Ignite Creation Date:
2025-12-24 @ 5:07 PM
Ignite Modification Date:
2026-04-14 @ 12:00 PM
Study NCT ID:
NCT02270450
Status:
COMPLETED
Last Update Posted:
2023-03-30
First Post:
2014-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
S1316, Surgery or Non-Surgical Management in Treating Patients With Intra-Abdominal Cancer and Bowel Obstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003248', 'term': 'Constipation'}, {'id': 'D007415', 'term': 'Intestinal Obstruction'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'karnold@fredhutch.org', 'phone': '2066674623', 'title': 'Palliative and End of Life Care Committee Statistician', 'organization': 'SWOG Statistics and Data Management Center'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From date of registration until death or 53 weeks post registration', 'description': 'CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.', 'eventGroups': [{'id': 'EG000', 'title': 'Randomization Surgery', 'description': 'Patients who are randomized to surgical management undergo therapeutic conventional surgery (abdominal) as defined by the treating physician.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 5, 'seriousNumAtRisk': 24, 'deathsNumAffected': 19, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Randomization Non-surgical Management', 'description': 'Patients on the randomized to non-surgical management are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 1, 'seriousNumAtRisk': 25, 'deathsNumAffected': 20, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Patient Choice Surgery', 'description': 'Patients who choose surgical management undergo conventional surgery (abdominal) as defined by the treating physician as in Arm 1.', 'otherNumAtRisk': 58, 'deathsNumAtRisk': 58, 'otherNumAffected': 12, 'seriousNumAtRisk': 58, 'deathsNumAffected': 37, 'seriousNumAffected': 5}, {'id': 'EG003', 'title': 'Patient Choice Non-surgical Management', 'description': 'Patients who choose non-surgical management are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician as in Arm 2.', 'otherNumAtRisk': 92, 'deathsNumAtRisk': 92, 'otherNumAffected': 14, 'seriousNumAtRisk': 92, 'deathsNumAffected': 68, 'seriousNumAffected': 16}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neoplasms benign, malignant and unspecified - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 10}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal and urinary disorders-Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Days Alive and Outside of the Hospital', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '92', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomization Surgery', 'description': 'Patients who are randomized to surgical management undergo therapeutic conventional surgery (abdominal) as defined by the treating physician.'}, {'id': 'OG001', 'title': 'Randomization Non-surgical Management', 'description': 'Patients who are randomized to non-surgical management are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician.'}, {'id': 'OG002', 'title': 'Patient Choice Surgery', 'description': 'Patients who choose surgical management undergo conventional surgery (abdominal) as defined by the treating physician as in Arm 1.'}, {'id': 'OG003', 'title': 'Patient Choice Non-surgical Management', 'description': 'Patients who choose non-surgical management are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician as in Arm 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '42.6', 'spread': '32.2', 'groupId': 'OG000'}, {'value': '43.9', 'spread': '29.5', 'groupId': 'OG001'}, {'value': '54.8', 'spread': '27.0', 'groupId': 'OG002'}, {'value': '52.7', 'spread': '30.7', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.50', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '2.87', 'pValueComment': 'A p-value less than 0.05 is considered statistically significant.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.3', 'estimateComment': 'Comparing surgery to non-surgical management.', 'groupDescription': 'A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the number of "good days" between patients assigned to surgery and patients assigned to non-surgical management.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.'}], 'paramType': 'MEAN', 'timeFrame': 'From date of registration up to 91 days', 'description': 'Number of days alive and outside of the hospital', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible and evaluable participants'}, {'type': 'SECONDARY', 'title': 'Number of Days in Hospital', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '92', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomization Surgery', 'description': 'Patients who are randomized to surgical management undergo therapeutic conventional surgery (abdominal) as defined by the treating physician.'}, {'id': 'OG001', 'title': 'Randomization Non-surgical Management', 'description': 'Patients who are randomized to non-surgical management are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician.'}, {'id': 'OG002', 'title': 'Patient Choice Surgery', 'description': 'Patients who choose surgical management undergo conventional surgery (abdominal) as defined by the treating physician as in Arm 1.'}, {'id': 'OG003', 'title': 'Patient Choice Non-surgical Management', 'description': 'Patients who choose non-surgical management are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician as in Arm 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.3', 'spread': '9.3', 'groupId': 'OG000'}, {'value': '12.8', 'spread': '12.2', 'groupId': 'OG001'}, {'value': '11.6', 'spread': '7.8', 'groupId': 'OG002'}, {'value': '6.2', 'spread': '6.6', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.64', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.09', 'pValueComment': 'For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.', 'estimateComment': 'Comparing surgery to non-surgical management.', 'groupDescription': 'A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the length of the initial hospital stay between patients assigned to surgery and patients and patients assigned to non-surgical management. An interaction term between treatment and pathway was included.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.'}], 'paramType': 'MEAN', 'timeFrame': 'During initial hospitalization, from date of registration to a maximum of 53 weeks post registration', 'description': 'Length of initial hospital stay in days.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible and evaluable participants'}, {'type': 'SECONDARY', 'title': 'NG Tube Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '92', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomization Surgery', 'description': 'Patients who are randomized to surgical management undergo therapeutic conventional surgery (abdominal) as defined by the treating physician.'}, {'id': 'OG001', 'title': 'Randomization Non-surgical Management', 'description': 'Patients who are randomized to non-surgical management are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician.'}, {'id': 'OG002', 'title': 'Patient Choice Surgery', 'description': 'Patients who choose surgical management undergo conventional surgery (abdominal) as defined by the treating physician as in Arm 1.'}, {'id': 'OG003', 'title': 'Patient Choice Non-surgical Management', 'description': 'Patients who choose non-surgical management are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician as in Arm 2.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.60', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.82', 'pValueComment': 'For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.', 'estimateComment': 'Comparing surgery to non-surgical management.', 'groupDescription': 'A parallel logistic regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares NG tube use vs no NG tube use between patients assigned to surgery and patients assigned to non-surgical management.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During initial hospitalization, from date of registration to a maximum of 53 weeks post registration', 'description': 'Use of a nasogastric tube', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible and evaluable participants'}, {'type': 'SECONDARY', 'title': 'Days of NG Tube Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '90', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomization Surgery', 'description': 'Patients who are randomized to surgical management undergo therapeutic conventional surgery (abdominal) as defined by the treating physician.'}, {'id': 'OG001', 'title': 'Randomization Non-surgical Management', 'description': 'Patients who are randomized to non-surgical management are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician.'}, {'id': 'OG002', 'title': 'Patient Choice Surgery', 'description': 'Patients who choose surgical management undergo conventional surgery (abdominal) as defined by the treating physician as in Arm 1.'}, {'id': 'OG003', 'title': 'Patient Choice Non-surgical Management', 'description': 'Patients who choose non-surgical management are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician as in Arm 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '7.7', 'spread': '8.4', 'groupId': 'OG001'}, {'value': '6.5', 'spread': '5.6', 'groupId': 'OG002'}, {'value': '5.1', 'spread': '5.3', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.47', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.64', 'pValueComment': 'For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.', 'estimateComment': 'Comparing surgery to non-surgical management.', 'groupDescription': 'A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the number of days of NG tube use between patients assigned to surgery and patients and patients assigned to non-surgical management.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.'}], 'paramType': 'MEAN', 'timeFrame': 'During entire initial hospitalization (admission to discharge) to a maximum of 53 weeks post registration', 'description': "Number of days a nasogastric tube was used during the patient's initial hospitalization", 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible and evaluable participants. Number of participants analyzed in the Patient Choice Surgery arm and Patient Choice Non-surgical Management arm differs from the overall number of eligible and evaluable participants due to missing data.'}, {'type': 'SECONDARY', 'title': 'MDASI-GI Symptom Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomization Surgery', 'description': 'Patients who are randomized to surgical management undergo therapeutic conventional surgery (abdominal) as defined by the treating physician.'}, {'id': 'OG001', 'title': 'Randomization Non-surgical Management', 'description': 'Patients who are randomized to non-surgical management are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician.'}, {'id': 'OG002', 'title': 'Patient Choice Surgery', 'description': 'Patients who choose surgical management undergo conventional surgery (abdominal) as defined by the treating physician as in Arm 1.'}, {'id': 'OG003', 'title': 'Patient Choice Non-surgical Management', 'description': 'Patients who choose non-surgical management are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician as in Arm 2.'}], 'classes': [{'title': 'Nausea Severity', 'categories': [{'measurements': [{'value': '0.64', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '3.8', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '3.1', 'groupId': 'OG002'}, {'value': '2.3', 'spread': '3.0', 'groupId': 'OG003'}]}]}, {'title': 'Vomiting Severity', 'categories': [{'measurements': [{'value': '0.64', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '3.5', 'groupId': 'OG001'}, {'value': '0.58', 'spread': '1.5', 'groupId': 'OG002'}, {'value': '1.9', 'spread': '3.0', 'groupId': 'OG003'}]}]}, {'title': 'Bloating Severity', 'categories': [{'measurements': [{'value': '1.5', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '3.2', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '2.4', 'groupId': 'OG002'}, {'value': '2.3', 'spread': '2.9', 'groupId': 'OG003'}]}]}, {'title': 'Pain Severity', 'categories': [{'measurements': [{'value': '2.9', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '3.6', 'groupId': 'OG001'}, {'value': '4.1', 'spread': '3.3', 'groupId': 'OG002'}, {'value': '3.8', 'spread': '3.6', 'groupId': 'OG003'}]}]}, {'title': 'Constipation Severity', 'categories': [{'measurements': [{'value': '0.55', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '3.9', 'groupId': 'OG001'}, {'value': '0.77', 'spread': '2.2', 'groupId': 'OG002'}, {'value': '2.2', 'spread': '3.4', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-4.1', 'pValueComment': 'For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.', 'estimateComment': 'Comparing surgery to non-surgical management.', 'groupDescription': 'A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the MDASI-GI Symptom Assessment score for nausea severity between patients assigned to surgery and patients and patients assigned to non-surgical management. An interaction term between treatment and pathway was included.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.'}, {'pValue': '0.008', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.63', 'pValueComment': 'For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.', 'estimateComment': 'Comparing surgery to non-surgical management.', 'groupDescription': 'A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the MDASI-GI Symptom Assessment score for vomiting severity between patients assigned to surgery and patients and patients assigned to non-surgical management.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.'}, {'pValue': '0.04', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.31', 'pValueComment': 'For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.', 'estimateComment': 'Comparing surgery to non-surgical management.', 'groupDescription': 'A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the MDASI-GI Symptom Assessment score for bloating severity between patients assigned to surgery and patients and patients assigned to non-surgical management.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.'}, {'pValue': '0.01', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-3.6', 'pValueComment': 'For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.', 'estimateComment': 'Comparing surgery to non-surgical management.', 'groupDescription': 'A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the MDASI-GI Symptom Assessment score for pain severity between patients assigned to surgery and patients and patients assigned to non-surgical management. An interaction term between treatment and pathway was included.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.'}, {'pValue': '0.007', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.90', 'pValueComment': 'For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.', 'estimateComment': 'Comparing surgery to non-surgical management.', 'groupDescription': 'A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the MDASI-GI Symptom Assessment score for constipation severity between patients assigned to surgery and patients and patients assigned to non-surgical management.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.'}], 'paramType': 'MEAN', 'timeFrame': 'Assessed at 4 weeks post registration', 'description': 'The MD Anderson Symptom Inventory for gastrointestinal cancer (MDASI-GI) was used to assess nausea, vomiting, pain, bloating, and constipation. The MDASI measures symptom severity on an 11-point scale, from 0 ("not present") to 10 ("as bad as you can imagine"). A difference of at least 1.2 points was considered a clinically meaningful difference between groups for MDASI-GI outcomes.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible and evaluable participants who were alive with data at the time of the assessment'}, {'type': 'SECONDARY', 'title': 'Ability to Eat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomization Surgery', 'description': 'Patients who are randomized to surgical management undergo therapeutic conventional surgery (abdominal) as defined by the treating physician.'}, {'id': 'OG001', 'title': 'Randomization Non-surgical Management', 'description': 'Patients who are randomized to non-surgical management are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician.'}, {'id': 'OG002', 'title': 'Patient Choice Surgery', 'description': 'Patients who choose surgical management undergo conventional surgery (abdominal) as defined by the treating physician as in Arm 1.'}, {'id': 'OG003', 'title': 'Patient Choice Non-surgical Management', 'description': 'Patients who choose non-surgical management are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician as in Arm 2.'}], 'classes': [{'title': 'Eating', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}]}, {'title': 'Not eating', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.52', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.64', 'pValueComment': 'For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.', 'estimateComment': 'Comparing surgery to non-surgical management.', 'groupDescription': 'A parallel logistic regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares ability to eat between patients assigned to surgery and patients and patients assigned to non-surgical management.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for treatment, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed at 5 weeks post registration', 'description': 'Ability to consume food was assessed based on self or caregiver-reported 24-hour dietary recalls. Dietary recalls were collected by trained assessors at the University of Arizona Cancer Center Behavioral Measurement and Interventions Shared Resource (BMISR) via telephone using standardized protocols and Nutrient Database for Research.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible and evaluable participants who were alive with data at the assessment time'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '92', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomization Surgery', 'description': 'Patients who are randomized to surgical management undergo therapeutic conventional surgery (abdominal) as defined by the treating physician.'}, {'id': 'OG001', 'title': 'Randomization Non-surgical Management', 'description': 'Patients who are randomized to non-surgical management are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician.'}, {'id': 'OG002', 'title': 'Patient Choice Surgery', 'description': 'Patients who choose surgical management undergo conventional surgery (abdominal) as defined by the treating physician as in Arm 1.'}, {'id': 'OG003', 'title': 'Patient Choice Non-surgical Management', 'description': 'Patients who choose non-surgical management are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician as in Arm 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000', 'lowerLimit': '51', 'upperLimit': '102'}, {'value': '80', 'groupId': 'OG001', 'lowerLimit': '39', 'upperLimit': '102'}, {'value': '156', 'groupId': 'OG002', 'lowerLimit': '71', 'upperLimit': '303'}, {'value': '96', 'groupId': 'OG003', 'lowerLimit': '71', 'upperLimit': '144'}]}]}], 'analyses': [{'pValue': '0.12', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.70', 'ciLowerLimit': '0.45', 'ciUpperLimit': '1.09', 'estimateComment': 'Comparing surgery to non-surgical management.', 'groupDescription': 'A Cox proportional hazards regression model stratified by pathway (randomized vs Patient Choice) was used to estimate the effect of treatment assignment (surgery vs non-surgical management) on overall survival.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.'}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of registration to maximum of 53 weeks', 'description': 'Time from date of registration to date of death due to any cause.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible and evaluable participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm I (Randomized to Surgery)', 'description': 'Patients undergo therapeutic conventional surgery (abdominal) as defined by the treating physician.\n\ntherapeutic conventional surgery: Undergo abdominal surgery\n\nquality-of-life assessment: Ancillary studies'}, {'id': 'FG001', 'title': 'Arm II (Randomized to Non-surgical Management)', 'description': 'Patients are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician.\n\ngastrointestinal complications management/prevention: Undergo non-surgical management\n\nquality-of-life assessment: Ancillary studies'}, {'id': 'FG002', 'title': 'Arm III (no Randomization, Surgery)', 'description': 'Patients undergo therapeutic conventional surgery (abdominal) as defined by the treating physician as in Arm I.\n\ntherapeutic conventional surgery: Undergo abdominal surgery\n\nquality-of-life assessment: Ancillary studies'}, {'id': 'FG003', 'title': 'Arm IV (no Randomization, Non-surgical Management)', 'description': 'Patients are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician as in Arm II.\n\ngastrointestinal complications management/prevention: Undergo non-surgical management\n\nquality-of-life assessment: Ancillary studies'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '58'}, {'groupId': 'FG003', 'numSubjects': '92'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '40'}, {'groupId': 'FG003', 'numSubjects': '82'}]}], 'dropWithdraws': [{'type': 'Refusal unrelated to adverse event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '14'}]}, {'type': 'Progression/relapse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '31'}, {'groupId': 'FG003', 'numSubjects': '59'}]}]}], 'preAssignmentDetails': '221 patients were initially enrolled. 19 were ineligible: 12 with no small bowel obstruction, 3 with no confirmed bowel obstruction, 3 who were treated prior to registration and 1 with no intra-abdominal cancer. Another 3 patients were ineligible for analysis, due to withdrawal of consent prior to the end of their first hospitalization. In all, 199 patients were treated and evaluable for analysis: 49 randomized (24 surgery; 25 non-surgery) and 150 non-randomized (58 surgery; 92 non-surgery).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm I (Randomized to Surgery)', 'description': 'Patients undergo therapeutic conventional surgery (abdominal) as defined by the treating physician.\n\ntherapeutic conventional surgery: Undergo abdominal surgery\n\nquality-of-life assessment: Ancillary studies'}, {'id': 'BG001', 'title': 'Arm II (Randomized to Non-surgical Management)', 'description': 'Patients are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician.\n\ngastrointestinal complications management/prevention: Undergo non-surgical management\n\nquality-of-life assessment: Ancillary studies'}, {'id': 'BG002', 'title': 'Arm III (no Randomization, Surgery)', 'description': 'Patients undergo therapeutic conventional surgery (abdominal) as defined by the treating physician as in Arm I.\n\ntherapeutic conventional surgery: Undergo abdominal surgery\n\nquality-of-life assessment: Ancillary studies'}, {'id': 'BG003', 'title': 'Arm IV (no Randomization, Non-surgical Management)', 'description': 'Patients are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician as in Arm II.\n\ngastrointestinal complications management/prevention: Undergo non-surgical management\n\nquality-of-life assessment: Ancillary studies'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '63.4', 'groupId': 'BG000', 'lowerLimit': '43.2', 'upperLimit': '84.7'}, {'value': '61.2', 'groupId': 'BG001', 'lowerLimit': '45.7', 'upperLimit': '82.3'}, {'value': '61.1', 'groupId': 'BG002', 'lowerLimit': '23.0', 'upperLimit': '90.8'}, {'value': '59.3', 'groupId': 'BG003', 'lowerLimit': '32.7', 'upperLimit': '85.6'}, {'value': '60.4', 'groupId': 'BG004', 'lowerLimit': '23.0', 'upperLimit': '90.8'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Customized', 'classes': [{'title': '< 65 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}, {'value': '131', 'groupId': 'BG004'}]}]}, {'title': '>= 65 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}, {'value': '129', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '70', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race - Black', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '186', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '42', 'groupId': 'BG004'}]}]}, {'title': 'Race - White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '186', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '69', 'groupId': 'BG003'}, {'value': '129', 'groupId': 'BG004'}]}]}, {'title': 'Race - Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '186', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}]}, {'title': 'Race - Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '186', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}]}, {'title': 'Ethnicity - Hispanic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}]}]}, {'title': 'Ethnicity - Non-Hispanic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '78', 'groupId': 'BG003'}, {'value': '161', 'groupId': 'BG004'}]}]}, {'title': 'Ethnicity - Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Race and ethnicity are categorized separately.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race was not applicable for participants from Mexico and Peru.'}, {'title': 'Primary Cancer Site', 'classes': [{'title': 'Colorectal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '57', 'groupId': 'BG004'}]}]}, {'title': 'Gynecologic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}, {'value': '74', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI), Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '23.8', 'groupId': 'BG000', 'lowerLimit': '15.6', 'upperLimit': '39.6'}, {'value': '25.7', 'groupId': 'BG001', 'lowerLimit': '16.4', 'upperLimit': '37.9'}, {'value': '24.4', 'groupId': 'BG002', 'lowerLimit': '14.0', 'upperLimit': '51.1'}, {'value': '24.7', 'groupId': 'BG003', 'lowerLimit': '16.0', 'upperLimit': '50.4'}, {'value': '24.6', 'groupId': 'BG004', 'lowerLimit': '14.0', 'upperLimit': '51.1'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'FULL_RANGE'}, {'title': 'Body Mass Index (BMI), Categorical', 'classes': [{'title': '<18.5 (Underweight)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}]}]}, {'title': '18.5 - <25 (Normal)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '91', 'groupId': 'BG004'}]}]}, {'title': '25 - <30 (Overweight)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '45', 'groupId': 'BG004'}]}]}, {'title': '>=30 (Obese)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '45', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Albumin, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '91', 'groupId': 'BG003'}, {'value': '198', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '3.1', 'spread': '0.9', 'groupId': 'BG000'}, {'value': '3.1', 'spread': '0.7', 'groupId': 'BG001'}, {'value': '3.2', 'spread': '0.7', 'groupId': 'BG002'}, {'value': '3.2', 'spread': '0.7', 'groupId': 'BG003'}, {'value': '3.2', 'spread': '0.7', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'g/dL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Number of participants analyzed differs from overall number of baseline participants due to missing data.'}, {'title': 'Albumin, Child-Pugh', 'classes': [{'title': '<2.8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '57', 'groupId': 'BG004'}]}]}, {'title': '2.8 - 3.5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '75', 'groupId': 'BG004'}]}]}, {'title': '>3.5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '66', 'groupId': 'BG004'}]}]}, {'title': 'Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ascites', 'classes': [{'title': 'No evidence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}, {'value': '89', 'groupId': 'BG004'}]}]}, {'title': 'Evidence of ascites: trace/small amount', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '71', 'groupId': 'BG004'}]}]}, {'title': 'Evidence of ascites: large/massive amount', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '39', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Carcinomatosis', 'classes': [{'title': 'No evidence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '67', 'groupId': 'BG004'}]}]}, {'title': 'Suspicion of carcinomatosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}]}]}, {'title': 'Clear evidence: trace/small amount', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}]}, {'title': 'Clear evidence: large/massive amount', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '107', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Performance Status', 'classes': [{'title': '0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}]}]}, {'title': '1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}, {'value': '94', 'groupId': 'BG004'}]}]}, {'title': '2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants were graded according to the Zubrod Performance Status Scale:\n\n0 - Fully active, able to carry on all pre-disease performance without restriction.1 - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work. 2 - Ambulatory and capable of self-care but unable to carry out any work activities; up and about more than 50% of waking hours.', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Prior Malignant Bowel Obstructions (MBOs)', 'classes': [{'title': 'None', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '116', 'groupId': 'BG004'}]}]}, {'title': 'At least one', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '61', 'groupId': 'BG004'}]}]}, {'title': 'Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}]}, {'title': 'Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Care Providers', 'classes': [{'title': 'Family member', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '77', 'groupId': 'BG003'}, {'value': '171', 'groupId': 'BG004'}]}]}, {'title': 'Hospice/Skilled nursing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}]}, {'title': 'No one', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants may have had more than one care provider.', 'unitOfMeasure': 'Participants'}, {'title': 'Admitting Attending Physician Specialty', 'classes': [{'title': 'Medical Specialty', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}]}, {'title': 'General Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}]}]}, {'title': 'Gynecologic Oncology', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '42', 'groupId': 'BG004'}]}]}, {'title': 'Surgical Oncology', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '124', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': '"Medical Specialty" includes Family practice, Internal medicine, and Medical oncology.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Eligible and evaluable participants'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-06-18', 'size': 1817606, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2022-07-21T14:14', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 221}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2021-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-28', 'studyFirstSubmitDate': '2014-10-10', 'resultsFirstSubmitDate': '2022-07-21', 'studyFirstSubmitQcDate': '2014-10-17', 'lastUpdatePostDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-11-09', 'studyFirstPostDateStruct': {'date': '2014-10-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Days Alive and Outside of the Hospital', 'timeFrame': 'From date of registration up to 91 days', 'description': 'Number of days alive and outside of the hospital'}], 'secondaryOutcomes': [{'measure': 'Number of Days in Hospital', 'timeFrame': 'During initial hospitalization, from date of registration to a maximum of 53 weeks post registration', 'description': 'Length of initial hospital stay in days.'}, {'measure': 'NG Tube Use', 'timeFrame': 'During initial hospitalization, from date of registration to a maximum of 53 weeks post registration', 'description': 'Use of a nasogastric tube'}, {'measure': 'Days of NG Tube Use', 'timeFrame': 'During entire initial hospitalization (admission to discharge) to a maximum of 53 weeks post registration', 'description': "Number of days a nasogastric tube was used during the patient's initial hospitalization"}, {'measure': 'MDASI-GI Symptom Assessment', 'timeFrame': 'Assessed at 4 weeks post registration', 'description': 'The MD Anderson Symptom Inventory for gastrointestinal cancer (MDASI-GI) was used to assess nausea, vomiting, pain, bloating, and constipation. The MDASI measures symptom severity on an 11-point scale, from 0 ("not present") to 10 ("as bad as you can imagine"). A difference of at least 1.2 points was considered a clinically meaningful difference between groups for MDASI-GI outcomes.'}, {'measure': 'Ability to Eat', 'timeFrame': 'Assessed at 5 weeks post registration', 'description': 'Ability to consume food was assessed based on self or caregiver-reported 24-hour dietary recalls. Dietary recalls were collected by trained assessors at the University of Arizona Cancer Center Behavioral Measurement and Interventions Shared Resource (BMISR) via telephone using standardized protocols and Nutrient Database for Research.'}, {'measure': 'Overall Survival', 'timeFrame': 'From date of registration to maximum of 53 weeks', 'description': 'Time from date of registration to date of death due to any cause.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Constipation, Impaction, and Bowel Obstruction', 'Unspecified Adult Solid Tumor, Protocol Specific']}, 'referencesModule': {'references': [{'pmid': '37541263', 'type': 'DERIVED', 'citation': "Krouse RS, Anderson GL, Arnold KB, Thomson CA, Nfonsam VN, Al-Kasspooles MF, Walker JL, Sun V, Alvarez Secord A, Han ES, Leon-Takahashi AM, Isla-Ortiz D, Rodgers P, Hendren S, Sanchez Salcedo M, Laryea JA, Graybill WS, Flaherty DC, Mogal H, Miner TJ, Pimiento JM, Kitano M, Badgwell B, Whalen G, Lamont JP, Guevara OA, Senthil MS, Dewdney SB, Silberfein E, Wright JD, Friday B, Fahy B, Anantha Sathyanarayana S, O'Rourke M, Bakitas M, Sloan J, Grant M, Deutsch GB, Deneve JL. Surgical versus non-surgical management for patients with malignant bowel obstruction (S1316): a pragmatic comparative effectiveness trial. Lancet Gastroenterol Hepatol. 2023 Oct;8(10):908-918. doi: 10.1016/S2468-1253(23)00191-7. Epub 2023 Aug 1."}]}, 'descriptionModule': {'briefSummary': 'This partially randomized clinical trial studies surgery or non-surgical management in treating patients with intra-abdominal cancer and bowel obstruction. Bowel obstruction is a common problem for advanced cancer patients and can negatively affect quality of life. It is not yet known whether surgery or non-surgical management is the best treatment option for bowel obstruction and can lead to better quality of life.', 'detailedDescription': 'This partially randomized clinical trial studies surgery or non-surgical management in treating patients with intra-abdominal cancer and bowel obstruction. Bowel obstruction is a common problem for advanced cancer patients and can negatively affect quality of life. It is not yet known whether surgery or non-surgical management is the best treatment option for bowel obstruction and can lead to better quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Patient must have malignant bowel obstruction (MBO) as evidenced by all of the following:\n\n * Clinical evidence of a bowel obstruction (via history, physical, and radiographic examination)\n * Bowel obstruction below (distal to) ligament of Treitz\n * Intra-abdominal primary cancer with incurable disease\n* Patients must have malignant bowel obstruction due to an intra-abdominal primary cancer (i.e. stomach, small bowel \\[including duodenum\\], pancreas, colon, rectum, appendiceal, ovarian, uterine, cervical, kidney, bladder, prostate, gastrointestinal stromal tumor \\[GIST\\] \\[all sites\\], and sarcoma)\n* Patient must be able to tolerate a major surgical procedure based on clinical evaluation, status of their cancer, and any other underlying medical problems\n* A member of the patient\'s surgical team must indicate equipoise for the benefit of the surgical treatment for MBO; the surgeon must respond "Yes" to each of the following questions and sign the S1316 Surgical Equipoise Documentation form for the patient to be eligible:\n\n * Is surgery for treatment of malignant bowel obstruction (MBO) being considered for this patient?\n * Do you have equipoise (If the treating team finds that an operation is required \\[e.g., for acute abdomen\\], or they would not offer the patient an operation \\[e.g., patient is too weak to tolerate surgery\\], then there is no equipoise)?\n* Patients must not have signs of bowel perforation or "acute" abdomen as evidenced by free air on radiologic imaging or peritonitis on physical exam within 2 days prior to registration\n* Patients must be registered to the study within 3 days after surgical consult for MBO and prior to any treatment (surgical or non-surgical) for MBO\n* Patients must have Zubrod performance status of 0-2 within 7 days prior to registration\n* Serum albumin must be planned to be collected after admission, but prior to treatment\n* Patients must be able to complete the study questionnaires in English\n* Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines\n* As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution\'s identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\n* Patients must consent and provide both their contact information and that of their representative for a monthly 24-hour dietary recall phone call to be conducted by the Arizona Diet, Behavior and Quality of Life Assessment Lab'}, 'identificationModule': {'nctId': 'NCT02270450', 'briefTitle': 'S1316, Surgery or Non-Surgical Management in Treating Patients With Intra-Abdominal Cancer and Bowel Obstruction', 'organization': {'class': 'NETWORK', 'fullName': 'SWOG Cancer Research Network'}, 'officialTitle': 'S1316, Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction', 'orgStudyIdInfo': {'id': 'S1316'}, 'secondaryIdInfos': [{'id': 'U10CA037429', 'link': 'https://reporter.nih.gov/quickSearch/U10CA037429', 'type': 'NIH'}, {'id': '1R01HS021491-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01HS021491-01A1', 'type': 'AHRQ'}, {'id': 'S1316', 'type': 'OTHER', 'domain': 'SWOG'}, {'id': 'NCI-2014-01497', 'type': 'OTHER', 'domain': 'NCI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I (randomized to surgery)', 'description': 'Patients undergo therapeutic conventional surgery (abdominal) as defined by the treating physician.', 'interventionNames': ['Procedure: therapeutic conventional surgery', 'Other: quality-of-life assessment']}, {'type': 'EXPERIMENTAL', 'label': 'Arm II (randomized to non-surgical management)', 'description': 'Patients are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician.', 'interventionNames': ['Procedure: gastrointestinal complications management/prevention', 'Other: quality-of-life assessment']}, {'type': 'EXPERIMENTAL', 'label': 'Arm III (no randomization, surgery)', 'description': 'Patients undergo therapeutic conventional surgery (abdominal) as defined by the treating physician as in Arm I.', 'interventionNames': ['Procedure: therapeutic conventional surgery', 'Other: quality-of-life assessment']}, {'type': 'EXPERIMENTAL', 'label': 'Arm IV (no randomization, non-surgical management)', 'description': 'Patients are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician as in Arm II.', 'interventionNames': ['Procedure: gastrointestinal complications management/prevention', 'Other: quality-of-life assessment']}], 'interventions': [{'name': 'therapeutic conventional surgery', 'type': 'PROCEDURE', 'description': 'Undergo abdominal surgery', 'armGroupLabels': ['Arm I (randomized to surgery)', 'Arm III (no randomization, surgery)']}, {'name': 'gastrointestinal complications management/prevention', 'type': 'PROCEDURE', 'otherNames': ['complications management/prevention, gastrointestinal, management/prevention, gastrointestinal complications'], 'description': 'Undergo non-surgical management', 'armGroupLabels': ['Arm II (randomized to non-surgical management)', 'Arm IV (no randomization, non-surgical management)']}, {'name': 'quality-of-life assessment', 'type': 'OTHER', 'otherNames': ['quality of life assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (randomized to surgery)', 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