Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-02-21 @ 10:01 AM
Study NCT ID:
NCT00994760
Status:
COMPLETED
Last Update Posted:
2012-09-27
First Post:
2009-10-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Tolerability of Intranasal Fentanyl Spray for the Treatment of Breakthrough Pain in Cancer Patients Older Than 18 Years
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059390', 'term': 'Breakthrough Pain'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@nycomed.com', 'phone': '+49 7531 3666', 'title': 'Medical Responsible', 'phoneExt': '0', 'organization': 'Nycomed Deutschland GmbH'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'First until last visit (planned 4 weeks)', 'description': 'Patients included and treated with at least one application of Instanyl', 'eventGroups': [{'id': 'EG000', 'title': 'All Patients Treated', 'otherNumAtRisk': 131, 'otherNumAffected': 0, 'seriousNumAtRisk': 131, 'seriousNumAffected': 19}], 'seriousEvents': [{'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Osteosynthesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Dose of Instanyl', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Start'}, {'id': 'OG001', 'title': 'Study End'}], 'classes': [{'title': '50 µg', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': '100 µg', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}]}, {'title': '200 µg', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': '400 µg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'during therapy with Instanyl (planned: 28 days)', 'description': 'Initially prescribed dose/ most efficient single dose of Instanyl at study end', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients included and treated (without imputation of missing values), intention to treat.\n\nAll patients included'}, {'type': 'PRIMARY', 'title': 'Physician: Degree of Maximum Pain Intensity During the Last Days/ Since the Last Examination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Initial Visit'}, {'id': 'OG001', 'title': 'Last Visit'}], 'classes': [{'title': 'Persistent pain (IV: N= 126, LV: N= 116)', 'categories': [{'measurements': [{'value': '2.3', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Breakthrough pain (IV: N= 126, LV: N= 115)', 'categories': [{'measurements': [{'value': '3.5', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '1.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'before and after therapy with Instanyl (first/last visit)', 'description': 'Scale: 0=no, 1=mild, 2=moderate, 3=strong, 4=very strong, 5=extreme', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "All patients included and treated, intention to treat, missing values not imputed.\n\nAll patients with valid values ('as observed'). N= number of valid cases."}, {'type': 'SECONDARY', 'title': 'Physician: Degree of Relief of Breakthrough Pain Achieved by Instanyl at Study End', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Last Visit'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '1.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'after therapy with Instanyl (planned: 4 weeks)', 'description': '0=no reduction, 1=slight, 2=medium, 3=strong, 4=very strong, 5=complete', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients included and treated with valid data (without imputation of missing values), intention to treat.\n\nAll patients with valid values at last visit. N= number of valid cases (=114). From the 116 participants analyzed, only 114 participants had valid values at the last visit.'}, {'type': 'PRIMARY', 'title': 'Physician: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'First Visit (FV): Patients With Previous BTP- Medication Only'}, {'id': 'OG001', 'title': 'Last Visit (LV)'}], 'classes': [{'title': 'speed of action (FV: N= 45, LV: N= 114)', 'categories': [{'measurements': [{'value': '4.0', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'strength of action (FV: N= 45, LV: N= 115)', 'categories': [{'measurements': [{'value': '4.0', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'tolerability (FV: N= 44, LV: N= 113)', 'categories': [{'measurements': [{'value': '3.0', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'safety (FV: N= 45, LV: N= 114)', 'categories': [{'measurements': [{'value': '2.9', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'handling (FV: N= 45, LV: N= 115)', 'categories': [{'measurements': [{'value': '3.4', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'patient satisfaction (FV: N= 45, LV: N= 116)', 'categories': [{'measurements': [{'value': '4.2', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '1.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'before and after therapy with Instanyl (first/last visit)', 'description': 'Scale: 1=very good, 2=good, 3=satisfactory, 4=poor, 5=very poor, 6=insufficient', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "All patients included and treated, intention to treat, missing values not imputed.\n\nAll patients with valid values ('as observed')= N."}, {'type': 'PRIMARY', 'title': 'Physician: To What Extent Did Your Expectations in Instanyl Have Met? (Last Visit)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Physician Last Visit (LV)'}], 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'spread': '0.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'after therapy with Instanyl (planned: 4 weeks)', 'description': '5=completely, 4=for the most part, 3=partially, 2= more or less, 1=rather not, 0=not at all', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients included and treated with valid data (without imputation of missing values), intention to treat.\n\nAll patients with valid values at last visit. N= number of valid cases (=110). From the 116 participants analyzed, only 110 participants had valid values at the last visit.'}, {'type': 'PRIMARY', 'title': 'Physician: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GENISIS', 'description': 'Intranasal Fentanyl Spray'}], 'classes': [{'title': 'Nursing and support efforts (N= 113)', 'categories': [{'measurements': [{'value': '-1.2', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'Autonomy of the patient (N= 113)', 'categories': [{'measurements': [{'value': '-1.5', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'Pain-related impairment in everyday life (N= 113)', 'categories': [{'measurements': [{'value': '-1.6', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': "Quality of patient's life (N= 112)", 'categories': [{'measurements': [{'value': '-1.5', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'Extent of use of other medical services (N= 112)', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '1.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'after therapy with Instanyl (at last visit)', 'description': 'Scale: -3= very much improved, -2= much improved, -1= improved, 0= comparable, 1= worsened, 2= much worsened ,3= very much worsened', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "All patients included and treated, intention to treat, missing values not imputed.\n\nAll patients with valid values ('as observed'). N=number of valid cases."}, {'type': 'PRIMARY', 'title': 'Physician: What is the Current Treatment Needs of Your Patient Regarding ...', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Initial Visit (IV)'}, {'id': 'OG001', 'title': 'Last Visit (LV)'}], 'classes': [{'title': 'persistent pain (IV: N=131, LV: N=112)', 'categories': [{'measurements': [{'value': '2.0', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'breakthrough pain (IV: N=130, LV: N=111)', 'categories': [{'measurements': [{'value': '2.5', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'nausea (IV: N=130, LV: N=112)', 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'vomiting (IV: N=130, LV: N=112)', 'categories': [{'measurements': [{'value': '1.2', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'dyspnoea (IV: N=130, LV: N=111)', 'categories': [{'measurements': [{'value': '1.0', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'constipation (IV: N=129, LV: N=112)', 'categories': [{'measurements': [{'value': '1.2', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'weakness (IV: N=129, LV: N=112)', 'categories': [{'measurements': [{'value': '2.0', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'poor appetite (IV: N=131, LV: N=112)', 'categories': [{'measurements': [{'value': '1.8', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'tiredness (IV: N=130, LV: N=112)', 'categories': [{'measurements': [{'value': '1.8', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'efforts due to wounds/decubitus (N=130, N=112)', 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'need for assistance (IV: N=130, LV: N=111)', 'categories': [{'measurements': [{'value': '1.8', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'depressiveness (IV: N=129, LV: N=111)', 'categories': [{'measurements': [{'value': '1.6', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'anxiety (IV: N=130, LV: N=112)', 'categories': [{'measurements': [{'value': '1.6', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'tension (IV: N=130, LV: N=112)', 'categories': [{'measurements': [{'value': '1.6', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'disorientation, confusion (IV: N=130, LV: N=111)', 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Problems with organization of care (N=129, N=112)', 'categories': [{'measurements': [{'value': '1.1', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Overburdening family/environment N=129, N=112', 'categories': [{'measurements': [{'value': '1.4', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'before and after therapy with Instanyl (first/last visit)', 'description': 'Scale: 0=no, 1=low, 2=medium, 3=high', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "All patients included and treated, intention to treat, missing values not imputed.\n\nAll patients with valid values ('as observed'). N= number of valid cases."}, {'type': 'SECONDARY', 'title': 'Patient: How Many Episodes of Pain You Experience on Average?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'First Visit'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'spread': '2.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'initial visit (before start of therapy with Instanyl)', 'unitOfMeasure': 'episodes per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.\n\nAll patients with valid values ('as observed'). N= number of valid cases (= 91). From the 95 participants analyzed, only 91 participants had valid values at the last visit."}, {'type': 'SECONDARY', 'title': 'Patient: Description of Pain at Initial Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients at First Visit'}], 'classes': [{'title': 'Persistent pain in the last 24 hrs on average N=94', 'categories': [{'measurements': [{'value': '5.6', 'spread': '2.3', 'groupId': 'OG000'}]}]}, {'title': 'Pain during the last pain attacks maximally N=93', 'categories': [{'measurements': [{'value': '8.3', 'spread': '1.4', 'groupId': 'OG000'}]}]}, {'title': 'Pain intensity bearable N= 94', 'categories': [{'measurements': [{'value': '4.0', 'spread': '1.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'initial visit (before start of therapy with Instanyl)', 'description': '0=no pain, 10= most intense pain imaginable', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.\n\nAll patients with valid values ('as observed') =N."}, {'type': 'SECONDARY', 'title': 'Patient: How do You Feel Today?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Initial Visit'}, {'id': 'OG001', 'title': 'Last Visit'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'before and after therapy with Instanyl (first/last visit)', 'description': 'Scale: 1=very bad, 2=bad, 3=mediocre, 4=good, 5=very good', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.\n\nAll patients with valid values ('as observed'). N= number of valid cases.\n\n* Initial Visit N=94\n* Last Visit N=83"}, {'type': 'SECONDARY', 'title': 'Patient: To What Extent Your Present Condition is Affected by Your Pain Attacks?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Initial Visit'}, {'id': 'OG001', 'title': 'Last Visit'}], 'classes': [{'categories': [{'measurements': [{'value': '7.6', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '2.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'before and after therapy with Instanyl (first/last visit)', 'description': 'Scale: 0=not at all, 10=completely', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.\n\nAll patients with valid values ('as observed'). N= number of valid cases.\n\n* Initial Visit N=94\n* Last Visit N=83"}, {'type': 'SECONDARY', 'title': 'Patient: Modified Pain Disability Index (mPDI) - Sum - Score (Complete Questionnaires Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Initial Visit'}, {'id': 'OG001', 'title': 'Last Visit'}], 'classes': [{'categories': [{'measurements': [{'value': '51.9', 'spread': '11.4', 'groupId': 'OG000'}, {'value': '29.1', 'spread': '16.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'before and after therapy with Instanyl (first/last visit)', 'description': 'Scale: 0=no impairment, 70=complete impairment', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.\n\nAll patients with valid values ('as observed'). N= number of valid cases.\n\n* Initial Visit N=92\n* Last Visit N= 80"}, {'type': 'SECONDARY', 'title': 'Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Initial Visit'}, {'id': 'OG001', 'title': 'Last Visit'}], 'classes': [{'categories': [{'measurements': [{'value': '12.3', 'spread': '6.6', 'groupId': 'OG000'}, {'value': '24.7', 'spread': '7.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'before and after therapy with Instanyl (first/last visit)', 'description': 'Scale: 0=complete impairment, 43=no impairment', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.\n\nAll patients with valid values ('as observed'). N= number of valid cases.\n\n* Initial Visit N=93\n* Last Visit N=82"}, {'type': 'SECONDARY', 'title': 'Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only) Conspicuous ≤20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Initial Visit'}, {'id': 'OG001', 'title': 'Last Visit'}], 'classes': [{'title': 'QLIP - score (classified):QLIP conspicuous (≤20)', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'QLIP - score (classified):QLIP inconspicuous (>20)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'before and after therapy with Instanyl (first/last visit)', 'description': '0= conspicuous ≤20\n\n1= inconspicuous \\>20', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.\n\nAll patients with valid values ('as observed'). N= number of valid cases."}, {'type': 'SECONDARY', 'title': 'Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Initial Visit'}, {'id': 'OG001', 'title': 'Last Visit'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '1.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'before and after therapy with Instanyl (first/last visit)', 'description': 'Scale: 0=worst, 5=best', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.\n\nAll patients with valid values ('as observed'). N= number of valid cases.\n\n* Initial Visit N=93\n* Last Visit N=81"}, {'type': 'SECONDARY', 'title': 'Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only) Conspicuous <1.5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Initial Visit'}, {'id': 'OG001', 'title': 'Last Visit'}], 'classes': [{'title': 'MQHH - score (classified):conspicuous:score <1.5', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'MQHH - score (classified):inconspicuous:score ≥1.5', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'before and after therapy with Instanyl (first/last visit)', 'description': 'conspicuous score \\<1.5 inconspicuous score ≥1.5', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.\n\nAll patients with valid values ('as observed'). N= number of valid cases."}, {'type': 'SECONDARY', 'title': 'Patient: Degree of Relief of Breakthrough Pain Achieved by Instanyl at Study End', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients at Final Visit'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '1.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'after therapy with Instanyl (planned: 4 weeks)', 'description': '0=no reduction, 1=slight, 2=medium, 3=strong, 4=very strong, 5=complete', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Patients included and treated who filled in the patient's documentation with valid data (without imputation of missing values), intention to treat.\n\nAll patients with valid values at last visit. N= number of valid cases (80). From the 83 participants analyzed, only 80 participants had valid values at the last visit."}, {'type': 'SECONDARY', 'title': 'Patient: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'First Visit (FV)(Patients With Previous BTP-medication Only)'}, {'id': 'OG001', 'title': 'Last Visit (LV)'}], 'classes': [{'title': 'speed of action (FV: N=33, LV: N=82)', 'categories': [{'measurements': [{'value': '4.1', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'strength of action (FV: N=33, LV: N=82)', 'categories': [{'measurements': [{'value': '3.9', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'tolerability (FV: N=33, LV: N=82)', 'categories': [{'measurements': [{'value': '3.2', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'handling (FV: N=33, LV: N=80)', 'categories': [{'measurements': [{'value': '3.4', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'total satisfaction (FV: N=NA, LV: N=82)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'no participants contributed data', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '1.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'before and after therapy with Instanyl (first/last visit)', 'description': 'Scale: 1=very good, 2=good, 3=satisfactory, 4=poor, 5=very poor, 6=insufficient', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.\n\nAll patients with valid values ('as observed')."}, {'type': 'SECONDARY', 'title': 'Patient: To What Extent Did Your Expectations in Instanyl Have Met With Respect to ... (Last Visit)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients at Final Visit'}], 'classes': [{'title': 'speed of action (N=79)', 'categories': [{'measurements': [{'value': '4.2', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'strength of action (N=80)', 'categories': [{'measurements': [{'value': '4.2', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'tolerability (N=78)', 'categories': [{'measurements': [{'value': '4.3', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'handling (N=79)', 'categories': [{'measurements': [{'value': '4.2', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'total satisfaction (N=80)', 'categories': [{'measurements': [{'value': '4.2', 'spread': '0.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'after therapy with Instanyl (planned: 4 weeks)', 'description': '5=completely, 4=for the most part, 3=partially, 2=more or less, 1=rather not, 0=not at all', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Patients included and treated who filled in the patient's documentation with valid data (without imputation of missing values), intention to treat.\n\nAll patients with valid values at last visit. N= number of valid cases."}, {'type': 'SECONDARY', 'title': 'Patient: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ...(at Last Visit)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients at Final Visit'}], 'classes': [{'title': 'Nursing and support efforts (N= 81)', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'Autonomy of the patient (N= 81)', 'categories': [{'measurements': [{'value': '-1.4', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Pain-related impairment in everyday life (N= 81)', 'categories': [{'measurements': [{'value': '-1.3', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': "Quality of patient's life (N= 81)", 'categories': [{'measurements': [{'value': '-1.4', 'spread': '0.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'after therapy with Instanyl (at last visit)', 'description': 'Scale: -3= very much improved, -2= much improved, -1= improved , 0= comparable, 1= worsened, 2= much worsened, 3= very much worsened', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.\n\nAll patients with valid values ('as observed'). N= number of valid cases (=81). From the 83 participants analyzed, only 81 participants had valid values at the last visit."}, {'type': 'SECONDARY', 'title': 'Caregiver: Degree of Relief of Breakthrough Pain Achieved by Instany at Study End', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Caregiver at Final Visit'}], 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'spread': '1.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'after therapy with Instanyl (planned: 4 weeks)', 'description': '0=no reduction, 1=slight, 2=medium, 3=strong, 4=very strong, 5=complete', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients included and treated with caregiver documentation (without imputation of missing values), ITT.\n\nAll patients with valid values at last visit. N= number of valid cases (=67). From the 70 participants analyzed, only 67 participants had valid values at the last visit.'}, {'type': 'SECONDARY', 'title': 'Caregiver: Assessment of Breakthrough Pain Therapy by Instanyl (Last Visit)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Caregiver at Final Visit'}], 'classes': [{'title': 'speed of action (N=69)', 'categories': [{'measurements': [{'value': '2.2', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'strength of action (N=69)', 'categories': [{'measurements': [{'value': '2.1', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'tolerability (N=69)', 'categories': [{'measurements': [{'value': '1.9', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'safety (N=68)', 'categories': [{'measurements': [{'value': '2.0', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'handling (N=69)', 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'patient satisfaction (N=68)', 'categories': [{'measurements': [{'value': '2.1', 'spread': '1.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'after therapy with Instanyl (first/last visit)', 'description': 'Scale: 1=very good, 2=good, 3=satisfactory, 4=poor, 5=very poor, 6=insufficient', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Patients included and treated with caregiver documentation (without imputation of missing values), intention to treat.\n\nAll patients with valid values ('as observed'). N= number of valid cases."}, {'type': 'SECONDARY', 'title': 'Caregiver: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Caregiver at Final Visit'}], 'classes': [{'title': 'Nursing and support efforts (N= 69)', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Autonomy of the patient (N= 69)', 'categories': [{'measurements': [{'value': '-1.2', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Pain-related impairment in everyday life (N= 69)', 'categories': [{'measurements': [{'value': '-1.3', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': "Quality of patient's life (N= 68)", 'categories': [{'measurements': [{'value': '-1.3', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'Extent of use of other medical services (N= 69)', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'after therapy with Instanyl (at last visit)', 'description': 'Scale: -3= very much improved, -2= much improved, -1= improved , 0= comparable, 1= worsened, 2= much worsened, 3= very much worsened', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Patients included and treated with caregiver documentation (without imputation of missing values), ITT.\n\nAll patients with valid values ('as observed') =N."}, {'type': 'SECONDARY', 'title': 'Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ...', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Caregiver at Final Visit'}], 'classes': [{'title': 'persistent pain (N=68)', 'categories': [{'measurements': [{'value': '-1.2', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'breakthrough pain (N=68)', 'categories': [{'measurements': [{'value': '-1.8', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'nausea (N=68)', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'vomiting (N=65)', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'dyspnoea (N=66)', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'constipation (N=68)', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'weakness (N=68)', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'poor appetite (N=68)', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'tiredness (N=67)', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'efforts due to wounds/decubitus (N=68)', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'need for assistance in daily activities (N=68)', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'depressiveness (N=67)', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'anxiety (N=67)', 'categories': [{'measurements': [{'value': '-1.2', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'tension (N=67)', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'disorientation, confusion (N=67)', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'Problems with the organization of care (N=68)', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'Overburdening family/environment (N=68)', 'categories': [{'measurements': [{'value': '-1.2', 'spread': '1.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'after therapy with Instanyl (last visit)', 'description': 'Scale: -3= very much less, -2= much less, -1= less, 0=comparable, 1= more, 2= much more, 3= very much more', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Patients included and treated with caregiver documentation (without imputation of missing values), ITT.\n\nAll patients with valid values ('as observed'). N= number of valid cases"}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GENISIS', 'description': 'Intranasal Fentanyl Spray'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '131'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '107'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'GENISIS', 'description': 'Intranasal Fentanyl Spray'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.1', 'spread': '12.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Number of valid cases = 130. Number of valid cases = patients with data available.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '23.2', 'spread': '4.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Number of valid cases = 126. Number of valid cases = patients with data available.', 'unitOfMeasure': 'kgˆm2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Tumor diagnosis (malignant neop-lasms ICD10)', 'classes': [{'title': 'Pain not caused by tumor', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'BG000'}]}]}, {'title': 'C00-C14 lip, oral cavity and pharynx', 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'BG000'}]}]}, {'title': 'C15-C26 digestive organs', 'categories': [{'measurements': [{'value': '26.0', 'groupId': 'BG000'}]}]}, {'title': 'C30-C39 respiratory and intrathoracic organs', 'categories': [{'measurements': [{'value': '16.0', 'groupId': 'BG000'}]}]}, {'title': 'C40-C41 bone and articular cartilage', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'BG000'}]}]}, {'title': 'C43-C44 Melanoma and other skin', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'BG000'}]}]}, {'title': 'C50-C50 Mamma', 'categories': [{'measurements': [{'value': '20.6', 'groupId': 'BG000'}]}]}, {'title': 'C51-C58 female genital organs', 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'BG000'}]}]}, {'title': 'C60-C63 male genital organs', 'categories': [{'measurements': [{'value': '13.0', 'groupId': 'BG000'}]}]}, {'title': 'C64-C68 urinary tract', 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'BG000'}]}]}, {'title': 'C73-C75 thyroid and other endocrine glands', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'BG000'}]}]}, {'title': 'C76-C80 ill-defined, secondary + unspecified sites', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'BG000'}]}]}, {'title': 'C81-C96 lymphoid, hematopoietic and related tissue', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'BG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'percentage of participants'}, {'title': 'Karnofsky-index', 'classes': [{'categories': [{'measurements': [{'value': '58.6', 'spread': '21.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'score 0= worst (death) , 100= best (no limitation in health)\n\nNumber of valid cases = 125. Number of valid cases = patients with data available.', 'unitOfMeasure': 'scores', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'American Society of Anesthesiologists (ASA)-physical state (2-5)', 'classes': [{'title': 'ASA 2', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}, {'title': 'ASA 3', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}, {'title': 'ASA 4', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}]}]}, {'title': 'ASA 5', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'ASA = physical status.\n\n* state 2: patient with slight generalized disease\n* state 3: patient with severe generalized disease\n* state 4: life threatening generalized disease\n* state 5: moribund patient, unlikly to survive without operation', 'unitOfMeasure': 'participants'}, {'title': 'ECOG (Eastern Cooperative Oncology Group) performance status (0-4)', 'classes': [{'title': 'ECOG 0', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'ECOG 1', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}, {'title': 'ECOG 2', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}, {'title': 'ECOG 3', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}]}]}, {'title': 'ECOG 4', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'ECOG 0 (fully active) ECOG 1 (restricted in strenuous activity, ambulatory) ECOG 2 (ambulatory, up and about more than 50% of waking hours ECOG 3 (limited selfcare, confined to bed \\> 50% of waking hours ECOG 4 (completely disabled, no selfcare)', 'unitOfMeasure': 'participants'}, {'title': 'Reason for the use of Instanyl', 'classes': [{'title': 'No previous BTP medication', 'categories': [{'measurements': [{'value': '86', 'groupId': 'BG000'}]}]}, {'title': 'Previous BTP medic./Insufficient efficacy', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}]}]}, {'title': 'Previous BTP medic./Insufficient speed of action', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}]}]}, {'title': 'Previous BTP medic./Insufficient handling', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': 'Previous BTP medic./Insufficient tolerability', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Previous BTP medic./Other reasons', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': '(multiple reasons possible)', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 131}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-27', 'studyFirstSubmitDate': '2009-10-05', 'resultsFirstSubmitDate': '2012-03-13', 'studyFirstSubmitQcDate': '2009-10-13', 'lastUpdatePostDateStruct': {'date': '2012-09-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-08-27', 'studyFirstPostDateStruct': {'date': '2009-10-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-09-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose of Instanyl', 'timeFrame': 'during therapy with Instanyl (planned: 28 days)', 'description': 'Initially prescribed dose/ most efficient single dose of Instanyl at study end'}, {'measure': 'Physician: Degree of Maximum Pain Intensity During the Last Days/ Since the Last Examination', 'timeFrame': 'before and after therapy with Instanyl (first/last visit)', 'description': 'Scale: 0=no, 1=mild, 2=moderate, 3=strong, 4=very strong, 5=extreme'}, {'measure': 'Physician: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl)', 'timeFrame': 'before and after therapy with Instanyl (first/last visit)', 'description': 'Scale: 1=very good, 2=good, 3=satisfactory, 4=poor, 5=very poor, 6=insufficient'}, {'measure': 'Physician: To What Extent Did Your Expectations in Instanyl Have Met? (Last Visit)', 'timeFrame': 'after therapy with Instanyl (planned: 4 weeks)', 'description': '5=completely, 4=for the most part, 3=partially, 2= more or less, 1=rather not, 0=not at all'}, {'measure': 'Physician: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit)', 'timeFrame': 'after therapy with Instanyl (at last visit)', 'description': 'Scale: -3= very much improved, -2= much improved, -1= improved, 0= comparable, 1= worsened, 2= much worsened ,3= very much worsened'}, {'measure': 'Physician: What is the Current Treatment Needs of Your Patient Regarding ...', 'timeFrame': 'before and after therapy with Instanyl (first/last visit)', 'description': 'Scale: 0=no, 1=low, 2=medium, 3=high'}], 'secondaryOutcomes': [{'measure': 'Physician: Degree of Relief of Breakthrough Pain Achieved by Instanyl at Study End', 'timeFrame': 'after therapy with Instanyl (planned: 4 weeks)', 'description': '0=no reduction, 1=slight, 2=medium, 3=strong, 4=very strong, 5=complete'}, {'measure': 'Patient: How Many Episodes of Pain You Experience on Average?', 'timeFrame': 'initial visit (before start of therapy with Instanyl)'}, {'measure': 'Patient: Description of Pain at Initial Visit', 'timeFrame': 'initial visit (before start of therapy with Instanyl)', 'description': '0=no pain, 10= most intense pain imaginable'}, {'measure': 'Patient: How do You Feel Today?', 'timeFrame': 'before and after therapy with Instanyl (first/last visit)', 'description': 'Scale: 1=very bad, 2=bad, 3=mediocre, 4=good, 5=very good'}, {'measure': 'Patient: To What Extent Your Present Condition is Affected by Your Pain Attacks?', 'timeFrame': 'before and after therapy with Instanyl (first/last visit)', 'description': 'Scale: 0=not at all, 10=completely'}, {'measure': 'Patient: Modified Pain Disability Index (mPDI) - Sum - Score (Complete Questionnaires Only)', 'timeFrame': 'before and after therapy with Instanyl (first/last visit)', 'description': 'Scale: 0=no impairment, 70=complete impairment'}, {'measure': 'Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only)', 'timeFrame': 'before and after therapy with Instanyl (first/last visit)', 'description': 'Scale: 0=complete impairment, 43=no impairment'}, {'measure': 'Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only) Conspicuous ≤20', 'timeFrame': 'before and after therapy with Instanyl (first/last visit)', 'description': '0= conspicuous ≤20\n\n1= inconspicuous \\>20'}, {'measure': 'Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only)', 'timeFrame': 'before and after therapy with Instanyl (first/last visit)', 'description': 'Scale: 0=worst, 5=best'}, {'measure': 'Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only) Conspicuous <1.5', 'timeFrame': 'before and after therapy with Instanyl (first/last visit)', 'description': 'conspicuous score \\<1.5 inconspicuous score ≥1.5'}, {'measure': 'Patient: Degree of Relief of Breakthrough Pain Achieved by Instanyl at Study End', 'timeFrame': 'after therapy with Instanyl (planned: 4 weeks)', 'description': '0=no reduction, 1=slight, 2=medium, 3=strong, 4=very strong, 5=complete'}, {'measure': 'Patient: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl)', 'timeFrame': 'before and after therapy with Instanyl (first/last visit)', 'description': 'Scale: 1=very good, 2=good, 3=satisfactory, 4=poor, 5=very poor, 6=insufficient'}, {'measure': 'Patient: To What Extent Did Your Expectations in Instanyl Have Met With Respect to ... (Last Visit)', 'timeFrame': 'after therapy with Instanyl (planned: 4 weeks)', 'description': '5=completely, 4=for the most part, 3=partially, 2=more or less, 1=rather not, 0=not at all'}, {'measure': 'Patient: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ...(at Last Visit)', 'timeFrame': 'after therapy with Instanyl (at last visit)', 'description': 'Scale: -3= very much improved, -2= much improved, -1= improved , 0= comparable, 1= worsened, 2= much worsened, 3= very much worsened'}, {'measure': 'Caregiver: Degree of Relief of Breakthrough Pain Achieved by Instany at Study End', 'timeFrame': 'after therapy with Instanyl (planned: 4 weeks)', 'description': '0=no reduction, 1=slight, 2=medium, 3=strong, 4=very strong, 5=complete'}, {'measure': 'Caregiver: Assessment of Breakthrough Pain Therapy by Instanyl (Last Visit)', 'timeFrame': 'after therapy with Instanyl (first/last visit)', 'description': 'Scale: 1=very good, 2=good, 3=satisfactory, 4=poor, 5=very poor, 6=insufficient'}, {'measure': 'Caregiver: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit)', 'timeFrame': 'after therapy with Instanyl (at last visit)', 'description': 'Scale: -3= very much improved, -2= much improved, -1= improved , 0= comparable, 1= worsened, 2= much worsened, 3= very much worsened'}, {'measure': 'Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ...', 'timeFrame': 'after therapy with Instanyl (last visit)', 'description': 'Scale: -3= very much less, -2= much less, -1= less, 0=comparable, 1= more, 2= much more, 3= very much more'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['intranasal fentanyl spray'], 'conditions': ['Breakthrough Pain', 'Cancer']}, 'descriptionModule': {'briefSummary': 'The aim of the study was to evaluate the safety and efficacy of intranasal fentanyl spray in cancer patients over four weeks, especially during cancer-related breakthrough pain (BTP) attacks. The fentanyl spray was applied into the nose by a metered-spray device. The study was to provide further data on pharmacoeconomic efficiency of intranasal fentanyl spray.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Outpatients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* decision to start treatment with intranasal fentanyl spray\n* written informed consent\n\nExclusion criteria:\n\n* criteria as defined in the Summary of Product Characteristics (Fachinformation Chapter 4.3)'}, 'identificationModule': {'nctId': 'NCT00994760', 'acronym': 'GENISIS', 'briefTitle': 'Efficacy and Tolerability of Intranasal Fentanyl Spray for the Treatment of Breakthrough Pain in Cancer Patients Older Than 18 Years', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Prospective Non-interventional/Observational Patient Cohort Study on the Efficacy of Intranasal Fentanyl Spray for the Treatment of Breakthrough Pain in Cancer Patients.', 'orgStudyIdInfo': {'id': 'FT-1301-401-DE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'GENISIS', 'interventionNames': ['Drug: Instanyl (Intranasal Fentanyl)']}], 'interventions': [{'name': 'Instanyl (Intranasal Fentanyl)', 'type': 'DRUG', 'description': 'This was an observational study. 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