Ignite Creation Date:
2025-12-25 @ 3:07 AM
Ignite Modification Date:
2025-12-26 @ 1:46 AM
Study NCT ID:
NCT00293033
Status:
COMPLETED
Last Update Posted:
2019-11-18
First Post:
2006-02-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of BEMA™ Fentanyl in the Treatment of Breakthrough Pain in Cancer Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005283', 'term': 'Fentanyl'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'larry.gever@meda.us', 'phone': '732-564-2400', 'title': 'Larry Gever, PharmD, Director, Medical Affairs', 'organization': 'Meda Pharmaceuticals Inc.'}, 'certainAgreement': {'otherDetails': 'The oral or written use of study results by the investigator are not permitted without the express written consent from BDSI. All data resulting from this study remain property of BDSI.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'There were no limitations or caveats.'}}, 'adverseEventsModule': {'timeFrame': 'A prior-treatment adverse event (AE) was defined as an AE that began before the first dose of the study drug. A treatment-emergent AE was defined as an AE that began on or after the initial dose of study medication up until the Follow-up Visit on Day 29.', 'description': 'At each visit, after the subject had an opportunity to spontaneously mention any problems, the investigator inquired about AEs by asking the following:\n\n1. Have you had any (other) medical problems since your last visit/assessment?\n2. Have you taken any new medications, other than those given to you in this study, since your last visit/assessment?', 'eventGroups': [{'id': 'EG000', 'title': 'Onsolis', 'description': 'All AEs were assigned to BEMA™ Fentanyl (Onsolis). Because of the multiple crossover design and the number of breakthrough pain episodes that usually occur during the day, it was likely that a subject would receive both active and placebo doses within a few hours of each other. Given the proximity of these different treatments, attempts to ascribe individual AEs to one treatment or another would be difficult, therefore, the chosen convention was to consider all AEs as occurring on active medication.', 'otherNumAtRisk': 151, 'otherNumAffected': 44, 'seriousNumAtRisk': 151, 'seriousNumAffected': 23}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 19, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}], 'seriousEvents': [{'term': 'Splenomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Gastrointestinal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Hematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Esophageal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Bile duct obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Failure to thrive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Vaginal cancer recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Grand mal convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Hemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Arterial thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Summary of Pain Intensity Differences (SPID)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}, {'units': 'Breakthrough Pain (BTP) Episodes', 'counts': [{'value': '394', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '47.9', 'spread': '3.87', 'groupId': 'OG000'}, {'value': '38.1', 'spread': '4.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.74', 'ciLowerLimit': '3.31', 'ciUpperLimit': '16.18', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.28', 'estimateComment': 'Onsolis minus placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'The SPID was analyzed using a mixed model of repeated measures with fixed effects for treatment, pooled site, and a random effect for subjects.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '0-30 minutes', 'description': 'Pain intensity (using an 11-point \\[0 = no pain to 10 = worst pain\\] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is\n\n-10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Breakthrough Pain (BTP) Episodes', 'denomUnitsSelected': 'Breakthrough Pain (BTP) Episodes', 'populationDescription': 'In double-blind period, subjects received 3 doses placebo and 6 doses Onsolis. Mean SPID of Onsolis episodes and mean SPID of placebo episodes are calculated per subject and are used in analysis.Missing data were imputed on an episode-by-episode basis by carrying forward last observed data value (last observation carried forward \\[LOCF\\]).'}, {'type': 'SECONDARY', 'title': 'SPID', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}, {'units': 'BTP Episodes', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '0.36', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.440', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.25', 'ciLowerLimit': '-0.40', 'ciUpperLimit': '0.91', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.33', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '0-5 minutes', 'description': 'Pain intensity (using an 11-point \\[0 = no pain to 10 = worst pain\\] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome.SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'BTP Episodes', 'denomUnitsSelected': 'BTP Episodes'}, {'type': 'SECONDARY', 'title': 'SPID', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}, {'units': 'BTP Episodes', 'counts': [{'value': '379', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '5.9', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '0.90', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.179', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '-0.44', 'ciUpperLimit': '2.33', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.70', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '0-10 minutes', 'description': 'Pain intensity (using an 11-point \\[0 = no pain to 10 = worst pain\\] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome.SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'BTP Episodes', 'denomUnitsSelected': 'BTP Episodes'}, {'type': 'SECONDARY', 'title': 'SPID', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}, {'units': 'BTP Episodes', 'counts': [{'value': '382', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '12.8', 'spread': '1.47', 'groupId': 'OG000'}, {'value': '10.4', 'spread': '1.61', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.047', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.32', 'ciLowerLimit': '0.04', 'ciUpperLimit': '4.61', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.16', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '0-15 minutes', 'description': 'Pain intensity (using an 11-point \\[0 = no pain to 10 = worst pain\\] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome.SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'BTP Episodes', 'denomUnitsSelected': 'BTP Episodes'}, {'type': 'SECONDARY', 'title': 'SPID', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}, {'units': 'BTP Episodes', 'counts': [{'value': '382', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '90.5', 'spread': '6.63', 'groupId': 'OG000'}, {'value': '70.8', 'spread': '7.41', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.68', 'ciLowerLimit': '8.50', 'ciUpperLimit': '30.86', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.70', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '0-45 minutes', 'description': 'Pain intensity (using an 11-point \\[0 = no pain to 10 = worst pain\\] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome.SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'BTP Episodes', 'denomUnitsSelected': 'BTP Episodes'}, {'type': 'SECONDARY', 'title': 'SPID', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}, {'units': 'BTP Episodes', 'counts': [{'value': '382', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '138.0', 'spread': '9.41', 'groupId': 'OG000'}, {'value': '106.0', 'spread': '10.58', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '31.98', 'ciLowerLimit': '15.85', 'ciUpperLimit': '48.12', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.23', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '0-60 minutes', 'description': 'Pain intensity (using an 11-point \\[0 = no pain to 10 = worst pain\\] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome.SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'BTP Episodes', 'denomUnitsSelected': 'BTP Episodes'}, {'type': 'SECONDARY', 'title': 'PID', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}, {'units': 'BTP Episodes', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo DIsc'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.06', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.517', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '5 minutes after dosing', 'description': 'Pain intensity (using an 11-point \\[0 = no pain to 10 = worst pain\\] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'BTP Episodes', 'denomUnitsSelected': 'BTP Episodes', 'populationDescription': 'During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.\n\nAll efficacy analyses were conducted using the intent-to-treat (ITT) population.\n\nLast observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage.'}, {'type': 'SECONDARY', 'title': 'PID', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}, {'units': 'BTP Episodes', 'counts': [{'value': '379', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.08', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.458', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '10 minutes after dosing', 'description': 'Pain intensity (using an 11-point \\[0 = no pain to 10 = worst pain\\] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'BTP Episodes', 'denomUnitsSelected': 'BTP Episodes'}, {'type': 'SECONDARY', 'title': 'PID', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}, {'units': 'BTP Episodes', 'counts': [{'value': '382', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.223', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '15 minutes after dosing', 'description': 'Pain intensity (using an 11-point \\[0 = no pain to 10 = worst pain\\] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'BTP Episodes', 'denomUnitsSelected': 'BTP Episodes'}, {'type': 'SECONDARY', 'title': 'PID', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}, {'units': 'BTP Episodes', 'counts': [{'value': '394', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '0.14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.015', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '30 minutes after dosing', 'description': 'Pain intensity (using an 11-point \\[0 = no pain to 10 = worst pain\\] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'BTP Episodes', 'denomUnitsSelected': 'BTP Episodes'}, {'type': 'SECONDARY', 'title': 'PID', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}, {'units': 'BTP Episodes', 'counts': [{'value': '404', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '0.17', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '45 minutes after dosing', 'description': 'Pain intensity (using an 11-point \\[0 = no pain to 10 = worst pain\\] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'BTP Episodes', 'denomUnitsSelected': 'BTP Episodes'}, {'type': 'SECONDARY', 'title': 'PID', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}, {'units': 'BTP Episodes', 'counts': [{'value': '408', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '0.18', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '60 minutes after dosing', 'description': 'Pain intensity (using an 11-point \\[0 = no pain to 10 = worst pain\\] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'BTP Episodes', 'denomUnitsSelected': 'BTP Episodes'}, {'type': 'SECONDARY', 'title': 'Pain Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}, {'units': 'BTP Episodes', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.06', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.193', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '5 minutes after dosing', 'description': 'Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief) at 5, 10, 15, 30, 45, and 60 minutes after taking the study medication or until rescue.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'BTP Episodes', 'denomUnitsSelected': 'BTP Episodes', 'populationDescription': 'During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.\n\nAll efficacy analyses were conducted using the intent-to-treat (ITT) population.\n\nLast observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage.'}, {'type': 'SECONDARY', 'title': 'Pain Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}, {'units': 'BTP Episodes', 'counts': [{'value': '379', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.06', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.113', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '10 minutes after dosing', 'description': 'Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief) at 5, 10, 15, 30, 45, and 60 minutes after taking the study medication or until rescue.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'BTP Episodes', 'denomUnitsSelected': 'BTP Episodes', 'populationDescription': 'During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.\n\nAll efficacy analyses were conducted using the intent-to-treat (ITT) population.\n\nLast observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage.'}, {'type': 'SECONDARY', 'title': 'Pain Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}, {'units': 'BTP Episodes', 'counts': [{'value': '382', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.07', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.192', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '15 minutes after dosing', 'description': 'Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief) at 5, 10, 15, 30, 45, and 60 minutes after taking the study medication or until rescue.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'BTP Episodes', 'denomUnitsSelected': 'BTP Episodes', 'populationDescription': 'During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.\n\nAll efficacy analyses were conducted using the intent-to-treat (ITT) population.\n\nLast observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage.'}, {'type': 'SECONDARY', 'title': 'Pain Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}, {'units': 'BTP Episodes', 'counts': [{'value': '394', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.08', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '30 minutes after dosing', 'description': 'Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief) at 5, 10, 15, 30, 45, and 60 minutes after taking the study medication or until rescue.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'BTP Episodes', 'denomUnitsSelected': 'BTP Episodes', 'populationDescription': 'During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.\n\nAll efficacy analyses were conducted using the intent-to-treat (ITT) population.\n\nLast observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage.'}, {'type': 'SECONDARY', 'title': 'Pain Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}, {'units': 'BTP Episodes', 'counts': [{'value': '404', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '0.09', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '45 minutes after dosing', 'description': 'Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief) at 5, 10, 15, 30, 45, and 60 minutes after taking the study medication or until rescue.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'BTP Episodes', 'denomUnitsSelected': 'BTP Episodes', 'populationDescription': 'During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.\n\nAll efficacy analyses were conducted using the intent-to-treat (ITT) population.\n\nLast observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage.'}, {'type': 'SECONDARY', 'title': 'Pain Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}, {'units': 'BTP Episodes', 'counts': [{'value': '409', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '0.09', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '60 minutes after dosing', 'description': 'Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief) at 5, 10, 15, 30, 45, and 60 minutes after taking the study medication or until rescue.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'BTP Episodes', 'denomUnitsSelected': 'BTP Episodes', 'populationDescription': 'During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.\n\nAll efficacy analyses were conducted using the intent-to-treat (ITT) population.\n\nLast observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage.'}, {'type': 'SECONDARY', 'title': 'Total Pain Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}, {'units': 'BTP Episodes', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '0.28', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.157', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '5 minutes', 'description': 'Total Pain Relief (TOTPAR) is calculated as the weighted sum of the pain relief (PR) of all time points at or prior to the time point of interest.Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief)compared to baseline (pre-dose)', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'BTP Episodes', 'denomUnitsSelected': 'BTP Episodes', 'populationDescription': 'During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.\n\nAll efficacy analyses were conducted using the intent-to-treat (ITT) population.\n\nLast observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage.'}, {'type': 'SECONDARY', 'title': 'Total Pain Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}, {'units': 'BTP Episodes', 'counts': [{'value': '379', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '6.1', 'spread': '0.40', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '0.54', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.278', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '10 minutes', 'description': 'Total Pain Relief (TOTPAR) is calculated as the weighted sum of the pain relief (PR) of all time points at or prior to the time point of interest. Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief)compared to baseline (pre-dose)', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'BTP Episodes', 'denomUnitsSelected': 'BTP Episodes', 'populationDescription': 'During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.\n\nAll efficacy analyses were conducted using the intent-to-treat (ITT) population.\n\nLast observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage.'}, {'type': 'SECONDARY', 'title': 'Total Pain Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}, {'units': 'BTP Episodes', 'counts': [{'value': '382', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '11.6', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '9.8', 'spread': '0.82', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.062', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '15 minutes', 'description': 'Total Pain Relief (TOTPAR) is calculated as the weighted sum of the pain relief (PR) of all time points at or prior to the time point of interest. Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief)compared to baseline (pre-dose)', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'BTP Episodes', 'denomUnitsSelected': 'BTP Episodes', 'populationDescription': 'During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.\n\nAll efficacy analyses were conducted using the intent-to-treat (ITT) population.\n\nLast observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage.'}, {'type': 'SECONDARY', 'title': 'Total Pain Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}, {'units': 'BTP Episodes', 'counts': [{'value': '394', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '36.1', 'spread': '1.30', 'groupId': 'OG000'}, {'value': '29.5', 'spread': '1.79', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '30 minutes', 'description': 'Total Pain Relief (TOTPAR) is calculated as the weighted sum of the pain relief (PR) of all time points at or prior to the time point of interest. Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief)compared to baseline (pre-dose)', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'BTP Episodes', 'denomUnitsSelected': 'BTP Episodes', 'populationDescription': 'During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.\n\nAll efficacy analyses were conducted using the intent-to-treat (ITT) population.\n\nLast observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage.'}, {'type': 'SECONDARY', 'title': 'Total Pain Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}, {'units': 'BTP Episodes', 'counts': [{'value': '404', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '64.2', 'spread': '2.05', 'groupId': 'OG000'}, {'value': '52.3', 'spread': '2.93', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '45 minutes', 'description': 'Total Pain Relief (TOTPAR) is calculated as the weighted sum of the pain relief (PR) of all time points at or prior to the time point of interest. Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief)compared to baseline (pre-dose)', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'BTP Episodes', 'denomUnitsSelected': 'BTP Episodes', 'populationDescription': 'During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.\n\nAll efficacy analyses were conducted using the intent-to-treat (ITT) population.\n\nLast observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage.'}, {'type': 'SECONDARY', 'title': 'Total Pain Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}, {'units': 'BTP Episodes', 'counts': [{'value': '409', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '94.8', 'spread': '2.84', 'groupId': 'OG000'}, {'value': '76.0', 'spread': '4.16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '60 minutes', 'description': 'Total Pain Relief (TOTPAR) is calculated as the weighted sum of the pain relief (PR) of all time points at or prior to the time point of interest. Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief)compared to baseline (pre-dose)', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'BTP Episodes', 'denomUnitsSelected': 'BTP Episodes', 'populationDescription': 'During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.\n\nAll efficacy analyses were conducted using the intent-to-treat (ITT) population.\n\nLast observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage.'}, {'type': 'SECONDARY', 'title': 'Subject Overall Satisfaction With Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}, {'units': 'Subject Overall Satisfaction', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '0.10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '60 minutes or at time of rescue medication use', 'description': 'Subjects evaluated their overall satisfaction with study drug at the time rescue medication was consumed or at the 60-minute time point using a 5-point categorical scale (0 = poor, 1 = fair, 2 = good, 3 = very good, and 4 = excellent).', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Subject Overall Satisfaction', 'denomUnitsSelected': 'Subject Overall Satisfaction', 'populationDescription': 'All efficacy analyses were conducted using the intent-to-treat (ITT) population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Pain Free Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.37', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.000', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '5 minutes', 'description': 'A pain free episode is one with 0 pain intensity at the specified time point. Percentage of episodes that are pain-free per subject is analyzed.', 'unitOfMeasure': 'percentage of episodes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.\n\nAll efficacy analyses were conducted using the intent-to-treat (ITT) population, however, only available data is summarized here.'}, {'type': 'SECONDARY', 'title': 'Percentage of Pain Free Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl - Includes all subjects and all dose levels.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Disc - Includes all subjects and all dose levels.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.35', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.000', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '10 minutes', 'description': 'A pain free episode is one with 0 pain intensity at the specified time point. Percentage of episodes that are pain-free per subject is analyzed.', 'unitOfMeasure': 'percentage of episodes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.\n\nAll efficacy analyses were conducted using the intent-to-treat (ITT) population.\n\nLast observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage.'}, {'type': 'SECONDARY', 'title': 'Percentage of Pain Free Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'spread': '1.02', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '1.48', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.563', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '15 minutes', 'description': 'A pain free episode is one with 0 pain intensity at the specified time point. Percentage of episodes that are pain-free per subject is analyzed.', 'unitOfMeasure': 'percentage of episodes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.\n\nAll efficacy analyses were conducted using the intent-to-treat (ITT) population.\n\nLast observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage.'}, {'type': 'SECONDARY', 'title': 'Percentage of Pain Free Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '5.3', 'spread': '1.57', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '1.88', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.498', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '30 minutes', 'description': 'A pain free episode is one with 0 pain intensity at the specified time point. Percentage of episodes that are pain-free per subject is analyzed.', 'unitOfMeasure': 'percentage of episodes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.\n\nAll efficacy analyses were conducted using the intent-to-treat (ITT) population.\n\nLast observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage.'}, {'type': 'SECONDARY', 'title': 'Percentage of Pain Free Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '10.5', 'spread': '2.34', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '2.27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.077', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '45 minutes', 'description': 'A pain free episode is one with 0 pain intensity at the specified time point. Percentage of episodes that are pain-free per subject is analyzed.', 'unitOfMeasure': 'percentage of episodes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.\n\nAll efficacy analyses were conducted using the intent-to-treat (ITT) population.\n\nLast observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage.'}, {'type': 'SECONDARY', 'title': 'Percentage of Pain Free Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '14.2', 'spread': '2.62', 'groupId': 'OG000'}, {'value': '9.6', 'spread': '2.90', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.031', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '60 minutes', 'description': 'A pain free episode is one with 0 pain intensity at the specified time point. Percentage of episodes that are pain-free per subject is analyzed.', 'unitOfMeasure': 'percentage of episodes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.\n\nAll efficacy analyses were conducted using the intent-to-treat (ITT) population.\n\nLast observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage.'}, {'type': 'SECONDARY', 'title': 'Episodes With at Least 50% Decreases in Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '14.9', 'spread': '2.81', 'groupId': 'OG000'}, {'value': '14.7', 'spread': '3.35', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.963', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '15 minutes', 'description': 'Number of episodes where the total pain score has at least a 50% reduction from baseline.', 'unitOfMeasure': 'episodes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.\n\nAll efficacy analyses were conducted using the intent-to-treat (ITT) population.\n\nLast observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage.'}, {'type': 'SECONDARY', 'title': 'Episodes With at Least 50% Decreases in Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '32.8', 'spread': '3.78', 'groupId': 'OG000'}, {'value': '24.1', 'spread': '3.87', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '30 minutes', 'description': 'Number of episodes where the total pain score has at least a 50% reduction from baseline.', 'unitOfMeasure': 'episodes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.\n\nAll efficacy analyses were conducted using the intent-to-treat (ITT) population.\n\nLast observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage.'}, {'type': 'SECONDARY', 'title': 'Episodes With at Least 50% Decreases in Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '41.1', 'spread': '4.11', 'groupId': 'OG000'}, {'value': '30.5', 'spread': '4.10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.008', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '45 minutes', 'description': 'Number of episodes where the total pain score has at least a 50% reduction from baseline.', 'unitOfMeasure': 'episodes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.\n\nAll efficacy analyses were conducted using the intent-to-treat (ITT) population.\n\nLast observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage.'}, {'type': 'SECONDARY', 'title': 'Episodes With at Least 50% Decreases in Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '46.1', 'spread': '4.17', 'groupId': 'OG000'}, {'value': '34.0', 'spread': '4.30', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '60 minutes', 'description': 'Number of episodes where the total pain score has at least a 50% reduction from baseline.', 'unitOfMeasure': 'episodes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.\n\nAll efficacy analyses were conducted using the intent-to-treat (ITT) population.\n\nLast observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage.'}, {'type': 'SECONDARY', 'title': 'Episodes With at Least 33% Decreases in Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '26.4', 'spread': '3.55', 'groupId': 'OG000'}, {'value': '21.3', 'spread': '3.66', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.100', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '15 minutes', 'description': 'Number of episodes where the total pain score has at least a 33% reduction from baseline.', 'unitOfMeasure': 'episodes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.\n\nAll efficacy analyses were conducted using the intent-to-treat (ITT) population.\n\nLast observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage.'}, {'type': 'SECONDARY', 'title': 'Episodes With at Least 33% Decreases in Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '47.3', 'spread': '4.05', 'groupId': 'OG000'}, {'value': '38.2', 'spread': '4.45', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '30 minutes', 'description': 'Number of episodes where the total pain score has at least a 33% reduction from baseline.', 'unitOfMeasure': 'episodes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.\n\nAll efficacy analyses were conducted using the intent-to-treat (ITT) population.\n\nLast observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage.'}, {'type': 'SECONDARY', 'title': 'Episodes With at Least 33% Decreases in Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '57.5', 'spread': '3.93', 'groupId': 'OG000'}, {'value': '46.5', 'spread': '4.50', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '45 minutes', 'description': 'Number of episodes where the total pain score has at least a 33% reduction from baseline.', 'unitOfMeasure': 'episodes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.\n\nAll efficacy analyses were conducted using the intent-to-treat (ITT) population.\n\nLast observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage.'}, {'type': 'SECONDARY', 'title': 'Episodes With at Least 33% Decreases in Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '64.3', 'spread': '3.72', 'groupId': 'OG000'}, {'value': '48.2', 'spread': '4.51', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '60 minutes', 'description': 'Number of episodes where the total pain score has at least a 50% reduction from baseline.', 'unitOfMeasure': 'episodes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.\n\nAll efficacy analyses were conducted using the intent-to-treat (ITT) population.\n\nLast observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage.'}, {'type': 'SECONDARY', 'title': 'Episodes With Complete Pain Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.68', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.000', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '5 minutes', 'description': 'Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief). Percentage of episodes with complete relief per subject is analyzed where a complete pain relief episode is defined as pain relief of value 4 at the specified time point.', 'unitOfMeasure': 'percentage of episodes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All efficacy analyses were conducted using the intent-to-treat (ITT) population.'}, {'type': 'SECONDARY', 'title': 'Episodes With Complete Pain Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.68', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.000', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '10 minutes', 'description': 'Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief).Percentage of episodes with complete relief per subject is analyzed where a complete pain relief episode is defined as pain relief of value 4 at the specified time point.', 'unitOfMeasure': 'percentage of episodes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All efficacy analyses were conducted using the intent-to-treat (ITT) population.'}, {'type': 'SECONDARY', 'title': 'Episodes With Complete Pain Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.94', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.750', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '15 minutes', 'description': 'Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief).Percentage of episodes with complete relief per subject is analyzed where a complete pain relief episode is defined as pain relief of value 4 at the specified time point.', 'unitOfMeasure': 'percentage of episodes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All efficacy analyses were conducted using the intent-to-treat (ITT) population.'}, {'type': 'SECONDARY', 'title': 'Episodes With Complete Pain Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '5.4', 'spread': '1.63', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '1.33', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.032', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '30 minutes', 'description': 'Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief). Percentage of episodes with complete relief per subject is analyzed where a complete pain relief episode is defined as pain relief of value 4 at the specified time point.', 'unitOfMeasure': 'percentage of episodes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All efficacy analyses were conducted using the intent-to-treat (ITT) population.'}, {'type': 'SECONDARY', 'title': 'Episodes With Complete Pain Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '9.4', 'spread': '2.18', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '2.27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.131', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '45 minutes', 'description': 'Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief). Percentage of episodes with complete relief per subject is analyzed where a complete pain relief episode is defined as pain relief of value 4 at the specified time point.', 'unitOfMeasure': 'percentage of episodes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All efficacy analyses were conducted using the intent-to-treat (ITT) population.'}, {'type': 'SECONDARY', 'title': 'Episodes With Complete Pain Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '12.8', 'spread': '2.49', 'groupId': 'OG000'}, {'value': '7.2', 'spread': '2.40', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '60 minutes', 'description': 'Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief). Percentage of episodes with complete relief per subject is analyzed where a complete pain relief episode is defined as pain relief of value 4 at the specified time point.', 'unitOfMeasure': 'percentage of episodes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All efficacy analyses were conducted using the intent-to-treat (ITT) population.'}, {'type': 'SECONDARY', 'title': 'Rescue Medication Usage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '30.0', 'spread': '3.53', 'groupId': 'OG000'}, {'value': '44.6', 'spread': '4.38', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '28 Days', 'description': 'Rescue medication is medication taken if adequate pain relief is not realized within 30 minutes following application of the study drug. Percentage of episodes when rescue medication was used per subject is analyzed.', 'unitOfMeasure': 'percentage of episodes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All efficacy analyses were conducted using the intent-to-treat (ITT) population.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'SPID in Neuropathic Pain Subpopulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '13.8', 'spread': '2.93', 'groupId': 'OG000'}, {'value': '7.8', 'spread': '3.20', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.023', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.96', 'ciLowerLimit': '0.92', 'ciUpperLimit': '11.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.57', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '15 minutes', 'description': 'Pain intensity (using an 11-point \\[0 = no pain to 10 = worst pain\\] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome. SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest for the Neuropathic pain subpopulation for relevant time points (15, 30, 45, 60 minutes). Neuropathic pain subpopulation is a subset of ITT population who have neuropathic pain at baseline.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.\n\nAll efficacy analyses were conducted using the intent-to-treat (ITT) population.\n\nMissing data were imputed on an episode-by-episode basis by carrying forward the last observed data value (last observation carried forward \\[LOCF\\]).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'SPID in Neuropathic Pain Subpopulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '51.6', 'spread': '8.05', 'groupId': 'OG000'}, {'value': '31.8', 'spread': '8.86', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.84', 'ciLowerLimit': '5.63', 'ciUpperLimit': '34.04', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.25', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '30 minutes', 'description': 'Pain intensity (using an 11-point \\[0 = no pain to 10 = worst pain\\] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome. SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest for the Neuropathic pain subpopulation for relevant time points (15, 30, 45, 60 minutes). Neuropathic pain subpopulation is a subset of ITT population who have neuropathic pain at baseline.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.\n\nAll efficacy analyses were conducted using the intent-to-treat (ITT) population.\n\nMissing data were imputed on an episode-by-episode basis by carrying forward the last observed data value (last observation carried forward \\[LOCF\\]).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'SPID in Neuropathic Pain Subpopulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '93.0', 'spread': '14.09', 'groupId': 'OG000'}, {'value': '59.7', 'spread': '15.63', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.012', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '33.26', 'ciLowerLimit': '8.32', 'ciUpperLimit': '58.20', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '12.72', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '45 minutes', 'description': 'Pain intensity (using an 11-point \\[0 = no pain to 10 = worst pain\\] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome. SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest for the Neuropathic pain subpopulation for relevant time points (15, 30, 45, 60 minutes). Neuropathic pain subpopulation is a subset of ITT population who have neuropathic pain at baseline.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.\n\nAll efficacy analyses were conducted using the intent-to-treat (ITT) population.\n\nMissing data were imputed on an episode-by-episode basis by carrying forward the last observed data value (last observation carried forward \\[LOCF\\]).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'SPID in Neuropathic Pain Subpopulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Onsolis', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Disc'}], 'classes': [{'categories': [{'measurements': [{'value': '137.8', 'spread': '20.19', 'groupId': 'OG000'}, {'value': '90.9', 'spread': '22.53', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.015', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '46.88', 'ciLowerLimit': '10.69', 'ciUpperLimit': '83.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '18.46', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '60 minutes', 'description': 'Pain intensity (using an 11-point \\[0 = no pain to 10 = worst pain\\] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome. SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest for the Neuropathic pain subpopulation for relevant time points (15, 30, 45, 60 minutes). Neuropathic pain subpopulation is a subset of ITT population who have neuropathic pain at baseline.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis.\n\nAll efficacy analyses were conducted using the intent-to-treat (ITT) population.\n\nMissing data were imputed on an episode-by-episode basis by carrying forward the last observed data value (last observation carried forward \\[LOCF\\]).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Onsolis', 'description': 'Subjects were administered BEMA™ Fentanyl at escalating doses (200, 400, 600, 800, and 1200 μg) in Titration period. During the double-blind period, subjects were randomly assigned to a sequence of active and placebo discs. Each subject acted as his or her own control. For each subject, the sequencing of the placebo and BEMA™ Fentanyl discs was random.'}], 'periods': [{'title': 'Open-label Titration Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '152 subjects enrolled; 151 subjects received at least one dose of study drug', 'groupId': 'FG000', 'numSubjects': '151'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'Noncompliance and other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}]}]}, {'title': 'Double-blind Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': "82 randomized; 1 didn't take double-blind drug; 1 didn't report a pain assessment within 30 minutes", 'groupId': 'FG000', 'numSubjects': '82'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}], 'recruitmentDetails': '24FEB2006 to 14MAR2007', 'preAssignmentDetails': 'During the open-label titration period, subjects were treated with Onsolis at escalating doses (200, 400, 600, 800, and 1200 μg) over a period of up to two weeks until subjects identified a dose that produced satisfactory pain relief for at least two episodes.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Onsolis', 'description': 'Includes all subjects and all dose levels'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '104', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '47', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.1', 'spread': '12.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '85', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '66', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '131', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '151', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Female reproductive status', 'classes': [{'categories': [{'title': 'Post-menopausal', 'measurements': [{'value': '43', 'groupId': 'BG000'}]}, {'title': 'Sterile', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}, {'title': 'Potentially able to bear children', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '67', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height (inches)', 'classes': [{'categories': [{'measurements': [{'value': '66.4', 'spread': '3.86', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Inches', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight (pounds)', 'classes': [{'categories': [{'measurements': [{'value': '160.89', 'spread': '42.011', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pounds', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Safety Population'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-04', 'studyFirstSubmitDate': '2006-02-15', 'resultsFirstSubmitDate': '2012-01-20', 'studyFirstSubmitQcDate': '2006-02-15', 'lastUpdatePostDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-27', 'studyFirstPostDateStruct': {'date': '2006-02-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'SPID in Neuropathic Pain Subpopulation', 'timeFrame': '15 minutes', 'description': 'Pain intensity (using an 11-point \\[0 = no pain to 10 = worst pain\\] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome. SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest for the Neuropathic pain subpopulation for relevant time points (15, 30, 45, 60 minutes). Neuropathic pain subpopulation is a subset of ITT population who have neuropathic pain at baseline.'}, {'measure': 'SPID in Neuropathic Pain Subpopulation', 'timeFrame': '30 minutes', 'description': 'Pain intensity (using an 11-point \\[0 = no pain to 10 = worst pain\\] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome. SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest for the Neuropathic pain subpopulation for relevant time points (15, 30, 45, 60 minutes). Neuropathic pain subpopulation is a subset of ITT population who have neuropathic pain at baseline.'}, {'measure': 'SPID in Neuropathic Pain Subpopulation', 'timeFrame': '45 minutes', 'description': 'Pain intensity (using an 11-point \\[0 = no pain to 10 = worst pain\\] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome. SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest for the Neuropathic pain subpopulation for relevant time points (15, 30, 45, 60 minutes). Neuropathic pain subpopulation is a subset of ITT population who have neuropathic pain at baseline.'}, {'measure': 'SPID in Neuropathic Pain Subpopulation', 'timeFrame': '60 minutes', 'description': 'Pain intensity (using an 11-point \\[0 = no pain to 10 = worst pain\\] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome. SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest for the Neuropathic pain subpopulation for relevant time points (15, 30, 45, 60 minutes). Neuropathic pain subpopulation is a subset of ITT population who have neuropathic pain at baseline.'}], 'primaryOutcomes': [{'measure': 'Summary of Pain Intensity Differences (SPID)', 'timeFrame': '0-30 minutes', 'description': 'Pain intensity (using an 11-point \\[0 = no pain to 10 = worst pain\\] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is\n\n-10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome.'}], 'secondaryOutcomes': [{'measure': 'SPID', 'timeFrame': '0-5 minutes', 'description': 'Pain intensity (using an 11-point \\[0 = no pain to 10 = worst pain\\] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome.SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest.'}, {'measure': 'SPID', 'timeFrame': '0-10 minutes', 'description': 'Pain intensity (using an 11-point \\[0 = no pain to 10 = worst pain\\] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome.SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest.'}, {'measure': 'SPID', 'timeFrame': '0-15 minutes', 'description': 'Pain intensity (using an 11-point \\[0 = no pain to 10 = worst pain\\] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome.SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest.'}, {'measure': 'SPID', 'timeFrame': '0-45 minutes', 'description': 'Pain intensity (using an 11-point \\[0 = no pain to 10 = worst pain\\] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome.SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest.'}, {'measure': 'SPID', 'timeFrame': '0-60 minutes', 'description': 'Pain intensity (using an 11-point \\[0 = no pain to 10 = worst pain\\] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome.SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest.'}, {'measure': 'PID', 'timeFrame': '5 minutes after dosing', 'description': 'Pain intensity (using an 11-point \\[0 = no pain to 10 = worst pain\\] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.'}, {'measure': 'PID', 'timeFrame': '10 minutes after dosing', 'description': 'Pain intensity (using an 11-point \\[0 = no pain to 10 = worst pain\\] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.'}, {'measure': 'PID', 'timeFrame': '15 minutes after dosing', 'description': 'Pain intensity (using an 11-point \\[0 = no pain to 10 = worst pain\\] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.'}, {'measure': 'PID', 'timeFrame': '30 minutes after dosing', 'description': 'Pain intensity (using an 11-point \\[0 = no pain to 10 = worst pain\\] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.'}, {'measure': 'PID', 'timeFrame': '45 minutes after dosing', 'description': 'Pain intensity (using an 11-point \\[0 = no pain to 10 = worst pain\\] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.'}, {'measure': 'PID', 'timeFrame': '60 minutes after dosing', 'description': 'Pain intensity (using an 11-point \\[0 = no pain to 10 = worst pain\\] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point.'}, {'measure': 'Pain Relief', 'timeFrame': '5 minutes after dosing', 'description': 'Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief) at 5, 10, 15, 30, 45, and 60 minutes after taking the study medication or until rescue.'}, {'measure': 'Pain Relief', 'timeFrame': '10 minutes after dosing', 'description': 'Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief) at 5, 10, 15, 30, 45, and 60 minutes after taking the study medication or until rescue.'}, {'measure': 'Pain Relief', 'timeFrame': '15 minutes after dosing', 'description': 'Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief) at 5, 10, 15, 30, 45, and 60 minutes after taking the study medication or until rescue.'}, {'measure': 'Pain Relief', 'timeFrame': '30 minutes after dosing', 'description': 'Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief) at 5, 10, 15, 30, 45, and 60 minutes after taking the study medication or until rescue.'}, {'measure': 'Pain Relief', 'timeFrame': '45 minutes after dosing', 'description': 'Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief) at 5, 10, 15, 30, 45, and 60 minutes after taking the study medication or until rescue.'}, {'measure': 'Pain Relief', 'timeFrame': '60 minutes after dosing', 'description': 'Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief) at 5, 10, 15, 30, 45, and 60 minutes after taking the study medication or until rescue.'}, {'measure': 'Total Pain Relief', 'timeFrame': '5 minutes', 'description': 'Total Pain Relief (TOTPAR) is calculated as the weighted sum of the pain relief (PR) of all time points at or prior to the time point of interest.Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief)compared to baseline (pre-dose)'}, {'measure': 'Total Pain Relief', 'timeFrame': '10 minutes', 'description': 'Total Pain Relief (TOTPAR) is calculated as the weighted sum of the pain relief (PR) of all time points at or prior to the time point of interest. Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief)compared to baseline (pre-dose)'}, {'measure': 'Total Pain Relief', 'timeFrame': '15 minutes', 'description': 'Total Pain Relief (TOTPAR) is calculated as the weighted sum of the pain relief (PR) of all time points at or prior to the time point of interest. Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief)compared to baseline (pre-dose)'}, {'measure': 'Total Pain Relief', 'timeFrame': '30 minutes', 'description': 'Total Pain Relief (TOTPAR) is calculated as the weighted sum of the pain relief (PR) of all time points at or prior to the time point of interest. Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief)compared to baseline (pre-dose)'}, {'measure': 'Total Pain Relief', 'timeFrame': '45 minutes', 'description': 'Total Pain Relief (TOTPAR) is calculated as the weighted sum of the pain relief (PR) of all time points at or prior to the time point of interest. Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief)compared to baseline (pre-dose)'}, {'measure': 'Total Pain Relief', 'timeFrame': '60 minutes', 'description': 'Total Pain Relief (TOTPAR) is calculated as the weighted sum of the pain relief (PR) of all time points at or prior to the time point of interest. Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief)compared to baseline (pre-dose)'}, {'measure': 'Subject Overall Satisfaction With Study Drug', 'timeFrame': '60 minutes or at time of rescue medication use', 'description': 'Subjects evaluated their overall satisfaction with study drug at the time rescue medication was consumed or at the 60-minute time point using a 5-point categorical scale (0 = poor, 1 = fair, 2 = good, 3 = very good, and 4 = excellent).'}, {'measure': 'Percentage of Pain Free Episodes', 'timeFrame': '5 minutes', 'description': 'A pain free episode is one with 0 pain intensity at the specified time point. Percentage of episodes that are pain-free per subject is analyzed.'}, {'measure': 'Percentage of Pain Free Episodes', 'timeFrame': '10 minutes', 'description': 'A pain free episode is one with 0 pain intensity at the specified time point. Percentage of episodes that are pain-free per subject is analyzed.'}, {'measure': 'Percentage of Pain Free Episodes', 'timeFrame': '15 minutes', 'description': 'A pain free episode is one with 0 pain intensity at the specified time point. Percentage of episodes that are pain-free per subject is analyzed.'}, {'measure': 'Percentage of Pain Free Episodes', 'timeFrame': '30 minutes', 'description': 'A pain free episode is one with 0 pain intensity at the specified time point. Percentage of episodes that are pain-free per subject is analyzed.'}, {'measure': 'Percentage of Pain Free Episodes', 'timeFrame': '45 minutes', 'description': 'A pain free episode is one with 0 pain intensity at the specified time point. Percentage of episodes that are pain-free per subject is analyzed.'}, {'measure': 'Percentage of Pain Free Episodes', 'timeFrame': '60 minutes', 'description': 'A pain free episode is one with 0 pain intensity at the specified time point. Percentage of episodes that are pain-free per subject is analyzed.'}, {'measure': 'Episodes With at Least 50% Decreases in Pain', 'timeFrame': '15 minutes', 'description': 'Number of episodes where the total pain score has at least a 50% reduction from baseline.'}, {'measure': 'Episodes With at Least 50% Decreases in Pain', 'timeFrame': '30 minutes', 'description': 'Number of episodes where the total pain score has at least a 50% reduction from baseline.'}, {'measure': 'Episodes With at Least 50% Decreases in Pain', 'timeFrame': '45 minutes', 'description': 'Number of episodes where the total pain score has at least a 50% reduction from baseline.'}, {'measure': 'Episodes With at Least 50% Decreases in Pain', 'timeFrame': '60 minutes', 'description': 'Number of episodes where the total pain score has at least a 50% reduction from baseline.'}, {'measure': 'Episodes With at Least 33% Decreases in Pain', 'timeFrame': '15 minutes', 'description': 'Number of episodes where the total pain score has at least a 33% reduction from baseline.'}, {'measure': 'Episodes With at Least 33% Decreases in Pain', 'timeFrame': '30 minutes', 'description': 'Number of episodes where the total pain score has at least a 33% reduction from baseline.'}, {'measure': 'Episodes With at Least 33% Decreases in Pain', 'timeFrame': '45 minutes', 'description': 'Number of episodes where the total pain score has at least a 33% reduction from baseline.'}, {'measure': 'Episodes With at Least 33% Decreases in Pain', 'timeFrame': '60 minutes', 'description': 'Number of episodes where the total pain score has at least a 50% reduction from baseline.'}, {'measure': 'Episodes With Complete Pain Relief', 'timeFrame': '5 minutes', 'description': 'Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief). Percentage of episodes with complete relief per subject is analyzed where a complete pain relief episode is defined as pain relief of value 4 at the specified time point.'}, {'measure': 'Episodes With Complete Pain Relief', 'timeFrame': '10 minutes', 'description': 'Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief).Percentage of episodes with complete relief per subject is analyzed where a complete pain relief episode is defined as pain relief of value 4 at the specified time point.'}, {'measure': 'Episodes With Complete Pain Relief', 'timeFrame': '15 minutes', 'description': 'Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief).Percentage of episodes with complete relief per subject is analyzed where a complete pain relief episode is defined as pain relief of value 4 at the specified time point.'}, {'measure': 'Episodes With Complete Pain Relief', 'timeFrame': '30 minutes', 'description': 'Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief). Percentage of episodes with complete relief per subject is analyzed where a complete pain relief episode is defined as pain relief of value 4 at the specified time point.'}, {'measure': 'Episodes With Complete Pain Relief', 'timeFrame': '45 minutes', 'description': 'Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief). Percentage of episodes with complete relief per subject is analyzed where a complete pain relief episode is defined as pain relief of value 4 at the specified time point.'}, {'measure': 'Episodes With Complete Pain Relief', 'timeFrame': '60 minutes', 'description': 'Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief). Percentage of episodes with complete relief per subject is analyzed where a complete pain relief episode is defined as pain relief of value 4 at the specified time point.'}, {'measure': 'Rescue Medication Usage', 'timeFrame': '28 Days', 'description': 'Rescue medication is medication taken if adequate pain relief is not realized within 30 minutes following application of the study drug. Percentage of episodes when rescue medication was used per subject is analyzed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Breakthrough Pain in Patients with Cancer'], 'conditions': ['Pain', 'Cancer']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate the efficacy of BEMA Fentanyl (Onsolis) at any dose in the management of breakthrough pain in cancer subjects on background opioid therapy. The standard of care for these breakthrough pain episodes is a rapid onset, short acting analgesic with minimal associated sleepiness. Oral morphine, oxycodone and hydromorphone are routinely used, but because of slow and variable oral absorption, the pain control is not the best with these products. Oral transmucosal fentanyl citrate (OTFC) has been used successfully in treating breakthrough pain episodes associated with cancer. OTFC is a lozenge of fentanyl on a stick and is administered by continuously swabbing the interior of the subject's mouth until the product is dissolved (approximately 15 to 30 minutes). The buccal route of administration avoids the delay and variability associated with oral absorption.", 'detailedDescription': 'This is a randomized, double-blind, placebo controlled, multiple cross-over study. Eligible subjects will be treated with open label BEMA fentanyl over a period of up to two weeks. Doses will be titrated upward, starting at 200 μg, until a dose is identified that produces satisfactory pain relief for at least 2 episodes. Those subjects who identify a dose of BEMA fentanyl that produces satisfactory relief of breakthrough pain episodes will enter the double-blind, placebo controlled period of the trial. They will receive 3 placebo doses and 6 BEMA fentanyl doses in a random sequence per randomization schedule.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or non-pregnant and non-lactating female. A female of child-bearing potential is eligible to participate in this study if she is using an acceptable method of birth control.\n* 18 years or older\n* Patient must have pain associated with cancer or cancer treatment.\n* Patient must be on a stable current regimen of oral opioids equivalent to 60 - 1000 mg/day of oral morphine or 50 - 300 µg/hr of transdermal fentanyl (e.g. oxycodone 30 mg, methadone 20 mg, and hydromorphone 7.5 mg).\n* Regularly experiences 1 - 4 breakthrough pain episodes per day that require additional opioids for pain control\n* At least partial relief of breakthrough pain by use of opioid therapy\n* Subject must be able to self-administer the study medication correctly.\n* Subject must be willing and able to complete the electronic diary card with each pain episode.\n* Signed consent must be obtained at screening prior to any procedures being performed.\n\nExclusion Criteria:\n\n* Psychiatric/cognitive or neurological impairment that would limit the subject's ability to understand or complete the diary\n* Cardiopulmonary disease that, in the opinion of the investigator, would significantly increase the risk of respiratory depression\n* Recent history or current evidence of alcohol or other drug substance (licit or illicit) abuse\n* Rapidly escalating pain that the investigator believes may require an increase in the dosage of background pain medication during the study\n* Moderate (Grade 3) to severe (Grade 4) mucositis (Subjects with less than moderate mucositis are permitted and must be instructed to not apply the BEMA disc at a site of inflammation.)\n* Strontium 89 therapy within the previous 6 months\n* Any other therapy prior to the study that the investigator considers could alter pain or the response to pain medication.\n* Use of an investigational drug within 4 weeks preceding this study\n* History of hypersensitivity or intolerance to fentanyl\n* Regularly more than 4 episodes per day\n* Eastern Cooperative Oncology Group (ECOG) performance status of 4 or 5\n* Subject is pregnant, actively trying to become pregnant, breast feeding or not using adequate contraceptive measures"}, 'identificationModule': {'nctId': 'NCT00293033', 'briefTitle': 'Study of BEMA™ Fentanyl in the Treatment of Breakthrough Pain in Cancer Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'BioDelivery Sciences International'}, 'officialTitle': 'A Double-blind, Placebo Controlled Evaluation of the Efficacy, Safety and Tolerability of BEMA™ Fentanyl in the Treatment of Breakthrough Pain in Cancer Subjects', 'orgStudyIdInfo': {'id': 'FEN-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: BEMA™', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'BEMA™ Fentanyl', 'description': 'BioErodible MucoAdhesive (BEMA) Fentanyl', 'interventionNames': ['Drug: BEMA™']}], 'interventions': [{'name': 'BEMA™', 'type': 'DRUG', 'otherNames': ['Onsolis (fentanyl buccal soluble film)'], 'description': 'BioDelivery Sciences International, Inc. (BDSI) has developed BioErodible MucoAdhesive (BEMA) Fentanyl, an alternative product to OTFC that does not require the subject to continuously paint the inside of the mouth with the dosage form. The BDSI product is a small soluble film that is placed against the mucosal membrane inside the mouth. The mucoadhesive polymers in the film readily adhere to the mucosal membrane (within 5 seconds) when moistened. The components of the film are water soluble, so the entire dosage form dissolves within 30 minutes of application.', 'armGroupLabels': ['BEMA™ Fentanyl', 'Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28412', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'PPD Development', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}], 'overallOfficials': [{'name': 'Andrew Finn, PharmD', 'role': 'STUDY_CHAIR', 'affiliation': 'BioDelivery Sciences International'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BioDelivery Sciences International', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}