Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2026-02-02 @ 5:21 PM
Study NCT ID:
NCT02646566
Status:
COMPLETED
Last Update Posted:
2019-01-22
First Post:
2016-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of APD421 as PONV Treatment (Prior Prophylaxis)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D014839', 'term': 'Vomiting'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GabrielFox@acaciapharma.com', 'phone': '01223875919764', 'title': 'Dr Gabriel Fox', 'organization': 'Acacia Pharma'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'There were no limitations or caveats with this study'}}, 'adverseEventsModule': {'timeFrame': '7 days', 'description': 'Any AE that is serious, occurring during the relevant study period (from study drug administration to 7-day follow-up), irrespective of the treatment received by the subject, must be reported to the Pharmacovigilance provider within 24 hours', 'eventGroups': [{'id': 'EG000', 'title': 'APD421 IV 5mg', 'description': 'IV dose of APD421 5mg (IV dose)- was administered to each patient in a double-blind fashion, by slow IV push over about two minutes into a peripheral or central venous cannula.', 'otherNumAtRisk': 237, 'deathsNumAtRisk': 237, 'otherNumAffected': 64, 'seriousNumAtRisk': 237, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'APD421 IV 10mg', 'description': 'IV dose of APD421 10mg (IV dose)- was administered to each patient in a double-blind fashion by slow IV push over about two minutes into a peripheral or central venous cannula.', 'otherNumAtRisk': 230, 'deathsNumAtRisk': 230, 'otherNumAffected': 66, 'seriousNumAtRisk': 230, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Placebo', 'description': 'IV dose of Placebo (IV dose)- was administered to each patient in a double-blind fashion by slow IV push over about two minutes into a peripheral or central venous cannula.', 'otherNumAtRisk': 235, 'deathsNumAtRisk': 235, 'otherNumAffected': 78, 'seriousNumAtRisk': 235, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numEvents': 33, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 28, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 32, 'numAffected': 30}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Infusion site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'seriousEvents': [{'term': 'Anastomosis Insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Non-infectious gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Unspecified Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Intra-abdominal Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Intractable vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Post procedural hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abscess Presacral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Fatty tissue prolapse at the tempral lobe', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Numbness in the leg', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Postoperative rise in creatinine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Post cholecystectomy bile leak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Postoperative Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastrointestinal bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Complete Response (Success of Initial PONV Treatment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}, {'value': '235', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'APD421 5mg', 'description': 'APD421 5mg administered as a single, slow intravenous (IV) push over about two minutes'}, {'id': 'OG001', 'title': 'APD421 10mg', 'description': 'APD421 10mg administered as a single, slow intravenous (IV) push over about two minutes'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching placebo administered as a single, slow, IV push over about two minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG001', 'OG002'], 'pValueComment': "One-sided p-value. After adjustment for multiplicity using Hommel's method. (Note: unadjusted p value = 0.003) A priori threshold for statistical significance = 0.025.", 'groupDescription': "The primary efficacy analysis was a comparison of the incidence of the primary efficacy variable between the two groups that received APD421 and the group that received placebo, using Pearson's χ2 test. The threshold for determining statistical significance in the comparison of incidence of success between the active and placebo groups (the primary efficacy analysis) was a p-value of 2.5% one-sided.", 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.109', 'groupIds': ['OG000', 'OG002'], 'pValueComment': "One-sided p-value. After adjustment for multiplicity using Hommel's method. (Note: unadjusted p value = 0.109) A priori threshold for statistical significance = 0.025.", 'groupDescription': "The primary efficacy analysis was a comparison of the incidence of the primary efficacy variable between the two groups that received APD421 and the group that received placebo, using Pearson's χ2 test. The threshold for determining statistical significance in the comparison of incidence of success between the active and placebo groups (the primary efficacy analysis) was a p-value of 2.5% one-sided.", 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0-24 hours after administration of study medication', 'description': 'The primary efficacy variable was the dichotomous variable: success or failure of initial PONV treatment, where success is defined as no emetic episodes (vomiting or retching) from 30 minutes\\* to 24 hours after administration of study medication and no administration of anti-emetic rescue medication at any time in the 24-hour period after administration of study medication.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Complete Response 0-2 Hrs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}, {'value': '235', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'APD421 5mg', 'description': 'APD421 5mg administered as a single, slow intravenous (IV) push over about two minutes'}, {'id': 'OG001', 'title': 'APD421 10mg', 'description': 'APD421 10mg administered as a single, slow intravenous (IV) push over about two minutes'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching placebo administered as a single, slow, IV push over about two minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '134', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.059', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0-2 hours after administration of study medication', 'description': 'Success of initial PONV treatment, where success is defined as no emetic episodes (vomiting or retching) from 30 minutes\\* to 2 hours after administration of study medication and no administration of anti-emetic rescue medication at any time in the 2-hour period after administration of study medication.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Complete Response 0-4 Hrs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}, {'value': '235', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'APD421 5mg', 'description': 'APD421 5mg administered as a single, slow intravenous (IV) push over about two minutes'}, {'id': 'OG001', 'title': 'APD421 10mg', 'description': 'APD421 10mg administered as a single, slow intravenous (IV) push over about two minutes'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching placebo administered as a single, slow, IV push over about two minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.053', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0-4 hours after administration of study medication', 'description': 'Success of initial PONV treatment, where success is defined as no emetic episodes (vomiting or retching) from 30 minutes\\* to 4 hours after administration of study medication and no administration of anti-emetic rescue medication at any time in the 4-hour period after administration of study medication.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Complete Response 0-6 Hrs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}, {'value': '235', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'APD421 5mg', 'description': 'APD421 5mg administered as a single, slow intravenous (IV) push over about two minutes'}, {'id': 'OG001', 'title': 'APD421 10mg', 'description': 'APD421 10mg administered as a single, slow intravenous (IV) push over about two minutes'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching placebo administered as a single, slow, IV push over about two minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.021', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0-6 hours after administration of study medication', 'description': 'Success of initial PONV treatment, where success is defined as no emetic episodes (vomiting or retching) from 30 minutes to 6 hours after administration of study medication and no administration of anti-emetic rescue medication at any time in the 6-hour period after administration of study medication.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified ITT population'}, {'type': 'SECONDARY', 'title': 'Time to Treatment Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}, {'value': '235', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'APD421 5mg', 'description': 'APD421 5mg administered as a single, slow intravenous (IV) push over about two minutes'}, {'id': 'OG001', 'title': 'APD421 10mg', 'description': 'APD421 10mg administered as a single, slow intravenous (IV) push over about two minutes'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching placebo administered as a single, slow, IV push over about two minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '188', 'comment': 'Treatment failure occurred in less than 75% of patients', 'groupId': 'OG000', 'lowerLimit': '43', 'upperLimit': 'NA'}, {'value': '443', 'comment': 'Treatment failure occurred in less than 75% of patients', 'groupId': 'OG001', 'lowerLimit': '70', 'upperLimit': 'NA'}, {'value': '120', 'comment': 'Treatment failure occurred in less than 75% of patients', 'groupId': 'OG002', 'lowerLimit': '35', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.084', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '0-24 hours after study drug administration', 'description': 'Time to first violation of the criteria for complete response', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Incidence of Emesis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}, {'value': '235', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'APD421 5mg', 'description': 'APD421 5mg administered as a single, slow intravenous (IV) push over about two minutes'}, {'id': 'OG001', 'title': 'APD421 10mg', 'description': 'APD421 10mg administered as a single, slow intravenous (IV) push over about two minutes'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching placebo administered as a single, slow, IV push over about two minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.004', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 mins to 24 hours after study drug administration', 'description': 'Number of patients experiencing vomiting or retching during the time period from 30 minutes to 24 hours after administration of study medication', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients Receiving Rescue Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}, {'value': '235', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'APD421 5mg', 'description': 'APD421 5mg administered as a single, slow intravenous (IV) push over about two minutes'}, {'id': 'OG001', 'title': 'APD421 10mg', 'description': 'APD421 10mg administered as a single, slow intravenous (IV) push over about two minutes'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching placebo administered as a single, slow, IV push over about two minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '155', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.179', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0-24 hours after study drug administration', 'description': 'Number of patients receiving pre-specified anti-emetic rescue medication at any time in the 24 hours post-treatment period', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Patients With an Incidence of Significant Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}, {'value': '235', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'APD421 5mg', 'description': 'APD421 5mg administered as a single, slow intravenous (IV) push over about two minutes'}, {'id': 'OG001', 'title': 'APD421 10mg', 'description': 'APD421 10mg administered as a single, slow intravenous (IV) push over about two minutes'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching placebo administered as a single, slow, IV push over about two minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.009', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.315', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 mins to 24 hours after study drug administration', 'description': 'Number of patients with nausea score ≥4 on an 11-point verbal rating scale (0=no nausea, 10=worst possible nausea, therefore higher value is worse outcome) during the time period from 30 minutes to 24 hours after administration of study medication.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Patients With an Incidence of Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}, {'value': '235', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'APD421 5mg', 'description': 'APD421 5mg administered as a single, slow intravenous (IV) push over about two minutes'}, {'id': 'OG001', 'title': 'APD421 10mg', 'description': 'APD421 10mg administered as a single, slow intravenous (IV) push over about two minutes'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching placebo administered as a single, slow, IV push over about two minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '183', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.065', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.520', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 mins to 24 hours after drug administration', 'description': 'Number of patients with nausea score ≥1 on an 11-point verbal rating scale (0=no nausea, 10=worst possible nausea, therefore higher value is worse outcome) during the time period from 30 minutes to 24 hours after administration of study medication.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified ITT population'}, {'type': 'SECONDARY', 'title': 'Maximum Severity of Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}, {'value': '235', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'APD421 5mg', 'description': 'APD421 5mg administered as a single, slow intravenous (IV) push over about two minutes'}, {'id': 'OG001', 'title': 'APD421 10mg', 'description': 'APD421 10mg administered as a single, slow intravenous (IV) push over about two minutes'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching placebo administered as a single, slow, IV push over about two minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'spread': '3.08', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '3.03', 'groupId': 'OG001'}, {'value': '4.2', 'spread': '3.04', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.008', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.420', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '30 mins to 24 hours after study drug administration', 'description': 'Highest recorded nausea score on an 11-point verbal rating scale (0=no nausea, 10=worst possible nausea, therefore higher value is worse outcome) during the time period from 30 minutes to 24 hours after administration of study medication.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified ITT population'}, {'type': 'SECONDARY', 'title': 'Evolution Score of Nausea (0-180 Mins)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}, {'value': '235', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'APD421 5mg', 'description': 'APD421 5mg administered as a single, slow intravenous (IV) push over about two minutes'}, {'id': 'OG001', 'title': 'APD421 10mg', 'description': 'APD421 10mg administered as a single, slow intravenous (IV) push over about two minutes'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching placebo administered as a single, slow, IV push over about two minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '6994.7', 'spread': '5659.6', 'groupId': 'OG000'}, {'value': '5637.9', 'spread': '6046.6', 'groupId': 'OG001'}, {'value': '7629.2', 'spread': '6640.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.258', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '0-180 minutes after study drug administration', 'description': 'The evolution score of nausea was calculated as the area under the curve (AUC) of the nausea scores on a scale 0-10 (where 0 is no nausea and 10 is the worst nausea imaginable) obtained at five pre-planned time points: pre-dose (0-min), and 5, 15 and 30 minutes and 2 hours after administration of study medication, as well as any spontaneously reported episodes of nausea during the time period, plotted against time. A higher score represents a worse outcome.', 'unitOfMeasure': 'Score on a scale*min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified ITT population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'APD421 5mg', 'description': 'APD421 5mg administered as a single, slow intravenous (IV) push over about two minutes'}, {'id': 'FG001', 'title': 'APD421 10mg', 'description': 'APD421 10mg administered as a single,slow intravenous (IV) push over about two minutes'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Matching Placebo administered as a single, slow intravenous (IV) push over about two minutes'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '237'}, {'groupId': 'FG001', 'numSubjects': '230'}, {'groupId': 'FG002', 'numSubjects': '235'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '231'}, {'groupId': 'FG001', 'numSubjects': '226'}, {'groupId': 'FG002', 'numSubjects': '230'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Treatment failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Estimated recruitment was 700, to deliver 690 evaluable, randomised patients, providing an average of 230 evaluable patients in each of the three groups. The number of randomised patients planned per country was as follows: Germany, 190; France, 15; Canada, 100; and USA, 395', 'preAssignmentDetails': 'Three patients were randomised but not dosed: 2 due to withdrawal of consent, 1 for other reasons.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'BG000'}, {'value': '230', 'groupId': 'BG001'}, {'value': '235', 'groupId': 'BG002'}, {'value': '702', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'APD421 5mg', 'description': 'APD421 5mg administered as a single, slow intravenous (IV) push over about two minutes'}, {'id': 'BG001', 'title': 'APD421 10mg', 'description': 'APD421 10mg administered as a single, slow intravenous (IV) push over about two minutes'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Matching placebo administered as a single, slow, IV push over about two minutes'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '214', 'groupId': 'BG000'}, {'value': '204', 'groupId': 'BG001'}, {'value': '216', 'groupId': 'BG002'}, {'value': '634', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.8', 'spread': '13.12', 'groupId': 'BG000'}, {'value': '46.9', 'spread': '13.03', 'groupId': 'BG001'}, {'value': '46.0', 'spread': '13.38', 'groupId': 'BG002'}, {'value': '46.3', 'spread': '13.17', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '213', 'groupId': 'BG000'}, {'value': '208', 'groupId': 'BG001'}, {'value': '212', 'groupId': 'BG002'}, {'value': '633', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '69', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '196', 'groupId': 'BG000'}, {'value': '189', 'groupId': 'BG001'}, {'value': '193', 'groupId': 'BG002'}, {'value': '578', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 705}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-07', 'studyFirstSubmitDate': '2016-01-04', 'resultsFirstSubmitDate': '2018-09-26', 'studyFirstSubmitQcDate': '2016-01-04', 'lastUpdatePostDateStruct': {'date': '2019-01-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-11-27', 'studyFirstPostDateStruct': {'date': '2016-01-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Complete Response (Success of Initial PONV Treatment)', 'timeFrame': '0-24 hours after administration of study medication', 'description': 'The primary efficacy variable was the dichotomous variable: success or failure of initial PONV treatment, where success is defined as no emetic episodes (vomiting or retching) from 30 minutes\\* to 24 hours after administration of study medication and no administration of anti-emetic rescue medication at any time in the 24-hour period after administration of study medication.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Complete Response 0-2 Hrs', 'timeFrame': '0-2 hours after administration of study medication', 'description': 'Success of initial PONV treatment, where success is defined as no emetic episodes (vomiting or retching) from 30 minutes\\* to 2 hours after administration of study medication and no administration of anti-emetic rescue medication at any time in the 2-hour period after administration of study medication.'}, {'measure': 'Number of Participants With Complete Response 0-4 Hrs', 'timeFrame': '0-4 hours after administration of study medication', 'description': 'Success of initial PONV treatment, where success is defined as no emetic episodes (vomiting or retching) from 30 minutes\\* to 4 hours after administration of study medication and no administration of anti-emetic rescue medication at any time in the 4-hour period after administration of study medication.'}, {'measure': 'Number of Participants With Complete Response 0-6 Hrs', 'timeFrame': '0-6 hours after administration of study medication', 'description': 'Success of initial PONV treatment, where success is defined as no emetic episodes (vomiting or retching) from 30 minutes to 6 hours after administration of study medication and no administration of anti-emetic rescue medication at any time in the 6-hour period after administration of study medication.'}, {'measure': 'Time to Treatment Failure', 'timeFrame': '0-24 hours after study drug administration', 'description': 'Time to first violation of the criteria for complete response'}, {'measure': 'Number of Patients With Incidence of Emesis', 'timeFrame': '30 mins to 24 hours after study drug administration', 'description': 'Number of patients experiencing vomiting or retching during the time period from 30 minutes to 24 hours after administration of study medication'}, {'measure': 'Number of Patients Receiving Rescue Medication', 'timeFrame': '0-24 hours after study drug administration', 'description': 'Number of patients receiving pre-specified anti-emetic rescue medication at any time in the 24 hours post-treatment period'}, {'measure': 'Number of Patients With an Incidence of Significant Nausea', 'timeFrame': '30 mins to 24 hours after study drug administration', 'description': 'Number of patients with nausea score ≥4 on an 11-point verbal rating scale (0=no nausea, 10=worst possible nausea, therefore higher value is worse outcome) during the time period from 30 minutes to 24 hours after administration of study medication.'}, {'measure': 'Number of Patients With an Incidence of Nausea', 'timeFrame': '30 mins to 24 hours after drug administration', 'description': 'Number of patients with nausea score ≥1 on an 11-point verbal rating scale (0=no nausea, 10=worst possible nausea, therefore higher value is worse outcome) during the time period from 30 minutes to 24 hours after administration of study medication.'}, {'measure': 'Maximum Severity of Nausea', 'timeFrame': '30 mins to 24 hours after study drug administration', 'description': 'Highest recorded nausea score on an 11-point verbal rating scale (0=no nausea, 10=worst possible nausea, therefore higher value is worse outcome) during the time period from 30 minutes to 24 hours after administration of study medication.'}, {'measure': 'Evolution Score of Nausea (0-180 Mins)', 'timeFrame': '0-180 minutes after study drug administration', 'description': 'The evolution score of nausea was calculated as the area under the curve (AUC) of the nausea scores on a scale 0-10 (where 0 is no nausea and 10 is the worst nausea imaginable) obtained at five pre-planned time points: pre-dose (0-min), and 5, 15 and 30 minutes and 2 hours after administration of study medication, as well as any spontaneously reported episodes of nausea during the time period, plotted against time. A higher score represents a worse outcome.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Postoperative Nausea and Vomiting']}, 'descriptionModule': {'briefSummary': 'Double-blind, randomised, parallel-group, placebo-controlled, adaptive, seamless, dose-selecting study to compare the efficacy of APD421 to placebo as treatment of established PONV, in patients who have had prior PONV prophylaxis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Male or female patients ≥ 18 years of age\n* Provision of written informed consent\n* Patients scheduled to undergo elective surgery (open or laparoscopic technique) under general anaesthesia (other than total intravenous anaesthesia with propofol) expected to last at least one hour from induction of anaesthesia to extubation\n* Patients judged by the investigator to have a moderate or high risk of experiencing PONV. In forming this judgment, investigators should pay particular attention to risk factors such as a past history of PONV and/or motion sickness; habitual non-smoking status; female sex; and likely use of opioid analgesia post-operatively.\n* For females of child-bearing potential: ability and willingness to use a highly effective form of contraception (as defined in ICH M3 guidance, e.g., abstinence from sexual intercourse, surgical sterilisation (of subject or partner), combined oral contraceptive pill, a double-barrier method of contraception such as either an intra-uterine device (IUD) or an occlusive cap with spermicide, in conjunction with partner\'s use of a condom, or any other method or combination of methods with a failure rate generally considered to be \\<1% per year) between the date of screening and at least 48 hours after administration of study drug\n* In order to be eligible for randomisation, subjects must also:\n\n (i) have experienced a first episode of PONV not more than 24 hours after the end of their operation (wound closure) and prior to discharge from hospital ("qualifying PONV episode"), for which they have not already received any anti-emetic treatment; and (ii) not have received any dopamine-antagonist agent likely to prevent or treat nausea or vomiting (given as prophylaxis or otherwise) in the period from 24 hours prior to the start of their operation up to the time of the qualifying PONV episode.\n\nExclusion Criteria:\n\n* Patients scheduled to undergo transplant surgery or any surgery where post-operative emesis may pose a significant danger to the patient\n* Patients planned to receive only a local anaesthetic and/or regional neuraxial (intrathecal or epidural) block\n* Patients who have received APD421 active ingredient for any indication within the last 2 weeks\n* Patients who are allergic to APD421 active ingredient or any of the excipients of APD421\n* Patients with a significant, ongoing history of vestibular disease or dizziness\n* Patients with a known prolactin-dependent tumour (e.g. pituitary gland prolactinoma or breast cancer) or phaeochromocytoma.\n* Patients with documented or suspected alcohol or substance abuse within the past 6 months.\n* Patients with direct or indirect evidence of clinically significant hypokalaemia, such as a serum potassium level \\< 3.0 mmol/L.\n* Patients who have received in the post-operative period, and prior to receiving study drug, any medication with a substantial risk of inducing torsades de pointes, including Class Ia antiarrhythmic agents such as quinidine, disopyramide, procainamide; Class III antiarrhythmic agents such as amiodarone and sotalol; and other medications such as bepridil, cisapride, thioridazine, methadone, IV erythromycin, IV vincamine, halofantrine, pentamidine, sparfloxacin, etc.\n* Patients who have a documented, clinically significant cardiac arrhythmia or congenital long QT syndrome.\n* Patients who are pregnant or breast feeding.\n* Patients being treated with levodopa.\n* Patients diagnosed with Parkinson\'s disease.\n* Patients who have received emetogenic anti-cancer chemotherapy in the previous 4 weeks.\n* Patients with a history of epilepsy.\n* Any other concurrent disease or illness that, in the opinion of the investigator makes the patient unsuitable for the study.\n* Patients who have previously participated in this study or who have participated in another interventional clinical study involving pharmacological therapy within the previous 28 days (or longer exclusion period, if required by national or local regulations).\n* Where local laws/regulations require: patients under legal protection.'}, 'identificationModule': {'nctId': 'NCT02646566', 'briefTitle': 'Study of APD421 as PONV Treatment (Prior Prophylaxis)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Acacia Pharma Ltd'}, 'officialTitle': 'Randomised, Double-blind, Placebo-controlled Study of APD421 (Amisulpride for IV Injection) as Treatment of Established Post-operative Nausea and Vomiting, in Patients Who Have Had Prior Prophylaxis', 'orgStudyIdInfo': {'id': 'DP10019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'APD421 standard', 'description': 'Single (standard) dose IV APD421', 'interventionNames': ['Drug: APD421']}, {'type': 'EXPERIMENTAL', 'label': 'APD421 high', 'description': 'Single (high) dose IV APD421', 'interventionNames': ['Drug: APD421']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Single IV placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'APD421', 'type': 'DRUG', 'armGroupLabels': ['APD421 high', 'APD421 standard']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Jackson Memorial Hospital', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University School of Medicine', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'city': 'Strasbourg', 'country': 'France', 'facility': 'CHU de Hautepierre', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '08280', 'city': 'Aue', 'country': 'Germany', 'facility': 'HELIOS Klinikum Aue', 'geoPoint': {'lat': 50.59034, 'lon': 12.70657}}, {'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Universität Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'city': 'Marburg', 'country': 'Germany', 'facility': 'Philipps University', 'geoPoint': {'lat': 50.80904, 'lon': 8.77069}}], 'overallOfficials': [{'name': 'Gabriel Fox, MB BChir', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Acacia Pharma Ltd'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acacia Pharma Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}