Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT01157351
Status:
COMPLETED
Last Update Posted:
2015-04-24
First Post:
2010-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
15 Month Study for Adults Who Have Been Diagnosed With Schizophrenia and Incarcerated
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': 'D000068882', 'term': 'Paliperidone Palmitate'}, {'id': 'D018967', 'term': 'Risperidone'}, {'id': 'D010546', 'term': 'Perphenazine'}, {'id': 'D000068180', 'term': 'Aripiprazole'}, {'id': 'D000069348', 'term': 'Quetiapine Fumarate'}, {'id': 'D000077152', 'term': 'Olanzapine'}], 'ancestors': [{'id': 'D007555', 'term': 'Isoxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D010640', 'term': 'Phenothiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D003987', 'term': 'Dibenzothiazepines'}, {'id': 'D013841', 'term': 'Thiazepines'}, {'id': 'D013846', 'term': 'Thiepins'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosure@its.jnj.com', 'title': 'Director, Clinical Development', 'organization': 'Janssen Research & Development'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Paliperidone Palmitate', 'description': "Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator's discretion starting on Day 38 up to 15 months.", 'otherNumAtRisk': 226, 'otherNumAffected': 178, 'seriousNumAtRisk': 226, 'seriousNumAffected': 42}, {'id': 'EG001', 'title': 'Oral Antipsychotics', 'description': 'One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.', 'otherNumAtRisk': 218, 'otherNumAffected': 155, 'seriousNumAtRisk': 218, 'seriousNumAffected': 53}], 'otherEvents': [{'term': 'Hyperprolactinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 4}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Abdominal Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Salivary Hypersecretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Injection Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Joint Sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 12}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Blood Prolactin Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Semen Volume Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Weight Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 16}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Abnormal Weight Gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Increased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Musculoskeletal Stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Pain in Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Akathisia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Dyskinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Dystonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Extrapyramidal Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 18}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 17}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Hallucination, Auditory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 27}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Libido Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Suicidal Ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 9}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Amenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Erectile Dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Galactorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Nasal Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Oropharyngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}], 'seriousEvents': [{'term': 'Cardiac Failure Congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Intestinal Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Drug Withdrawal Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Non-cardiac Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Sudden Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Acquired Immunodeficiency Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Cholecystitis Infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'H1N1 Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'HIV Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Otitis Media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Wound Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Accidental Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Alcohol Poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Gun Shot Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Hip Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Intentional Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Lower Limb Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Perirenal Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Traumatic Brain Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Traumatic Lung Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Gastric Cancer Stage III', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Akathisia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Cerebellar Ataxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Dystonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Encephalitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Facial Paresis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Ischaemic Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Stillbirth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Acute Psychosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Aggression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Alcohol Withdrawal Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Alcoholism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Delusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Depression Suicidal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Depressive Symptom', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Factitious Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Hallucination, Auditory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Hallucinations, Mixed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Homicidal Ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Mania', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Mental Status Changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Paranoia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Polysubstance Dependence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Psychotic Behaviour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Psychotic Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Schizoaffective Disorder Bipolar Type', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 11}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Schizophrenia, Paranoid Type', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Substance Abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Suicidal Ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 11}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Suicide Attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Renal Failure Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Acute Respiratory Distress Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Status Asthmaticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to First Treatment Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paliperidone Palmitate', 'description': "Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator's discretion starting on Day 38 up to 15 months."}, {'id': 'OG001', 'title': 'Oral Antipsychotics', 'description': 'One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '416', 'comment': 'Upper limit of 95 percent (%) confidence interval was not estimable due to insufficient number of participants with event.', 'groupId': 'OG000', 'lowerLimit': '285', 'upperLimit': 'NA'}, {'value': '226', 'groupId': 'OG001', 'lowerLimit': '147', 'upperLimit': '304'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of randomization up to Month 15', 'description': 'Time to first treatment failure was the time from participant randomization to the first treatment failure, which was a composite endpoint consisting of any of the following events: arrest/incarceration, psychiatric hospitalization, discontinuation of antipsychotic treatment due to safety or tolerability, treatment supplementation with another antipsychotic due to inadequate efficacy, discontinuation of antipsychotic treatment due to inadequate efficacy, increase in level of psychiatric services to prevent imminent psychiatric hospitalization, suicide. A Treatment Failure Event Monitoring Board (EMB), blinded to individual participant treatment assignment, determined the occurrence and date of the first treatment failure event.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Explanatory Intent-to-Treat (eITT) population included all ITT participants who had their study assessments for time period between randomization date and eITT end point. The eITT end point for paliperidone palmitate was the last injection date+28 days and for oral antipsychotics was the last prescription date + the number of days' supply + 1 day."}, {'type': 'SECONDARY', 'title': 'Time to First Psychiatric Hospitalization or Arrest/Incarceration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paliperidone Palmitate', 'description': "Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator's discretion starting on Day 38 up to 15 months."}, {'id': 'OG001', 'title': 'Oral Antipsychotics', 'description': 'One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and 95% confidence interval was not estimable due to insufficient number of participants with event.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '274', 'groupId': 'OG001', 'lowerLimit': '202', 'upperLimit': '407'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of randomization up to Month 15', 'description': "A time to parameter looking only at 2 component events of treatment failure: arrest or incarceration, and psychiatric hospitalization. An arrest was defined as the taking of a participant into custody by legal authority, for any reason. Incarceration was defined as involuntary confinement by an officer of the law. Psychiatric hospitalization was an inpatient psychiatric hospitalization that occurred due to the participant's clinically significant worsening of symptoms of schizophrenia.", 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "eITT population included all ITT participants who had their study assessments for time period between randomization date and eITT end point. The eITT end point for paliperidone palmitate was the last injection date+28 days and for oral antipsychotics was the last prescription date + the number of days' supply + 1 day."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Personal and Social Performance (PSP) Total Score During Overall Treatment Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paliperidone Palmitate', 'description': "Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator's discretion starting on Day 38 up to 15 months."}, {'id': 'OG001', 'title': 'Oral Antipsychotics', 'description': 'One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.75', 'spread': '0.690', 'groupId': 'OG000'}, {'value': '5.36', 'spread': '0.690', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline up to Month 15', 'description': "The PSP score assesses the degree of difficulty a participant exhibit over a 1 month period within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior. The investigators rate participants' degree of difficulty in each of the 4 domains using a 6-point Likert scale (from 0=absent to 5=very severe). The domain ratings were then transformed to PSP total score ranging from 1 to 100. Higher PSP total scores denote better functioning. A score between 71 and 100 represents normal to mild degree of dysfunction; a score between 31 and 70 represents varying degree of difficulty; and a score \\<=30 represents poor function that requires intensive supervision.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "eITT population. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Time to First Psychiatric Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paliperidone Palmitate', 'description': "Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator's discretion starting on Day 38 up to 15 months."}, {'id': 'OG001', 'title': 'Oral Antipsychotics', 'description': 'One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and 95% confidence interval was not estimable due to insufficient number of participants with event.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and 95% confidence interval was not estimable due to insufficient number of participants with event.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of randomization up to Month 15', 'description': 'A time-to parameter looking only at 1 component event of treatment failure: psychiatric hospitalization. Time to first psychiatric hospitalization was admission date of the psychiatric hospitalization recorded in the "Assessment of Treatment Failure - Psychiatric Hospitalization."', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "eITT population included all ITT participants who had their study assessments for time period between randomization date and eITT end point. The eITT end point for paliperidone palmitate was the last injection date+28 days and for oral antipsychotics was the last prescription date + the number of days' supply + 1 day."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score During Overall Treatment Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paliperidone Palmitate', 'description': "Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator's discretion starting on Day 38 up to 15 months."}, {'id': 'OG001', 'title': 'Oral Antipsychotics', 'description': 'One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.48', 'spread': '0.038', 'groupId': 'OG000'}, {'value': '-0.43', 'spread': '0.037', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline up to Month 15', 'description': 'The CGI-S rating scale was a 7-point global assessment of symptom severity with scores determined by clinician as follows: 1=Not ill, 2=Very Mild, 3= Mild, 4= Moderate, 5= Marked, 6= Severe, and 7= Extremely Severe. The higher the score the worse the illness.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "eITT population. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Percentage of Participants in Each Event Category of First Treatment Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paliperidone Palmitate', 'description': "Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator's discretion starting on Day 38 up to 15 months."}, {'id': 'OG001', 'title': 'Oral Antipsychotics', 'description': 'One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.'}], 'classes': [{'title': 'Treatment Failure Due to Any Event', 'categories': [{'measurements': [{'value': '39.8', 'groupId': 'OG000'}, {'value': '53.7', 'groupId': 'OG001'}]}]}, {'title': 'Arrest/incarceration', 'categories': [{'measurements': [{'value': '21.2', 'groupId': 'OG000'}, {'value': '29.4', 'groupId': 'OG001'}]}]}, {'title': 'Psychiatric hospitalization', 'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000'}, {'value': '11.9', 'groupId': 'OG001'}]}]}, {'title': 'D/C due to safety/tolerability', 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000'}, {'value': '3.7', 'groupId': 'OG001'}]}]}, {'title': 'Treatment supplementation', 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '2.8', 'groupId': 'OG001'}]}]}, {'title': 'D/C due to inadequate efficacy', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '4.1', 'groupId': 'OG001'}]}]}, {'title': 'Increase in level of psychiatric services', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Suicide', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From date of randomization up to Month 15', 'description': 'First treatment failure was a composite endpoint consisting of any of the following events: arrest/incarceration, psychiatric hospitalization, discontinuation (D/C) of antipsychotic treatment due to safety or tolerability, treatment supplementation with another antipsychotic due to inadequate efficacy, discontinuation of antipsychotic treatment due to inadequate efficacy, increase in level of psychiatric services to prevent imminent psychiatric hospitalization, suicide. A Treatment Failure Event Monitoring Board (EMB), blinded to individual participant treatment assignment, determined the occurrence and date of the first treatment failure event. Percentage of participants who experienced treatment failure due to any event and for each specific category of event were assessed.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "eITT population included all ITT participants who had their study assessments for time period between randomization date and eITT end point. The eITT end point for paliperidone palmitate was the last injection date+28 days and for oral antipsychotics was the last prescription date + the number of days' supply + 1 day."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Paliperidone Palmitate', 'description': "Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator's discretion starting on Day 38 up to 15 months."}, {'id': 'FG001', 'title': 'Oral Antipsychotics', 'description': 'One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '230'}, {'groupId': 'FG001', 'numSubjects': '220'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '226'}, {'groupId': 'FG001', 'numSubjects': '218'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93'}, {'groupId': 'FG001', 'numSubjects': '88'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '137'}, {'groupId': 'FG001', 'numSubjects': '132'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'Noncompliance with Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Randomized but not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'BG000'}, {'value': '218', 'groupId': 'BG001'}, {'value': '444', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Paliperidone Palmitate', 'description': "Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator's discretion starting on Day 38 up to 15 months."}, {'id': 'BG001', 'title': 'Oral Antipsychotics', 'description': 'One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.7', 'spread': '10.57', 'groupId': 'BG000'}, {'value': '38.6', 'spread': '10.36', 'groupId': 'BG001'}, {'value': '38.1', 'spread': '10.47', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '193', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '383', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Personal and Social Performance (PSP) Total Score', 'classes': [{'categories': [{'measurements': [{'value': '54.8', 'spread': '12.83', 'groupId': 'BG000'}, {'value': '55.0', 'spread': '12.73', 'groupId': 'BG001'}, {'value': '54.9', 'spread': '12.76', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The PSP score assesses degree of difficulty within 4 domains of behavior using 6-point Likert scale(0=absent to 5=very severe).The domain ratings were then transformed to PSP total score ranging from 1 to 100. Higher PSP total scores=better functioning.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Clinical Global Impression - Severity (CGI-S) Total Score', 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'spread': '0.80', 'groupId': 'BG000'}, {'value': '3.9', 'spread': '0.70', 'groupId': 'BG001'}, {'value': '3.8', 'spread': '0.75', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The CGI-S rating scale was a 7-point global assessment of symptom severity with scores determined by clinician as follows: 1=Not ill, 2=Very Mild, 3= Mild, 4= Moderate, 5= Marked, 6= Severe, and 7= Extremely Severe. The higher the score the worse the illness.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 450}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-07', 'studyFirstSubmitDate': '2010-05-03', 'resultsFirstSubmitDate': '2014-11-28', 'studyFirstSubmitQcDate': '2010-07-01', 'lastUpdatePostDateStruct': {'date': '2015-04-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-11-28', 'studyFirstPostDateStruct': {'date': '2010-07-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to First Treatment Failure', 'timeFrame': 'From date of randomization up to Month 15', 'description': 'Time to first treatment failure was the time from participant randomization to the first treatment failure, which was a composite endpoint consisting of any of the following events: arrest/incarceration, psychiatric hospitalization, discontinuation of antipsychotic treatment due to safety or tolerability, treatment supplementation with another antipsychotic due to inadequate efficacy, discontinuation of antipsychotic treatment due to inadequate efficacy, increase in level of psychiatric services to prevent imminent psychiatric hospitalization, suicide. A Treatment Failure Event Monitoring Board (EMB), blinded to individual participant treatment assignment, determined the occurrence and date of the first treatment failure event.'}, {'measure': 'Percentage of Participants in Each Event Category of First Treatment Failure', 'timeFrame': 'From date of randomization up to Month 15', 'description': 'First treatment failure was a composite endpoint consisting of any of the following events: arrest/incarceration, psychiatric hospitalization, discontinuation (D/C) of antipsychotic treatment due to safety or tolerability, treatment supplementation with another antipsychotic due to inadequate efficacy, discontinuation of antipsychotic treatment due to inadequate efficacy, increase in level of psychiatric services to prevent imminent psychiatric hospitalization, suicide. A Treatment Failure Event Monitoring Board (EMB), blinded to individual participant treatment assignment, determined the occurrence and date of the first treatment failure event. Percentage of participants who experienced treatment failure due to any event and for each specific category of event were assessed.'}], 'secondaryOutcomes': [{'measure': 'Time to First Psychiatric Hospitalization or Arrest/Incarceration', 'timeFrame': 'From date of randomization up to Month 15', 'description': "A time to parameter looking only at 2 component events of treatment failure: arrest or incarceration, and psychiatric hospitalization. An arrest was defined as the taking of a participant into custody by legal authority, for any reason. Incarceration was defined as involuntary confinement by an officer of the law. Psychiatric hospitalization was an inpatient psychiatric hospitalization that occurred due to the participant's clinically significant worsening of symptoms of schizophrenia."}, {'measure': 'Change From Baseline in Personal and Social Performance (PSP) Total Score During Overall Treatment Duration', 'timeFrame': 'Baseline up to Month 15', 'description': "The PSP score assesses the degree of difficulty a participant exhibit over a 1 month period within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior. The investigators rate participants' degree of difficulty in each of the 4 domains using a 6-point Likert scale (from 0=absent to 5=very severe). The domain ratings were then transformed to PSP total score ranging from 1 to 100. Higher PSP total scores denote better functioning. A score between 71 and 100 represents normal to mild degree of dysfunction; a score between 31 and 70 represents varying degree of difficulty; and a score \\<=30 represents poor function that requires intensive supervision."}, {'measure': 'Time to First Psychiatric Hospitalization', 'timeFrame': 'From date of randomization up to Month 15', 'description': 'A time-to parameter looking only at 1 component event of treatment failure: psychiatric hospitalization. Time to first psychiatric hospitalization was admission date of the psychiatric hospitalization recorded in the "Assessment of Treatment Failure - Psychiatric Hospitalization."'}, {'measure': 'Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score During Overall Treatment Duration', 'timeFrame': 'Baseline up to Month 15', 'description': 'The CGI-S rating scale was a 7-point global assessment of symptom severity with scores determined by clinician as follows: 1=Not ill, 2=Very Mild, 3= Mild, 4= Moderate, 5= Marked, 6= Severe, and 7= Extremely Severe. The higher the score the worse the illness.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Schizophrenia', 'Risperidone', 'Risperdal', 'Paliperidone palmitate', 'Aripiprazole', 'Haloperidol', 'Olanzapine', 'Paliperidone', 'Perphenazine', 'Quetiapine'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '37756123', 'type': 'DERIVED', 'citation': 'Lopena OJ, Alphs LD, Sajatovic M, Turkoz I, Sun L, Johnston KL, Sliwa JK, Najarian DM, Starr HL. Earlier Use of Long-Acting Injectable Paliperidone Palmitate Versus Oral Antipsychotics in Patients With Schizophrenia: An Integrated Patient-Level Post Hoc Analysis. J Clin Psychiatry. 2023 Sep 25;84(6):23m14788. doi: 10.4088/JCP.23m14788.'}, {'pmid': '33988924', 'type': 'DERIVED', 'citation': 'Bell Lynum KS, Henderson DC, Wright HJ, Gogate JP, Kim E. Treatment Effect With Paliperidone Palmitate Compared With Oral Antipsychotics in Black/African American Patients With Schizophrenia and a History of Criminal Justice System Involvement: A Post Hoc Analysis of the PRIDE Study. J Clin Psychiatry. 2021 Feb 23;82(2):20m13356. doi: 10.4088/JCP.20m13356.'}, {'pmid': '26742509', 'type': 'DERIVED', 'citation': 'Alphs L, Mao L, Lynn Starr H, Benson C. A pragmatic analysis comparing once-monthly paliperidone palmitate versus daily oral antipsychotic treatment in patients with schizophrenia. Schizophr Res. 2016 Feb;170(2-3):259-64. doi: 10.1016/j.schres.2015.12.012. Epub 2015 Dec 29.'}, {'pmid': '26403322', 'type': 'DERIVED', 'citation': 'Alphs L, Bossie C, Mao L, Lee E, Starr HL. Treatment effect with paliperidone palmitate compared with oral antipsychotics in patients with recent-onset versus more chronic schizophrenia and a history of criminal justice system involvement. Early Interv Psychiatry. 2018 Feb;12(1):55-65. doi: 10.1111/eip.12271. Epub 2015 Sep 25.'}, {'pmid': '25938474', 'type': 'DERIVED', 'citation': 'Alphs L, Benson C, Cheshire-Kinney K, Lindenmayer JP, Mao L, Rodriguez SC, Starr HL. Real-world outcomes of paliperidone palmitate compared to daily oral antipsychotic therapy in schizophrenia: a randomized, open-label, review board-blinded 15-month study. J Clin Psychiatry. 2015 May;76(5):554-61. doi: 10.4088/JCP.14m09584.'}, {'pmid': '25375367', 'type': 'DERIVED', 'citation': 'Alphs L, Mao L, Rodriguez SC, Hulihan J, Starr HL. Design and rationale of the Paliperidone Palmitate Research in Demonstrating Effectiveness (PRIDE) study: a novel comparative trial of once-monthly paliperidone palmitate versus daily oral antipsychotic treatment for delaying time to treatment failure in persons with schizophrenia. J Clin Psychiatry. 2014 Dec;75(12):1388-93. doi: 10.4088/JCP.13m08965.'}]}, 'descriptionModule': {'briefSummary': 'The study will assess the use of paliperidone palmitate compared with oral antipsychotic treatment in delaying time to a protocol-defined treatment failure over 15 months, in patients diagnosed with schizophrenia who have been incarcerated.', 'detailedDescription': 'The primary objective of this study is to compare the efficacy of paliperidone palmitate with oral antipsychotic treatment in delaying time to a protocol-defined treatment failure over 15 months, in patients diagnosed with schizophrenia who have been incarcerated. Protocol-defined treatment failure is defined as arrest, psychiatric hospitalization, increase in psychiatric services to prevent imminent hospitalization, discontinuation of antipsychotic treatment due to inadequate efficacy, treatment supplementation with another antipsychotic due to inadequate efficacy, discontinuation of antipsychotic treatment due to safety or tolerability or completed suicide. Protocol was amended on March 15, 2011 to reflect changes in the inclusion/exclusion criteria as well as the study objectives. Patients will receive either paliperidone palmitate 78, 117, 156, or 234 mg monthly by injection for fifteen months OR oral aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone at doses selected by the study doctor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Must be able to understand and sign the informed consent form approved by the Institutional Review Board (IRB)\n* Must successfully answer all the questions on the Informed Consent quiz indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study\n* Have a current diagnosis of schizophrenia\n* Taking no more than 1 oral antipsychotic on the day before randomization\n* Have been placed into custody at least twice with one of them leading to incarceration within the 24 months previous to study start, with the last release occurring within the 90 days before the first day of screening\n* in the opinion of the investigator, may benefit from a change in their prior antipsychotic treatment\n* Have available a designated individual (eg, family member, case manager, significant other, probation/parole officer) who has knowledge of the patient and is generally aware of the patient's daily activities, and who agrees to let the study site personnel know of changes in the patients circumstances when the patient is not able to provide this information, ie, arrests, protocol-defined hospitalizations, emergency room visits, becoming homeless, etc.\n* Have either an address or phone number where they can be reached, or be accessible to the designated individual\n* Must agree to receive regular injections for 15 months if randomly assigned to the paliperidone palmitate treatment group, or continue with oral study medication treatment for 15 months if randomly assigned to the oral antipsychotic treatment group\n* Women must be postmenopausal (for at least 2 years), surgically sterile (hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), abstinent, or if sexually active, be practicing a highly effective method of birth control\n\nExclusion Criteria:\n\n* Allergies, hypersensitivity (anaphylaxis-type reaction), or intolerance to risperidone or paliperidone\n* Actively abusing intravenous drugs within the past 3 months or have an opiate dependence disorder\n* Have a positive urine drug screen test for barbiturates, cocaine, amphetamines, or opiates at screening\n* Women who are pregnant or breast-feeding, or planning to become pregnant\n* Have received injectable antipsychotic treatment within 2 injection cycles prior to screening\n* Received treatment with clozapine within 3 months of screening\n* Are at a high risk of violence in the next 15 months, in the opinion of the investigator\n* who have a history of sex offenses including felony sex offenses, child molestation"}, 'identificationModule': {'nctId': 'NCT01157351', 'briefTitle': '15 Month Study for Adults Who Have Been Diagnosed With Schizophrenia and Incarcerated', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Scientific Affairs, LLC'}, 'officialTitle': 'A Fifteen-month, Prospective, Randomized, Active-controlled, Open-label, Flexible Dose Study of Paliperidone Palmitate Compared With Oral Antipsychotic Treatment in Delaying Time to Treatment Failure in Adults With Schizophrenia Who Have Been Incarcerated', 'orgStudyIdInfo': {'id': 'CR015625'}, 'secondaryIdInfos': [{'id': 'R092670SCH3006', 'type': 'OTHER', 'domain': 'Janssen Scientific Affairs, LLC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '001', 'description': 'paliperidone palmitate 78 117 156 or 234 mg monthly injection for 15 months', 'interventionNames': ['Drug: paliperidone palmitate']}, {'type': 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