evaluable at specific categories.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Tumor Stage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Small Cell Lung Cancer', 'description': 'Tissue samples of participants of MENA previously diagnosed with NSCLC were tested retrospectively for the prevalence of ALK rearrangement.'}], 'classes': [{'title': 'Stage 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}]}]}, {'title': 'Stage 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.8', 'groupId': 'OG000'}]}]}, {'title': 'Stage 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}]}]}, {'title': 'Stage 3 A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Stage 3 B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}]}]}, {'title': 'Stage 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}]}]}, {'title': 'Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.9067', 'groupIds': ['OG000'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the tumor stage of study participants.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies the participants evaluable at specific categories.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Treatment Type', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Small Cell Lung Cancer', 'description': 'Tissue samples of participants of MENA previously diagnosed with NSCLC were tested retrospectively for the prevalence of ALK rearrangement.'}], 'classes': [{'title': 'Surgery with chemotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000'}]}]}, {'title': 'Surgery without chemotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.2', 'groupId': 'OG000'}]}]}, {'title': 'Targeted therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}]}]}, {'title': 'Chemotherapy only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.8', 'groupId': 'OG000'}]}]}, {'title': 'Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.9', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.8785', 'groupIds': ['OG000'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the treatment type of study participants.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies the participants evaluable at specific categories.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Small Cell Lung Cancer', 'description': 'Tissue samples of participants of MENA previously diagnosed with NSCLC were tested retrospectively for the prevalence of ALK rearrangement.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.9231', 'groupIds': ['OG000'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the PFS of study participants.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Line of Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Small Cell Lung Cancer', 'description': 'Tissue samples of participants of MENA previously diagnosed with NSCLC were tested retrospectively for the prevalence of ALK rearrangement.'}], 'classes': [{'title': 'First-line', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000'}]}]}, {'title': 'Second-line', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000'}]}]}, {'title': 'Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000'}]}]}, {'title': 'Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.9780', 'groupIds': ['OG000'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the line of therapy of study participants.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies the participants evaluable at specific categories.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Overall Response (OR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Small Cell Lung Cancer', 'description': 'Tissue samples of participants of MENA previously diagnosed with NSCLC were tested retrospectively for the prevalence of ALK rearrangement.'}], 'classes': [{'title': 'CR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}]}]}, {'title': 'PR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}]}]}, {'title': 'PD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000'}]}]}, {'title': 'SD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}]}]}, {'title': 'Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.9', 'groupId': 'OG000'}]}]}, {'title': 'Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.1144', 'groupIds': ['OG000'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'Percentage of participants with best overall response. Complete response (CR) is equal to (=) disappearance of all target lesions. Partial Response (PR) = greater than equal to (\\>=) 30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions. Progressive disease (PD) \\>= 20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of the longest dimensions since treatment start, or the appearance of \\>= 1 new lesion. Stable disease (SD) =neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies the participants evaluable at specific categories.'}, {'type': 'SECONDARY', 'title': "Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Participant's Status", 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Small Cell Lung Cancer', 'description': 'Tissue samples of participants of MENA previously diagnosed with NSCLC were tested retrospectively for the prevalence of ALK rearrangement.'}], 'classes': [{'title': 'Treatment-naive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '415', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000'}]}]}, {'title': 'Treated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000'}]}]}, {'title': 'Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0862', 'groupIds': ['OG000'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': "In this outcome measure participant's status at the time of sampling were evaluable for treatment-naive and treated.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies the participants evaluable at specific categories.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Epidermal Growth Factor Receptor (EGFR) Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Small Cell Lung Cancer', 'description': 'Tissue samples of participants of MENA previously diagnosed with NSCLC were tested retrospectively for the prevalence of ALK rearrangement.'}], 'classes': [{'title': 'Not tested', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.0', 'groupId': 'OG000'}]}]}, {'title': 'Wild type', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000'}]}]}, {'title': 'Mutant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0294', 'groupIds': ['OG000'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'In this outcome measure EGFR status of participants were evaluable for not tested, wild type and mutant.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies the participants evaluable at specific categories.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Knowledge Representation for Autonomous Systems (KRAS) Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Small Cell Lung Cancer', 'description': 'Tissue samples of participants of MENA previously diagnosed with NSCLC were tested retrospectively for the prevalence of ALK rearrangement.'}], 'classes': [{'title': 'Not tested', 'denoms': [{'units': 'Participants', 'counts': [{'value': '433', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000'}]}]}, {'title': 'Wild type', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Mutant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.6877', 'groupIds': ['OG000'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'In this outcome measure KRAS status of participants were evaluable for not tested, wild type, and mutant.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies the participants evaluable at specific categories.'}, {'type': 'SECONDARY', 'title': 'Percentage Agreement Between Vysis Fluorescent In Situ Hybridization (FISH) and Ventana Immunohistochemistry (IHC) Methods for ALK Rearrangement Detection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Small Cell Lung Cancer', 'description': 'Tissue samples of participants of MENA previously diagnosed with NSCLC were tested retrospectively for the prevalence of ALK rearrangement.'}], 'classes': [{'categories': [{'measurements': [{'value': '98.45', 'groupId': 'OG000', 'lowerLimit': '94.51', 'upperLimit': '99.81'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'Percent overall agreement between Vysis ALK-FISH and Ventana ALK IHC tests and its 95% CI is reported in this outcome measure.', 'unitOfMeasure': 'percentage agreement', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Non-Small Cell Lung Cancer', 'description': 'Tissue samples of participants of Middle East North Africa (MENA) previously diagnosed with non-small cell lung cancer (NSCLC) were tested retrospectively for the prevalence of anaplastic lymphoma kinase (ALK) rearrangement.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '449'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '449'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Non-Small Cell Lung Cancer', 'description': 'Tissue samples of participants of MENA previously diagnosed with NSCLC were tested retrospectively for the prevalence of ALK rearrangement.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18 to 65 years', 'categories': [{'measurements': [{'value': '272', 'groupId': 'BG000'}]}]}, {'title': 'Greater than equal to 65 years', 'categories': [{'measurements': [{'value': '157', 'groupId': 'BG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '141', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '308', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Arabic', 'categories': [{'measurements': [{'value': '389', 'groupId': 'BG000'}]}]}, {'title': 'White / Caucasian', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set: Participants above age 18 years with confirmed NSCLC, sufficient tissue sample, routinely processed formalin-fixed, paraffin-embedded)for ALK testing, with any Eastern Cooperative Oncology Group performance status, alive/death confirmed before inclusion/unknown. Diagnosed/treated in 1 of study centers.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-04-21', 'size': 443957, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-01-24T10:32', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'The tissue samples of NSCLC cases will be retrieved from tissue banks of the molecular diagnostic units \\& pathology departments in these study centers. The histological diagnosis will be confirmed by the pathologists. The retained samples will then be tested by performing the Ventana ALK-IHC to assess the absence or presence of the ALK rearrangement by the detection of the ALK protein in formalin-fixed, paraffin-embedded NSCLC stored tissue samples using Ventana anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody (Roche Diagnostics GmbH) in the selected study centers.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 449}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2018-02-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-14', 'studyFirstSubmitDate': '2014-11-14', 'resultsFirstSubmitDate': '2019-01-24', 'studyFirstSubmitQcDate': '2014-12-01', 'lastUpdatePostDateStruct': {'date': '2019-07-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-14', 'studyFirstPostDateStruct': {'date': '2014-12-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Prevalence of Anaplastic Lymphoma Kinase (ALK) Rearrangement', 'timeFrame': '3 years', 'description': 'Participants with prevalence of ALK rearrangement were positive for ALK: defined as presence of strong granular cytoplasmic staining in tumor cells (any percentage of positive tumor cells).'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Gender', 'timeFrame': '3 years', 'description': 'In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the gender of study participants.'}, {'measure': 'Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Race', 'timeFrame': '3 years', 'description': 'In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the race of study participants.'}, {'measure': 'Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Smoking History', 'timeFrame': '3 years', 'description': 'In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the smoking history of study participants as participants who never smoked, current smoker and ex-smoker.'}, {'measure': 'Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Tumor Histologic Diagnosis', 'timeFrame': '3 years', 'description': 'In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the diagnosis of tumor histology of study participants.'}, {'measure': 'Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Tumor Stage', 'timeFrame': '3 years', 'description': 'In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the tumor stage of study participants.'}, {'measure': 'Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Treatment Type', 'timeFrame': '3 years', 'description': 'In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the treatment type of study participants.'}, {'measure': 'Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Progression Free Survival (PFS)', 'timeFrame': '3 years', 'description': 'In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the PFS of study participants.'}, {'measure': 'Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Line of Therapy', 'timeFrame': '3 years', 'description': 'In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the line of therapy of study participants.'}, {'measure': 'Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Overall Response (OR)', 'timeFrame': '3 years', 'description': 'Percentage of participants with best overall response. Complete response (CR) is equal to (=) disappearance of all target lesions. Partial Response (PR) = greater than equal to (\\>=) 30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions. Progressive disease (PD) \\>= 20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of the longest dimensions since treatment start, or the appearance of \\>= 1 new lesion. Stable disease (SD) =neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.'}, {'measure': "Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Participant's Status", 'timeFrame': '3 years', 'description': "In this outcome measure participant's status at the time of sampling were evaluable for treatment-naive and treated."}, {'measure': 'Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Epidermal Growth Factor Receptor (EGFR) Status', 'timeFrame': '3 years', 'description': 'In this outcome measure EGFR status of participants were evaluable for not tested, wild type and mutant.'}, {'measure': 'Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Knowledge Representation for Autonomous Systems (KRAS) Status', 'timeFrame': '3 years', 'description': 'In this outcome measure KRAS status of participants were evaluable for not tested, wild type, and mutant.'}, {'measure': 'Percentage Agreement Between Vysis Fluorescent In Situ Hybridization (FISH) and Ventana Immunohistochemistry (IHC) Methods for ALK Rearrangement Detection', 'timeFrame': '3 years', 'description': 'Percent overall agreement between Vysis ALK-FISH and Ventana ALK IHC tests and its 95% CI is reported in this outcome measure.'}]}, 'conditionsModule': {'keywords': ['prevalence of ALK rearrangement, NSCLC, MENA'], 'conditions': ['Non-small Cell Lung Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A8081046&StudyName=Retrospective%20Epidemiology%20Study%20Of%20Eml4-alk%20Rearrangement%20In%20Non-small%20Cell%20Lung%20Cancer%20Patients%20In%20The%20Middle%20East%20%26%20North%20Africa', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'Thet study aims to estimate the prevalence of ALK rearrangement in the Middle East North Africa population by using the Ventana ALK-IHC method for ALK protein detection in retrospective NSCLC clinical samples, \\& to evaluate the association of ALK rearrangement with clinical and pathological parameters of NSCLC patients in MENA.', 'detailedDescription': "This is a retrospective, cross-sectional non-interventional epidemiology study to investigate the prevalence of ALK rearrangement in NSCLC patients in Middle East \\& North Africa. Approximately 700 retained tumor tissue specimens (tissue block) of patients previously diagnosed with NSCLC will be selected \\& subjected to ALK immune-staining using Ventana anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody combined with OptiView Benchmark System in 6-8 centers in 5-7 countries in the MENA region.\n\nThe tissue samples of NSCLC cases will be retrieved from tissue banks of the molecular diagnostic units \\& pathology departments in these study centers. The histological diagnosis will be confirmed by the pathologists. The retained samples will then be tested by performing the Ventana ALK-IHC to assess the absence or presence of the ALK rearrangement by the detection of the ALK protein in formalin-fixed, paraffin-embedded NSCLC stored tissue samples using Ventana anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody (Roche Diagnostics GmbH) in the selected study centers. The results of ALK testing within this study population will then be used to establish the prevalence of ALK rearrangement in MENA NSCLC patients.\n\nThe patients' characteristics, demographic, clinical and pathologic parameters will be obtained from their medical records \\& analyzed to determine any association with the presence of the EML4-ALK fusion gene in MENA NSCLC patients.\n\nThe assessment of concordance of the results between FISH \\& IHC will be done in 2-3 centers. Results of FISH testing will be collected \\& recorded, if the retained tissue samples had been previously tested. If not, the Vysis FISH test will be performed, to assess the concordance between the results obtained using Vysis Break-apart FISH \\& Ventana IHC testing methods for ALK rearrangement detection."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Since this is a retrospective epidemiology study, no patients will be enrolled. Tissue samples of non-squamous NSCLC cases less than 5 years old from each of the centers will be selected.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n\\- 1. Histological confirmation of nonsquamous NSCLC, with any TNM stage. 2. Available and sufficient tissue sample for ALK testing 3.Tissue samples are less than 5 years old 4.Routinely processed formalin-fixed, paraffin-embedded tissue samples only (see exclusion criteria pertaining to tissue samples).\n\n5.Histological sections mounted on glass slides must not be older than 3 months 6.Age \\> 18 years 7.Any ECOG Performance status 8.Still alive, or death confirmed before inclusion, or is unknown 9.Disease diagnosis and/or treatment in one of the centers, in the last 5 years, assigned to participate in the study; 10.Written informed consent for general investigational testing was previously obtained, or specifically obtained for this retrospective epidemiology study, or having a documented waiver for the Informed consent document use, as required by local regulatory authorities, \\&/or Research Ethics committee/Institutional Review Board.\n\nExclusion Criteria:\n\n* 1- Tumor tissue samples older than 5 year period or samples not properly stored.\n\n 2-Tumor tissue samples fixed by using AFA, B5, Bouin's, 95% ETOH, \\& alcohol fixatives.\n\n 3-Under-fixed tissue samples (i.e. \\< 6 hrs) 4-Tumor tissue samples that have been subject to any decalcification processes. 5-Recycled paraffin-embedded tissue samples. 6-Cut slides stored longer than 3 months. 7-Insufficient tissue samples with less tumor cells \\& high amount of necrosis."}, 'identificationModule': {'nctId': 'NCT02304406', 'acronym': 'ALK NSCLC MENA', 'briefTitle': 'Retrospective Epidemiology Study Of ALK Rearrangement In Non-Small Cell Lung Cancer Patients In The Middle East & North Africa', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'RETROSPECTIVE EPIDEMIOLOGY STUDY OF ALK REARRANGEMENT IN NON-SMALL CELL LUNG CANCER PATIENTS IN THE MIDDLE EAST & NORTH AFRICA.', 'orgStudyIdInfo': {'id': 'A8081046'}}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'National Cancer Institute', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo / Misr Al Qadimah', 'country': 'Egypt', 'facility': 'National Cancer Institute'}, {'city': 'Beirut', 'country': 'Lebanon', 'facility': 'American University in Beirut', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}, {'city': 'Beirut', 'country': 'Lebanon', 'facility': 'American University of Beirut', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}, {'city': 'Rabat', 'country': 'Morocco', 'facility': "Institut National d'Oncologie", 'geoPoint': {'lat': 34.01325, 'lon': -6.83255}}, {'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'King Abdulaziz Medical City - National Guard Hospital', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}, {'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'King Faisal Specialty Hospital, Riyadh/Oncology Department', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}, {'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'King Faisal Specialty Hospital', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}, {'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'National Guard Hospital', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}, {'city': 'Al Ain City', 'country': 'United Arab Emirates', 'facility': 'Tawam Hospital', 'geoPoint': {'lat': 24.19167, 'lon': 55.76056}}, {'city': 'Al Ain/Al Maqam', 'country': 'United Arab Emirates', 'facility': 'Tawam Hospital'}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}