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Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-24 @ 2:42 PM

Ignite Modification Date: 2025-12-26 @ 10:53 AM

Study NCT ID: NCT01680159

Status: COMPLETED

Last Update Posted: 2017-03-13

First Post: 2012-08-28

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: A Clinical Study of Increased Dose of TA-650 in Patients With Psoriasis

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015535', 'term': 'Arthritis, Psoriatic'}, {'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cti-inq-ml@ml.mt-pharma.co.jp', 'title': 'Clinical Trials, Information Desk', 'organization': 'Mitsubishi Tanabe Pharma Corporation'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'TA-650（Normal Dose Period）Overall', 'description': 'Overall(Plaque Psoriasis・Psoriatic Arthritis)', 'otherNumAtRisk': 46, 'otherNumAffected': 24, 'seriousNumAtRisk': 46, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'TA-650（Normal Dose Period）Plaque Psoriasis', 'description': 'Plaque Psoriasis', 'otherNumAtRisk': 36, 'otherNumAffected': 19, 'seriousNumAtRisk': 36, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'TA-650（Normal Dose Period）Psoriatic Arthritis', 'description': 'Psoriatic Arthritis', 'otherNumAtRisk': 10, 'otherNumAffected': 5, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'TA-650（Dose Escalation Period）Overall', 'description': 'Overall(Plaque Psoriasis・Psoriatic Arthritis・Pustular Psoriasis・Psoriatic Erythroderma)', 'otherNumAtRisk': 51, 'otherNumAffected': 47, 'seriousNumAtRisk': 51, 'seriousNumAffected': 5}, {'id': 'EG004', 'title': 'TA-650（Dose Escalation Period）Plaque Psoriasis', 'description': 'Plaque Psoriasis', 'otherNumAtRisk': 31, 'otherNumAffected': 30, 'seriousNumAtRisk': 31, 'seriousNumAffected': 4}, {'id': 'EG005', 'title': 'TA-650（Dose Escalation Period）Psoriatic Arthritis', 'description': 'Psoriatic Arthritis', 'otherNumAtRisk': 8, 'otherNumAffected': 7, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'TA-650（Dose Escalation Period）Pustular Psoriasis', 'description': 'Pustular Psoriasis', 'otherNumAtRisk': 7, 'otherNumAffected': 6, 'seriousNumAtRisk': 7, 'seriousNumAffected': 1}, {'id': 'EG007', 'title': 'TA-650（Dose Escalation Period）Psoriatic Erythroderma', 'description': 'Psoriatic Erythroderma', 'otherNumAtRisk': 5, 'otherNumAffected': 4, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'TA-650（Entire Evaluation Period）Plaque Psoriasis', 'description': 'Plaque Psoriasis', 'otherNumAtRisk': 36, 'otherNumAffected': 34, 'seriousNumAtRisk': 36, 'seriousNumAffected': 4}, {'id': 'EG009', 'title': 'TA-650（Entire Evaluation Period）Psoriatic Arthritis', 'description': 'Psoriatic Arthritis', 'otherNumAtRisk': 10, 'otherNumAffected': 9, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Enteritis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Furuncle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 36, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 36, 'numAffected': 8}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Vaginitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Vulvovaginal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Vulvovaginitis trichomonal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Gastric adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Depressive symptom', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 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'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Limb crushing injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Nail avulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}], 'seriousEvents': [{'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Bacterial pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall', 'description': 'From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.'}, {'id': 'OG001', 'title': 'Plaque Psoriasis', 'description': 'From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.'}, {'id': 'OG002', 'title': 'Psoriatic Arthritis', 'description': 'From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.'}, {'id': 'OG003', 'title': 'Pustular Psoriasis', 'description': 'From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.'}, {'id': 'OG004', 'title': 'Psoriatic Erythroderma', 'description': 'From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.'}], 'classes': [{'title': 'Week 0 (n=51,31,8,7,5)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}]}]}, {'title': 'Week 4 (n=51,31,8,7,5)', 'categories': [{'measurements': [{'value': '13.7', 'groupId': 'OG000'}, {'value': '16.1', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '40.0', 'groupId': 'OG004'}]}]}, {'title': 'Week 8 (n=50,31,8,6,5)', 'categories': [{'measurements': [{'value': '18.0', 'groupId': 'OG000'}, {'value': '16.1', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '33.3', 'groupId': 'OG003'}, {'value': '40.0', 'groupId': 'OG004'}]}]}, {'title': 'Week 12 (n=49,30,8,6,5)', 'categories': [{'measurements': [{'value': '36.7', 'groupId': 'OG000'}, {'value': '40.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '50.0', 'groupId': 'OG003'}, {'value': '60.0', 'groupId': 'OG004'}]}]}, {'title': 'Week 16 (n=48,29,8,6,5)', 'categories': [{'measurements': [{'value': '31.3', 'groupId': 'OG000'}, {'value': '34.5', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '50.0', 'groupId': 'OG003'}, {'value': '40.0', 'groupId': 'OG004'}]}]}, {'title': 'Week 20 (n=46,28,7,6,5)', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '53.6', 'groupId': 'OG001'}, {'value': '14.3', 'groupId': 'OG002'}, {'value': '50.0', 'groupId': 'OG003'}, {'value': '80.0', 'groupId': 'OG004'}]}]}, {'title': 'Week 24 (n=45,27,7,6,5)', 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}, {'value': '40.7', 'groupId': 'OG001'}, {'value': '42.9', 'groupId': 'OG002'}, {'value': '33.3', 'groupId': 'OG003'}, {'value': '40.0', 'groupId': 'OG004'}]}]}, {'title': 'Week 28 (n=44,26,7,6,5)', 'categories': [{'measurements': [{'value': '63.6', 'groupId': 'OG000'}, {'value': '69.2', 'groupId': 'OG001'}, {'value': '28.6', 'groupId': 'OG002'}, {'value': '83.3', 'groupId': 'OG003'}, {'value': '60.0', 'groupId': 'OG004'}]}]}, {'title': 'Week 32 (n=44,26,7,6,5)', 'categories': [{'measurements': [{'value': '45.5', 'groupId': 'OG000'}, {'value': '38.5', 'groupId': 'OG001'}, {'value': '42.9', 'groupId': 'OG002'}, {'value': '50.0', 'groupId': 'OG003'}, {'value': '80.0', 'groupId': 'OG004'}]}]}, {'title': 'Week 36 (n=44,26,7,6,5)', 'categories': [{'measurements': [{'value': '47.7', 'groupId': 'OG000'}, {'value': '42.3', 'groupId': 'OG001'}, {'value': '28.6', 'groupId': 'OG002'}, {'value': '66.7', 'groupId': 'OG003'}, {'value': '80.0', 'groupId': 'OG004'}]}]}, {'title': 'Week 40 (n=43,26,7,5,5)', 'categories': [{'measurements': [{'value': '44.2', 'groupId': 'OG000'}, {'value': '30.8', 'groupId': 'OG001'}, {'value': '42.9', 'groupId': 'OG002'}, {'value': '80.0', 'groupId': 'OG003'}, {'value': '80.0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period', 'description': 'The investigator or the subinvestigator examined the head, trunk, and upper and lower limbs, and assessed skin findings (erythema, induration, and scaling \\[scale\\]) at each of the regions and the extent of area affected. Total sores were calculated scores of the each regions.\n\nWhen the day of the assessment fell on a day on which study product was to be administered, the assessment was performed before the study product was administered.\n\nAs a rule, the PASI score assessments for each patient were performed by the same investigator throughout the study, unless there was a special reason why this was not done (e.g., the investigator changed jobs).\n\nThe number and percentage of patients achieving a 75% improvement in their PASI scores at each assessment time point.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Psoriasis Area and Severity Index (PASI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall', 'description': 'From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.'}, {'id': 'OG001', 'title': 'Plaque Psoriasis', 'description': 'From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.'}, {'id': 'OG002', 'title': 'Psoriatic Arthritis', 'description': 'From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.'}, {'id': 'OG003', 'title': 'Pustular Psoriasis', 'description': 'From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.'}, {'id': 'OG004', 'title': 'Psoriatic Erythroderma', 'description': 'From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.'}], 'classes': [{'title': 'Week 0 (n=51,31,8,7,5)', 'categories': [{'measurements': [{'value': '14.70', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '44.0'}, {'value': '12.80', 'groupId': 'OG001', 'lowerLimit': '4.6', 'upperLimit': '44.0'}, {'value': '13.95', 'groupId': 'OG002', 'lowerLimit': '3.0', 'upperLimit': '29.2'}, {'value': '14.70', 'groupId': 'OG003', 'lowerLimit': '3.1', 'upperLimit': '37.2'}, {'value': '22.20', 'groupId': 'OG004', 'lowerLimit': '14.7', 'upperLimit': '35.2'}]}]}, {'title': 'Week 4 (n=51,31,8,7,5)', 'categories': [{'measurements': [{'value': '7.60', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '30.7'}, {'value': '6.20', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '29.4'}, {'value': '8.20', 'groupId': 'OG002', 'lowerLimit': '0.6', 'upperLimit': '28.0'}, {'value': '9.90', 'groupId': 'OG003', 'lowerLimit': '3.0', 'upperLimit': '19.3'}, {'value': '9.20', 'groupId': 'OG004', 'lowerLimit': '4.2', 'upperLimit': '30.7'}]}]}, {'title': 'Week 8 (n=50,31,8,6,5)', 'categories': [{'measurements': [{'value': '7.25', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '46.0'}, {'value': '7.50', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '46.0'}, {'value': '8.20', 'groupId': 'OG002', 'lowerLimit': '0.8', 'upperLimit': '27.6'}, {'value': '4.20', 'groupId': 'OG003', 'lowerLimit': '1.2', 'upperLimit': '34.8'}, {'value': '14.00', 'groupId': 'OG004', 'lowerLimit': '3.5', 'upperLimit': '34.7'}]}]}, {'title': 'Week 12 (n=49,30,8,6,5)', 'categories': [{'measurements': [{'value': '4.40', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '39.3'}, {'value': '4.40', 'groupId': 'OG001', 'lowerLimit': '0.7', 'upperLimit': '39.3'}, {'value': '6.60', 'groupId': 'OG002', 'lowerLimit': '0.8', 'upperLimit': '24.1'}, {'value': '3.70', 'groupId': 'OG003', 'lowerLimit': '1.2', 'upperLimit': '20.9'}, {'value': '3.40', 'groupId': 'OG004', 'lowerLimit': '1.6', 'upperLimit': '25.7'}]}]}, {'title': 'Week 16 (n=48,29,8,6,5)', 'categories': [{'measurements': [{'value': '6.80', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '39.6'}, {'value': '6.60', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '16.2'}, {'value': '6.60', 'groupId': 'OG002', 'lowerLimit': '1.3', 'upperLimit': '24.9'}, {'value': '7.40', 'groupId': 'OG003', 'lowerLimit': '0.4', 'upperLimit': '23.0'}, {'value': '9.50', 'groupId': 'OG004', 'lowerLimit': '1.5', 'upperLimit': '39.6'}]}]}, {'title': 'Week 20 (n=46,28,7,6,5)', 'categories': [{'measurements': [{'value': '3.80', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '22.0'}, {'value': '3.95', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '10.9'}, {'value': '3.80', 'groupId': 'OG002', 'lowerLimit': '1.2', 'upperLimit': '22.0'}, {'value': '4.80', 'groupId': 'OG003', 'lowerLimit': '2.1', 'upperLimit': '15.8'}, {'value': '3.40', 'groupId': 'OG004', 'lowerLimit': '1.2', 'upperLimit': '14.8'}]}]}, {'title': 'Week 24 (n=45,27,7,6,5)', 'categories': [{'measurements': [{'value': '4.80', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '27.9'}, {'value': '4.70', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '15.1'}, {'value': '4.80', 'groupId': 'OG002', 'lowerLimit': '0.4', 'upperLimit': '18.8'}, {'value': '5.80', 'groupId': 'OG003', 'lowerLimit': '2.0', 'upperLimit': '14.0'}, {'value': '5.60', 'groupId': 'OG004', 'lowerLimit': '2.4', 'upperLimit': '27.9'}]}]}, {'title': 'Week 28 (n=44,26,7,6,5)', 'categories': [{'measurements': [{'value': '3.25', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '20.4'}, {'value': '3.25', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '11.9'}, {'value': '4.20', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '20.4'}, {'value': '2.75', 'groupId': 'OG003', 'lowerLimit': '0.8', 'upperLimit': '6.3'}, {'value': '5.30', 'groupId': 'OG004', 'lowerLimit': '0.9', 'upperLimit': '11.6'}]}]}, {'title': 'Week 32 (n=44,26,7,6,5)', 'categories': [{'measurements': [{'value': '4.70', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '25.3'}, {'value': '4.50', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '21.6'}, {'value': '4.20', 'groupId': 'OG002', 'lowerLimit': '0.4', 'upperLimit': '16.4'}, {'value': '6.05', 'groupId': 'OG003', 'lowerLimit': '1.2', 'upperLimit': '8.8'}, {'value': '4.80', 'groupId': 'OG004', 'lowerLimit': '0.9', 'upperLimit': '25.3'}]}]}, {'title': 'Week 36 (n=44,26,7,6,5)', 'categories': [{'measurements': [{'value': '3.40', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '29.8'}, {'value': '3.40', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '18.3'}, {'value': '1.80', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '29.8'}, {'value': '3.15', 'groupId': 'OG003', 'lowerLimit': '2.5', 'upperLimit': '11.7'}, {'value': '3.90', 'groupId': 'OG004', 'lowerLimit': '0.9', 'upperLimit': '24.6'}]}]}, {'title': 'Week 40 (n=43,26,7,5,5)', 'categories': [{'measurements': [{'value': '3.70', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '29.3'}, {'value': '4.70', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '27.6'}, {'value': '2.40', 'groupId': 'OG002', 'lowerLimit': '0.8', 'upperLimit': '29.3'}, {'value': '2.70', 'groupId': 'OG003', 'lowerLimit': '2.1', 'upperLimit': '6.2'}, {'value': '3.30', 'groupId': 'OG004', 'lowerLimit': '2.7', 'upperLimit': '14.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period', 'description': 'Score range is 0-72. Higher values represent a worse outcome. The investigator or the subinvestigator examined the head, trunk, and upper and lower limbs, and assessed skin findings (erythema, induration, and scaling \\[scale\\]) at each of the regions and the extent of area affected. Total sores were added scores of the each regions.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Cleared and Minimal Skin Lesions of Physician Global Assessment (PGA) (Only for Patients With Plaque Psoriasis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Plaque Psoriasis', 'description': 'From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.'}], 'classes': [{'title': 'Week 0 (n=31)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 (n=31)', 'categories': [{'measurements': [{'value': '32.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 (n=31)', 'categories': [{'measurements': [{'value': '32.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 (n=30)', 'categories': [{'measurements': [{'value': '43.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 16 (n=29)', 'categories': [{'measurements': [{'value': '41.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 20 (n=28)', 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (n=27)', 'categories': [{'measurements': [{'value': '40.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 28 (n=26)', 'categories': [{'measurements': [{'value': '69.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 32 (n=26)', 'categories': [{'measurements': [{'value': '57.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 36 (n=26)', 'categories': [{'measurements': [{'value': '61.5', 'groupId': 'OG000'}]}]}, {'title': 'Week 40 (n=26)', 'categories': [{'measurements': [{'value': '46.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period', 'description': 'The investigator or the subinvestigator made a global assessment of skin lesions in terms of the degree of erythema, induration, and scaling (scale), using the following 6-point scale (0 to 5). When the day of the assessment fell on a day on which study product was to be administered, the assessment was performed before the study product was administered. As a rule, the PGA for each patient were performed by the same investigator or subinvestigator throughout the study, unless there was a special reason why this was not done (e.g., the investigator or the subinvestigator changed jobs). Outcome measure data table is reported percentage of participants with Cleared and Minimal skin lesions.\n\n0: Cleared, 1: Minimal, 2: Mild, 3: Moderate, 4: Marked, 5: Severe', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Visual Analog Scale（VAS） of Pain Assessment by Subjects (Only for Patients With Psoriatic Arthritis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Psoriatic Arthritis', 'description': 'From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.'}], 'classes': [{'title': 'Week 0 (n=8)', 'categories': [{'measurements': [{'value': '59.5', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '92'}]}]}, {'title': 'Week 4 (n=8)', 'categories': [{'measurements': [{'value': '19.0', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '67'}]}]}, {'title': 'Week 8 (n=8)', 'categories': [{'measurements': [{'value': '49.5', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '98'}]}]}, {'title': 'Week 12 (n=8)', 'categories': [{'measurements': [{'value': '14.0', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '64'}]}]}, {'title': 'Week 16 (n=8)', 'categories': [{'measurements': [{'value': '41.0', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '96'}]}]}, {'title': 'Week 20 (n=7)', 'categories': [{'measurements': [{'value': '27.0', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '78'}]}]}, {'title': 'Week 24 (n=7)', 'categories': [{'measurements': [{'value': '28.0', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '72'}]}]}, {'title': 'Week 28 (n=7)', 'categories': [{'measurements': [{'value': '17.0', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '78'}]}]}, {'title': 'Week 32 (n=7)', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '80'}]}]}, {'title': 'Week 36 (n=7)', 'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '49'}]}]}, {'title': 'Week 40 (n=7)', 'categories': [{'measurements': [{'value': '27.0', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '64'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period', 'description': 'From 0 (best) to 100 (worst)', 'unitOfMeasure': 'mm', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Assessment of Severity (Only for Patients With Pustular Psoriasis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pustular Psoriasis', 'description': 'From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.'}], 'classes': [{'title': 'Week 0 (n=7)', 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '10'}]}]}, {'title': 'Week 4 (n=7)', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '6'}]}]}, {'title': 'Week 8 (n=6)', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '10'}]}]}, {'title': 'Week 12 (n=6)', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '6'}]}]}, {'title': 'Week 16 (n=6)', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '9'}]}]}, {'title': 'Week 20 (n=6)', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '4'}]}]}, {'title': 'Week 24 (n=6)', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}]}]}, {'title': 'Week 28 (n=6)', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '4'}]}]}, {'title': 'Week 32 (n=6)', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '4'}]}]}, {'title': 'Week 36 (n=6)', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}]}]}, {'title': 'Week 40 (n=5)', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period', 'description': 'From 0 (best) to 17 (worst)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TA-650', 'description': 'During the normal dose period, patients received doses of TA-650 5 mg per 1 kg body weight as a slow intravenous infusion over at least 2 hours on the treatment day at week 0, and at week 8 (if patients were not assessed as being either "efficacy attenuated" or "efficacy maintained" at week 8 of the normal dose period).'}], 'periods': [{'title': 'Screening Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Not meet criteria for dose-up period', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}]}, {'title': 'Increased Dose Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'Patients of Pustular Psoriasis and Psoriatic Erythroderma could directly receive doses of TA-650 10mg per 1kg not to go though screening period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Plaque Psoriasis', 'description': 'From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.'}, {'id': 'BG001', 'title': 'Psoriatic Arthritis', 'description': 'From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.'}, {'id': 'BG002', 'title': 'Pustular Psoriasis', 'description': 'From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.'}, {'id': 'BG003', 'title': 'Psoriatic Erythroderma', 'description': 'From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.2', 'spread': '13.9', 'groupId': 'BG000'}, {'value': '50.1', 'spread': '11.9', 'groupId': 'BG001'}, {'value': '36.7', 'spread': '9.7', 'groupId': 'BG002'}, {'value': '55.8', 'spread': '12.5', 'groupId': 'BG003'}, {'value': '49.5', 'spread': '13.7', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-23', 'studyFirstSubmitDate': '2012-08-28', 'resultsFirstSubmitDate': '2016-11-09', 'studyFirstSubmitQcDate': '2012-09-03', 'lastUpdatePostDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-23', 'studyFirstPostDateStruct': {'date': '2012-09-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score', 'timeFrame': 'Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period', 'description': 'The investigator or the subinvestigator examined the head, trunk, and upper and lower limbs, and assessed skin findings (erythema, induration, and scaling \\[scale\\]) at each of the regions and the extent of area affected. Total sores were calculated scores of the each regions.\n\nWhen the day of the assessment fell on a day on which study product was to be administered, the assessment was performed before the study product was administered.\n\nAs a rule, the PASI score assessments for each patient were performed by the same investigator throughout the study, unless there was a special reason why this was not done (e.g., the investigator changed jobs).\n\nThe number and percentage of patients achieving a 75% improvement in their PASI scores at each assessment time point.'}], 'secondaryOutcomes': [{'measure': 'Psoriasis Area and Severity Index (PASI) Score', 'timeFrame': 'Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period', 'description': 'Score range is 0-72. Higher values represent a worse outcome. The investigator or the subinvestigator examined the head, trunk, and upper and lower limbs, and assessed skin findings (erythema, induration, and scaling \\[scale\\]) at each of the regions and the extent of area affected. Total sores were added scores of the each regions.'}, {'measure': 'Percentage of Participants With Cleared and Minimal Skin Lesions of Physician Global Assessment (PGA) (Only for Patients With Plaque Psoriasis)', 'timeFrame': 'Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period', 'description': 'The investigator or the subinvestigator made a global assessment of skin lesions in terms of the degree of erythema, induration, and scaling (scale), using the following 6-point scale (0 to 5). When the day of the assessment fell on a day on which study product was to be administered, the assessment was performed before the study product was administered. As a rule, the PGA for each patient were performed by the same investigator or subinvestigator throughout the study, unless there was a special reason why this was not done (e.g., the investigator or the subinvestigator changed jobs). Outcome measure data table is reported percentage of participants with Cleared and Minimal skin lesions.\n\n0: Cleared, 1: Minimal, 2: Mild, 3: Moderate, 4: Marked, 5: Severe'}, {'measure': 'Visual Analog Scale（VAS） of Pain Assessment by Subjects (Only for Patients With Psoriatic Arthritis)', 'timeFrame': 'Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period', 'description': 'From 0 (best) to 100 (worst)'}, {'measure': 'Assessment of Severity (Only for Patients With Pustular Psoriasis)', 'timeFrame': 'Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period', 'description': 'From 0 (best) to 17 (worst)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Infliximab', 'REMICADE', 'TA-650', 'psoriasis'], 'conditions': ['Plaque Psoriasis', 'Psoriatic Arthritis', 'Pustular Psoriasis (Excluding a Localized)', 'Psoriatic Erythroderma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of TA-650 at increased dose of 10 mg/kg every 8 weeks in patients with psoriasis in whom effect of the treatment was confirmed after the treatment with Remicade® at 5 mg/kg every 8 weeks but decreased thereafter.', 'detailedDescription': '* Patients with plaque psoriasis or psoriatic arthritis:\n\n 1. Screening Period:\n\n TA-650 at 5 mg per kg body weight is administered on the day of TA-650 administration at the start (week 0) and week 8 (if efficacy is not judged as decreased or maintained at week 8 of the screening period) , respectively, by intravenous infusion slowly over at least 2 hours.\n 2. Increased Dose Period:\n\n If efficacy is judged as decreased in the screening period, TA-650 at 10 mg per kg body weight is administered on the day of TA-650 administration at the start (week 0) and at every 8 weeks up to week 32 in the increased dose period , respectively, as one dose by intravenous infusion slowly over at least 2 hours.\n* Patients with pustular psoriasis or psoriatic erythroderma:\n\nTA-650 at 10 mg per kg body weight is administered on the day of TA-650 administration at the start (week 0) and at every 8 weeks up to week 32, respectively, as one dose by intravenous infusion slowly over at least 2 hours.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have already been diagnosed as having plaque psoriasis, psoriatic arthritis, pustular psoriasis (excluding a localized), or psoriatic erythroderma.\n* Patients in whom effect of the treatment was confirmed for a certain period after the start of administration of Remicade® at 5 mg/kg at every 8 weeks but decreased thereafter.\n\nExclusion Criteria:\n\n* Patients who have guttate psoriasis.\n* Patients who have drug-induced psoriasis\n* Patients who have previously used any other biological products than infliximab.\n* Patients who have a concomitant diagnosis, or a history within 6 months prior to provisional enrollment, of serious infections that need hospitalization.\n* Patients who have a concomitant diagnosis, or a history within 6 months prior to provisional enrollment, of opportunistic infections\n* Female patients who are pregnant, breast-feeding, or possibly pregnant.'}, 'identificationModule': {'nctId': 'NCT01680159', 'briefTitle': 'A Clinical Study of Increased Dose of TA-650 in Patients With Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tanabe Pharma Corporation'}, 'orgStudyIdInfo': {'id': 'TA-650-24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TA-650', 'interventionNames': ['Drug: TA-650']}], 'interventions': [{'name': 'TA-650', 'type': 'DRUG', 'armGroupLabels': ['TA-650']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chugoku', 'country': 'Japan', 'facility': 'Investigational site'}, {'city': 'Chūbu', 'country': 'Japan', 'facility': 'Investigational site', 'geoPoint': {'lat': 35.43379, 'lon': 140.2797}}, {'city': 'Hokkaido', 'country': 'Japan', 'facility': 'Investigational site'}, {'city': 'Kanto', 'country': 'Japan', 'facility': 'Investigational site'}, {'city': 'Kinki', 'country': 'Japan', 'facility': 'Investigational site'}, {'city': 'Kyushu', 'country': 'Japan', 'facility': 'Investigational site'}, {'city': 'Tōhoku', 'country': 'Japan', 'facility': 'Investigational site', 'geoPoint': {'lat': 35.81882, 'lon': 139.57138}}], 'overallOfficials': [{'name': 'Hideshi Torii, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Social Insurance Central General Hospital'}, {'name': 'Kazuoki Kondo, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mitsubihsi Tanabe Pharma Corporation'}, {'name': 'Hidemi Nakagawa, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'The Jikei University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanabe Pharma Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}