Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2026-03-03 @ 9:15 PM
Study NCT ID:
NCT01175135
Status:
COMPLETED
Last Update Posted:
2018-05-22
First Post:
2010-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Inpatient Study Of The Efficacy, Safety, And Tolerability Of PF-02545920 In The Treatment Of Acute Exacerbation Of Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C545121', 'term': '2-((4-(1-methyl-4-pyridin-4-yl-1H-pyrazol-3-yl)phenoxy)methyl)quinoline'}, {'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': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'PF-02545920 5 mg', 'description': 'Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.', 'otherNumAtRisk': 74, 'otherNumAffected': 53, 'seriousNumAtRisk': 74, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'PF-02545920 15 mg', 'description': 'Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.', 'otherNumAtRisk': 74, 'otherNumAffected': 47, 'seriousNumAtRisk': 74, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'Risperidone 3 mg', 'description': 'Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.', 'otherNumAtRisk': 36, 'otherNumAffected': 22, 'seriousNumAtRisk': 36, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.', 'otherNumAtRisk': 74, 'otherNumAffected': 51, 'seriousNumAtRisk': 74, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cerumen impaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Oculogyric crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gingival pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Glossodynia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Lip disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Lip swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Salivary hypersecretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Feeling jittery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Furuncle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Infected bites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Otitis externa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pelvic inflammatory disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 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'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Homicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-02545920 5 mg', 'description': 'Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.'}, {'id': 'OG001', 'title': 'PF-02545920 15 mg', 'description': 'Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.'}, {'id': 'OG002', 'title': 'Risperidone 3 mg', 'description': 'Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '98.1', 'spread': '11.81', 'groupId': 'OG000'}, {'value': '97.7', 'spread': '11.14', 'groupId': 'OG001'}, {'value': '97.4', 'spread': '15.05', 'groupId': 'OG002'}, {'value': '97.2', 'spread': '14.92', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-15.3', 'spread': '15.56', 'groupId': 'OG000'}, {'value': '-13.8', 'spread': '17.93', 'groupId': 'OG001'}, {'value': '-17.9', 'spread': '10.99', 'groupId': 'OG002'}, {'value': '-12.6', 'spread': '15.29', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.2053', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Least Squares (LS) Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-2.21', 'ciLowerLimit': '-5.66', 'ciUpperLimit': '1.24', 'pValueComment': 'Reported p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.683', 'groupDescription': 'Mixed effect repeated measures (MMRM) model with fixed effect for baseline PANSS total score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS total score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.4024', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.67', 'ciLowerLimit': '-4.14', 'ciUpperLimit': '2.80', 'pValueComment': 'Reported p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.698', 'groupDescription': 'MMRM model with fixed effect for baseline PANSS total score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS total score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0090', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-8.24', 'ciLowerLimit': '-12.68', 'ciUpperLimit': '-3.80', 'pValueComment': 'Reported p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.453', 'groupDescription': 'MMRM model with fixed effect for baseline PANSS total score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS total score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4', 'description': 'PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included all participants who received at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline measurement.'}, {'type': 'PRIMARY', 'title': 'Proportion of Participants With Dystonia Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-02545920 5 mg', 'description': 'Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.'}, {'id': 'OG001', 'title': 'PF-02545920 15 mg', 'description': 'Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.'}, {'id': 'OG002', 'title': 'Risperidone 3 mg', 'description': 'Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'groupId': 'OG000'}, {'value': '0.08', 'groupId': 'OG001'}, {'value': '0.00', 'groupId': 'OG002'}, {'value': '0.04', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in Proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.03', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.01', 'estimateComment': 'The adjusted 80% Confidence Interval (CI) equals 88.6% CI, adjusted due to 1 interim look.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in Proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.04', 'ciLowerLimit': '-0.02', 'ciUpperLimit': '0.10', 'estimateComment': 'The adjusted 80% CI equals 88.6% CI, adjusted due to 1 interim look.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in Proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.04', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '-0.00', 'estimateComment': 'The adjusted 80% CI equals 88.6% CI, adjusted due to 1 interim look.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to end of study (7 to 10 days after administration of last dose of study medication)', 'description': 'Participants were assessed for presence of symptoms for any one of the following: dystonia, oromandibular dystonia, and oculogyric crisis.', 'unitOfMeasure': 'proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive, Negative, and General Subscales Score at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-02545920 5 mg', 'description': 'Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.'}, {'id': 'OG001', 'title': 'PF-02545920 15 mg', 'description': 'Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.'}, {'id': 'OG002', 'title': 'Risperidone 3 mg', 'description': 'Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.'}], 'classes': [{'title': 'Baseline: Positive Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '26.9', 'spread': '4.00', 'groupId': 'OG000'}, {'value': '26.1', 'spread': '3.89', 'groupId': 'OG001'}, {'value': '26.6', 'spread': '4.74', 'groupId': 'OG002'}, {'value': '26.8', 'spread': '4.16', 'groupId': 'OG003'}]}]}, {'title': 'Baseline: Negative Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '23.4', 'spread': '4.15', 'groupId': 'OG000'}, {'value': '23.4', 'spread': '4.32', 'groupId': 'OG001'}, {'value': '24.0', 'spread': '5.18', 'groupId': 'OG002'}, {'value': '23.2', 'spread': '5.12', 'groupId': 'OG003'}]}]}, {'title': 'Baseline: General Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '47.9', 'spread': '6.67', 'groupId': 'OG000'}, {'value': '48.2', 'spread': '6.43', 'groupId': 'OG001'}, {'value': '46.8', 'spread': '8.25', 'groupId': 'OG002'}, {'value': '47.2', 'spread': '7.73', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 4: Positive Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-5.0', 'spread': '5.26', 'groupId': 'OG000'}, {'value': '-4.5', 'spread': '5.51', 'groupId': 'OG001'}, {'value': '-6.7', 'spread': '3.84', 'groupId': 'OG002'}, {'value': '-4.5', 'spread': '4.68', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 4: Negative Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.7', 'spread': '4.62', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '5.09', 'groupId': 'OG001'}, {'value': '-2.7', 'spread': '4.03', 'groupId': 'OG002'}, {'value': '-1.5', 'spread': '3.78', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 4: General Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-7.5', 'spread': '7.75', 'groupId': 'OG000'}, {'value': '-7.1', 'spread': '8.80', 'groupId': 'OG001'}, {'value': '-8.6', 'spread': '5.85', 'groupId': 'OG002'}, {'value': '-6.6', 'spread': '8.20', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.3144', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.41', 'ciLowerLimit': '-1.50', 'ciUpperLimit': '0.68', 'pValueComment': 'Reported p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.845', 'groupDescription': 'Positive Score: MMRM model with fixed effect for baseline PANSS positive subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS positive subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.5700', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.15', 'ciLowerLimit': '-0.95', 'ciUpperLimit': '1.25', 'pValueComment': 'Reported p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.854', 'groupDescription': 'Positive Score: MMRM model with fixed effect for baseline PANSS positive subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS positive subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0034', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-2.99', 'ciLowerLimit': '-4.40', 'ciUpperLimit': '-1.59', 'pValueComment': 'Reported p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.093', 'groupDescription': 'Positive Score: MMRM model with fixed effect for baseline PANSS positive subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS positive subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0942', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.96', 'ciLowerLimit': '-1.90', 'ciUpperLimit': '-0.02', 'pValueComment': 'Reported p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.730', 'groupDescription': 'Negative Score: MMRM model with fixed effect for baseline PANSS negative subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS negative subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.2030', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.61', 'ciLowerLimit': '-1.56', 'ciUpperLimit': '0.33', 'pValueComment': 'Reported p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.735', 'groupDescription': 'Negative Score: MMRM model with fixed effect for baseline PANSS negative subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS negative subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0907', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-1.26', 'ciLowerLimit': '-2.48', 'ciUpperLimit': '-0.05', 'pValueComment': 'Reported p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.944', 'groupDescription': 'Negative Score: MMRM model with fixed effect for baseline PANSS negative subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS negative subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.2904', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.74', 'ciLowerLimit': '-2.45', 'ciUpperLimit': '0.97', 'pValueComment': 'Reported p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.330', 'groupDescription': 'General Score: MMRM model with fixed effect for baseline PANSS general subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS general subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.4710', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.10', 'ciLowerLimit': '-1.82', 'ciUpperLimit': '1.62', 'pValueComment': 'Reported p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.339', 'groupDescription': 'General Score: MMRM model with fixed effect for baseline PANSS general subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS general subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0172', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-3.66', 'ciLowerLimit': '-5.86', 'ciUpperLimit': '-1.45', 'pValueComment': 'Reported p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.718', 'groupDescription': 'General Score: MMRM model with fixed effect for baseline PANSS general subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS general subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4', 'description': 'PANSS - positive, negative, and general subscales assesses positive, negative and general psychopathological symptoms associated with schizophrenia respectively. Seven (7) items each make up the positive scale (for example; delusions, conceptual disorganization, and hallucinatory behavior) and negative scale (for example; blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal) and 16 items make up the general scale (for example; somatic concern, anxiety, guilt feelings, mannerisms and posturing, motor retardation, uncooperativeness, disorientation, poor impulse control, pre-occupation). Each item is rated on a 7-point Likert scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total scores range for positive as well as negative subscale is 7 to 49 and for general subscale is 16 to 112; higher subscale score indicates greater severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who received at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-02545920 5 mg', 'description': 'Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.'}, {'id': 'OG001', 'title': 'PF-02545920 15 mg', 'description': 'Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.'}, {'id': 'OG002', 'title': 'Risperidone 3 mg', 'description': 'Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.0', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '0.49', 'groupId': 'OG001'}, {'value': '4.9', 'spread': '0.67', 'groupId': 'OG002'}, {'value': '5.0', 'spread': '0.58', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '1.06', 'groupId': 'OG001'}, {'value': '-0.8', 'spread': '0.78', 'groupId': 'OG002'}, {'value': '-0.6', 'spread': '0.92', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.1970', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.13', 'ciLowerLimit': '-0.33', 'ciUpperLimit': '0.07', 'pValueComment': 'Reported p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.154', 'groupDescription': 'MMRM model with fixed effect for baseline CGI-S, investigator site, treatment, visit, treatment by visit interaction, a baseline CGI-S by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.3835', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.05', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '0.15', 'pValueComment': 'Reported p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.154', 'groupDescription': 'MMRM model with fixed effect for baseline CGI-S, investigator site, treatment, visit, treatment by visit interaction, a baseline CGI-S by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0395', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.35', 'ciLowerLimit': '-0.61', 'ciUpperLimit': '-0.10', 'pValueComment': 'Reported p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.199', 'groupDescription': 'MMRM model with fixed effect for baseline CGI-S, investigator site, treatment, visit, treatment by visit interaction, a baseline CGI-S by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4', 'description': 'CGI-S: 7-point clinician rated scale to assess severity of participant\'s current illness state. Clinician responded to a question "Considering your total clinical experience with this particular population, how mentally ill is your patient at this time?" on the following scores: 1 (normal - not ill at all), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill), 7 (among the most severely ill participants). Higher score = more affected.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who received at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-02545920 5 mg', 'description': 'Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.'}, {'id': 'OG001', 'title': 'PF-02545920 15 mg', 'description': 'Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.'}, {'id': 'OG002', 'title': 'Risperidone 3 mg', 'description': 'Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.'}], 'classes': [{'title': 'Baseline: Positive score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '30.9', 'spread': '4.51', 'groupId': 'OG000'}, {'value': '30.6', 'spread': '4.12', 'groupId': 'OG001'}, {'value': '30.3', 'spread': '5.45', 'groupId': 'OG002'}, {'value': '31.0', 'spread': '4.68', 'groupId': 'OG003'}]}]}, {'title': 'Baseline: Negative Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '23.0', 'spread': '4.43', 'groupId': 'OG000'}, {'value': '23.3', 'spread': '4.99', 'groupId': 'OG001'}, {'value': '22.9', 'spread': '5.04', 'groupId': 'OG002'}, {'value': '23.0', 'spread': '5.06', 'groupId': 'OG003'}]}]}, {'title': 'Baseline: Dis. Thought Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '20.4', 'spread': '5.13', 'groupId': 'OG000'}, {'value': '21.0', 'spread': '4.37', 'groupId': 'OG001'}, {'value': '21.3', 'spread': '5.49', 'groupId': 'OG002'}, {'value': '20.3', 'spread': '5.70', 'groupId': 'OG003'}]}]}, {'title': 'Baseline: Uncon. Hos/Exc Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.4', 'spread': '2.92', 'groupId': 'OG000'}, {'value': '9.8', 'spread': '2.98', 'groupId': 'OG001'}, {'value': '10.6', 'spread': '3.97', 'groupId': 'OG002'}, {'value': '10.0', 'spread': '3.44', 'groupId': 'OG003'}]}]}, {'title': 'Baseline: Anx/Dep Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13.5', 'spread': '2.81', 'groupId': 'OG000'}, {'value': '13.0', 'spread': '3.16', 'groupId': 'OG001'}, {'value': '12.4', 'spread': '3.17', 'groupId': 'OG002'}, {'value': '12.9', 'spread': '2.56', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 4: Positive score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-5.5', 'spread': '5.34', 'groupId': 'OG000'}, {'value': '-5.0', 'spread': '5.56', 'groupId': 'OG001'}, {'value': '-6.2', 'spread': '4.53', 'groupId': 'OG002'}, {'value': '-4.6', 'spread': '5.00', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 4: Negative Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': '4.99', 'groupId': 'OG000'}, {'value': '-2.9', 'spread': '5.69', 'groupId': 'OG001'}, {'value': '-2.5', 'spread': '4.44', 'groupId': 'OG002'}, {'value': '-2.3', 'spread': '4.91', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 4:Dis. Thought Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'spread': '3.47', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '4.39', 'groupId': 'OG001'}, {'value': '-3.0', 'spread': '3.06', 'groupId': 'OG002'}, {'value': '-1.9', 'spread': '3.05', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 4:Uncon.Hos/ExcScore', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'spread': '3.31', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '3.12', 'groupId': 'OG001'}, {'value': '-2.4', 'spread': '2.28', 'groupId': 'OG002'}, {'value': '-1.0', 'spread': '2.95', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 4: Anx/DepScore', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'spread': '3.72', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '3.85', 'groupId': 'OG001'}, {'value': '-3.8', 'spread': '3.31', 'groupId': 'OG002'}, {'value': '-2.9', 'spread': '3.22', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.1999', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.73', 'ciLowerLimit': '-1.84', 'ciUpperLimit': '0.38', 'pValueComment': 'Reported p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.863', 'groupDescription': 'Positive Score: MMRM model with fixed effect for baseline PANSS Marder positive score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder positive score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.3399', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.36', 'ciLowerLimit': '-1.48', 'ciUpperLimit': '0.76', 'pValueComment': 'Reported p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.870', 'groupDescription': 'Positive Score: MMRM model with fixed effect for baseline PANSS Marder positive score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder positive score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0100', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-2.62', 'ciLowerLimit': '-4.06', 'ciUpperLimit': '-1.18', 'pValueComment': 'Reported p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.117', 'groupDescription': 'Positive Score: MMRM model with fixed effect for baseline PANSS Marder positive score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder positive score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.1625', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.77', 'ciLowerLimit': '-1.77', 'ciUpperLimit': '0.23', 'pValueComment': 'Reported p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.778', 'groupDescription': 'Negative Score: MMRM model with fixed effect for baseline PANSS Marder negative score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder negative score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.2354', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.57', 'ciLowerLimit': '-1.57', 'ciUpperLimit': '0.44', 'pValueComment': 'Reported p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.783', 'groupDescription': 'Negative Score: MMRM model with fixed effect for baseline PANSS Marder negative score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder negative score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.2161', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.79', 'ciLowerLimit': '-2.08', 'ciUpperLimit': '0.50', 'pValueComment': 'Reported p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.002', 'groupDescription': 'Negative Score: MMRM model with fixed effect for baseline PANSS Marder negative score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder negative score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.2480', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.43', 'ciLowerLimit': '-1.23', 'ciUpperLimit': '0.38', 'pValueComment': 'Reported p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.627', 'groupDescription': 'Disorganized Thought Score: MMRM model with fixed effect for baseline PANSS Marder disorganized thought score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder disorganized thought score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.4345', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.10', 'ciLowerLimit': '-0.92', 'ciUpperLimit': '0.71', 'pValueComment': 'Reported p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.632', 'groupDescription': 'Disorganized Thought Score: MMRM model with fixed effect for baseline PANSS Marder disorganized thought score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder disorganized thought score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0346', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-1.48', 'ciLowerLimit': '-2.53', 'ciUpperLimit': '-0.44', 'pValueComment': 'Reported p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.813', 'groupDescription': 'Disorganized Thought Score: MMRM model with fixed effect for baseline PANSS Marder disorganized thought score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder disorganized thought score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.4685', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.04', 'ciLowerLimit': '-0.68', 'ciUpperLimit': '0.60', 'pValueComment': 'Reported p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.495', 'groupDescription': 'Uncontrolled hostility/excitement Score: MMRM model with fixed effect for baseline PANSS Marder hostility/excitement score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder hostility/excitement score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.6214', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.15', 'ciLowerLimit': '-0.49', 'ciUpperLimit': '0.80', 'pValueComment': 'Reported p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.499', 'groupDescription': 'Uncontrolled hostility/excitement Score: MMRM model with fixed effect for baseline PANSS Marder hostility/excitement score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder hostility/excitement score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0052', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-1.66', 'ciLowerLimit': '-2.48', 'ciUpperLimit': '-0.84', 'pValueComment': 'Reported p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.641', 'groupDescription': 'Uncontrolled hostility/excitement Score: MMRM model with fixed effect for baseline PANSS Marder hostility/excitement score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder hostility/excitement score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.5894', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.12', 'ciLowerLimit': '-0.55', 'ciUpperLimit': '0.79', 'pValueComment': 'Reported p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.523', 'groupDescription': 'Anxiety/Depression Score: MMRM model with fixed effect for baseline PANSS Marder anxiety/depression score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder anxiety/depression score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.8155', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.47', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '1.15', 'pValueComment': 'Reported p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.526', 'groupDescription': 'Anxiety/Depression Score: MMRM model with fixed effect for baseline PANSS Marder anxiety/depression score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder anxiety/depression score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0069', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-1.68', 'ciLowerLimit': '-2.55', 'ciUpperLimit': '-0.81', 'pValueComment': 'Reported p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.677', 'groupDescription': 'Anxiety/Depression Score: MMRM model with fixed effect for baseline PANSS Marder anxiety/depression score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder anxiety/depression score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4', 'description': 'PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). PANSS Marder positive symptoms subscale consists of 8 items with total score equal to sum of 8 items ranging from 8-56; Marder negative symptoms subscale and Marder disorganized thoughts (Dis. Thought) subscale, each consists of 7 items with total score equal to sum of 7 items each, ranging from 7-49, Marder uncontrolled hostility/excitement (Uncon. Hos/Exc) subscale and Marder anxiety/depression (Anx/Dep) subscale, each consists of 4 items with total score equal to sum of 4 items each ranging from 4-28. Higher subscale score indicates greater severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who received at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Derived Brief Psychiatric Rating Scale (BPRS) Core Score at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-02545920 5 mg', 'description': 'Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.'}, {'id': 'OG001', 'title': 'PF-02545920 15 mg', 'description': 'Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.'}, {'id': 'OG002', 'title': 'Risperidone 3 mg', 'description': 'Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '17.4', 'spread': '2.74', 'groupId': 'OG000'}, {'value': '17.3', 'spread': '2.32', 'groupId': 'OG001'}, {'value': '17.2', 'spread': '2.77', 'groupId': 'OG002'}, {'value': '17.3', 'spread': '2.39', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.7', 'spread': '3.39', 'groupId': 'OG000'}, {'value': '-3.4', 'spread': '3.75', 'groupId': 'OG001'}, {'value': '-4.7', 'spread': '2.99', 'groupId': 'OG002'}, {'value': '-3.2', 'spread': '3.12', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.2727', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.34', 'ciLowerLimit': '-1.06', 'ciUpperLimit': '0.38', 'pValueComment': 'Reported p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.559', 'groupDescription': 'MMRM model with fixed effect for baseline PANSS derived BPRS core score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS derived BPRS core score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.4747', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.04', 'ciLowerLimit': '-0.76', 'ciUpperLimit': '0.69', 'pValueComment': 'Reported p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.562', 'groupDescription': 'MMRM model with fixed effect for baseline PANSS derived BPRS core score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS derived BPRS core score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0031', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-2.00', 'ciLowerLimit': '-2.93', 'ciUpperLimit': '-1.07', 'pValueComment': 'Reported p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.723', 'groupDescription': 'MMRM model with fixed effect for baseline PANSS derived BPRS core score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS derived BPRS core score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4', 'description': 'PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. PANSS derived BPRS is an 18-item clinician rated scale which assesses symptoms such as hostility, suspiciousness, hallucinations, grandiosity, and a number of other psychiatric symptoms. Items scored on a 7-point scale (1=not present and 7=extremely severe), with higher score indicating greater severity of symptom. BPRS core score consists of 4 items (Conceptual disorganization, Hallucinatory behavior, Suspiciousness/persecution, Unusual thought content) with total score equal to sum of the 4 items, ranging from 4 to 28, with higher score indicating greater severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who received at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline measurement.'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impression - Improvement (CGI-I) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-02545920 5 mg', 'description': 'Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.'}, {'id': 'OG001', 'title': 'PF-02545920 15 mg', 'description': 'Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.'}, {'id': 'OG002', 'title': 'Risperidone 3 mg', 'description': 'Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'spread': '0.98', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '1.35', 'groupId': 'OG001'}, {'value': '2.7', 'spread': '0.89', 'groupId': 'OG002'}, {'value': '3.2', 'spread': '1.05', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.3598', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.07', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '0.18', 'pValueComment': 'Reported p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.196', 'groupDescription': 'MMRM model with fixed effect for investigator site, treatment, visit, treatment by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.7275', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.12', 'ciLowerLimit': '-0.13', 'ciUpperLimit': '0.37', 'pValueComment': 'Reported p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.198', 'groupDescription': 'MMRM model with fixed effect for investigator site, treatment, visit, treatment by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0019', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.75', 'ciLowerLimit': '-1.07', 'ciUpperLimit': '-0.42', 'pValueComment': 'Reported p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.255', 'groupDescription': 'MMRM model with fixed effect for investigator site, treatment, visit, treatment by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': 'CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Clinician responded to a question: "Compared to your subject\'s condition at the beginning of treatment, how much has your subject changed?" Compared to Baseline (Day 1), improvement was defined as score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who received at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-02545920 5 mg', 'description': 'Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.'}, {'id': 'OG001', 'title': 'PF-02545920 15 mg', 'description': 'Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.'}, {'id': 'OG002', 'title': 'Risperidone 3 mg', 'description': 'Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '38.4', 'spread': '8.31', 'groupId': 'OG000'}, {'value': '38.5', 'spread': '7.82', 'groupId': 'OG001'}, {'value': '38.7', 'spread': '10.58', 'groupId': 'OG002'}, {'value': '38.2', 'spread': '8.78', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.3', 'spread': '9.08', 'groupId': 'OG000'}, {'value': '6.9', 'spread': '8.92', 'groupId': 'OG001'}, {'value': '7.7', 'spread': '8.45', 'groupId': 'OG002'}, {'value': '6.3', 'spread': '8.14', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.5429', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.16', 'ciLowerLimit': '-2.06', 'ciUpperLimit': '1.74', 'pValueComment': 'Reported p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.478', 'groupDescription': 'MMRM model with fixed effect for baseline GAF score, investigator site, treatment, visit, treatment by visit interaction, baseline GAF score by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.4354', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.24', 'ciLowerLimit': '-1.68', 'ciUpperLimit': '2.16', 'pValueComment': 'Reported p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.492', 'groupDescription': 'MMRM model with fixed effect for baseline GAF score, investigator site, treatment, visit, treatment by visit interaction, baseline GAF score by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0930', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '2.53', 'ciLowerLimit': '0.08', 'ciUpperLimit': '4.99', 'pValueComment': 'Reported p-value was 1-sided.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.907', 'groupDescription': 'MMRM model with fixed effect for baseline GAF score, investigator site, treatment, visit, treatment by visit interaction, baseline GAF score by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4', 'description': 'GAF is a 100-point, clinician rated single item scale that rates the severity of illness-related impairment in psychological, social and occupational functioning of participants on a hypothetical continuum of mental illness to mental health. The scale values range from 1 to 100 with lower score indicating greater severity of illness and is divided into 10 equal intervals (descriptors): from 1-10 (persistent danger of hurting self - serious suicidal acting with clear expectations of death) to 91-100 (superior functioning - no symptoms). Each descriptor has a nine-point range to allow for some variability of severity within the descriptor.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Treatment Satisfaction Questionnaire for Medication (TSQM) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-02545920 5 mg', 'description': 'Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.'}, {'id': 'OG001', 'title': 'PF-02545920 15 mg', 'description': 'Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.'}, {'id': 'OG002', 'title': 'Risperidone 3 mg', 'description': 'Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.'}], 'classes': [{'title': 'Effectiveness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '53.68', 'spread': '24.84', 'groupId': 'OG000'}, {'value': '51.90', 'spread': '24.28', 'groupId': 'OG001'}, {'value': '63.37', 'spread': '24.07', 'groupId': 'OG002'}, {'value': '53.70', 'spread': '19.68', 'groupId': 'OG003'}]}]}, {'title': 'Side-Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '86.43', 'spread': '24.45', 'groupId': 'OG000'}, {'value': '79.20', 'spread': '28.67', 'groupId': 'OG001'}, {'value': '87.30', 'spread': '22.02', 'groupId': 'OG002'}, {'value': '87.41', 'spread': '24.00', 'groupId': 'OG003'}]}]}, {'title': 'Convenience', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '70.46', 'spread': '17.46', 'groupId': 'OG000'}, {'value': '68.37', 'spread': '18.49', 'groupId': 'OG001'}, {'value': '75.69', 'spread': '15.44', 'groupId': 'OG002'}, {'value': '66.83', 'spread': '15.12', 'groupId': 'OG003'}]}]}, {'title': 'Global Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '56.84', 'spread': '28.30', 'groupId': 'OG000'}, {'value': '51.02', 'spread': '27.79', 'groupId': 'OG001'}, {'value': '66.07', 'spread': '23.38', 'groupId': 'OG002'}, {'value': '49.48', 'spread': '24.69', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': "TSQM assesses the participant's level of satisfaction with study medication. It consists of a 14-item questionnaire which comprises of 3 specific scales (effectiveness, side effects, convenience) and 1 global satisfaction scale. Effectiveness, convenience and global satisfaction scale are rated on a 7-point scale (0= Extremely Dissatisfied, 1= Very Dissatisfied, 2= Dissatisfied, 3= Somewhat Satisfied, 4= Satisfied, 5= Very Satisfied, 6= Extremely Satisfied) and side effects are rated on a 5-point scale (0= Extremely Dissatisfied, 1=Very Dissatisfied, 2= Somewhat Dissatisfied, 3= Slightly Dissatisfied, 4= Not at all Dissatisfied). Scale scores are transformed into scores ranging from 0 to 100, with a higher score indicating more satisfaction.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-02545920 5 mg', 'description': 'Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.'}, {'id': 'OG001', 'title': 'PF-02545920 15 mg', 'description': 'Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.'}, {'id': 'OG002', 'title': 'Risperidone 3 mg', 'description': 'Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '86.1', 'spread': '15.06', 'groupId': 'OG000'}, {'value': '87.5', 'spread': '14.46', 'groupId': 'OG001'}, {'value': '83.9', 'spread': '16.99', 'groupId': 'OG002'}, {'value': '84.3', 'spread': '19.31', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.18', 'spread': '2.23', 'groupId': 'OG000'}, {'value': '-1.23', 'spread': '3.18', 'groupId': 'OG001'}, {'value': '2.69', 'spread': '3.00', 'groupId': 'OG002'}, {'value': '1.04', 'spread': '2.61', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4', 'unitOfMeasure': 'kilogram (kg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Safety analysis set included all participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Abdominal Girth at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-02545920 5 mg', 'description': 'Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.'}, {'id': 'OG001', 'title': 'PF-02545920 15 mg', 'description': 'Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.'}, {'id': 'OG002', 'title': 'Risperidone 3 mg', 'description': 'Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '96.5', 'spread': '12.33', 'groupId': 'OG000'}, {'value': '97.2', 'spread': '13.49', 'groupId': 'OG001'}, {'value': '95.6', 'spread': '13.58', 'groupId': 'OG002'}, {'value': '93.5', 'spread': '16.05', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.71', 'spread': '5.07', 'groupId': 'OG000'}, {'value': '0.70', 'spread': '5.73', 'groupId': 'OG001'}, {'value': '3.33', 'spread': '4.54', 'groupId': 'OG002'}, {'value': '0.74', 'spread': '4.29', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4', 'unitOfMeasure': 'centimeter (cm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Safety analysis set included all participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Findings in Vital Signs and Electrocardiogram (ECG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-02545920 5 mg', 'description': 'Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.'}, {'id': 'OG001', 'title': 'PF-02545920 15 mg', 'description': 'Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.'}, {'id': 'OG002', 'title': 'Risperidone 3 mg', 'description': 'Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to end of study (7 to 10 days after administration of last dose of study medication)', 'description': "Clinically significant findings based on investigator's discretion were assessed in vital sign parameters (including pulse rate, blood pressure and body temperature) and ECG parameters (including respiratory rate, heart rate, PR interval, QRS interval, QT interval, QT corrected using Bazett's correction \\[QTcB\\] interval, and QT corrected using Fridericia's correction \\[QTcF\\]).", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Changes in Physical Examinations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-02545920 5 mg', 'description': 'Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.'}, {'id': 'OG001', 'title': 'PF-02545920 15 mg', 'description': 'Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.'}, {'id': 'OG002', 'title': 'Risperidone 3 mg', 'description': 'Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Screening, Week 4', 'description': "Clinically significant findings in physical examinations based on investigator's discretion were assessed. Screening was the 7 day time (from Day -8 to Day -2) before dosing on Day 1. Number of participants with clinically significant changes in physical examinations compared to screening was assessed.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Laboratory Test Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-02545920 5 mg', 'description': 'Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.'}, {'id': 'OG001', 'title': 'PF-02545920 15 mg', 'description': 'Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.'}, {'id': 'OG002', 'title': 'Risperidone 3 mg', 'description': 'Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Screening up to end of study (7 to 10 days after administration of last dose of study medication)', 'description': 'Criteria for abnormality:hematology: hemoglobin, hematocrit, red blood cell count: less than(\\<) 0.8\\*lower limit of normal (LLN); mean corpuscular volume; mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration: \\<0.9\\*LLN,\\>1.1\\*upper limit of normal (ULN); platelets: \\<0.5\\*LLN,\\>1.75\\*ULN, white blood cell count: \\<0.6\\*LLN, \\>1.5\\*ULN; lymphocytes, total neutrophils: \\<0.8\\*LLN, \\>1.2\\*ULN; eosinophils, basophils, monocytes: \\>1.2\\*ULN; coagulation: activated partial thromboplastin time, prothrombin, prothrombin international ratio: \\>1.1\\*ULN; liver function: bilirubin: \\>1.5\\*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: \\>3.0\\*ULN; protein, albumin: \\<0.8\\*LLN\\>\\</0\\>1.2\\*ULN; renal function:blood urea nitrogen,creatinine: \\>1.3\\*ULN; uric acid: \\>1.2\\*ULN; electrolytes: sodium, potassium, chloride, calcium, bicarbonate: \\<0.9\\*LLN,\\>1.1\\*ULN; urinalysis: pH\\<4.5, \\>8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: \\<0.6\\*LLN,\\>1.5\\*ULN)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety analysis set included all participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Abnormal White Blood Cell (WBC) Count and Absolute Neutrophil Count (ANC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-02545920 5 mg', 'description': 'Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.'}, {'id': 'OG001', 'title': 'PF-02545920 15 mg', 'description': 'Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.'}, {'id': 'OG002', 'title': 'Risperidone 3 mg', 'description': 'Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.'}], 'classes': [{'title': 'WBC', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'ANC', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to Week 4', 'description': 'Pre-defined criteria was established for WBC Count (less than 0.6 times the lower limit of normal) and absolute neutrophil count (less than 0.8 times the lower limit of normal) to define the values that would be identified as abnormal.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety analysis set included all participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure"}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Laboratory Test Abnormalities for Fasting Insulin, High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Cholesterol, Triglycerides, Hemoglobin Type A1c (HbA1c) and Prolactin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-02545920 5 mg', 'description': 'Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.'}, {'id': 'OG001', 'title': 'PF-02545920 15 mg', 'description': 'Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.'}, {'id': 'OG002', 'title': 'Risperidone 3 mg', 'description': 'Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to Week 4', 'description': "Clinically significant findings based on investigator's discretion were assessed in laboratory parameters (including fasting insulin, high-density lipoprotein \\[HDL\\], low-density lipoprotein \\[LDL\\], Cholesterol, Triglycerides, glycosylated hemoglobin type A1c \\[HbA1c\\] and Prolactin).", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety analysis set included all participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-02545920 5 mg', 'description': 'Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.'}, {'id': 'OG001', 'title': 'PF-02545920 15 mg', 'description': 'Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.'}, {'id': 'OG002', 'title': 'Risperidone 3 mg', 'description': 'Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.'}], 'classes': [{'title': 'Baseline: Parkinsonism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.257', 'spread': '1.0476', 'groupId': 'OG000'}, {'value': '0.500', 'spread': '1.5283', 'groupId': 'OG001'}, {'value': '0.194', 'spread': '0.6242', 'groupId': 'OG002'}, {'value': '0.473', 'spread': '1.5809', 'groupId': 'OG003'}]}]}, {'title': 'Baseline: Dystonia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.095', 'spread': '0.5278', 'groupId': 'OG000'}, {'value': '0.000', 'spread': '0.0000', 'groupId': 'OG001'}, {'value': '0.000', 'spread': '0.0000', 'groupId': 'OG002'}, {'value': '0.027', 'spread': '0.1633', 'groupId': 'OG003'}]}]}, {'title': 'Baseline: Dyskinesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.122', 'spread': '0.4038', 'groupId': 'OG000'}, {'value': '0.095', 'spread': '0.4432', 'groupId': 'OG001'}, {'value': '0.194', 'spread': '0.5767', 'groupId': 'OG002'}, {'value': '0.135', 'spread': '0.5054', 'groupId': 'OG003'}]}]}, {'title': 'Baseline: Akathisia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.162', 'spread': '0.5496', 'groupId': 'OG000'}, {'value': '0.068', 'spread': '0.4778', 'groupId': 'OG001'}, {'value': '0.111', 'spread': '0.6667', 'groupId': 'OG002'}, {'value': '0.243', 'spread': '0.7551', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 4: Parkinsonism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.143', 'spread': '0.8397', 'groupId': 'OG000'}, {'value': '0.086', 'spread': '1.3414', 'groupId': 'OG001'}, {'value': '-0.038', 'spread': '0.9157', 'groupId': 'OG002'}, {'value': '-0.190', 'spread': '1.4126', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 4: Dystonia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.000', 'spread': '0.4016', 'groupId': 'OG000'}, {'value': '0.207', 'spread': '1.1044', 'groupId': 'OG001'}, {'value': '0.000', 'spread': '0.0000', 'groupId': 'OG002'}, {'value': '0.032', 'spread': '0.2520', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 4: Dyskinesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.016', 'spread': '0.4916', 'groupId': 'OG000'}, {'value': '0.207', 'spread': '1.0884', 'groupId': 'OG001'}, {'value': '0.038', 'spread': '0.4455', 'groupId': 'OG002'}, {'value': '-0.032', 'spread': '0.3578', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 4: Akathisia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.032', 'spread': '0.6713', 'groupId': 'OG000'}, {'value': '0.328', 'spread': '1.3297', 'groupId': 'OG001'}, {'value': '0.154', 'spread': '1.2866', 'groupId': 'OG002'}, {'value': '-0.095', 'spread': '0.9283', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4', 'description': 'ESRS-A is a clinician rated scale consisting of 24 items to assess severity of extra-pyramidal symptoms for following parameters: parkinsonism (10 items), dystonia (6 items), dyskinesia (6 items) and akathisia (2 items). Each item is scored on a 6-point Likert scale (0=absent, 1=minimal, 2=mild, 3=moderate, 4=severe, 5=extreme). Total score for a parameter is average of individual item scores included under the parameter, ranging from 0 to 5, with higher score = more affected.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Movement Disorder Burden Score for Dystonia (MDBS-D) at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-02545920 5 mg', 'description': 'Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.'}, {'id': 'OG001', 'title': 'PF-02545920 15 mg', 'description': 'Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.'}, {'id': 'OG002', 'title': 'Risperidone 3 mg', 'description': 'Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0019', 'spread': '0.01648', 'groupId': 'OG000'}, {'value': '0.0163', 'spread': '0.08087', 'groupId': 'OG001'}, {'value': '0.0000', 'spread': '0.00000', 'groupId': 'OG002'}, {'value': '0.0126', 'spread': '0.10349', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4', 'description': 'MDBS-D score reflects the numbers and durations of movement disorder adverse events for dystonia, the severity of the events, required treatment, and the total number of days the participant received study treatment. MDBS-D score = (S \\* D \\* C)/TTD; where S= Movement Disorder Severity Score for Dystonia (possible values: 1 \\[mild\\]; 2 \\[moderate\\]; 3 \\[severe\\]), D=adverse event duration (in days), C=concomitant medication factor (C=1.5 if an anti-cholinergic or beta blocker is used for the treatment of a movement disorder; C=1 if no concomitant medication is used), TTD=total treatment days for the participant. Value for MDBS score may range from zero to infinity. A higher MDBS-D score indicates a greater movement disorder adverse event liability compared to baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-02545920 5 mg', 'description': 'Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.'}, {'id': 'OG001', 'title': 'PF-02545920 15 mg', 'description': 'Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.'}, {'id': 'OG002', 'title': 'Risperidone 3 mg', 'description': 'Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.'}], 'classes': [{'title': 'Baseline: Event code 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Baseline: Event code 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Baseline: Event code 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Baseline: Event code 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Week 1: Event code 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Week 1: Event code 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Week 1: Event code 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Week 1: Event code 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Week 2: Event code 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Week 2: Event code 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Week 2: Event code 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Week 2: Event code 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Week 3: Event code 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Week 3: Event code 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Week 3: Event code 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Week 3: Event code 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Week 4: Event code 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Week 4: Event code 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Week 4: Event code 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Week 4: Event code 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'FU: Event code 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'FU: Event code 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'FU: Event code 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'FU: Event code 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 1, 2, 3, 4, Follow-up (FU) (7 to 10 days after administration of last dose of study medication)', 'description': 'Data relevant to the assessment of suicidality is mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) event codes. C-SSRS assesses whether participant experiences following: suicide attempt (Event code 2) (Response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (Event code 3) ("Yes" on "aborted attempt", "interrupted attempt", "preparatory acts or behavior"), suicidal ideation (Event code 4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act/some intent to act without specific plan or with specific plan and intent), self-injurious behavior, no suicidal intent (Event code 7) ("Yes" on "Has participant engaged in non-suicidal self-injurious behavior"). Number of participants with "Yes" response for above mentioned categories are assessed. Baseline is defined as the Week 0 measurement.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least 1 dose of study medication.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PF-02545920 5 mg', 'description': 'Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.'}, {'id': 'FG001', 'title': 'PF-02545920 15 mg', 'description': 'Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.'}, {'id': 'FG002', 'title': 'Risperidone 3 mg', 'description': 'Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '74'}, {'groupId': 'FG002', 'numSubjects': '37'}, {'groupId': 'FG003', 'numSubjects': '74'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '74'}, {'groupId': 'FG002', 'numSubjects': '36'}, {'groupId': 'FG003', 'numSubjects': '74'}]}, {'type': 'Analyzed for Efficacy', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '73'}, {'groupId': 'FG002', 'numSubjects': '34'}, {'groupId': 'FG003', 'numSubjects': '73'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Randomized But Not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 2 days during the placebo lead-in phase (before randomization in the study).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '74', 'groupId': 'BG003'}, {'value': '258', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'PF-02545920 5 mg', 'description': 'Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.'}, {'id': 'BG001', 'title': 'PF-02545920 15 mg', 'description': 'Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.'}, {'id': 'BG002', 'title': 'Risperidone 3 mg', 'description': 'Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.1', 'spread': '11.2', 'groupId': 'BG000'}, {'value': '41.7', 'spread': '10.5', 'groupId': 'BG001'}, {'value': '41.3', 'spread': '10.9', 'groupId': 'BG002'}, {'value': '41.2', 'spread': '10.9', 'groupId': 'BG003'}, {'value': '41.9', 'spread': '10.8', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}, {'value': '198', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Included all randomized participants who received at least 1 dose of study medication.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 259}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'dispFirstSubmitDate': '2013-04-09', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-27', 'studyFirstSubmitDate': '2010-08-03', 'dispFirstSubmitQcDate': '2013-04-09', 'resultsFirstSubmitDate': '2018-01-05', 'studyFirstSubmitQcDate': '2010-08-03', 'dispFirstPostDateStruct': {'date': '2013-04-16', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-05-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-02-21', 'studyFirstPostDateStruct': {'date': '2010-08-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4', 'timeFrame': 'Baseline, Week 4', 'description': 'PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.'}, {'measure': 'Proportion of Participants With Dystonia Adverse Events', 'timeFrame': 'Baseline up to end of study (7 to 10 days after administration of last dose of study medication)', 'description': 'Participants were assessed for presence of symptoms for any one of the following: dystonia, oromandibular dystonia, and oculogyric crisis.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive, Negative, and General Subscales Score at Week 4', 'timeFrame': 'Baseline, Week 4', 'description': 'PANSS - positive, negative, and general subscales assesses positive, negative and general psychopathological symptoms associated with schizophrenia respectively. Seven (7) items each make up the positive scale (for example; delusions, conceptual disorganization, and hallucinatory behavior) and negative scale (for example; blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal) and 16 items make up the general scale (for example; somatic concern, anxiety, guilt feelings, mannerisms and posturing, motor retardation, uncooperativeness, disorientation, poor impulse control, pre-occupation). Each item is rated on a 7-point Likert scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total scores range for positive as well as negative subscale is 7 to 49 and for general subscale is 16 to 112; higher subscale score indicates greater severity.'}, {'measure': 'Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 4', 'timeFrame': 'Baseline, Week 4', 'description': 'CGI-S: 7-point clinician rated scale to assess severity of participant\'s current illness state. Clinician responded to a question "Considering your total clinical experience with this particular population, how mentally ill is your patient at this time?" on the following scores: 1 (normal - not ill at all), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill), 7 (among the most severely ill participants). Higher score = more affected.'}, {'measure': 'Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4', 'timeFrame': 'Baseline, Week 4', 'description': 'PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). PANSS Marder positive symptoms subscale consists of 8 items with total score equal to sum of 8 items ranging from 8-56; Marder negative symptoms subscale and Marder disorganized thoughts (Dis. Thought) subscale, each consists of 7 items with total score equal to sum of 7 items each, ranging from 7-49, Marder uncontrolled hostility/excitement (Uncon. Hos/Exc) subscale and Marder anxiety/depression (Anx/Dep) subscale, each consists of 4 items with total score equal to sum of 4 items each ranging from 4-28. Higher subscale score indicates greater severity.'}, {'measure': 'Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Derived Brief Psychiatric Rating Scale (BPRS) Core Score at Week 4', 'timeFrame': 'Baseline, Week 4', 'description': 'PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. PANSS derived BPRS is an 18-item clinician rated scale which assesses symptoms such as hostility, suspiciousness, hallucinations, grandiosity, and a number of other psychiatric symptoms. Items scored on a 7-point scale (1=not present and 7=extremely severe), with higher score indicating greater severity of symptom. BPRS core score consists of 4 items (Conceptual disorganization, Hallucinatory behavior, Suspiciousness/persecution, Unusual thought content) with total score equal to sum of the 4 items, ranging from 4 to 28, with higher score indicating greater severity.'}, {'measure': 'Clinical Global Impression - Improvement (CGI-I) Score', 'timeFrame': 'Week 4', 'description': 'CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Clinician responded to a question: "Compared to your subject\'s condition at the beginning of treatment, how much has your subject changed?" Compared to Baseline (Day 1), improvement was defined as score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.'}, {'measure': 'Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 4', 'timeFrame': 'Baseline, Week 4', 'description': 'GAF is a 100-point, clinician rated single item scale that rates the severity of illness-related impairment in psychological, social and occupational functioning of participants on a hypothetical continuum of mental illness to mental health. The scale values range from 1 to 100 with lower score indicating greater severity of illness and is divided into 10 equal intervals (descriptors): from 1-10 (persistent danger of hurting self - serious suicidal acting with clear expectations of death) to 91-100 (superior functioning - no symptoms). Each descriptor has a nine-point range to allow for some variability of severity within the descriptor.'}, {'measure': 'Treatment Satisfaction Questionnaire for Medication (TSQM) Score', 'timeFrame': 'Week 4', 'description': "TSQM assesses the participant's level of satisfaction with study medication. It consists of a 14-item questionnaire which comprises of 3 specific scales (effectiveness, side effects, convenience) and 1 global satisfaction scale. Effectiveness, convenience and global satisfaction scale are rated on a 7-point scale (0= Extremely Dissatisfied, 1= Very Dissatisfied, 2= Dissatisfied, 3= Somewhat Satisfied, 4= Satisfied, 5= Very Satisfied, 6= Extremely Satisfied) and side effects are rated on a 5-point scale (0= Extremely Dissatisfied, 1=Very Dissatisfied, 2= Somewhat Dissatisfied, 3= Slightly Dissatisfied, 4= Not at all Dissatisfied). Scale scores are transformed into scores ranging from 0 to 100, with a higher score indicating more satisfaction."}, {'measure': 'Change From Baseline in Body Weight at Week 4', 'timeFrame': 'Baseline, Week 4'}, {'measure': 'Change From Baseline in Abdominal Girth at Week 4', 'timeFrame': 'Baseline, Week 4'}, {'measure': 'Number of Participants With Clinically Significant Findings in Vital Signs and Electrocardiogram (ECG)', 'timeFrame': 'Baseline up to end of study (7 to 10 days after administration of last dose of study medication)', 'description': "Clinically significant findings based on investigator's discretion were assessed in vital sign parameters (including pulse rate, blood pressure and body temperature) and ECG parameters (including respiratory rate, heart rate, PR interval, QRS interval, QT interval, QT corrected using Bazett's correction \\[QTcB\\] interval, and QT corrected using Fridericia's correction \\[QTcF\\])."}, {'measure': 'Number of Participants With Clinically Significant Changes in Physical Examinations', 'timeFrame': 'Screening, Week 4', 'description': "Clinically significant findings in physical examinations based on investigator's discretion were assessed. Screening was the 7 day time (from Day -8 to Day -2) before dosing on Day 1. Number of participants with clinically significant changes in physical examinations compared to screening was assessed."}, {'measure': 'Number of Participants With Laboratory Test Abnormalities', 'timeFrame': 'Screening up to end of study (7 to 10 days after administration of last dose of study medication)', 'description': 'Criteria for abnormality:hematology: hemoglobin, hematocrit, red blood cell count: less than(\\<) 0.8\\*lower limit of normal (LLN); mean corpuscular volume; mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration: \\<0.9\\*LLN,\\>1.1\\*upper limit of normal (ULN); platelets: \\<0.5\\*LLN,\\>1.75\\*ULN, white blood cell count: \\<0.6\\*LLN, \\>1.5\\*ULN; lymphocytes, total neutrophils: \\<0.8\\*LLN, \\>1.2\\*ULN; eosinophils, basophils, monocytes: \\>1.2\\*ULN; coagulation: activated partial thromboplastin time, prothrombin, prothrombin international ratio: \\>1.1\\*ULN; liver function: bilirubin: \\>1.5\\*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: \\>3.0\\*ULN; protein, albumin: \\<0.8\\*LLN\\>\\</0\\>1.2\\*ULN; renal function:blood urea nitrogen,creatinine: \\>1.3\\*ULN; uric acid: \\>1.2\\*ULN; electrolytes: sodium, potassium, chloride, calcium, bicarbonate: \\<0.9\\*LLN,\\>1.1\\*ULN; urinalysis: pH\\<4.5, \\>8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: \\<0.6\\*LLN,\\>1.5\\*ULN)'}, {'measure': 'Number of Participants With Abnormal White Blood Cell (WBC) Count and Absolute Neutrophil Count (ANC)', 'timeFrame': 'Day 1 up to Week 4', 'description': 'Pre-defined criteria was established for WBC Count (less than 0.6 times the lower limit of normal) and absolute neutrophil count (less than 0.8 times the lower limit of normal) to define the values that would be identified as abnormal.'}, {'measure': 'Number of Participants With Clinically Significant Laboratory Test Abnormalities for Fasting Insulin, High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Cholesterol, Triglycerides, Hemoglobin Type A1c (HbA1c) and Prolactin', 'timeFrame': 'Day 1 up to Week 4', 'description': "Clinically significant findings based on investigator's discretion were assessed in laboratory parameters (including fasting insulin, high-density lipoprotein \\[HDL\\], low-density lipoprotein \\[LDL\\], Cholesterol, Triglycerides, glycosylated hemoglobin type A1c \\[HbA1c\\] and Prolactin)."}, {'measure': 'Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4', 'timeFrame': 'Baseline, Week 4', 'description': 'ESRS-A is a clinician rated scale consisting of 24 items to assess severity of extra-pyramidal symptoms for following parameters: parkinsonism (10 items), dystonia (6 items), dyskinesia (6 items) and akathisia (2 items). Each item is scored on a 6-point Likert scale (0=absent, 1=minimal, 2=mild, 3=moderate, 4=severe, 5=extreme). Total score for a parameter is average of individual item scores included under the parameter, ranging from 0 to 5, with higher score = more affected.'}, {'measure': 'Change From Baseline in Movement Disorder Burden Score for Dystonia (MDBS-D) at Week 4', 'timeFrame': 'Baseline, Week 4', 'description': 'MDBS-D score reflects the numbers and durations of movement disorder adverse events for dystonia, the severity of the events, required treatment, and the total number of days the participant received study treatment. MDBS-D score = (S \\* D \\* C)/TTD; where S= Movement Disorder Severity Score for Dystonia (possible values: 1 \\[mild\\]; 2 \\[moderate\\]; 3 \\[severe\\]), D=adverse event duration (in days), C=concomitant medication factor (C=1.5 if an anti-cholinergic or beta blocker is used for the treatment of a movement disorder; C=1 if no concomitant medication is used), TTD=total treatment days for the participant. Value for MDBS score may range from zero to infinity. A higher MDBS-D score indicates a greater movement disorder adverse event liability compared to baseline.'}, {'measure': 'Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS)', 'timeFrame': 'Baseline, Week 1, 2, 3, 4, Follow-up (FU) (7 to 10 days after administration of last dose of study medication)', 'description': 'Data relevant to the assessment of suicidality is mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) event codes. C-SSRS assesses whether participant experiences following: suicide attempt (Event code 2) (Response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (Event code 3) ("Yes" on "aborted attempt", "interrupted attempt", "preparatory acts or behavior"), suicidal ideation (Event code 4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act/some intent to act without specific plan or with specific plan and intent), self-injurious behavior, no suicidal intent (Event code 7) ("Yes" on "Has participant engaged in non-suicidal self-injurious behavior"). Number of participants with "Yes" response for above mentioned categories are assessed. Baseline is defined as the Week 0 measurement.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['schizophrenia', 'acute exacerbation', 'inpatient'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '22388170', 'type': 'DERIVED', 'citation': 'Targum SD, Little JA, Lopez E, Demartinis N, Rapaport M, Ereshefsky L. Application of external review for subject selection in a schizophrenia trial. J Clin Psychopharmacol. 2012 Apr;32(2):825-6. doi: 10.1097/JCP.0b013e318248da90. No abstract available.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A8241012&StudyName=An%20Inpatient%20Study%20Of%20The%20Efficacy%2C%20Safety%2C%20And%20Tolerability%20Of%20PF-02545920%20In%20The%20Treatment%20Of%20Acute%20Exacerbation%20Of%20Schizophrenia', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate whether PF-02545920 is safe and effective in the treatment of acute exacerbation of schizophrenia during a 4-week inpatient treatment period. The study will use the Positive and Negative Syndrome Scale (PANSS) to measure change in symptoms for PF-02545920 compared to risperidone and placebo treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of schizophrenia with acute exacerbation of illness\n* The current acute exacerbation of schizophrenia must be less than 4 weeks duration prior to the initial evaluation.\n\nExclusion Criteria:\n\n* Subjects with evidence or history of clinically significant uncontrolled medical illness\n* Subjects with a current diagnosis of schizoaffective disorder, major depression, bipolar disorder, or obsessive compulsive disorder.\n* Subjects who meet Diagnostic and Statistical Manual-IV (DSM-IV)defined diagnostic criteria for psychoactive substance dependence (excluding nicotine dependence) within 12 months of screening or DSM-IV defined substance abuse within 3 months prior to screening.'}, 'identificationModule': {'nctId': 'NCT01175135', 'briefTitle': 'An Inpatient Study Of The Efficacy, Safety, And Tolerability Of PF-02545920 In The Treatment Of Acute Exacerbation Of Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 2, Multicenter, Double-blind, Randomized, Parallel Group, 4-week Inpatient Study To Evaluate The Safety And Efficacy Of Two Fixed Doses Of Pf-02545920 Compared To Placebo In The Treatment Of Acute Exacerbation Of Schizophrenia Using Risperidone As An Active Control', 'orgStudyIdInfo': {'id': 'A8241012'}, 'secondaryIdInfos': [{'id': '2010-020764-38', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PF-02545920 5 mg', 'interventionNames': ['Drug: PF-02545920']}, {'type': 'EXPERIMENTAL', 'label': 'PF-02545920 15 mg', 'interventionNames': ['Drug: PF-02545920']}, {'type': 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