Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-28 @ 4:41 PM
Study NCT ID:
NCT01149369
Status:
COMPLETED
Last Update Posted:
2019-05-08
First Post:
2010-06-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Aprepitant for the Relief of Nausea in Patients With Chronic Nausea and Vomiting of Presumed Gastric Origin Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018589', 'term': 'Gastroparesis'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D014839', 'term': 'Vomiting'}], 'ancestors': [{'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077608', 'term': 'Aprepitant'}], 'ancestors': [{'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kyates1@jhu.edu', 'phone': '443-287-0082', 'title': 'Katherine Yates', 'organization': 'Johns Hopkins Data Coordinating Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '4 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 21, 'seriousNumAtRisk': 63, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 11, 'seriousNumAtRisk': 63, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea, vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Flashing lights/floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Gastrointestinal - Other (abdominal pain)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nausea, abdominal pain, diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Diarrhea, syncope', 'notes': 'Reaction to different medication; not study-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Musculoskeletal - Other (neck and right hand pain)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Diarrhea, loss of appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Gastrointestinal - Other (fainting sensation)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Renal/Genitourinary - Other (Bleeding)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fibromyalgia cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Gastrointestinal - Other (Nausea, malaise)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Musculoskeletal - Other (Limb pain)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nosebleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Asthmatic crisis', 'notes': 'High blood pressure, shortness of breath, dizziness, palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Depression', 'notes': 'Withdrawal from depression medication caused dizziness, vertigo, and light sensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neurology - other', 'notes': 'Migraines, pain, stiffness, chest pain, heart palpitations, lower left quad pain, chills, fever, burping', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'seriousEvents': [{'term': 'Hypoglycemia', 'notes': 'The patient was determined to be diabetic and had delayed retention. Hospitalization due to nausea and vomiting.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Improvement in Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.43', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.2', 'ciLowerLimit': '0.8', 'ciUpperLimit': '1.7', 'groupDescription': 'Either 1) improvement in mean of available nausea VAS scores over 28-day treatment period compared to means of VAS during the 7-day baseline (BL) period being ≤ -25 mm, or 2) mean VAS after 28-days of treatment was \\< 25 mm.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Stratified by clinic', 'nonInferiorityComment': 'P-values, relative risk ratios, and 95% confidence limits (CI) for the primary ITT were calculated using the Cochran-Mantel-Haenszel chi-square test, stratified by clinic.'}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': 'The primary outcome measure is a binary (0,1) variable indicating improvement in nausea or not in the mean of available visual analog scale (VAS) scores over the 28 day treatment period compared to the mean of VAS scores during the 7 day baseline period. The criteria for improvement are either a 25 mm or more reduction in mean VAS or attaining a mean VAS during the treatment period of \\< 25 mm.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea (Hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.5', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '4.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.5', 'ciLowerLimit': '-2.8', 'ciUpperLimit': '-0.1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "Measure Description: Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea is the participant's assessment of the number of hours of nausea experienced in the past 24 hours. The range is 0 to 24 hours. The outcome measure, change from baseline in number of hours of nausea, has a possible range from -24 to +24, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.", 'unitOfMeasure': 'hours of nausea', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting (No. Episodes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.5', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '1.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.94', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting is the participant's assessment of the number of episodes of vomiting experienced in the past 24 hours. The outcome is the change from baseleine in number of times vomited, where negative numbers indicate improvement in vomiting frequency, and positive numbers indicate worsening in vomiting frequency.", 'unitOfMeasure': 'number of episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Retching (No. Episodes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.5', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '2.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.73', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Retching is the participant's assessment of the number of episodes of retching (heaving as if to vomit, but nothing comes up) experienced in the past 24 hours. The outcome is the change from baseline in the number of retching episodes, where negative numbers indicate improvement in retching frequency, and positive numbers indicate worsening in retching frequency.", 'unitOfMeasure': 'number of episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): GCSI Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.22', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "The Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): GCSI total score is the average of 3 subscores: Nausea (average of two items: nausea and vomiting), Early Satiety (average of two items: not able to finish normal size meal and feeling excessively full after meals), and Bloating (feeling like you need to loosen your clothes). Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in GCSI total score, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.06', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '0.0', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea severity is the participant's assessment of nausea (feeling sick to your stomach as if you were going to vomit or throw up) during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in GCSI score, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.24', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting Severity is the participant's assessment of vomiting during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Vomiting Severity, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Upper Abdominal Pain Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '-0.1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Upper Abdominal Pain Severity is the participant's assessment of upper abdominal pain (above the navel) during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Upper Abdominal Pain Severity, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Excessive Fullness Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.22', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Excessive Fullness Severity is the participant's assessment of excessive fullness (feeling excessively full after meals) during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Excessive Fullness Severity, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Early Satiety Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.51', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '0.1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Early Satiety Severity is the participant's assessment of early satiety (not able to finish normal-size meal) during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Early Satiety Severity, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Bloating Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.6', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.12', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Bloating Severity is the participant's assessment of bloating (feeling like you need to loosen your clothes) during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Bloating Severity, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Overall Symptom Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '-0.1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Overall Symptom Severity is the participant's assessment of overall severity of gastroparesis symptoms during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome, change from baseline in Overall Symptom Severity score, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Clinical Global Patient Impression Score (Patient-rated)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.17', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '0.7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "The Clinical Global Patient Impression Score quantifies the overall relief of the patient's symptom, by asking the participant to consider how they felt over the past week in regard to stomach symptoms and overall well-being, and rate relief of symptoms in comparison to how they felt before entering the study. Possible scores are: -3=very considerably worse, -2=considerably worse, -1=somewhat worse, 0=unchanged, 1=somewhat better, 2=considerably better, 3=completely better. The range of scores is -3 to 3, where higher scores are considered a better outcome. The outcome measure, change from baseline in Clinical Global Patient Impression Score, has a possible range of -6 to +6, with positive values indicating a better outcome (improvement) and negative values indicating a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Liver Enzymes and Proteins: Alanine Aminotransferase (ALT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'spread': '36.6', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '7.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.59', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.6', 'ciLowerLimit': '-7.0', 'ciUpperLimit': '12.2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Change from baseline in serum alanine aminotransferase (ALT), U/L', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Liver Enzymes and Proteins: Aspartate Aminotransferase (AST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'spread': '30.2', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '7.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.61', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.1', 'ciLowerLimit': '-5.9', 'ciUpperLimit': '10.0', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Change from baseline in aspartate aminotransferase (AST), U/L', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Liver Enzymes and Proteins: Total Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.23', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '0.2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Change from baseline in total protein (g/dL)', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Hemoglobin A1c (HbA1c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.97', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Change from baseline in hemoglobin A1c (HbA1c) (%)', 'unitOfMeasure': 'percent glycosylated hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '9.6', 'spread': '66.8', 'groupId': 'OG000'}, {'value': '7.0', 'spread': '44.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.77', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.1', 'ciLowerLimit': '-18.0', 'ciUpperLimit': '24.2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Change from baseline in glucose (mg/dL)', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Liver Enzymes and Proteins: Albumin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.46', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Change from baseline in albumin (g/dL)', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.44', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Change from baseline in hemoglobin (g/dL)', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Hematocrit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.4', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.77', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '0.9', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Change from baseline in hematocrit', 'unitOfMeasure': 'percentage RBCs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'White Blood Cell Count (WBC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.3', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '1.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.80', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '0.5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Change from baseline in white blood cell count (WBC)', 'unitOfMeasure': 'x10^9 cells/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Red Blood Cell Count (RBC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.88', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '0.1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Change from baseline in red blood cell count (RBC)', 'unitOfMeasure': 'x10^6 cells/microliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Platelet Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.3', 'spread': '47.1', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '38.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.17', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.9', 'ciLowerLimit': '-26.5', 'ciUpperLimit': '4.7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Change from baseline in platelet count', 'unitOfMeasure': 'x10^3 cells/microliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Carbon Dioxide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.4', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.07', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '0.0', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Change from baseline in carbon dioxide (mEg/L)', 'unitOfMeasure': 'mEq/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Chloride', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '2.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.53', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '1.3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Change from baseline in chloride (mEq/L)', 'unitOfMeasure': 'mEq/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Sodium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. 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(everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.3', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '2.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.93', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '1.0', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Change from baseline in sodium (mEq/L)', 'unitOfMeasure': 'mEq/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Potassium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. 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(everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.52', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '0.2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Change from baseline in potassium (mEq/L)', 'unitOfMeasure': 'mEq/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Calcium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. 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(everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.76', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '0.1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Change from baseline in calcium (mg/dL)', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Blood Urea Nitrogen (BUN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. 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(everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.9', 'spread': '4.6', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '3.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.45', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '0.9', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Change from baseline in blood urea nitrogen (BUN) (mg/dL)', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Magnesium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. 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(everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.18', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '0.0', 'ciUpperLimit': '0.1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Change from baseline in magnesium (mg/dL)', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. 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(everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.008', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '-0', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Change from baseline in creatinine (mg/dL)', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'PAGI-SYM Severity Index: Gastroparesis Cardinal Symptom Index (GCSI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.3', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '-0.3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "PAGI-SYM Severity index: Gastroparesis Cardinal Symptom Index (GCSI) score is the average of 3 subscores: Nausea (average of 3 items: nausea, retching, and vomiting), Fullness/Early Satiety (average of 4 items: stomach fullness, not able to finish normal size meal, feeling excessively full after meals, and loss of appetite), and Bloating (average if 2 items: bloating and stomach visibly larger). Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The outcome measure, change from baseline in GCSI score, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'PAGI-SYM Severity Index: Nausea/Vomiting Severity Subscore', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.7', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '1.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '-0.4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "The PAGI-SYM Severity index: Nausea/vomiting severity subscore is the average of 3 items: nausea, retching, and vomiting. Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Nausea/vomiting severity subscore, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'PAGI-SYM Severity Index: Fullness/Early Satiety Subscore', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.0', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.13', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '0.1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "The PAGI-SYM Severity index: Fullness/Early Satiety Subscore is the average of 4 items: stomach fullness, not able to finish normal size meal, felling excessively full after meals, and loss of appetite. Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Fullness/Early Satiety Subscore, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'PAGI-SYM Severity Index: Bloating Subscore', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.2', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '1.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '-0.2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "The PAGI-SYM Severity index: Bloating Subscore is the average of 2 items: bloating (feeling like you need to loosen your clothes) and stomach visibly larger. Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The outcome measure, change from baseline in Bloating Subscore, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'PAGI-SYM Severity Index: Upper Abdominal Pain Subscore', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.1', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '1.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.08', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '0.1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "The PAGI-SYM Severity index: Upper Abdominal Pain subscore is the average of 2 items (upper abdominal pain, upper abdominal discomfort). Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Upper Abdominal Pain Subscore, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'PAGI-SYM Severity Index: GERD Subscore', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.1', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '-0.1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "PAGI-SYM Severity index: Gastroesophageal Reflux (GERD) Subscore is the average of 7 items (heartburn during day, heartburn lying down, chest discomfort day, chest discomfort during sleep, regurgitation during day, regurgitation lying down, bitter taste in mouth). Each item is the participant's assessment of severity of the symptom, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in GERD Subscore, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'PAGI-SYM Severity Index: Nausea Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.8', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '-0.2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "The PAGI-SYM Severity index: Nausea severity is the participant's assessment of nausea (feeling sick to your stomach as if you were going to vomit or throw up) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Nausea Severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'PAGI-SYM Severity Index: Vomiting Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.6', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '-0.3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "The PAGI-SYM Severity index: Vomiting Severity is the participant's assessment of vomiting during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Vomiting Severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'PAGI-SYM Severity Index: Retching Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.7', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-2.3', 'ciUpperLimit': '-0.3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "The PAGI-SYM Severity index: Retching Severity is the participant's assessment of retching (heaving as if to vomit, but nothing comes up) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Retching Severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'PAGI-SYM Severity Index: Stomach Fullness Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.1', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '-0.1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "PAGI-SYM Severity index: Stomach Fullness severity is the participant's assessment of stomach fullness during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Stomach Fullness severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'PAGI-SYM Severity Index: Unable to Finish Meal Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.16', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '0.1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "PAGI-SYM Severity index: Unable to Finish Meal severity is the participant's assessment of being unable to finish a normal size meal during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Unable to Finish Meal severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'PAGI-SYM Severity Index: Excessive Fullness Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.1', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '1.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '0.0', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "PAGI-SYM Severity index: Excessive fullness severity is the participant's assessment of feeling excessively full after meals during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Excessive Fullness severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'PAGI-SYM Severity Index: Loss of Appetite Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.9', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.72', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "PAGI-SYM Severity index: Loss of appetite severity is the participant's assessment of loss of appetite during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Loss of appetite severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'PAGI-SYM Severity Index: Bloating Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.2', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '-0.3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "The PAGI-SYM Severity index: Bloating Severity is the participant's assessment of bloating (feel like you need to loosen your clothes) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Bloating Severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'PAGI-SYM Severity Index: Stomach Distention Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.1', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '0.0', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "The PAGI-SYM Severity index: Stomach distention severity is the participant's assessment of stomach distention (stomach or belly visibly larger) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Stomach Distention severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'PAGI-SYM Severity Index: Upper Abdominal Pain Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.0', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.14', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '0.1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "The PAGI-SYM Severity index: Upper Abdominal Pain severity is the participant's assessment of upper abdominal pain (above the navel) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Upper Abdominal Pain severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'PAGI-SYM Severity Index: Upper Abdominal Discomfort Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.2', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.07', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '0.0', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "The PAGI-SYM Severity index: Upper Abdominal Discomfort severity is the participant's assessment of upper abdominal discomfort (above the navel) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Upper Abdominal Discomfort severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'PAGI-SYM Severity Index: Lower Abdominal Pain Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.19', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '0.2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "The PAGI-SYM Severity index: Lower Abdominal Pain severity is the participant's assessment of lower abdominal pain (below the navel) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Lower Abdominal Pain severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'PAGI-SYM Severity Index: Lower Abdominal Discomfort Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.1', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '-0.0', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "The PAGI-SYM Severity index: Lower Abdominal Discomfort severity is the participant's assessment of lower abdominal discomfort (below the navel) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Lower Abdominal Discomfort severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'PAGI-SYM Severity Index: Heartburn During the Day Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.2', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '-0.1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "The PAGI-SYM Severity index: Heartburn during the day severity is the participant's assessment of heartburn (burning pain rising in your chest or throat) during the day over the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Heartburn During the Day severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'PAGI-SYM Severity Index: Heartburn When Lying Down Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.2', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.06', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '0.0', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "The PAGI-SYM Severity index: Heartburn when lying down severity is the participant's assessment of heartburn (burning pain rising in your chest or throat) when lying down over the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Heartburn When Lying Down severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'PAGI-SYM Severity Index: Chest Discomfort During the Day Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.1', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.09', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '0.1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "The PAGI-SYM Severity index: Chest discomfort during the day severity is the participant's assessment of feeling of discomfort inside the chest during the day over the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Chest Discomfort During the Day severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'PAGI-SYM Severity Index: Chest Discomfort During Sleep Time Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.9', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.17', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-7', 'ciUpperLimit': '0.1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "The PAGI-SYM Severity index: Chest discomfort during sleep severity is the participant's assessment of feeling of discomfort inside the chest at night (during sleep time) over the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Chest Discomfort During Sleep Time severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'PAGI-SYM Severity Index: Regurgitation During the Day Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.2', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '-0.2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "The PAGI-SYM Severity index: Regurgitation during the day severity is the participant's assessment of regurgitation or reflux (fluid or liquid from your stomach coming up into throat) during the day over the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Regurgitation During the Day severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'PAGI-SYM Severity Index: Regurgitation When Lying Down Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.3', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '-0.2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "The PAGI-SYM Severity index: Regurgitation when lying down severity is the participant's assessment of regurgitation or reflux (fluid or liquid from your stomach coming up into throat) when lying down over the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Regurgitation When Lying Down severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'PAGI-SYM Severity: Bitter Taste Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.10', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '0.1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "The PAGI-SYM Severity index: Bitter Taste severity is the participant's assessment of bitter, acid, or sour taste in mouth during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Bitter Taste Severity score, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'PAGI-SYM Severity Index: Constipation Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.13', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '0.1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "The PAGI-SYM Severity index: Constipation severity is the participant's assessment of constipation during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Constipation Severity score, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'PAGI-SYM Severity Index: Diarrhea Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.98', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "The PAGI-SYM Severity index: Diarrhea severity is the participant's assessment of constipation during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Diarrhea Severity score, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Gastrointestinal Symptom Rating Scale (GSRS): Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '0.1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire for participants with gastrointestinal discomfort. The GSRS Total Score is the average of the 15 items. Each item is rated on a 0 to 7 scale, where 0 indicates no discomfort and 7 indicates very severe discomfort. The range of scores is 0 to 7, where higher scores are considered a worse outcome.The outcome measure, change from baseline in GSRS Total Score, has a possible range from -7 to +7, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Gastrointestinal Symptom Rating Scale (GSRS): Reflux Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.1', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '1.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.06', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '0.0', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire for participants with gastrointestinal discomfort. The GSRS Reflux Score is a measure of how bothered the participant has been by acid reflux during the past week. The range of scores is 0 to 7, where 0 indicates no discomfort and 7 indicates very severe discomfort. Higher scores are considered a worse outcome.The outcome measure, change from baseline in GSRS Reflux Score, has a possible range from -7 to +7, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Gastrointestinal Symptom Rating Scale (GSRS): Abdominal Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.3', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '-0.2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 week', 'description': 'The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire for participants with gastrointestinal discomfort. The GSRS Abdominal Pain Score is a measure of how bothered the participant has been by pain or discomfort in the upper abdomen or pit of the stomach during the past week. The range of scores is 0 to 7, where 0 indicates no discomfort and 7 indicates very severe discomfort. Higher scores are considered a worse outcome.The outcome measure, change from baseline in GSRS Abdominal Pain Score, has a possible range from -7 to +7, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Gastrointestinal Symptom Rating Scale (GSRS): Indigestion Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '1.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.28', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '0.2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire for participants with gastrointestinal discomfort. The GSRS Indigestion Score is a measure of how bothered the participant has been by indigestion during the past week. The range of scores is 0 to 7, where 0 indicates no discomfort and 7 indicates very severe discomfort. Higher scores are considered a worse outcome.The outcome measure, change from baseline in GSRS Indigestion Score, has a possible range from -7 to +7, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The small number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Gastrointestinal Symptom Rating Scale (GSRS): Diarrhea Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.5', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '0.0', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire for participants with gastrointestinal discomfort. The GSRS Diarrhea Score is a measure of how bothered the participant has been by diarrhea during the past week. The range of scores is 0 to 7, where 0 indicates no discomfort and 7 indicates very severe discomfort. Higher scores are considered a worse outcome.The outcome measure, change from baseline in GSRS Diarrhea Score, has a possible range from -7 to +7, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Gastrointestinal Symptom Rating Scale (GSRS): Constipation Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.08', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '0.1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire for participants with gastrointestinal discomfort. The GSRS Constipation Score is a measure of how bothered the participant has been by constipation during the past week. The range of scores is 0 to 7, where 0 indicates no discomfort and 7 indicates very severe discomfort. Higher scores are considered a worse outcome.The outcome measure, change from baseline in GSRS Constipation Score, has a possible range from -7 to +7, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Brief Pain Inventory: Severity Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.0', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '2.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.53', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '0.6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'The Brief Pain Inventory: Severity Score is the average of four questions in which the participant rates his or her pain: the worse pain in the past 24 hours, the least pain in the past 24 hours, average pain, and pain right now. The range of possible scores is 0 to 10, with higher scores indicating more severe pain. The outcome measure, change from baseline in Brief Pain Inventory Severity Score, has a possible range from -10 to +10, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Brief Pain Inventory: Interference Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.1', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '2.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.38', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '0.5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'The Brief Pain Inventory: Interference Score is the average of seven questions in which the participant rates the degree to which his or her pain interferes with daily functions and mood: general activity, mood, walking ability, normal work, relationships, sleep, enjoyment of life. The range of possible scores is 0 to 10, with higher scores indicating more interference caused by pain. The outcome measure, change from baseline in Brief Pain Inventory Interference Score, has a possible range from -10 to +10, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Beck Depression Inventory (BDI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.6', 'spread': '8.5', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '5.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.09', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.2', 'ciLowerLimit': '-4.7', 'ciUpperLimit': '0.4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'The Beck Depression Inventory (BDI) survey is comprised of 21 multiple choice questions that relate to depression, cognition, and physical well-being and is used to quantify depression. The BDI total score is the sum of the 21 items, where each item ranges from 0 to 3 (lower scores are less severe, higher scores are more severe). The range for the BDI total score is 0 to 63, where lower scores indicate less depression and higher scores indicate more severe depression. The outcome measure, change from baseline in BDI score, has a possible range from -63 to +63, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'State-Trait Anxiety Inventory (STAI): State Anxiety Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.1', 'spread': '8.7', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '10.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.28', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.8', 'ciLowerLimit': '-5.2', 'ciUpperLimit': '1.5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'The State-Trait Anxiety Inventory (STAI): State anxiety score is the sum of scores from 20 questions relating to state anxiety, which is a temporary state varying in intensity. The possible range of scores is from 20 to 80, with increasing scores considered a worse outcome. The outcome measure, change from baseline in STAI State Anxiety score, has a possible range from -60 to +60, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'State-Trait Anxiety Inventory (STAI): Trait Anxiety Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.8', 'spread': '8.8', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '8.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.30', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.6', 'ciLowerLimit': '-4.6', 'ciUpperLimit': '1.4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'The State-Trait Anxiety Inventory (STAI): Trait anxiety score is the sum of scores from 20 questions pertaining to trait anxiety, which is a general propensity to be anxious. The possible range of scores is from 20 to 80, with increasing scores considered a worse outcome. The outcome measure, change from baseline in STAI Trait Anxiety score, has a possible range from -60 to +60, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Satiety Test, Volume Consumed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.0', 'groupId': 'OG000', 'lowerLimit': '-75.85', 'upperLimit': '49.85'}, {'value': '9.2', 'groupId': 'OG001', 'lowerLimit': '-56.35', 'upperLimit': '74.75'}]}]}], 'analyses': [{'pValue': '0.40', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-21.2', 'ciLowerLimit': '-70.5', 'ciUpperLimit': '28.1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEDIAN', 'timeFrame': '4 weeks', 'description': 'The Satiety Test measures the total volume of liquid (Ensure) that the participant is able to consume. The participant drinks 150 mL of Ensure every 5 minutes until he/she is completely full. The outcome measure is the change from baseline in volume of liquid (Ensure) consumed (mL), where positive values indicate a positive outcome (improvement).', 'unitOfMeasure': 'mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Electrogastrography (EGG): Bradygastria (1-<2.5 Cpm) at 4 Weeks, Baseline Measurement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.6', 'spread': '24.6', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '21.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.28', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.2', 'ciLowerLimit': '-12.0', 'ciUpperLimit': '3.5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. Normal pacing is considered 2.5-3.7 cycles per minute (cpm). Bradygastria is when the rate of electrical activity in the stomach is \\<2.5 cycles per minute for at least 1 minute (a decrease in electrical activity in the stomach). The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (here, baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where negative values for bradygastria indicate improvement (less time in a dysrhythmic state).", 'unitOfMeasure': 'average power in frequency region, %', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Electrogastrography (EGG): Bradygastria (1-<2.5 Cpm) at 4 Weeks, 0-30 Post-satiety Measurement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '17.7', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '19.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.47', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.4', 'ciLowerLimit': '-4.1', 'ciUpperLimit': '8.9', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. The 0-30 post-satiety measurement of the test is that taken 30 minutes after the participant consumes Ensure until feeling completely full. Normal pacing is considered 2.5-3.7 cycles per minute (cpm). Bradygastria is when the rate of electrical activity in the stomach is \\<2.5 cycles per minute for at least 1 minute. Average power in frequency region is the % of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (baseline refers to test performed during screening, not baseline value of the EGG test) in % of time with frequencies in the ranges. Negative values for bradygastria indicate improvement (less time in a dysrhythmic state).", 'unitOfMeasure': 'average power in frequency region, %', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Electrogastrography (EGG): Normogastria (2.5-<3.8 Cpm) at 4 Weeks, Baseline Measurement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '19.9', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '16.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.68', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.2', 'ciLowerLimit': '-4.5', 'ciUpperLimit': '6.9', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. Normal pacing (normogastria) is considered 2.5-3.7 cycles per minute (cpm). The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (here, baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where positive values for normal rates indicate an increase in the normal pacing (improvement).", 'unitOfMeasure': 'average power in frequency region, %', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Electrogastrography (EGG): Normogastria (2.5-<3.8 Cpm) at 4 Weeks, 0-30 Post-satiety Measurement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '15.8', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '15.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.48', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.0', 'ciLowerLimit': '-3.6', 'ciUpperLimit': '7.6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. The 0-30 post-satiety measurement that taken 30 minutes after the participant consumes Ensure until feeling completely full. Normal pacing (normogastria) is considered 2.5-3.7 cycles per minute (cpm). The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where positive values for normal rates indicate an increase in the normal pacing (improvement).", 'unitOfMeasure': 'average power in frequency region, %', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Electrogastrography (EGG): Tachygastria (3.8-10 Cpm) at 4 Weeks, Baseline Measurement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'spread': '12.3', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '12.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.43', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.5', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '5.1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. Normal pacing is considered 2.5-3.7 cycles per minute (cpm). Tachygastria is when the rate of electrical activity in the stomach is 3.8-10 cycles per minute for at least 1 minute (an increase in electrical activity in the stomach). The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (here, baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where negative values for tachygastria indicate improvement (less time in a dysrhythmic state).", 'unitOfMeasure': 'average power in frequency region, %', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Electrogastrography (EGG): Tachygastria (3.8-10 Cpm) at 4 Weeks, 0-30 Post-satiety Measurement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.1', 'spread': '9.7', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '14.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.8', 'ciLowerLimit': '-8.5', 'ciUpperLimit': '-1.2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. The 0-30 post-satiety measurement that taken 30 minutes after the participant consumes Ensure until feeling completely full. Normal pacing is considered 2.5-3.7 cycles per minute (cpm). Tachygastria is when the rate of electrical activity in the stomach is 3.8-10 cycles per minute for at least 1 minute (an increase in electrical activity in the stomach). The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (here, baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where negative values for tachygastria indicate improvement (less time in a dysrhythmic state).", 'unitOfMeasure': 'average power in frequency region, %', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Electrogastrography (EGG): Duodenal (>10-15 Cpm) at 4 Weeks, Baseline Measurement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '13.5', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '13.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.57', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '-3.4', 'ciUpperLimit': '6.1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. Normal pacing is considered 2.5-3.7 cycles per minute (cpm). Duodenal is when the rate of electrical activity in the stomach is \\>10-15 cycles per minute for at least 1 minute. The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (here, baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where negative values for duodenal indicate improvement (less time in a dysrhythmic state).", 'unitOfMeasure': 'average power in frequency region, %', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week followup visit.'}, {'type': 'SECONDARY', 'title': 'Electrogastrography (EGG): Duodenal (>10-15 Cpm) at 4 Weeks, 0-30 Post-satiety Measurement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'OG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.8', 'spread': '7.3', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '5.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.34', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.84', 'ciLowerLimit': '-2.6', 'ciUpperLimit': '1.0', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. The 0-30 post-satiety measurement that taken 30 minutes after the participant consumes Ensure until feeling completely full. Normal pacing is considered 2.5-3.7 cycles per minute (cpm). Duodenal is when the rate of electrical activity in the stomach is \\>10-15 cycles per minute for at least 1 minute. The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (here, baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where negative values for duodenal indicate improvement (less time in a dysrhythmic state).", 'unitOfMeasure': 'average power in frequency region, %', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'FG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '63'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Between April 2013 and July 2015, 126 patients were enrolled at eight participating medical centers, of whom 63 were randomized to aprepitant and 63 to placebo', 'preAssignmentDetails': 'Adults, 18 years or older, with symptoms compatible with gastroparesis for 6 months, who had a 4-hour gastric emptying scintigraphy test and a total score \\>21 on the Gastroparesis Cardinal Symptom Index (GCSI) and a visual analog scale (VAS) mean score of nausea after 7 days of \\>25 mm on a 0 to 100 mm scale were considered for enrollment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg per day\n\nAprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'BG001', 'title': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day\n\nPlacebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.9', 'spread': '14.8', 'groupId': 'BG000'}, {'value': '46.8', 'spread': '13.5', 'groupId': 'BG001'}, {'value': '44.8', 'spread': '14.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Diabetes type 1 or type 2, No.', 'classes': [{'title': 'Have diabetes type 1 or type 2', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}, {'title': 'Do not have diabetes type 1 or type 2', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body mass index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '27.8', 'spread': '8.3', 'groupId': 'BG000'}, {'value': '28.0', 'spread': '7.5', 'groupId': 'BG001'}, {'value': '27.9', 'spread': '7.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '75.4', 'spread': '22.8', 'groupId': 'BG000'}, {'value': '75.1', 'spread': '20.6', 'groupId': 'BG001'}, {'value': '75.2', 'spread': '21.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Waist circumference', 'classes': [{'categories': [{'measurements': [{'value': '90.9', 'spread': '17.2', 'groupId': 'BG000'}, {'value': '91.3', 'spread': '18.0', 'groupId': 'BG001'}, {'value': '91.1', 'spread': '17.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Waist to hip ratio', 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'spread': '0.1', 'groupId': 'BG000'}, {'value': '0.9', 'spread': '0.1', 'groupId': 'BG001'}, {'value': '0.9', 'spread': '0.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ratio', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Systolic blood pressure', 'classes': [{'categories': [{'measurements': [{'value': '121.1', 'spread': '17.8', 'groupId': 'BG000'}, {'value': '122.1', 'spread': '15.0', 'groupId': 'BG001'}, {'value': '121.6', 'spread': '16.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diastolic blood pressure', 'classes': [{'categories': [{'measurements': [{'value': '73.6', 'spread': '11.6', 'groupId': 'BG000'}, {'value': '75.0', 'spread': '11.3', 'groupId': 'BG001'}, {'value': '74.3', 'spread': '11.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Medications in past month: proton pump inhibitors', 'classes': [{'title': 'Took medication', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}]}, {'title': 'Did not take medication', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Medications in past month: benzodiazepine or anxiolytic', 'classes': [{'title': 'Took medication', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}, {'title': 'Did not take medication', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Medications in past month: prokinetic', 'classes': [{'title': 'Took medication', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}, {'title': 'Did not take medication', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Medications in past month: antiemetic', 'classes': [{'title': 'Took medication', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}]}, {'title': 'Did not take medication', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Medications in past month: selective serotonin reuptake inhibitors (SSRI)', 'classes': [{'title': 'Took medication', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'Did not take medication', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Medications in past month: tricyclic antidepressant (TCA)', 'classes': [{'title': 'Took medication', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'Did not take medication', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Medications in past month: other antidepressant', 'classes': [{'title': 'Took medication', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'Did not take medication', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Medications in past month: narcotic', 'classes': [{'title': 'Took medication', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Did not take medication', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Medications in past month: neuropathic or pain modulator...', 'classes': [{'title': 'Took medication', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}, {'title': 'Did not take medication', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Participants who took medications in past month: neuropathic or pain modulator, anti-seizure, or other psychiatric medication', 'unitOfMeasure': 'participants'}, {'title': '7-day nausea visual analog scale (VAS) score', 'classes': [{'categories': [{'measurements': [{'value': '63.0', 'spread': '21.5', 'groupId': 'BG000'}, {'value': '64.1', 'spread': '20.2', 'groupId': 'BG001'}, {'value': '63.6', 'spread': '20.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The 7-Day Nausea Visual Analog Scale (VAS) measures severity of current nausea, ranging from a minimum value of 0 (no nausea) to a maximum value of 100 (severe nausea). Higher scores are considered a worse outcome. The VAS is a line measuring 100mm in length. For 7 consecutive days, participants mark their severity of nausea with a vertical line at the point they feel represents their current severity of nausea. The distance to the vertical line is measured with a ruler to the nearest millimeter. The values presented are the mean of the 7 measurements.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea', 'classes': [{'categories': [{'measurements': [{'value': '9.0', 'spread': '7.0', 'groupId': 'BG000'}, {'value': '9.3', 'spread': '7.1', 'groupId': 'BG001'}, {'value': '9.2', 'spread': '7.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea is the participant's assessment of the number of hours of nausea experienced in the past 24 hours. The range is 0 to 24 hours.", 'unitOfMeasure': 'hours of nausea', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): GCSI total score', 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'spread': '0.9', 'groupId': 'BG000'}, {'value': '2.3', 'spread': '0.7', 'groupId': 'BG001'}, {'value': '2.3', 'spread': '0.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): GCSI total score is the average of 3 subscores: Nausea (average of two items: nausea and vomiting), Early Satiety (average of two items: not able to finish normal size meal and feeling excessively full after meals), and Bloating (feeling like you need to loosen your clothes). Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea severity', 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'spread': '0.8', 'groupId': 'BG000'}, {'value': '2.6', 'spread': '0.8', 'groupId': 'BG001'}, {'value': '2.6', 'spread': '0.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea severity is the participant's assessment of nausea (feeling sick to your stomach as if you were going to vomit or throw up) during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting severity', 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '1.0', 'groupId': 'BG000'}, {'value': '0.9', 'spread': '1.0', 'groupId': 'BG001'}, {'value': '1.0', 'spread': '1.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting severity is the participant's assessment of vomiting during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Early satiety severity', 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'spread': '1.1', 'groupId': 'BG000'}, {'value': '2.7', 'spread': '0.9', 'groupId': 'BG001'}, {'value': '2.6', 'spread': '1.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Early Satiety is the participant's assessment of early satiety (not able to finish a normal-size meal) during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Excessive fullness severity', 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'spread': '1.1', 'groupId': 'BG000'}, {'value': '2.8', 'spread': '0.9', 'groupId': 'BG001'}, {'value': '2.7', 'spread': '1.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Excessive fullness is the participant's assessment of fullness (feel excessively full after meals) during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Bloating severity', 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'spread': '1.4', 'groupId': 'BG000'}, {'value': '2.6', 'spread': '1.1', 'groupId': 'BG001'}, {'value': '2.4', 'spread': '1.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Bloating is the participant's assessment of bloating (feeling like you need to loosen your clothes) during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Upper abdominal pain severity', 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'spread': '1.2', 'groupId': 'BG000'}, {'value': '2.3', 'spread': '1.0', 'groupId': 'BG001'}, {'value': '2.3', 'spread': '1.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Upper abdominal pain is the participant's assessment of upper abdominal pain (above the navel) during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting (No. episodes)', 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'spread': '1.6', 'groupId': 'BG000'}, {'value': '1.1', 'spread': '1.5', 'groupId': 'BG001'}, {'value': '1.2', 'spread': '1.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting is the participant's assessment of the number of episodes of vomiting experienced in the past 24 hours.", 'unitOfMeasure': 'number of episodes', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Retching (No. episodes)', 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'spread': '2.5', 'groupId': 'BG000'}, {'value': '2.3', 'spread': '2.8', 'groupId': 'BG001'}, {'value': '2.1', 'spread': '2.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Retching is the participant's assessment of the number of episodes of retching (heaving as if to vomit, but nothing comes up) experienced in the past 24 hours.", 'unitOfMeasure': 'number of episodes', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Overall symptom severity', 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'spread': '0.8', 'groupId': 'BG000'}, {'value': '2.6', 'spread': '0.7', 'groupId': 'BG001'}, {'value': '2.6', 'spread': '0.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Overall Symptom Severity is the participant's assessment of overall severity of gastroparesis symptoms during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'PAGI-SYM Severity index: Gastroparesis Cardinal Symptom Index (GCSI), total score', 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '0.9', 'groupId': 'BG000'}, {'value': '3.3', 'spread': '0.7', 'groupId': 'BG001'}, {'value': '3.4', 'spread': '0.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The PAGI-SYM Severity Index: GCSI Total Score is the average of 3 subscores: Nausea (mean of 3 items: nausea, retching, vomiting), Fullness/Early Satiety (mean of 4 items: stomach fullness, not able to finish normal size meal, feeling excessively full after meals, loss of appetite), and Bloating (mean of 2 items: bloating, stomach visibly larger). Each item is the participant's assessment of symptom severity during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'PAGI-SYM Severity index: Nausea/vomiting severity subscore', 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'spread': '1.1', 'groupId': 'BG000'}, {'value': '2.8', 'spread': '0.9', 'groupId': 'BG001'}, {'value': '3.0', 'spread': '1.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The PAGI-SYM Severity index: Nausea/vomiting severity subscore is the average of 3 items: nausea, retching, and vomiting. Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'PAGI-SYM Severity index: Nausea severity', 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'spread': '0.8', 'groupId': 'BG000'}, {'value': '4.0', 'spread': '0.9', 'groupId': 'BG001'}, {'value': '4.1', 'spread': '0.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The PAGI-SYM Severity index: Nausea severity is the participant's assessment of nausea (feeling sick to your stomach as if you were going to vomit or throw up) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'PAGI-SYM Severity index: Retching severity', 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'spread': '1.6', 'groupId': 'BG000'}, {'value': '2.6', 'spread': '1.3', 'groupId': 'BG001'}, {'value': '2.8', 'spread': '1.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The PAGI-SYM Severity index: Retching severity is the participant's assessment of retching (heaving as if to vomit, but nothing comes up) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'PAGI-SYM Severity index: Vomiting severity', 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'spread': '1.8', 'groupId': 'BG000'}, {'value': '1.9', 'spread': '1.6', 'groupId': 'BG001'}, {'value': '2.2', 'spread': '1.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The PAGI-SYM Severity index: Vomiting severity is the participant's assessment of vomiting during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'PAGI-SYM Severity index: Fullness/early satiety subscore', 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'spread': '1.0', 'groupId': 'BG000'}, {'value': '3.7', 'spread': '0.8', 'groupId': 'BG001'}, {'value': '3.7', 'spread': '0.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The PAGI-SYM Severity index: Fullness/early satiety subscore is the average of 4 items: stomach fullness, not able to finish normal size meal, felling excessively full after meals, and loss of appetite. Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'PAGI-SYM Severity index: Bloating subscore', 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'spread': '1.4', 'groupId': 'BG000'}, {'value': '3.4', 'spread': '1.4', 'groupId': 'BG001'}, {'value': '3.4', 'spread': '1.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The PAGI-SYM Severity index: Bloating subscore is the average of 2 items: bloating (feeling like you need to loosen your clothes) and stomach visibly larger. Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'PAGI-SYM Severity index: Upper abdominal pain subscore', 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '1.3', 'groupId': 'BG000'}, {'value': '3.3', 'spread': '1.3', 'groupId': 'BG001'}, {'value': '3.4', 'spread': '1.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The PAGI-SYM Severity index: Upper abdominal pain severity is the participant's assessment of upper abdominal pain (above the navel) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'PAGI-SYM Severity index: Lower abdominal pain', 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'spread': '1.6', 'groupId': 'BG000'}, {'value': '2.5', 'spread': '1.4', 'groupId': 'BG001'}, {'value': '2.5', 'spread': '1.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The PAGI-SYM Severity index: Lower abdominal pain severity is the participant's assessment of lower abdominal pain (below the navel) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'PAGI-SYM Severity index: Lower abdominal discomfort', 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'spread': '1.6', 'groupId': 'BG000'}, {'value': '2.6', 'spread': '1.4', 'groupId': 'BG001'}, {'value': '2.6', 'spread': '1.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The PAGI-SYM Severity index: Lower abdominal discomfort is the participant's assessment of lower abdominal discomfort (below the navel) severity during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'PAGI-SYM Severity index: Gastroesophageal Reflux (GERD) subscore', 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'spread': '1.4', 'groupId': 'BG000'}, {'value': '2.3', 'spread': '1.4', 'groupId': 'BG001'}, {'value': '2.3', 'spread': '1.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "PAGI-SYM Severity index: Gastroesophageal Reflux (GERD) subscore is the average of 7 items (heartburn during day, heartburn lying down, chest discomfort day, chest discomfort during sleep, regurgitation during day, regurgitation lying down, bitter taste in mouth). Each item is the participant's assessment of severity of the symptom, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'PAGI-SYM Severity index: Constipation severity', 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'spread': '1.7', 'groupId': 'BG000'}, {'value': '2.6', 'spread': '1.8', 'groupId': 'BG001'}, {'value': '2.8', 'spread': '1.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The PAGI-SYM Severity index: Constipation severity is the participant's assessment of constipation severity during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'PAGI-SYM Severity index: Diarrhea severity', 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'spread': '1.7', 'groupId': 'BG000'}, {'value': '1.8', 'spread': '1.7', 'groupId': 'BG001'}, {'value': '1.7', 'spread': '1.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The PAGI-SYM Severity index: Diarrhea severity is the participant's assessment of diarrhea severity during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'PAGI-SYM Severity index: Nausea/vomiting predominant symptom, No.', 'classes': [{'title': 'Nausea/vomiting predominant symptom', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}, {'title': 'Nausea/vomiting not predominant symptom', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Clinical Global Patient Impression Score (patient-rated)', 'classes': [{'categories': [{'measurements': [{'value': '-0.6', 'spread': '1.1', 'groupId': 'BG000'}, {'value': '-0.7', 'spread': '1.1', 'groupId': 'BG001'}, {'value': '-0.6', 'spread': '1.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The Clinical Global Patient Impression Score quantifies the overall relief of the patient's symptom, by asking the participant to consider how they felt over the past week in regard to stomach symptoms and overall well-being, and rate relief of symptoms in comparison to how they felt before entering the study. Possible scores are: -3=very considerably worse, -2=considerably worse, -1=somewhat worse, 0=unchanged, 1=somewhat better, 2=considerably better, 3=completely better. The range of scores is -3 to 3, where higher scores are considered a better outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Brief Pain Inventory: severity score', 'classes': [{'categories': [{'measurements': [{'value': '4.7', 'spread': '2.5', 'groupId': 'BG000'}, {'value': '4.6', 'spread': '2.5', 'groupId': 'BG001'}, {'value': '4.6', 'spread': '2.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Brief Pain Inventory: Severity Score is the average of four questions in which the participant rates his or her pain: the worse pain in the past 24 hours, the least pain in the past 24 hours, average pain, and pain right now. The range of possible scores is 0 to 10, with higher scores indicating more severe pain. Higher scores are considered a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Brief Pain Inventory: Interference score', 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'spread': '3.1', 'groupId': 'BG000'}, {'value': '5.4', 'spread': '3.0', 'groupId': 'BG001'}, {'value': '4.9', 'spread': '3.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Brief Pain Inventory: Interference Score is the average of seven questions in which the participant rates the degree to which his or her pain interferes with daily functions and mood: general activity, mood, walking ability, normal work, relationships, sleep, enjoyment of life. The range of possible scores is 0 to 10, with higher scores indicating more interference caused by pain. Higher scores are considered a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Beck Depression Inventory (BDI): Total score', 'classes': [{'categories': [{'measurements': [{'value': '18.0', 'spread': '11.8', 'groupId': 'BG000'}, {'value': '18.3', 'spread': '12.6', 'groupId': 'BG001'}, {'value': '18.2', 'spread': '12.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Beck Depression Inventory (BDI) survey is comprised of 21 multiple choice questions that relate to depression, cognition, and physical well-being and is extensively used to quantify depression in a range of clinical conditions. The BDI total score is the sum of the 21 items, where each item ranges from 0 to 3 (lower scores are less severe, higher scores are more severe). The range for the BDI total score is 0 to 63, where lower scores indicate less depression and higher scores indicate more sever depression. Higher scores are considered a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Beck Depression Inventory (BDI): Severe depression, No.', 'classes': [{'title': 'Have severe depression', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Do not have severe depression', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Severe depression defined as a Beck Depression Inventory (BDI) total score greater than 28 (based on a range of possible scores from 0-63, where higher scores indicate more severe depression).', 'unitOfMeasure': 'participants'}, {'title': 'State-Trait Anxiety Inventory (STAI): State anxiety score', 'classes': [{'categories': [{'measurements': [{'value': '39.6', 'spread': '13.9', 'groupId': 'BG000'}, {'value': '41.9', 'spread': '13.9', 'groupId': 'BG001'}, {'value': '40.7', 'spread': '13.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The State-Trait Anxiety Inventory (STAI): State anxiety score is the sum of scores from 20 questions relating to state anxiety, which is a temporary state varying in intensity. The possible range of scores is from 20 to 80, with increasing scores considered a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'State-Trait Anxiety Inventory (STAI): Severe state anxiety, No.', 'classes': [{'title': 'Have severe state anxiety', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}, {'title': 'Do not have severe state anxiety', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'State-Trait Anxiety Inventory (STAI): Trait anxiety score', 'classes': [{'categories': [{'measurements': [{'value': '40.3', 'spread': '14.2', 'groupId': 'BG000'}, {'value': '43.0', 'spread': '13.2', 'groupId': 'BG001'}, {'value': '41.6', 'spread': '13.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The State-Trait Anxiety Inventory (STAI): Trait anxiety score is the sum of scores from 20 questions pertaining to trait anxiety, which is a general propensity to be anxious. The possible range of scores is from 20 to 80, with increasing scores considered a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'State-Trait Anxiety Inventory: Severe trait anxiety, No.', 'classes': [{'title': 'Have severe trait anxiety', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}, {'title': 'Do not have severe trait anxiety', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'SF-36 Quality of Life (QOL): Physical component summary score', 'classes': [{'categories': [{'measurements': [{'value': '33.5', 'spread': '9.5', 'groupId': 'BG000'}, {'value': '29.8', 'spread': '8.8', 'groupId': 'BG001'}, {'value': '31.6', 'spread': '9.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The SF-36 Quality of Life (QOL) Physical component summary score is the sum of four physical subscores (physical functioning, role-physical, bodily pain, and general health), and is a more general measure of functional health. The range of possible scores is 0 to 100, normalized based on 1998 US population, with higher scores corresponding to higher quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'SF-36 Quality of Life (QOL): Mental component summary score', 'classes': [{'categories': [{'measurements': [{'value': '41.4', 'spread': '14.3', 'groupId': 'BG000'}, {'value': '40.5', 'spread': '13.5', 'groupId': 'BG001'}, {'value': '40.9', 'spread': '13.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The SF-36 Quality of Life (QOL) Mental component summary score is the sum of four mental subscores (vitality, social functioning, role-emotional, and mental health), and is a more general measure of well-being. The range of possible scores is 0 to 100, normalized based on 1998 US population, with higher scores corresponding to higher quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Scintigraphic gastric emptying (GES): Percent gastric retention at 1 hour', 'classes': [{'categories': [{'measurements': [{'value': '69.7', 'spread': '20.0', 'groupId': 'BG000'}, {'value': '73.0', 'spread': '19.3', 'groupId': 'BG001'}, {'value': '71.3', 'spread': '19.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Scintigraphic gastric emptying (GES): Percent gastric retention at 1 hour is the percent retention 1 hour after the participant ingests the test meal. The GES is a test performed during screening (baseline) to meet eligibility requirements.', 'unitOfMeasure': 'percent retention', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Scintigraphic gastric emptying (GES): Percent gastric retention at 2 hours', 'classes': [{'categories': [{'measurements': [{'value': '45.6', 'spread': '24.9', 'groupId': 'BG000'}, {'value': '53.1', 'spread': '23.4', 'groupId': 'BG001'}, {'value': '49.4', 'spread': '24.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Scintigraphic gastric emptying (GES): Percent gastric retention at 2 hours is the percent retention 2 hours after the participant ingests the test meal. The GES is a test performed during screening (baseline) to meet eligibility requirements.', 'unitOfMeasure': 'percent retention', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Scintigraphic gastric emptying (GES): Percent gastric retention at 4 hours', 'classes': [{'categories': [{'measurements': [{'value': '17.8', 'spread': '21.8', 'groupId': 'BG000'}, {'value': '20.4', 'spread': '17.5', 'groupId': 'BG001'}, {'value': '19.1', 'spread': '19.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Scintigraphic gastric emptying (GES): Percent gastric retention at 4 hours is the percent retention 4 hours after the participant ingests the test meal. The GES is a test performed during screening (baseline) to meet eligibility requirements.', 'unitOfMeasure': 'percent retention', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Scintigraphic gastric emptying (GES): Delayed gastric emptying, No.', 'classes': [{'title': 'Have delayed gastric emptying', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}, {'title': 'Do not have delayed gastric emptying', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Scintigraphic gastric emptying (GES): Delayed gastric emptying is defined as \\>60% retention 2 hours after the participant ingests the test meal, or \\>10% retention 4 hours after the participant ingests the test meal.', 'unitOfMeasure': 'participants'}, {'title': 'Scintigraphic gastric emptying (GES): Rapid gastric emptying, No.', 'classes': [{'title': 'Have rapid gastric emptying', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Do not have rapid gastric emptying', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Scintigraphic gastric emptying (GES): Rapid gastric emptying is defined as \\<30% gastric retention 1 hour after the participant ingests the test meal.', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-15', 'studyFirstSubmitDate': '2010-06-22', 'resultsFirstSubmitDate': '2018-08-17', 'studyFirstSubmitQcDate': '2010-06-22', 'lastUpdatePostDateStruct': {'date': '2019-05-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-15', 'studyFirstPostDateStruct': {'date': '2010-06-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Improvement in Nausea', 'timeFrame': '4 weeks', 'description': 'The primary outcome measure is a binary (0,1) variable indicating improvement in nausea or not in the mean of available visual analog scale (VAS) scores over the 28 day treatment period compared to the mean of VAS scores during the 7 day baseline period. The criteria for improvement are either a 25 mm or more reduction in mean VAS or attaining a mean VAS during the treatment period of \\< 25 mm.'}], 'secondaryOutcomes': [{'measure': 'Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea (Hours)', 'timeFrame': '4 weeks', 'description': "Measure Description: Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea is the participant's assessment of the number of hours of nausea experienced in the past 24 hours. The range is 0 to 24 hours. The outcome measure, change from baseline in number of hours of nausea, has a possible range from -24 to +24, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome."}, {'measure': 'Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting (No. Episodes)', 'timeFrame': '4 weeks', 'description': "Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting is the participant's assessment of the number of episodes of vomiting experienced in the past 24 hours. The outcome is the change from baseleine in number of times vomited, where negative numbers indicate improvement in vomiting frequency, and positive numbers indicate worsening in vomiting frequency."}, {'measure': 'Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Retching (No. Episodes)', 'timeFrame': '4 weeks', 'description': "Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Retching is the participant's assessment of the number of episodes of retching (heaving as if to vomit, but nothing comes up) experienced in the past 24 hours. The outcome is the change from baseline in the number of retching episodes, where negative numbers indicate improvement in retching frequency, and positive numbers indicate worsening in retching frequency."}, {'measure': 'Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): GCSI Total Score', 'timeFrame': '4 weeks', 'description': "The Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): GCSI total score is the average of 3 subscores: Nausea (average of two items: nausea and vomiting), Early Satiety (average of two items: not able to finish normal size meal and feeling excessively full after meals), and Bloating (feeling like you need to loosen your clothes). Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in GCSI total score, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome."}, {'measure': 'Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea Severity', 'timeFrame': '4 weeks', 'description': "Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea severity is the participant's assessment of nausea (feeling sick to your stomach as if you were going to vomit or throw up) during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in GCSI score, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome."}, {'measure': 'Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting Severity', 'timeFrame': '4 weeks', 'description': "Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting Severity is the participant's assessment of vomiting during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Vomiting Severity, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome."}, {'measure': 'Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Upper Abdominal Pain Severity', 'timeFrame': '4 weeks', 'description': "Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Upper Abdominal Pain Severity is the participant's assessment of upper abdominal pain (above the navel) during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Upper Abdominal Pain Severity, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome."}, {'measure': 'Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Excessive Fullness Severity', 'timeFrame': '4 weeks', 'description': "Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Excessive Fullness Severity is the participant's assessment of excessive fullness (feeling excessively full after meals) during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Excessive Fullness Severity, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome."}, {'measure': 'Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Early Satiety Severity', 'timeFrame': '4 weeks', 'description': "Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Early Satiety Severity is the participant's assessment of early satiety (not able to finish normal-size meal) during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Early Satiety Severity, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome."}, {'measure': 'Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Bloating Severity', 'timeFrame': '4 weeks', 'description': "Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Bloating Severity is the participant's assessment of bloating (feeling like you need to loosen your clothes) during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Bloating Severity, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome."}, {'measure': 'Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Overall Symptom Severity', 'timeFrame': '4 weeks', 'description': "Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Overall Symptom Severity is the participant's assessment of overall severity of gastroparesis symptoms during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome, change from baseline in Overall Symptom Severity score, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome."}, {'measure': 'Clinical Global Patient Impression Score (Patient-rated)', 'timeFrame': '4 weeks', 'description': "The Clinical Global Patient Impression Score quantifies the overall relief of the patient's symptom, by asking the participant to consider how they felt over the past week in regard to stomach symptoms and overall well-being, and rate relief of symptoms in comparison to how they felt before entering the study. Possible scores are: -3=very considerably worse, -2=considerably worse, -1=somewhat worse, 0=unchanged, 1=somewhat better, 2=considerably better, 3=completely better. The range of scores is -3 to 3, where higher scores are considered a better outcome. The outcome measure, change from baseline in Clinical Global Patient Impression Score, has a possible range of -6 to +6, with positive values indicating a better outcome (improvement) and negative values indicating a worse outcome."}, {'measure': 'Liver Enzymes and Proteins: Alanine Aminotransferase (ALT)', 'timeFrame': '4 weeks', 'description': 'Change from baseline in serum alanine aminotransferase (ALT), U/L'}, {'measure': 'Liver Enzymes and Proteins: Aspartate Aminotransferase (AST)', 'timeFrame': '4 weeks', 'description': 'Change from baseline in aspartate aminotransferase (AST), U/L'}, {'measure': 'Liver Enzymes and Proteins: Total Protein', 'timeFrame': '4 weeks', 'description': 'Change from baseline in total protein (g/dL)'}, {'measure': 'Hemoglobin A1c (HbA1c)', 'timeFrame': '4 weeks', 'description': 'Change from baseline in hemoglobin A1c (HbA1c) (%)'}, {'measure': 'Glucose', 'timeFrame': '4 weeks', 'description': 'Change from baseline in glucose (mg/dL)'}, {'measure': 'Liver Enzymes and Proteins: Albumin', 'timeFrame': '4 weeks', 'description': 'Change from baseline in albumin (g/dL)'}, {'measure': 'Hemoglobin', 'timeFrame': '4 weeks', 'description': 'Change from baseline in hemoglobin (g/dL)'}, {'measure': 'Hematocrit', 'timeFrame': '4 weeks', 'description': 'Change from baseline in hematocrit'}, {'measure': 'White Blood Cell Count (WBC)', 'timeFrame': '4 weeks', 'description': 'Change from baseline in white blood cell count (WBC)'}, {'measure': 'Red Blood Cell Count (RBC)', 'timeFrame': '4 weeks', 'description': 'Change from baseline in red blood cell count (RBC)'}, {'measure': 'Platelet Count', 'timeFrame': '4 weeks', 'description': 'Change from baseline in platelet count'}, {'measure': 'Carbon Dioxide', 'timeFrame': '4 weeks', 'description': 'Change from baseline in carbon dioxide (mEg/L)'}, {'measure': 'Chloride', 'timeFrame': '4 weeks', 'description': 'Change from baseline in chloride (mEq/L)'}, {'measure': 'Sodium', 'timeFrame': '4 weeks', 'description': 'Change from baseline in sodium (mEq/L)'}, {'measure': 'Potassium', 'timeFrame': '4 weeks', 'description': 'Change from baseline in potassium (mEq/L)'}, {'measure': 'Calcium', 'timeFrame': '4 weeks', 'description': 'Change from baseline in calcium (mg/dL)'}, {'measure': 'Blood Urea Nitrogen (BUN)', 'timeFrame': '4 weeks', 'description': 'Change from baseline in blood urea nitrogen (BUN) (mg/dL)'}, {'measure': 'Magnesium', 'timeFrame': '4 weeks', 'description': 'Change from baseline in magnesium (mg/dL)'}, {'measure': 'Creatinine', 'timeFrame': '4 weeks', 'description': 'Change from baseline in creatinine (mg/dL)'}, {'measure': 'PAGI-SYM Severity Index: Gastroparesis Cardinal Symptom Index (GCSI) Score', 'timeFrame': '4 weeks', 'description': "PAGI-SYM Severity index: Gastroparesis Cardinal Symptom Index (GCSI) score is the average of 3 subscores: Nausea (average of 3 items: nausea, retching, and vomiting), Fullness/Early Satiety (average of 4 items: stomach fullness, not able to finish normal size meal, feeling excessively full after meals, and loss of appetite), and Bloating (average if 2 items: bloating and stomach visibly larger). Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The outcome measure, change from baseline in GCSI score, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome."}, {'measure': 'PAGI-SYM Severity Index: Nausea/Vomiting Severity Subscore', 'timeFrame': '4 weeks', 'description': "The PAGI-SYM Severity index: Nausea/vomiting severity subscore is the average of 3 items: nausea, retching, and vomiting. Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Nausea/vomiting severity subscore, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome."}, {'measure': 'PAGI-SYM Severity Index: Fullness/Early Satiety Subscore', 'timeFrame': '4 weeks', 'description': "The PAGI-SYM Severity index: Fullness/Early Satiety Subscore is the average of 4 items: stomach fullness, not able to finish normal size meal, felling excessively full after meals, and loss of appetite. Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Fullness/Early Satiety Subscore, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome."}, {'measure': 'PAGI-SYM Severity Index: Bloating Subscore', 'timeFrame': '4 weeks', 'description': "The PAGI-SYM Severity index: Bloating Subscore is the average of 2 items: bloating (feeling like you need to loosen your clothes) and stomach visibly larger. Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The outcome measure, change from baseline in Bloating Subscore, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome."}, {'measure': 'PAGI-SYM Severity Index: Upper Abdominal Pain Subscore', 'timeFrame': '4 weeks', 'description': "The PAGI-SYM Severity index: Upper Abdominal Pain subscore is the average of 2 items (upper abdominal pain, upper abdominal discomfort). Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Upper Abdominal Pain Subscore, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome."}, {'measure': 'PAGI-SYM Severity Index: GERD Subscore', 'timeFrame': '4 weeks', 'description': "PAGI-SYM Severity index: Gastroesophageal Reflux (GERD) Subscore is the average of 7 items (heartburn during day, heartburn lying down, chest discomfort day, chest discomfort during sleep, regurgitation during day, regurgitation lying down, bitter taste in mouth). Each item is the participant's assessment of severity of the symptom, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in GERD Subscore, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome."}, {'measure': 'PAGI-SYM Severity Index: Nausea Severity', 'timeFrame': '4 weeks', 'description': "The PAGI-SYM Severity index: Nausea severity is the participant's assessment of nausea (feeling sick to your stomach as if you were going to vomit or throw up) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Nausea Severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome."}, {'measure': 'PAGI-SYM Severity Index: Vomiting Severity', 'timeFrame': '4 weeks', 'description': "The PAGI-SYM Severity index: Vomiting Severity is the participant's assessment of vomiting during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Vomiting Severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome."}, {'measure': 'PAGI-SYM Severity Index: Retching Severity', 'timeFrame': '4 weeks', 'description': "The PAGI-SYM Severity index: Retching Severity is the participant's assessment of retching (heaving as if to vomit, but nothing comes up) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Retching Severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome."}, {'measure': 'PAGI-SYM Severity Index: Stomach Fullness Severity', 'timeFrame': '4 weeks', 'description': "PAGI-SYM Severity index: Stomach Fullness severity is the participant's assessment of stomach fullness during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Stomach Fullness severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome."}, {'measure': 'PAGI-SYM Severity Index: Unable to Finish Meal Severity', 'timeFrame': '4 weeks', 'description': "PAGI-SYM Severity index: Unable to Finish Meal severity is the participant's assessment of being unable to finish a normal size meal during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Unable to Finish Meal severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome."}, {'measure': 'PAGI-SYM Severity Index: Excessive Fullness Severity', 'timeFrame': '4 weeks', 'description': "PAGI-SYM Severity index: Excessive fullness severity is the participant's assessment of feeling excessively full after meals during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Excessive Fullness severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome."}, {'measure': 'PAGI-SYM Severity Index: Loss of Appetite Severity', 'timeFrame': '4 weeks', 'description': "PAGI-SYM Severity index: Loss of appetite severity is the participant's assessment of loss of appetite during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Loss of appetite severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome."}, {'measure': 'PAGI-SYM Severity Index: Bloating Severity', 'timeFrame': '4 weeks', 'description': "The PAGI-SYM Severity index: Bloating Severity is the participant's assessment of bloating (feel like you need to loosen your clothes) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Bloating Severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome."}, {'measure': 'PAGI-SYM Severity Index: Stomach Distention Severity', 'timeFrame': '4 weeks', 'description': "The PAGI-SYM Severity index: Stomach distention severity is the participant's assessment of stomach distention (stomach or belly visibly larger) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Stomach Distention severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome."}, {'measure': 'PAGI-SYM Severity Index: Upper Abdominal Pain Severity', 'timeFrame': '4 weeks', 'description': "The PAGI-SYM Severity index: Upper Abdominal Pain severity is the participant's assessment of upper abdominal pain (above the navel) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Upper Abdominal Pain severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome."}, {'measure': 'PAGI-SYM Severity Index: Upper Abdominal Discomfort Severity', 'timeFrame': '4 weeks', 'description': "The PAGI-SYM Severity index: Upper Abdominal Discomfort severity is the participant's assessment of upper abdominal discomfort (above the navel) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Upper Abdominal Discomfort severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome."}, {'measure': 'PAGI-SYM Severity Index: Lower Abdominal Pain Severity', 'timeFrame': '4 weeks', 'description': "The PAGI-SYM Severity index: Lower Abdominal Pain severity is the participant's assessment of lower abdominal pain (below the navel) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Lower Abdominal Pain severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome."}, {'measure': 'PAGI-SYM Severity Index: Lower Abdominal Discomfort Severity', 'timeFrame': '4 weeks', 'description': "The PAGI-SYM Severity index: Lower Abdominal Discomfort severity is the participant's assessment of lower abdominal discomfort (below the navel) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Lower Abdominal Discomfort severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome."}, {'measure': 'PAGI-SYM Severity Index: Heartburn During the Day Severity', 'timeFrame': '4 weeks', 'description': "The PAGI-SYM Severity index: Heartburn during the day severity is the participant's assessment of heartburn (burning pain rising in your chest or throat) during the day over the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Heartburn During the Day severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome."}, {'measure': 'PAGI-SYM Severity Index: Heartburn When Lying Down Severity', 'timeFrame': '4 weeks', 'description': "The PAGI-SYM Severity index: Heartburn when lying down severity is the participant's assessment of heartburn (burning pain rising in your chest or throat) when lying down over the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Heartburn When Lying Down severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome."}, {'measure': 'PAGI-SYM Severity Index: Chest Discomfort During the Day Severity', 'timeFrame': '4 weeks', 'description': "The PAGI-SYM Severity index: Chest discomfort during the day severity is the participant's assessment of feeling of discomfort inside the chest during the day over the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Chest Discomfort During the Day severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome."}, {'measure': 'PAGI-SYM Severity Index: Chest Discomfort During Sleep Time Severity', 'timeFrame': '4 weeks', 'description': "The PAGI-SYM Severity index: Chest discomfort during sleep severity is the participant's assessment of feeling of discomfort inside the chest at night (during sleep time) over the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Chest Discomfort During Sleep Time severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome."}, {'measure': 'PAGI-SYM Severity Index: Regurgitation During the Day Severity', 'timeFrame': '4 weeks', 'description': "The PAGI-SYM Severity index: Regurgitation during the day severity is the participant's assessment of regurgitation or reflux (fluid or liquid from your stomach coming up into throat) during the day over the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Regurgitation During the Day severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome."}, {'measure': 'PAGI-SYM Severity Index: Regurgitation When Lying Down Severity', 'timeFrame': '4 weeks', 'description': "The PAGI-SYM Severity index: Regurgitation when lying down severity is the participant's assessment of regurgitation or reflux (fluid or liquid from your stomach coming up into throat) when lying down over the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Regurgitation When Lying Down severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome."}, {'measure': 'PAGI-SYM Severity: Bitter Taste Severity', 'timeFrame': '4 weeks', 'description': "The PAGI-SYM Severity index: Bitter Taste severity is the participant's assessment of bitter, acid, or sour taste in mouth during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Bitter Taste Severity score, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome."}, {'measure': 'PAGI-SYM Severity Index: Constipation Severity', 'timeFrame': '4 weeks', 'description': "The PAGI-SYM Severity index: Constipation severity is the participant's assessment of constipation during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Constipation Severity score, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome."}, {'measure': 'PAGI-SYM Severity Index: Diarrhea Severity', 'timeFrame': '4 weeks', 'description': "The PAGI-SYM Severity index: Diarrhea severity is the participant's assessment of constipation during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Diarrhea Severity score, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome."}, {'measure': 'Gastrointestinal Symptom Rating Scale (GSRS): Total Score', 'timeFrame': '4 weeks', 'description': 'The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire for participants with gastrointestinal discomfort. The GSRS Total Score is the average of the 15 items. Each item is rated on a 0 to 7 scale, where 0 indicates no discomfort and 7 indicates very severe discomfort. The range of scores is 0 to 7, where higher scores are considered a worse outcome.The outcome measure, change from baseline in GSRS Total Score, has a possible range from -7 to +7, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.'}, {'measure': 'Gastrointestinal Symptom Rating Scale (GSRS): Reflux Score', 'timeFrame': '4 weeks', 'description': 'The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire for participants with gastrointestinal discomfort. The GSRS Reflux Score is a measure of how bothered the participant has been by acid reflux during the past week. The range of scores is 0 to 7, where 0 indicates no discomfort and 7 indicates very severe discomfort. Higher scores are considered a worse outcome.The outcome measure, change from baseline in GSRS Reflux Score, has a possible range from -7 to +7, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.'}, {'measure': 'Gastrointestinal Symptom Rating Scale (GSRS): Abdominal Pain Score', 'timeFrame': '4 week', 'description': 'The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire for participants with gastrointestinal discomfort. The GSRS Abdominal Pain Score is a measure of how bothered the participant has been by pain or discomfort in the upper abdomen or pit of the stomach during the past week. The range of scores is 0 to 7, where 0 indicates no discomfort and 7 indicates very severe discomfort. Higher scores are considered a worse outcome.The outcome measure, change from baseline in GSRS Abdominal Pain Score, has a possible range from -7 to +7, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.'}, {'measure': 'Gastrointestinal Symptom Rating Scale (GSRS): Indigestion Score', 'timeFrame': '4 weeks', 'description': 'The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire for participants with gastrointestinal discomfort. The GSRS Indigestion Score is a measure of how bothered the participant has been by indigestion during the past week. The range of scores is 0 to 7, where 0 indicates no discomfort and 7 indicates very severe discomfort. Higher scores are considered a worse outcome.The outcome measure, change from baseline in GSRS Indigestion Score, has a possible range from -7 to +7, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.'}, {'measure': 'Gastrointestinal Symptom Rating Scale (GSRS): Diarrhea Score', 'timeFrame': '4 weeks', 'description': 'The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire for participants with gastrointestinal discomfort. The GSRS Diarrhea Score is a measure of how bothered the participant has been by diarrhea during the past week. The range of scores is 0 to 7, where 0 indicates no discomfort and 7 indicates very severe discomfort. Higher scores are considered a worse outcome.The outcome measure, change from baseline in GSRS Diarrhea Score, has a possible range from -7 to +7, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.'}, {'measure': 'Gastrointestinal Symptom Rating Scale (GSRS): Constipation Score', 'timeFrame': '4 weeks', 'description': 'The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire for participants with gastrointestinal discomfort. The GSRS Constipation Score is a measure of how bothered the participant has been by constipation during the past week. The range of scores is 0 to 7, where 0 indicates no discomfort and 7 indicates very severe discomfort. Higher scores are considered a worse outcome.The outcome measure, change from baseline in GSRS Constipation Score, has a possible range from -7 to +7, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.'}, {'measure': 'Brief Pain Inventory: Severity Score', 'timeFrame': '4 weeks', 'description': 'The Brief Pain Inventory: Severity Score is the average of four questions in which the participant rates his or her pain: the worse pain in the past 24 hours, the least pain in the past 24 hours, average pain, and pain right now. The range of possible scores is 0 to 10, with higher scores indicating more severe pain. The outcome measure, change from baseline in Brief Pain Inventory Severity Score, has a possible range from -10 to +10, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.'}, {'measure': 'Brief Pain Inventory: Interference Score', 'timeFrame': '4 weeks', 'description': 'The Brief Pain Inventory: Interference Score is the average of seven questions in which the participant rates the degree to which his or her pain interferes with daily functions and mood: general activity, mood, walking ability, normal work, relationships, sleep, enjoyment of life. The range of possible scores is 0 to 10, with higher scores indicating more interference caused by pain. The outcome measure, change from baseline in Brief Pain Inventory Interference Score, has a possible range from -10 to +10, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.'}, {'measure': 'Beck Depression Inventory (BDI) Score', 'timeFrame': '4 weeks', 'description': 'The Beck Depression Inventory (BDI) survey is comprised of 21 multiple choice questions that relate to depression, cognition, and physical well-being and is used to quantify depression. The BDI total score is the sum of the 21 items, where each item ranges from 0 to 3 (lower scores are less severe, higher scores are more severe). The range for the BDI total score is 0 to 63, where lower scores indicate less depression and higher scores indicate more severe depression. The outcome measure, change from baseline in BDI score, has a possible range from -63 to +63, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.'}, {'measure': 'State-Trait Anxiety Inventory (STAI): State Anxiety Score', 'timeFrame': '4 weeks', 'description': 'The State-Trait Anxiety Inventory (STAI): State anxiety score is the sum of scores from 20 questions relating to state anxiety, which is a temporary state varying in intensity. The possible range of scores is from 20 to 80, with increasing scores considered a worse outcome. The outcome measure, change from baseline in STAI State Anxiety score, has a possible range from -60 to +60, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.'}, {'measure': 'State-Trait Anxiety Inventory (STAI): Trait Anxiety Score', 'timeFrame': '4 weeks', 'description': 'The State-Trait Anxiety Inventory (STAI): Trait anxiety score is the sum of scores from 20 questions pertaining to trait anxiety, which is a general propensity to be anxious. The possible range of scores is from 20 to 80, with increasing scores considered a worse outcome. The outcome measure, change from baseline in STAI Trait Anxiety score, has a possible range from -60 to +60, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.'}, {'measure': 'Satiety Test, Volume Consumed', 'timeFrame': '4 weeks', 'description': 'The Satiety Test measures the total volume of liquid (Ensure) that the participant is able to consume. The participant drinks 150 mL of Ensure every 5 minutes until he/she is completely full. The outcome measure is the change from baseline in volume of liquid (Ensure) consumed (mL), where positive values indicate a positive outcome (improvement).'}, {'measure': 'Electrogastrography (EGG): Bradygastria (1-<2.5 Cpm) at 4 Weeks, Baseline Measurement', 'timeFrame': '4 weeks', 'description': "Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. Normal pacing is considered 2.5-3.7 cycles per minute (cpm). Bradygastria is when the rate of electrical activity in the stomach is \\<2.5 cycles per minute for at least 1 minute (a decrease in electrical activity in the stomach). The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (here, baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where negative values for bradygastria indicate improvement (less time in a dysrhythmic state)."}, {'measure': 'Electrogastrography (EGG): Bradygastria (1-<2.5 Cpm) at 4 Weeks, 0-30 Post-satiety Measurement', 'timeFrame': '4 weeks', 'description': "Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. The 0-30 post-satiety measurement of the test is that taken 30 minutes after the participant consumes Ensure until feeling completely full. Normal pacing is considered 2.5-3.7 cycles per minute (cpm). Bradygastria is when the rate of electrical activity in the stomach is \\<2.5 cycles per minute for at least 1 minute. Average power in frequency region is the % of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (baseline refers to test performed during screening, not baseline value of the EGG test) in % of time with frequencies in the ranges. Negative values for bradygastria indicate improvement (less time in a dysrhythmic state)."}, {'measure': 'Electrogastrography (EGG): Normogastria (2.5-<3.8 Cpm) at 4 Weeks, Baseline Measurement', 'timeFrame': '4 weeks', 'description': "Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. Normal pacing (normogastria) is considered 2.5-3.7 cycles per minute (cpm). The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (here, baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where positive values for normal rates indicate an increase in the normal pacing (improvement)."}, {'measure': 'Electrogastrography (EGG): Normogastria (2.5-<3.8 Cpm) at 4 Weeks, 0-30 Post-satiety Measurement', 'timeFrame': '4 weeks', 'description': "Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. The 0-30 post-satiety measurement that taken 30 minutes after the participant consumes Ensure until feeling completely full. Normal pacing (normogastria) is considered 2.5-3.7 cycles per minute (cpm). The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where positive values for normal rates indicate an increase in the normal pacing (improvement)."}, {'measure': 'Electrogastrography (EGG): Tachygastria (3.8-10 Cpm) at 4 Weeks, Baseline Measurement', 'timeFrame': '4 weeks', 'description': "Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. Normal pacing is considered 2.5-3.7 cycles per minute (cpm). Tachygastria is when the rate of electrical activity in the stomach is 3.8-10 cycles per minute for at least 1 minute (an increase in electrical activity in the stomach). The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (here, baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where negative values for tachygastria indicate improvement (less time in a dysrhythmic state)."}, {'measure': 'Electrogastrography (EGG): Tachygastria (3.8-10 Cpm) at 4 Weeks, 0-30 Post-satiety Measurement', 'timeFrame': '4 weeks', 'description': "Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. The 0-30 post-satiety measurement that taken 30 minutes after the participant consumes Ensure until feeling completely full. Normal pacing is considered 2.5-3.7 cycles per minute (cpm). Tachygastria is when the rate of electrical activity in the stomach is 3.8-10 cycles per minute for at least 1 minute (an increase in electrical activity in the stomach). The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (here, baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where negative values for tachygastria indicate improvement (less time in a dysrhythmic state)."}, {'measure': 'Electrogastrography (EGG): Duodenal (>10-15 Cpm) at 4 Weeks, Baseline Measurement', 'timeFrame': '4 weeks', 'description': "Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. Normal pacing is considered 2.5-3.7 cycles per minute (cpm). Duodenal is when the rate of electrical activity in the stomach is \\>10-15 cycles per minute for at least 1 minute. The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (here, baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where negative values for duodenal indicate improvement (less time in a dysrhythmic state)."}, {'measure': 'Electrogastrography (EGG): Duodenal (>10-15 Cpm) at 4 Weeks, 0-30 Post-satiety Measurement', 'timeFrame': '4 weeks', 'description': "Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. The 0-30 post-satiety measurement that taken 30 minutes after the participant consumes Ensure until feeling completely full. Normal pacing is considered 2.5-3.7 cycles per minute (cpm). Duodenal is when the rate of electrical activity in the stomach is \\>10-15 cycles per minute for at least 1 minute. The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (here, baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where negative values for duodenal indicate improvement (less time in a dysrhythmic state)."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['gastroparesis', 'nausea', 'vomiting'], 'conditions': ['Gastroparesis']}, 'referencesModule': {'references': [{'pmid': '29111115', 'type': 'DERIVED', 'citation': 'Pasricha PJ, Yates KP, Sarosiek I, McCallum RW, Abell TL, Koch KL, Nguyen LAB, Snape WJ, Hasler WL, Clarke JO, Dhalla S, Stein EM, Lee LA, Miriel LA, Van Natta ML, Grover M, Farrugia G, Tonascia J, Hamilton FA, Parkman HP; NIDDK Gastroparesis Clinical Research Consortium (GpCRC). Aprepitant Has Mixed Effects on Nausea and Reduces Other Symptoms in Patients With Gastroparesis and Related Disorders. Gastroenterology. 2018 Jan;154(1):65-76.e11. doi: 10.1053/j.gastro.2017.08.033. Epub 2017 Oct 28.'}], 'seeAlsoLinks': [{'url': 'https://jhuccs1.us/gpcrc/', 'label': 'Gastroparesis Clinical Research Consortium website'}]}, 'descriptionModule': {'briefSummary': 'The principal objective of this multicenter, randomized, placebo-controlled trial is to evaluate whether 4 weeks of treatment with aprepitant will improve nausea as compared with placebo in patients with symptoms of chronic nausea and vomiting of presumed gastric origin.', 'detailedDescription': 'APRON is a multicenter, randomized, double-masked, placebo controlled trial of 4 weeks of treatment with aprepitant or placebo for patients with symptoms of gastroparesis and related disorders. Screening for eligibility and collection of baseline data will span up to 4 weeks after obtaining informed consent and registration. Eligible patients will consist of patients with symptoms of gastroparesis and will be randomized to either aprepitant (125 mg per day) or placebo for 4 weeks.\n\nThe symptoms will be measured with the Gastroparesis Cardinal Symptom Index Daily Diary (GCSIDD) for one week at baseline and for four weeks after randomization. In addition, the nausea symptom will be measured daily on a 0 to 100 mm visual analog scale (VAS) for one week at baseline and daily for four weeks after randomization. There will be a 2 week washout period at the end of the treatment to ensure patient safety following the end of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older at registration\n* Gastric emptying scintigraphy within 2 years of registration\n* Normal upper endoscopy or upper GI series within 2 years of registration\n* Symptoms of chronic nausea or vomiting compatible with gastroparesis or other functional gastric disorder for at least 6 months (does not have to be contiguous) prior to registration with Gastroparesis Cardinal Symptom Index (GCSI) score of greater than or equal to 21\n* Significant nausea defined with a visual analog scale (VAS) score of greater than or equal to 25 mm on a 0 to 100 mm scale\n\nExclusion Criteria:\n\n* Another active disorder which could explain symptoms in the opinion of the investigator\n* Use of narcotics more than 3 days per week\n* Significant hepatic injury as defined by significant alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevations of greater than 2x the upper limit of normal (ULN) or a Child-Pugh score of 10 or greater\n* Contraindications to aprepitant such as hypersensitivity or allergy\n* Concurrent use of warfarin, pimozide, terfenadine, astemizole, or cisapride\n* Pregnancy or nursing\n* Any other condition, which in the opinion of the investigator would impede compliance or hinder the completion of the study\n* Failure to give informed consent'}, 'identificationModule': {'nctId': 'NCT01149369', 'acronym': 'APRON', 'briefTitle': 'Aprepitant for the Relief of Nausea in Patients With Chronic Nausea and Vomiting of Presumed Gastric Origin Trial', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)'}, 'officialTitle': 'Aprepitant for the Relief of Nausea in Patients With Chronic Nausea and Vomiting of Presumed Gastric Origin: A Multicenter, Randomized, Double-Masked, Placebo-Controlled Trial', 'orgStudyIdInfo': {'id': 'IND - DK-GpCRC-4APRON'}, 'secondaryIdInfos': [{'id': 'U01DK073983', 'link': 'https://reporter.nih.gov/quickSearch/U01DK073983', 'type': 'NIH'}, {'id': 'U01DK073975', 'link': 'https://reporter.nih.gov/quickSearch/U01DK073975', 'type': 'NIH'}, {'id': 'U01DK073985', 'link': 'https://reporter.nih.gov/quickSearch/U01DK073985', 'type': 'NIH'}, {'id': 'U01DK074007', 'link': 'https://reporter.nih.gov/quickSearch/U01DK074007', 'type': 'NIH'}, {'id': 'U01DK073974', 'link': 'https://reporter.nih.gov/quickSearch/U01DK073974', 'type': 'NIH'}, {'id': 'U01DK074008', 'link': 'https://reporter.nih.gov/quickSearch/U01DK074008', 'type': 'NIH'}, {'id': 'U01DK074035', 'link': 'https://reporter.nih.gov/quickSearch/U01DK074035', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Aprepitant', 'description': 'Aprepitant 125 mg per day', 'interventionNames': ['Drug: Aprepitant']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Aprepitant-placebo', 'description': 'Placebo aprepitant 125mg per day', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Aprepitant', 'type': 'DRUG', 'otherNames': ['Emend'], 'description': 'Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks', 'armGroupLabels': ['Aprepitant']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks', 'armGroupLabels': ['Aprepitant-placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'California Pacific Medical Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94305-5187', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Bayview Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Medical Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Health Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Temple University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '79905', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Tech University Health Sciences Center', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}], 'overallOfficials': [{'name': 'Frank Hamilton, MD, MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)'}]}, 'ipdSharingStatementModule': {'url': 'https://www.niddkrepository.org/home/', 'infoTypes': ['STUDY_PROTOCOL', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'The primary analysis analytic dataset will be available at the NIDDK Central Repository approximately 6 months after publication. The complete study dataset is due approximately 2 years post study publication.', 'ipdSharing': 'YES', 'description': 'Data will be deposited with the NIDDK Data Repository at the end of the funding cycle.', 'accessCriteria': 'The NIDDDK Central Repository staff is responsible for review of requests for use of the APRON public access datasets. A NIDDK SDUC form must be submitted.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}