Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-01-04 @ 12:21 AM
Study NCT ID:
NCT00600756
Status:
COMPLETED
Last Update Posted:
2012-10-05
First Post:
2008-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of the Subjective Well-being and Tolerability of Quetiapine XR to Risperidone
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Denmark']}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018967', 'term': 'Risperidone'}], 'ancestors': [{'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrialtransparency@astrazeneca.com', 'title': 'Gerard Lynch', 'organization': 'AstraZeneca'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Quetiapine XR', 'description': 'Experimental - oral, once daily, tablets of 400 mg to 800 mg', 'otherNumAtRisk': 391, 'otherNumAffected': 238, 'seriousNumAtRisk': 391, 'seriousNumAffected': 45}, {'id': 'EG001', 'title': 'Risperidone', 'description': 'Active Comparator - oral, once daily, tablets of 2 mg to 6 mg', 'otherNumAtRisk': 402, 'otherNumAffected': 258, 'seriousNumAtRisk': 402, 'seriousNumAffected': 26}], 'otherEvents': [{'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 47}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 39}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dizziness Postural', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 29}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 52}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 38}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Tension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 20}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Aptyalism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 25}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Weight Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 25}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'seriousEvents': [{'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Psychotic Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Abnormal Behavior', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Acute Psychosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Suicide Attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Aggression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Alcohol Abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Schizoaffective Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Confusional State', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Delusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Mental Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Panic Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Schizophreniform Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Suicidal Ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Brain Stem Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Extrapyramidal Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Ischaemic Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Neuroleptic Malignant Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Psychomotor Hyperactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Transient Ischaemic Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Humerus Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Joint Sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Diabetes Meelitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Bone Neoplasm Malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pituitary Tumor Benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Alanine Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Aspartate Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 391, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 402, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Responder Rate at Month 6 in the Per Protocol Population Using the Subjective Well-being Under Neuroleptics Scale, Short Version (SWN-K) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine XR', 'description': 'Experimental - oral, once daily, tablets of 400 mg to 800 mg'}, {'id': 'OG001', 'title': 'Risperidone', 'description': 'Active Comparator - oral, once daily, tablets of 2 mg to 6 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '136', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'The SWN-K is comprised of 20 questions, rated on a 6-point scale from 1 (not at all) to 6 (very much). Scores range from 20 to 120, with higher scores implying higher subjective well-being. A responder is defined as a subject with an increase of 10 points or 20% from baseline in SWN-K total score (non-inferiority limit of -9.7% in responder rate)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'For Per Protocol at Month 6 analysis, the difference from Randomized analysis (395) was no study drug (4); SWN-K score missing (12), and did not meet inclusion criteria (169) for Quetiapine XR. For Risperidone, the difference from Randomized analysis (403) was no study drug (1); SWN-K score missing (10), and did not meet inclusion criteria (160).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Total Score at Month 12 in the Per Protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine XR', 'description': 'Experimental - oral, once daily, tablets of 400 mg to 800 mg'}, {'id': 'OG001', 'title': 'Risperidone', 'description': 'Active Comparator - oral, once daily, tablets of 2 mg to 6 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '23.2', 'spread': '1.55', 'groupId': 'OG000'}, {'value': '21.1', 'spread': '1.49', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 12', 'description': 'The SWN-K is comprised of 20 questions, each of which is rated using a 6-point scale ranging from 1 (not at all) to 6 (very much). Possible scores range from 20 to 120, with higher scores implying higher subjective well-being.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'For Per Protocol at Month 12 analysis, the difference from Randomized analysis (395) was no study drug (4); SWN-K score missing (12), and did not meet inclusion criteria (206) for Quetiapine XR. For Risperidone, the difference from Randomized analysis (403) was no study drug (1); SWN-K score missing (10), and did not meet inclusion criteria (201).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Total Score at Month 12 in the Intent-to-Treat (ITT) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine XR', 'description': 'Experimental - oral, once daily, tablets of 400 mg to 800 mg'}, {'id': 'OG001', 'title': 'Risperidone', 'description': 'Active Comparator - oral, once daily, tablets of 2 mg to 6 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '22.7', 'spread': '1.34', 'groupId': 'OG000'}, {'value': '19.4', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 12', 'description': 'The SWN-K is comprised of 20 questions, each of which is rated using a 6-point scale ranging from 1 (not at all) to 6 (very much). Possible scores range from 20 to 120, with higher scores implying higher subjective well-being.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'For Per Protocol at Month 12 analysis, the difference from Randomized analysis (395) was no study drug (4); SWN-K score missing (12), and did not meet inclusion criteria (206) for Quetiapine XR. For Risperidone, the difference from Randomized analysis (403) was no study drug (1); SWN-K score missing (10), and did not meet inclusion criteria (201).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Physical Functioning at Month 12 in the ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine XR', 'description': 'Experimental - oral, once daily, tablets of 400 mg to 800 mg'}, {'id': 'OG001', 'title': 'Risperidone', 'description': 'Active Comparator - oral, once daily, tablets of 2 mg to 6 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '4.9', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '0.31', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 12 months', 'description': 'The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Social Integration at Month 12 in the ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine XR', 'description': 'Experimental - oral, once daily, tablets of 400 mg to 800 mg'}, {'id': 'OG001', 'title': 'Risperidone', 'description': 'Active Comparator - oral, once daily, tablets of 2 mg to 6 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '4.6', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '0.31', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 12 months', 'description': 'The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Mental Functioning at Month 12 in the ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine XR', 'description': 'Experimental - oral, once daily, tablets of 400 mg to 800 mg'}, {'id': 'OG001', 'title': 'Risperidone', 'description': 'Active Comparator - oral, once daily, tablets of 2 mg to 6 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '4.9', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '0.30', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 12 months', 'description': 'The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Self-control at Month 12 in the ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine XR', 'description': 'Experimental - oral, once daily, tablets of 400 mg to 800 mg'}, {'id': 'OG001', 'title': 'Risperidone', 'description': 'Active Comparator - oral, once daily, tablets of 2 mg to 6 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '0.29', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 12 months', 'description': 'The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Emotional Regulation at Month 12 in the ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine XR', 'description': 'Experimental - oral, once daily, tablets of 400 mg to 800 mg'}, {'id': 'OG001', 'title': 'Risperidone', 'description': 'Active Comparator - oral, once daily, tablets of 2 mg to 6 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '0.31', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 12 months', 'description': 'The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.'}, {'type': 'SECONDARY', 'title': 'The Remission Rate in Both the Quetiapine XR Group and the Risperidone Group at Month 12 in the ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine XR', 'description': 'Experimental - oral, once daily, tablets of 400 mg to 800 mg'}, {'id': 'OG001', 'title': 'Risperidone', 'description': 'Active Comparator - oral, once daily, tablets of 2 mg to 6 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '139', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Remission was defined as a SWN-K total score greater than or equal to 80. The reported population is participants who showed remission over, time from baseline to Month 12', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.'}, {'type': 'SECONDARY', 'title': 'The Effect of Quetiapine XR Versus Risperidone at Month 12 in the ITT Population on Core Schizophrenic and Depressive Symptoms by Evaluating the Change From Baseline in CGI-SCH Overall Severity Score (Improved).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine XR', 'description': 'Experimental - oral, once daily, tablets of 400 mg to 800 mg'}, {'id': 'OG001', 'title': 'Risperidone', 'description': 'Active Comparator - oral, once daily, tablets of 2 mg to 6 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '176', 'spread': '1.46', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'For the CGI-SCH overall severity of illness, the score ranged from 1 (normal, not ill) to 7 (among the most severely ill). CGI-SCH score was divided into 3 classes: worsening (change score\\>0), stable (change score=0) and improved (change score\\<0). Change from baseline in CGI-SCH overall severity of illness in number of participants with CGI-SCH overall severity score improvement.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.'}, {'type': 'SECONDARY', 'title': 'The Effect of Quetiapine XR Versus Risperidone at Month 12 in the ITT Population on Core Schizophrenic and Depressive Symptoms by Evaluating the Change From Baseline in CGI-SCH Overall Severity Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine XR', 'description': 'Experimental - oral, once daily, tablets of 400 mg to 800 mg'}, {'id': 'OG001', 'title': 'Risperidone', 'description': 'Active Comparator - oral, once daily, tablets of 2 mg to 6 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '0.67', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'For the CGI-SCH (Clinical Global Impression-Schizophrenia severity of illness scale) overall severity of illness, the score ranged from 1 (normal, not ill) to 7 (among the most severely ill). Change from baseline in CGI-SCH score was divided into 3 classes: worsening (change score\\>0), stable (change score=0) and improved (change score\\<0).', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.'}, {'type': 'SECONDARY', 'title': 'The Effect of Quetiapine XR Versus Risperidone at Month 12 in the ITT Population on Core Schizophrenic and Depressive Symptoms by Evaluating the Change From Baseline in the Calgary Depression Scale for Schizophrenia (CDSS) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '351', 'groupId': 'OG000'}, {'value': '362', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine XR', 'description': 'Experimental - oral, once daily, tablets of 400 mg to 800 mg'}, {'id': 'OG001', 'title': 'Risperidone', 'description': 'Active Comparator - oral, once daily, tablets of 2 mg to 6 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.7', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '-3.7', 'spread': '0.25', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 months', 'description': 'The CDSS total score is the sum of 9 questions and ranges from 0 to 27. The higher the score, the more severe are the symptoms.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.'}, {'type': 'SECONDARY', 'title': 'The Effect of Quetiapine XR Versus Risperidone by Evaluating the Relapse Rate at Month 12 in the ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine XR', 'description': 'Experimental - oral, once daily, tablets of 400 mg to 800 mg'}, {'id': 'OG001', 'title': 'Risperidone', 'description': 'Active Comparator - oral, once daily, tablets of 2 mg to 6 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Relapse is defined as at least one increase of greater than or equal to 2 points on the CGI-SCH overall severity score during the treatment period or at least one hospitalization due to psychiatric disorders during the treatment period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Reported population is participants who showed relapse over time, from baseline to Month 12.'}, {'type': 'SECONDARY', 'title': 'Evaluation of Effect of Quetiapine XR Versus Risperidone on the Health-related Quality of Life of Patients With Schizophrenia by Evaluating the Change From Baseline in EQ-5D(Euro Quality of Life-5 Dimension) Index Score at Month 12 in the ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '343', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine XR', 'description': 'Experimental - oral, once daily, tablets of 400 mg to 800 mg'}, {'id': 'OG001', 'title': 'Risperidone', 'description': 'Active Comparator - oral, once daily, tablets of 2 mg to 6 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '0.193', 'spread': '0.0167', 'groupId': 'OG000'}, {'value': '0.168', 'spread': '0.0162', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 months', 'description': 'The Euro Quality of Life - 5 dimension index (EQ-5D) is the result of the application of a formula that essentially attaches values (also called weights) to each of the levels (no, some, or heavy problems) in each dimension (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). These weights are issued from a representative sample of the general population. The total possible maximum value was 1 (healthy life) and the minimum value was 0 (death).', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.'}, {'type': 'SECONDARY', 'title': 'To Evaluate the Effect of Quetiapine XR Versus Risperidone at Month 12 in the ITT Population Regarding Health Economics Outcomes by Evaluating the Functional Improvement Rate of the Modified Vocational Status Index/ Location Code Index: Stable State', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine XR', 'description': 'Experimental - oral, once daily, tablets of 400 mg to 800 mg'}, {'id': 'OG001', 'title': 'Risperidone', 'description': 'Active Comparator - oral, once daily, tablets of 2 mg to 6 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '160', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Stable State was defined as having the same status in occupational and residential status as at Baseline.', 'unitOfMeasure': 'Participants with stable state', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.'}, {'type': 'SECONDARY', 'title': 'The Effect of Quetiapine XR Versus Risperidone Regarding Health Economics Outcomes by Evaluating the Mean Number of Lost School/Work Days at Month 12 in the ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine XR', 'description': 'Experimental - oral, once daily, tablets of 400 mg to 800 mg'}, {'id': 'OG001', 'title': 'Risperidone', 'description': 'Active Comparator - oral, once daily, tablets of 2 mg to 6 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'spread': '38.54', 'groupId': 'OG000'}, {'value': '6.7', 'spread': '30.53', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Workers and students are defined from the modified vocational status index excluding subjects "Retired" or "Unemployed, whether or not expected to work".', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.'}, {'type': 'SECONDARY', 'title': 'The Effect of Quetiapine XR Versus Risperidone Regarding Health Economics Outcomes by Evaluating the Participants With at Least 1 Hospitalization Due to Psychiatric Disorders at Month 12 in the ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine XR', 'description': 'Experimental - oral, once daily, tablets of 400 mg to 800 mg'}, {'id': 'OG001', 'title': 'Risperidone', 'description': 'Active Comparator - oral, once daily, tablets of 2 mg to 6 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'All hospitalizations due to psychiatric disorders during the study (i.e. from Visit 1 to Termination date + 30 days) in inpatients units, in emergency wards, and in day clinics.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Who Had an Unscheduled Visits Due to Worsening of Schizophrenia, Dose Change, or Adverse Event at Month 12 in the ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine XR', 'description': 'Experimental - oral, once daily, tablets of 400 mg to 800 mg'}, {'id': 'OG001', 'title': 'Risperidone', 'description': 'Active Comparator - oral, once daily, tablets of 2 mg to 6 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': 'Unscheduled visits due to worsening of schizophrenia, dose change or adverse event including the hospitalizations due to psychiatric disorders during the study (i.e. from Visit 1 to Termination date + 30 days) in inpatients units, in emergency wards and in day clinics.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.'}, {'type': 'SECONDARY', 'title': 'The Effect of Quetiapine XR Versus Risperidone Regarding Health Economics Outcomes by Evaluating the Time Between First Study Drug Intake and First Hospitalization for Patients With 1 Hospitalization in the ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine XR', 'description': 'Experimental - oral, once daily, tablets of 400 mg to 800 mg'}, {'id': 'OG001', 'title': 'Risperidone', 'description': 'Active Comparator - oral, once daily, tablets of 2 mg to 6 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '144.3', 'spread': '97.14', 'groupId': 'OG000'}, {'value': '152.8', 'spread': '87.86', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Using Antidepressants at Month 12 in the ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine XR', 'description': 'Experimental - oral, once daily, tablets of 400 mg to 800 mg'}, {'id': 'OG001', 'title': 'Risperidone', 'description': 'Active Comparator - oral, once daily, tablets of 2 mg to 6 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'The number of participants who were taking at least 1 antidepressant at Month 12. Antidepressants are all concomitant medications classified in the Anatomical Therapeutic Chemical(ATC)Subgroup "N06-Antidepressants".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.'}, {'type': 'SECONDARY', 'title': 'The Effect of Quetiapine XR Versus Risperidone Regarding Health Economics Outcomes by Evaluating the Number of Participants Using Other Psychotropic Medications at Month 12 in the ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine XR', 'description': 'Experimental - oral, once daily, tablets of 400 mg to 800 mg'}, {'id': 'OG001', 'title': 'Risperidone', 'description': 'Active Comparator - oral, once daily, tablets of 2 mg to 6 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '138', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Other psychotropic medications include antiepileptics, anti-parkinson drugs, antipsychotics, and antidepressants.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.'}, {'type': 'SECONDARY', 'title': 'The Compliance of Patients Taking Quetiapine XR Versus Risperidone at Month 12 by Evaluating the Number of Participants Who Returned Study Drug at Month 12 in the ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine XR', 'description': 'Experimental - oral, once daily, tablets of 400 mg to 800 mg'}, {'id': 'OG001', 'title': 'Risperidone', 'description': 'Active Comparator - oral, once daily, tablets of 2 mg to 6 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '270', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.'}, {'type': 'SECONDARY', 'title': 'The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants With a Treatment-emergent Adverse Event (TEAEs) at Month 12 in the Safety Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine XR', 'description': 'Experimental - oral, once daily, tablets of 400 mg to 800 mg'}, {'id': 'OG001', 'title': 'Risperidone', 'description': 'Active Comparator - oral, once daily, tablets of 2 mg to 6 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '238', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Treatment-emergent adverse events are defined as adverse events that occurred after the first intake of the study medication (or on the same day).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population at Month 12 is presented. For Quetiapine XR, 4 subjects did not take study drug, resulting in 391 evaluable subjects compared with the Randomized population (395 subjects). For Risperidone, 1 subject did not take study drug, results in 402 evaluable subjects compared with the Randomized population (403 subjects).'}, {'type': 'SECONDARY', 'title': 'The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants Who Discontinued the Study Because of an TEAE at Month 12 in the Safety Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine XR', 'description': 'Experimental - oral, once daily, tablets of 400 mg to 800 mg'}, {'id': 'OG001', 'title': 'Risperidone', 'description': 'Active Comparator - oral, once daily, tablets of 2 mg to 6 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Treatment-emergent adverse events are defined as adverse events that occurred after the first intake of the study medication (or on the same day).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population at Month 12 is presented. For Quetiapine XR, 4 subjects did not take study drug, resulting in 391 evaluable subjects compared with the Randomized population (395 subjects). For Risperidone, 1 subject did not take study drug, results in 402 evaluable subjects compared with the Randomized population (403 subjects).'}, {'type': 'SECONDARY', 'title': 'The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants Who Had at Least 1 Extra-pyramidal TEAE at Month 12 in the Safety Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine XR', 'description': 'Experimental - oral, once daily, tablets of 400 mg to 800 mg'}, {'id': 'OG001', 'title': 'Risperidone', 'description': 'Active Comparator - oral, once daily, tablets of 2 mg to 6 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Treatment-emergent adverse events are defined as adverse events that occurred after the first intake of the study medication (or on the same day).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population at Month 12 is presented. For Quetiapine XR, 4 subjects did not take study drug, resulting in 391 evaluable subjects compared with the Randomized population (395 subjects). For Risperidone, 1 subject did not take study drug, results in 402 evaluable subjects compared with the Randomized population (403 subjects).'}, {'type': 'SECONDARY', 'title': 'The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Extra-pyramidal Events at Month 12 in the Safety Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine XR', 'description': 'Experimental - oral, once daily, tablets of 400 mg to 800 mg'}, {'id': 'OG001', 'title': 'Risperidone', 'description': 'Active Comparator - oral, once daily, tablets of 2 mg to 6 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Extra-pyramidal events include tremor, hypokinesia, muscle rigidity, hyperkinesia, and extrapyramidal disorder.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population at Month 12 is presented. For Quetiapine XR, 4 subjects did not take study drug, resulting in 391 evaluable subjects compared with the Randomized population (395 subjects). For Risperidone, 1 subject did not take study drug, results in 402 evaluable subjects compared with the Randomized population (403 subjects).'}, {'type': 'SECONDARY', 'title': 'The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants Who Had at Least 1 Cardiac TEAE at Month 12 in the Safety Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine XR', 'description': 'Experimental - oral, once daily, tablets of 400 mg to 800 mg'}, {'id': 'OG001', 'title': 'Risperidone', 'description': 'Active Comparator - oral, once daily, tablets of 2 mg to 6 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Treatment-emergent adverse events are defined as adverse events that occurred after the first intake of the study medication (or on the same day).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population at Month 12 is presented. For Quetiapine XR, 4 subjects did not take study drug, resulting in 391 evaluable subjects compared with the Randomized population (395 subjects). For Risperidone, 1 subject did not take study drug, results in 402 evaluable subjects compared with the Randomized population (403 subjects).'}, {'type': 'SECONDARY', 'title': 'The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Mean Change From Baseline to Month 12 in Prolactin Levels in the Safety Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '332', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine XR', 'description': 'Experimental - oral, once daily, tablets of 400 mg to 800 mg'}, {'id': 'OG001', 'title': 'Risperidone', 'description': 'Active Comparator - oral, once daily, tablets of 2 mg to 6 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.735', 'spread': '32.8559', 'groupId': 'OG000'}, {'value': '15.990', 'spread': '46.3367', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'The normal range for men is 0 to 14, and for women is 0 to 24.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population at Month 12 is presented. For Quetiapine XR, 4 subjects did not take study drug, resulting in 391 evaluable subjects compared with the Randomized population (395 subjects). For Risperidone, 1 subject did not take study drug, results in 402 evaluable subjects compared with the Randomized population (403 subjects).'}, {'type': 'SECONDARY', 'title': 'The Safety and Tolerability of Quetiapine XR vs Risperidone by Evaluating the Number of Participants at Month 12 in Safety Population With Individual Symptoms Assessed by the Modified Udvalg for Kliniske Undersogelser, Side Effect Rating Scale: Neurologic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine XR', 'description': 'Experimental - oral, once daily, tablets of 400 mg to 800 mg'}, {'id': 'OG001', 'title': 'Risperidone', 'description': 'Active Comparator - oral, once daily, tablets of 2 mg to 6 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Symptoms are graded according to degree (not present to severe) and causal relationship (improbable, possible, probable). An individual AE is defined as an AE with a worse degree compared with Baseline and with a possible or probable relationship to study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population at Month 12 is presented. For Quetiapine XR, 4 subjects did not take study drug, resulting in 391 evaluable subjects compared with the Randomized population (395 subjects). For Risperidone, 1 subject did not take study drug, results in 402 evaluable subjects compared with the Randomized population (403 subjects).'}, {'type': 'SECONDARY', 'title': 'The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants at Month 12 in the Safety Population With Individual Symptoms Assessed by the Modified UKU: Hyperprolactinaemia in Women', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine XR', 'description': 'Experimental - oral, once daily, tablets of 400 mg to 800 mg'}, {'id': 'OG001', 'title': 'Risperidone', 'description': 'Active Comparator - oral, once daily, tablets of 2 mg to 6 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': 'Symptoms are graded according to degree (not present to severe) and causal relationship (improbable, possible, probable). Hyperprolactinaemia in women is defined as number of women who show the individual adverse event (AE) hyperprolactinaemia. An individual AE Hyperprolactinaemia is defined as an AE with a worse degree of hyperprolactinaemia compared with baseline and with a possible or probable relationship to study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population at Month 12 is presented. Quetiapine XR: Out of 160 evaluable women, 73 were missing individual AE "Hyperprolactinaemia" data.\n\nRisperidone: Out of 171 evaluable women, 74 were missing individual AE "Hyperprolactinaemia" data".'}, {'type': 'SECONDARY', 'title': 'The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants at Month 12 in the Safety Population With Individual Symptoms Assessed by the Modified UKU: Sexual Dysfunction in Men', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Quetiapine XR', 'description': 'Experimental - oral, once daily, tablets of 400 mg to 800 mg'}, {'id': 'OG001', 'title': 'Risperidone', 'description': 'Active Comparator - oral, once daily, tablets of 2 mg to 6 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': 'Symptoms are graded according to degree (not present to severe) and causal relationship (improbable, possible, probable). Sexual dysfunction in men is defined as number of men who show the individual adverse event (AE) sexual dysfunction. An individual AE sexual dysfunction is defined as an AE with a worse degree of sexual dysfunction compared with baseline and with a possible or probable relationship to study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population at Month 12 is presented. Quetiapine XR: Out of 231 evaluable men, 111 were missing individual AE "Sexual Dysfunction" data".\n\nRisperidone: Out of 231 evaluable men, 106 were missing individual AE "Sexual Dysfunction" data".'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Quetiapine XR', 'description': 'Experimental - oral, once daily, tablets of 400 mg to 800 mg'}, {'id': 'FG001', 'title': 'Risperidone', 'description': 'Active Comparator - oral, once daily, tablets of 2 mg to 6 mg'}], 'periods': [{'title': 'Analysis After 6 Months', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '395'}, {'groupId': 'FG001', 'numSubjects': '403'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completers are all patients who completed the study up to Visit 5 (including premature withdraw)', 'groupId': 'FG000', 'numSubjects': '264'}, {'comment': 'Completers are all patients who completed the study up to Visit 5 (including premature withdraw)', 'groupId': 'FG001', 'numSubjects': '283'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '131'}, {'groupId': 'FG001', 'numSubjects': '120'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'Incorrect Enrollment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'worsening symptom, lack of efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'Severe non-compliance to protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Study-specific discontinuation criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}, {'title': 'Overall Study Analysis After 12 Months', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '395'}, {'groupId': 'FG001', 'numSubjects': '403'}]}, {'type': 'Randomized Analysis', 'achievements': [{'groupId': 'FG000', 'numSubjects': '395'}, {'groupId': 'FG001', 'numSubjects': '403'}]}, {'type': 'Safety Analysis', 'achievements': [{'groupId': 'FG000', 'numSubjects': '391'}, {'groupId': 'FG001', 'numSubjects': '402'}]}, {'type': 'ITT Analysis', 'achievements': [{'groupId': 'FG000', 'numSubjects': '379'}, {'groupId': 'FG001', 'numSubjects': '392'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed study to Visit 7 (includes premature withdrawals with final visit in the Visit 7 window)', 'groupId': 'FG000', 'numSubjects': '212'}, {'comment': 'Completed study to Visit 7 (includes premature withdrawals with final visit in the Visit 7 window)', 'groupId': 'FG001', 'numSubjects': '227'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '183'}, {'groupId': 'FG001', 'numSubjects': '176'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'Incorrect enrollment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'worsening symptom, lack of efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'Severe non-compliance to protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Study-specific discontinuation criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}], 'recruitmentDetails': 'This study was a 1-year, randomized, prospective, parallel, open-label study. The study was conducted in 114 study centers in 13 countries.\n\nOR International multi-center study, 180 sites recruited between January 2008 and October 2009.', 'preAssignmentDetails': 'Screening for eligibility. Patients with a SWN-K total score ≤ 75 were entered into the study.\n\nAll patients with "no intake of IP and missing SWN-K total score at baseline or following baseline were included in the study "Overall Number of Participants" but these patients are excluded from the ITT Analysis set!'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'BG000'}, {'value': '403', 'groupId': 'BG001'}, {'value': '798', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Quetiapine XR', 'description': 'Experimental - oral, once daily, tablets of 400 mg to 800 mg'}, {'id': 'BG001', 'title': 'Risperidone', 'description': 'Active Comparator - oral, once daily, tablets of 2 mg to 6 mg'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.3', 'spread': '11.7', 'groupId': 'BG000'}, {'value': '40.0', 'spread': '11.66', 'groupId': 'BG001'}, {'value': '39.7', 'spread': '11.67', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '162', 'groupId': 'BG000'}, {'value': '171', 'groupId': 'BG001'}, {'value': '333', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '233', 'groupId': 'BG000'}, {'value': '232', 'groupId': 'BG001'}, {'value': '465', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 798}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-02', 'studyFirstSubmitDate': '2008-01-09', 'resultsFirstSubmitDate': '2010-10-20', 'studyFirstSubmitQcDate': '2008-01-15', 'lastUpdatePostDateStruct': {'date': '2012-10-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-08-13', 'studyFirstPostDateStruct': {'date': '2008-01-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Responder Rate at Month 6 in the Per Protocol Population Using the Subjective Well-being Under Neuroleptics Scale, Short Version (SWN-K) Total Score', 'timeFrame': '6 months', 'description': 'The SWN-K is comprised of 20 questions, rated on a 6-point scale from 1 (not at all) to 6 (very much). Scores range from 20 to 120, with higher scores implying higher subjective well-being. A responder is defined as a subject with an increase of 10 points or 20% from baseline in SWN-K total score (non-inferiority limit of -9.7% in responder rate)'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Mean Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Total Score at Month 12 in the Per Protocol Population', 'timeFrame': 'Baseline and Month 12', 'description': 'The SWN-K is comprised of 20 questions, each of which is rated using a 6-point scale ranging from 1 (not at all) to 6 (very much). Possible scores range from 20 to 120, with higher scores implying higher subjective well-being.'}, {'measure': 'Change From Baseline in Mean Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Total Score at Month 12 in the Intent-to-Treat (ITT) Population', 'timeFrame': 'Baseline and Month 12', 'description': 'The SWN-K is comprised of 20 questions, each of which is rated using a 6-point scale ranging from 1 (not at all) to 6 (very much). Possible scores range from 20 to 120, with higher scores implying higher subjective well-being.'}, {'measure': 'Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Physical Functioning at Month 12 in the ITT Population.', 'timeFrame': 'Baseline and 12 months', 'description': 'The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24.'}, {'measure': 'Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Social Integration at Month 12 in the ITT Population.', 'timeFrame': 'Baseline and 12 months', 'description': 'The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24.'}, {'measure': 'Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Mental Functioning at Month 12 in the ITT Population.', 'timeFrame': 'Baseline and 12 months', 'description': 'The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24.'}, {'measure': 'Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Self-control at Month 12 in the ITT Population.', 'timeFrame': 'Baseline and 12 months', 'description': 'The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24.'}, {'measure': 'Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Emotional Regulation at Month 12 in the ITT Population.', 'timeFrame': 'Baseline and 12 months', 'description': 'The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24.'}, {'measure': 'The Remission Rate in Both the Quetiapine XR Group and the Risperidone Group at Month 12 in the ITT Population', 'timeFrame': '12 months', 'description': 'Remission was defined as a SWN-K total score greater than or equal to 80. The reported population is participants who showed remission over, time from baseline to Month 12'}, {'measure': 'The Effect of Quetiapine XR Versus Risperidone at Month 12 in the ITT Population on Core Schizophrenic and Depressive Symptoms by Evaluating the Change From Baseline in CGI-SCH Overall Severity Score (Improved).', 'timeFrame': '12 months', 'description': 'For the CGI-SCH overall severity of illness, the score ranged from 1 (normal, not ill) to 7 (among the most severely ill). CGI-SCH score was divided into 3 classes: worsening (change score\\>0), stable (change score=0) and improved (change score\\<0). Change from baseline in CGI-SCH overall severity of illness in number of participants with CGI-SCH overall severity score improvement.'}, {'measure': 'The Effect of Quetiapine XR Versus Risperidone at Month 12 in the ITT Population on Core Schizophrenic and Depressive Symptoms by Evaluating the Change From Baseline in CGI-SCH Overall Severity Score', 'timeFrame': '12 months', 'description': 'For the CGI-SCH (Clinical Global Impression-Schizophrenia severity of illness scale) overall severity of illness, the score ranged from 1 (normal, not ill) to 7 (among the most severely ill). Change from baseline in CGI-SCH score was divided into 3 classes: worsening (change score\\>0), stable (change score=0) and improved (change score\\<0).'}, {'measure': 'The Effect of Quetiapine XR Versus Risperidone at Month 12 in the ITT Population on Core Schizophrenic and Depressive Symptoms by Evaluating the Change From Baseline in the Calgary Depression Scale for Schizophrenia (CDSS) Total Score', 'timeFrame': '12 months', 'description': 'The CDSS total score is the sum of 9 questions and ranges from 0 to 27. The higher the score, the more severe are the symptoms.'}, {'measure': 'The Effect of Quetiapine XR Versus Risperidone by Evaluating the Relapse Rate at Month 12 in the ITT Population', 'timeFrame': '12 months', 'description': 'Relapse is defined as at least one increase of greater than or equal to 2 points on the CGI-SCH overall severity score during the treatment period or at least one hospitalization due to psychiatric disorders during the treatment period.'}, {'measure': 'Evaluation of Effect of Quetiapine XR Versus Risperidone on the Health-related Quality of Life of Patients With Schizophrenia by Evaluating the Change From Baseline in EQ-5D(Euro Quality of Life-5 Dimension) Index Score at Month 12 in the ITT Population.', 'timeFrame': '12 months', 'description': 'The Euro Quality of Life - 5 dimension index (EQ-5D) is the result of the application of a formula that essentially attaches values (also called weights) to each of the levels (no, some, or heavy problems) in each dimension (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). These weights are issued from a representative sample of the general population. The total possible maximum value was 1 (healthy life) and the minimum value was 0 (death).'}, {'measure': 'To Evaluate the Effect of Quetiapine XR Versus Risperidone at Month 12 in the ITT Population Regarding Health Economics Outcomes by Evaluating the Functional Improvement Rate of the Modified Vocational Status Index/ Location Code Index: Stable State', 'timeFrame': '12 months', 'description': 'Stable State was defined as having the same status in occupational and residential status as at Baseline.'}, {'measure': 'The Effect of Quetiapine XR Versus Risperidone Regarding Health Economics Outcomes by Evaluating the Mean Number of Lost School/Work Days at Month 12 in the ITT Population', 'timeFrame': '12 months', 'description': 'Workers and students are defined from the modified vocational status index excluding subjects "Retired" or "Unemployed, whether or not expected to work".'}, {'measure': 'The Effect of Quetiapine XR Versus Risperidone Regarding Health Economics Outcomes by Evaluating the Participants With at Least 1 Hospitalization Due to Psychiatric Disorders at Month 12 in the ITT Population', 'timeFrame': '12 months', 'description': 'All hospitalizations due to psychiatric disorders during the study (i.e. from Visit 1 to Termination date + 30 days) in inpatients units, in emergency wards, and in day clinics.'}, {'measure': 'Number of Subjects Who Had an Unscheduled Visits Due to Worsening of Schizophrenia, Dose Change, or Adverse Event at Month 12 in the ITT Population', 'timeFrame': 'Month 12', 'description': 'Unscheduled visits due to worsening of schizophrenia, dose change or adverse event including the hospitalizations due to psychiatric disorders during the study (i.e. from Visit 1 to Termination date + 30 days) in inpatients units, in emergency wards and in day clinics.'}, {'measure': 'The Effect of Quetiapine XR Versus Risperidone Regarding Health Economics Outcomes by Evaluating the Time Between First Study Drug Intake and First Hospitalization for Patients With 1 Hospitalization in the ITT Population', 'timeFrame': '12 months'}, {'measure': 'Number of Participants Using Antidepressants at Month 12 in the ITT Population', 'timeFrame': '12 months', 'description': 'The number of participants who were taking at least 1 antidepressant at Month 12. Antidepressants are all concomitant medications classified in the Anatomical Therapeutic Chemical(ATC)Subgroup "N06-Antidepressants".'}, {'measure': 'The Effect of Quetiapine XR Versus Risperidone Regarding Health Economics Outcomes by Evaluating the Number of Participants Using Other Psychotropic Medications at Month 12 in the ITT Population', 'timeFrame': '12 months', 'description': 'Other psychotropic medications include antiepileptics, anti-parkinson drugs, antipsychotics, and antidepressants.'}, {'measure': 'The Compliance of Patients Taking Quetiapine XR Versus Risperidone at Month 12 by Evaluating the Number of Participants Who Returned Study Drug at Month 12 in the ITT Population', 'timeFrame': '12 months'}, {'measure': 'The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants With a Treatment-emergent Adverse Event (TEAEs) at Month 12 in the Safety Population', 'timeFrame': '12 months', 'description': 'Treatment-emergent adverse events are defined as adverse events that occurred after the first intake of the study medication (or on the same day).'}, {'measure': 'The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants Who Discontinued the Study Because of an TEAE at Month 12 in the Safety Population', 'timeFrame': '12 months', 'description': 'Treatment-emergent adverse events are defined as adverse events that occurred after the first intake of the study medication (or on the same day).'}, {'measure': 'The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants Who Had at Least 1 Extra-pyramidal TEAE at Month 12 in the Safety Population', 'timeFrame': '12 months', 'description': 'Treatment-emergent adverse events are defined as adverse events that occurred after the first intake of the study medication (or on the same day).'}, {'measure': 'The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Extra-pyramidal Events at Month 12 in the Safety Population', 'timeFrame': '12 months', 'description': 'Extra-pyramidal events include tremor, hypokinesia, muscle rigidity, hyperkinesia, and extrapyramidal disorder.'}, {'measure': 'The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants Who Had at Least 1 Cardiac TEAE at Month 12 in the Safety Population', 'timeFrame': '12 months', 'description': 'Treatment-emergent adverse events are defined as adverse events that occurred after the first intake of the study medication (or on the same day).'}, {'measure': 'The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Mean Change From Baseline to Month 12 in Prolactin Levels in the Safety Population', 'timeFrame': '12 months', 'description': 'The normal range for men is 0 to 14, and for women is 0 to 24.'}, {'measure': 'The Safety and Tolerability of Quetiapine XR vs Risperidone by Evaluating the Number of Participants at Month 12 in Safety Population With Individual Symptoms Assessed by the Modified Udvalg for Kliniske Undersogelser, Side Effect Rating Scale: Neurologic', 'timeFrame': '12 months', 'description': 'Symptoms are graded according to degree (not present to severe) and causal relationship (improbable, possible, probable). An individual AE is defined as an AE with a worse degree compared with Baseline and with a possible or probable relationship to study drug.'}, {'measure': 'The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants at Month 12 in the Safety Population With Individual Symptoms Assessed by the Modified UKU: Hyperprolactinaemia in Women', 'timeFrame': 'Month 12', 'description': 'Symptoms are graded according to degree (not present to severe) and causal relationship (improbable, possible, probable). Hyperprolactinaemia in women is defined as number of women who show the individual adverse event (AE) hyperprolactinaemia. An individual AE Hyperprolactinaemia is defined as an AE with a worse degree of hyperprolactinaemia compared with baseline and with a possible or probable relationship to study drug.'}, {'measure': 'The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants at Month 12 in the Safety Population With Individual Symptoms Assessed by the Modified UKU: Sexual Dysfunction in Men', 'timeFrame': 'Month 12', 'description': 'Symptoms are graded according to degree (not present to severe) and causal relationship (improbable, possible, probable). Sexual dysfunction in men is defined as number of men who show the individual adverse event (AE) sexual dysfunction. An individual AE sexual dysfunction is defined as an AE with a worse degree of sexual dysfunction compared with baseline and with a possible or probable relationship to study drug.'}]}, 'conditionsModule': {'keywords': ['schizophrenia', 'SWNK'], 'conditions': ['Schizophrenic Disorders']}, 'referencesModule': {'references': [{'pmid': '23953270', 'type': 'DERIVED', 'citation': 'Naber D, Peuskens J, Schwarzmann N, Goltz M, Kruger H, Lambert M, Haro JM. Subjective well-being in schizophrenia: a randomised controlled open-label 12-month non-inferiority study comparing quetiapine XR with risperidone (RECOVER). Eur Neuropsychopharmacol. 2013 Oct;23(10):1257-69. doi: 10.1016/j.euroneuro.2013.07.006. Epub 2013 Jul 29.'}]}, 'descriptionModule': {'briefSummary': 'The trial is designed to assess the long term subjective well-being in schizophrenic outpatients treated with quetiapine XR (extended release) or oral risperidone at flexible dose in a naturalistic setting over a period of one year. Secondary outcome measures have been selected for helping in the differentiation of the compared atypical antipsychotics. The primary objective of this study is to demonstrate the non-inferiority of quetiapine XR to risperidone assessed at month 6 in terms of responder rate using the self-report instrument SWN-K'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Treated for symptomatic schizophrenia (DSM-IV-TR codes: 295.10, 295.20, 295.30,295.60, 295.90) or schizoaffective disorder (DSM-IV-TR code:295.70) or schizophreniform disorder (DSM-IV-TR code: 295.40). Patients with co-morbid depressive symptoms may be enrolled\n* Patient with first episode of the above mentioned disease (item 3) or patient requiring a medication change for clinical reasons (effectiveness, tolerability, compliance, patient preference), i.e. switch from typical to atypical neuroleptics, switch from other atypical neuroleptics, excluding patients treated with risperidone or quetiapine at the time of enrolment.\n\nExclusion Criteria:\n\n* Patients with a baseline SWN-K total score of \\>75\n* Patients with previous treatment with risperidone or quetiapine may be enrolled if change of treatment has not been dictated by major lack of tolerability and efficacy and if date of last dose has been at least 3 months prior to enrolment.'}, 'identificationModule': {'nctId': 'NCT00600756', 'acronym': 'RECOVER', 'briefTitle': 'Comparison of the Subjective Well-being and Tolerability of Quetiapine XR to Risperidone', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A One-Year Randomized, Prospective, Parallel, Open Comparison of Subjective Well-being in Schizophrenic Out-patients Treated With Quetiapine XR (SEROQUEL XR™) or Oral Risperidone at Flexible Dose in a Naturalistic Setting', 'orgStudyIdInfo': {'id': 'D1443L00039'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Quetiapine XR', 'interventionNames': ['Drug: Quetiapine XR']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Risperidone', 'interventionNames': ['Drug: Risperidone']}], 'interventions': [{'name': 'Quetiapine XR', 'type': 'DRUG', 'otherNames': ['Seroquel XR'], 'description': 'Oral, once daily, tablets of 400 mg to 800 mg', 'armGroupLabels': ['Quetiapine XR']}, {'name': 'Risperidone', 'type': 'DRUG', 'otherNames': ['Risperdal'], 'description': 'Oral, once daily, tablets of 2 mg to 6 mg', 'armGroupLabels': ['Risperidone']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Assebroek', 'state': 'Belgium', 'country': 'Belgium', 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