Basal Cell Carcinoma Clinical Trial
Official title:
A Single Arm, Open-label, Phase II, Multicentre Study, to Assess the Safety of Vismodegib (GDC-0449) in Patient With Locally Advanced or Metastatic Basal Cell Carcinoma (BCC)
Verified date | March 2019 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This single-arm, open-label, multi-center study will evaluate the safety and efficacy of vismodegib (GDC-0449) in patients with locally advanced or metastatic basal cell carcinoma. Patients will receive oral doses of vismodegib 150 mg once daily until disease progression or unacceptable toxicity.
Status | Completed |
Enrollment | 1232 |
Est. completion date | June 14, 2017 |
Est. primary completion date | June 14, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adult patients, >/=18 years of age - Metastatic or locally advanced basal cell carcinoma considered inoperable or that surgery is contraindicated and radiotherapy is contraindicated or inappropriate - Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 Exclusion Criteria: - Concurrent anti-tumor therapy - Completion of the most recent anti-tumor therapy less than 21 days prior to the initiation of treatment - Uncontrolled medical illness |
Country | Name | City | State |
---|---|---|---|
Argentina | Inst. de Oncologia Angel H. Roffo ; Servicio de Oncologia | Buenos Aires | |
Australia | CMAX A division of IDT Australia Limited | Adelaide | South Australia |
Australia | Skin & Cancer Foundation | Carlton | Victoria |
Australia | Premier Specialists | Kogarah | New South Wales |
Australia | Skin and Cancer Foundation Australia | Westmead | New South Wales |
Austria | LKH Graz; Abteilung für allgemeine Dermatologie | Graz | |
Austria | LKH Salzburg; Universitätsklinik für Dermatologie | Salzburg | |
Austria | Landesklinikum St. Pölten | St. Pölten | |
Austria | Medizinische Universität Wien; Univ.Klinik für Dermatologie | Wien | |
Belgium | UZ Leuven Gasthuisberg | Leuven | |
Bosnia and Herzegovina | University Clinical Center of the Republic of Srpska | Banja Luka | |
Bosnia and Herzegovina | Clinic of Oncology, University Clinical Center Sarajevo | Sarajevo | |
Brazil | Hospital de Cancer de Barretos | Barretos | SP |
Brazil | Hospital das Clinicas - UFRGS | Porto Alegre | RS |
Brazil | Instituto do Cancer do Estado de Sao Paulo - ICESP | Sao Paulo | SP |
Bulgaria | District Oncology Dispensary; Department for Oncology and Dermatology | Plovdiv | |
Bulgaria | National Specialized Hospital for Active Oncology Treatment; Dermatology Clinic | Sofia | |
Canada | Western Canada Dermatology Institute | Edmonton | Alberta |
Canada | London Regional Cancer Centre | London | Ontario |
Canada | Victoria Park MediSpa | Montreal | Quebec |
Canada | Centre de Recherche Dermatologique du Quebec Metropolitain (CRDQ) | Quebec | |
Canada | Dr. Nowell Solish Cosmetic Dermatology | Toronto | Ontario |
Canada | Cancer Care Manitoba | Winnipeg | Manitoba |
Colombia | Inst. Nacional de Cancerologia; Clinica de Seno | Bogota | |
Colombia | Riesgo De Fractura; Rheumatology | Bogota | |
Colombia | Hemato Oncologos S.A. | Cali | |
Colombia | Reumalab Sas; Rheumatology | Medellin | |
Colombia | Hospital Pablo Tobon Uribe | Medellin-Antioquia | |
Croatia | Clinical Hospital Sisters of Mercy | Zagreb | |
Czechia | Nemocnice Ceske Budejovice | Ceske Budejovice | |
Czechia | Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology | Hradec Kralove | |
Czechia | Fakultní nemocnice Ostrava; Kožní oddelení | Ostrava | |
Czechia | Fakultni nemocnice Kralovske Vinohrady | Praha | |
Czechia | Fakultni Thomayerova Nemocnice; Onkologicke Oddeleni | Praha | |
Czechia | Vseobecna fakultni nemocnice v Praze | Praha 2 | |
Czechia | Fakultni nemocnice v Motole | Praha 5 | |
Denmark | Herlev Hospital; Onkologisk afdeling | Herlev | |
Finland | Helsinki University Central Hospital; Skin & Allergy Hospital | Helsinki | |
Finland | Kuopion yliopistollinen sairaala | Kuopio | |
France | Hopital Saint Andre CHU De Bordeaux; Dermatologie | Bordeaux | |
France | Hopital Ambroise Pare; Sce Dermatologie | Boulogne-billancourt | |
France | Chu Site Du Bocage;Dermatologie | Dijon | |
France | Hopital Claude Huriez; Sce Dermatologie | Lille | |
France | Hopital Timone Adultes; Dermatologie | Marseille | |
France | Hopital Saint Eloi; CHU de Montpellier; Svc de Dermatologie | Montpellier | |
France | Hopital Hotel Dieu Et Hme; Clinique Dermatologique | Nantes | |
France | Hopital Saint Louis; Dermatologie 1 | Paris | |
France | Centre Hospitalier Lyon Sud; Dermatologie | Pierre Benite | |
France | Hôpital Larrey Université Paul Sabatier; Service Dermatologie | Toulouse | |
France | Institut Gustave Roussy; Comite 5 | Villejuif | |
Germany | Charité Campus Mitte; Hauttumorcentrum Charité (HTCC); Klinik für Dermatologie, Venerologie und Alle | Berlin | |
Germany | Vivantes Klinikum Spandau | Berlin | |
Germany | Elbekliniken Buxtehude; Klinik für Dermatologie | Buxtehude | |
Germany | Klinikum Dortmund gGmbH Klinikzentrum Mitte | Dortmund | |
Germany | Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Dermatologie | Dresden | |
Germany | Universitätsklinikum Düsseldorf; Hautklinik | Düsseldorf | |
Germany | HELIOS Klinikum Erfurt; Klinik für Dermatologie & Allergologie | Erfurt | |
Germany | Universitätsklinikum Essen | Essen | |
Germany | Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie | Frankfurt | |
Germany | Universitätsklinikum Freiburg Universitäts-Hautklinik | Freiburg | |
Germany | Universitätsmedizin Greifswald; Klinik für MKG-Chirurgie und Plastische Operationen | Greifswald | |
Germany | Universitätsklinikum Hamburg-Eppendorf Zentrum f.Innere Medizin Klinik f.Dermatologie | Hamburg | |
Germany | Medizinische Hochschule Hannover; Klinik für Dermatologie, Allergologie und Venerologie | Hannover | |
Germany | Universitätsklinikum Heidelberg | Heidelberg | |
Germany | Klinikum am Gesundbrunnen; Tumorzentrum | Heilbronn | |
Germany | Klinikum Kassel; Hautklinik | Kassel | |
Germany | UNI-Klinikum Campus Kiel Klinik f.Dermatologie Tagesklinik f.Dermatologie | Kiel | |
Germany | Klinik der Uni zu Köln; Klinik & Poliklinik fuer Dermatologie & Venerologie | Köln | |
Germany | Uni Schleswig-Holstein; Klinik für Dermatologie, Allergologie und Venerologie (Hautklinik) | Lübeck | |
Germany | Klinikum d.Stadt Ludwigshafen Hautklinik | Ludwigshafen | |
Germany | Universitätsklinikum Magdeburg; Hautklinik; Klinik für Dermatologie und Venerologie | Magdeburg | |
Germany | Klinikum Mannheim Klinik fuer Dermatologie, Venerologie und Allergologie | Mannheim | |
Germany | Universitätsklinikum Marburg Klinik f. Dermatologie | Marburg | |
Germany | Universitätsklinikum Münster; Klinik für Hautkrankheiten; Allgemeine Dermatologie und Venerologie | Muenster | |
Germany | Klinikum der LMU München; Klinik und Poliklinik für Dermatologie und Allergologie | München | |
Germany | Klinikum rechts der Isar der TU München; Klinik & Poliklinik für Dermatologie und Allergologie | München | |
Germany | Klinikum Nürnberg Nord; Hautklinik; Klinik für Dermatologie | Nürnberg | |
Germany | Harzklinikum Dorothea Christiane Erxleben GmbH; Klinik für Dermatologie und Allergologie | Quedlinburg | |
Germany | Universitätsklinikum Regensburg; Klinik und Poliklinik für Dermatologie | Regensburg | |
Germany | Universitaets-Hautklinik Tuebingen | Tübingen | |
Germany | Universitätsklinikum Würzburg; Klinik und Poliklinik für Dermatologie Venerologie u. Allergologie | Würzburg | |
Greece | Andreas Syggros Hospital; 1st University Dermatology Clinic; Oncology Department | Athens | |
Greece | Laiko General Hospital; 1St Pathological Clinic | Athens | |
Greece | Univ General Hosp Heraklion; Medical Oncology | Heraklion | |
Greece | University General Hospital of loannina; Dermatology and Venereal Diseases Clinic | Ioannina | |
Greece | Euromedical General Clinic of Thessaloniki; Oncology Department | Thessaloniki | |
Hungary | Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly | Budapest | |
Hungary | Semmelweis Egyetem; Bor-, Nemikortani es Boronkologiai Klinika | Budapest | |
Hungary | Debreceni Egyetem Klinikai Központ; Borgyógyászati Klinika | Debrecen | |
Hungary | Kaposi Mor Teaching Hospital | Kaposvár | |
Hungary | Szegedi Tud.Egyetem Szent-Gyorgyi Albert Klin.Kozp. | Szeged | |
Ireland | Cork University Hospital; Dermatology Dept | Cork | |
Ireland | St Vincent'S Uni Hospital; Medical Oncology | Dublin | |
Israel | Rambam Medical Center | Halfa | |
Israel | Hadassah University Hospital - Ein Kerem | Jerusalem | |
Israel | Rabin Medical Center-Beilinson Campus | Petach Tikva | |
Israel | Sheba Medical Center; Tel Hashomer | Ramat Gan | |
Italy | A.O.U. Ospedali Riuniti Umberto I-G.M.Lancisi-G.Salesi Ancona;S.O.D. MED.Interna-Clinica Oncologica | Ancona | Marche |
Italy | Policlinico Sant'Orsola Malpighi; U.O. Dermatologia | Bologna | Emilia-Romagna |
Italy | Università di Brescia; Dipartimento di Dermatologia | Brescia | Lombardia |
Italy | Ospedale Antonio Perrino; Oncologia Medica | Brindisi | Puglia |
Italy | Ospedale Armando Businco; Dermatologia | Cagliari | Sardegna |
Italy | Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico | Candiolo | Piemonte |
Italy | Ospedale IOT- Palagi Dermatologia 2 | Firenze | Toscana |
Italy | IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A | Genova | Liguria |
Italy | Ospedale San Salvatore (ASL-01); Dip. di Dermatologia U.O.S. di Dermatologia Oncol | L'Aquila | Abruzzo |
Italy | I.R.S.T. Srl - Meldola - FC; Day Hospital Oncologico | Meldola | Emilia-Romagna |
Italy | Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia | Milano | Lombardia |
Italy | Fondazione IRCCS Istituto Nazionale dei Tumori;S.S. Trattamento MedicoTumori dellaTesta e delCollo | Milano | Lombardia |
Italy | Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica | Milano | Lombardia |
Italy | Istituto Nazionale Tumori Fondazione G. Pascale | Napoli | Campania |
Italy | IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda | Padova | Veneto |
Italy | Azienda Ospedaliera Umberto I; Clinica Dermatologica | Roma | Lazio |
Italy | Fondazione Ptv Policlinico Tor Vergata; Dermatologia | Roma | Lazio |
Italy | Istituto Dermatologico San Gallicano IRCCS; Dermatologia Oncolgica | Roma | Lazio |
Italy | Istituto Dermopatico dell'Immacolata (IDI)-IRCCS; IV Divisione Oncologica e Dermatologia Oncologica | Roma | Lazio |
Italy | IRCCS Istituto Clinico Humanitas; Farmacia | Rozzano | Lombardia |
Italy | A.O.U. Senese Policlinico Santa Maria Alle Scotte | Siena | Toscana |
Lithuania | National Cancer Institute | Vilnius | |
Mexico | Hospital General de México | Mexico City | Mexico CITY (federal District) |
Netherlands | Academ Ziekenhuis Groningen; Medical Oncology | Groningen | |
Netherlands | LUMC; Dermatologie | Leiden | |
Netherlands | Maastricht University Medical Centre; Dermatologie | Maastricht | |
Netherlands | Erasmus MC; Dermatology | Rotterdam | |
New Zealand | Waitemata District Health; General Surgery | Takapuna | |
Norway | Oslo Universitetssykehus HF; Radiumhospitalet | Oslo | |
Poland | Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii | Gdansk | |
Poland | DERMED Centrum Medyczne; Sp zoo | Lodz | |
Poland | Centrum Diagnostyki Znamion | Poznan | |
Poland | Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie; Klinika Onkologiczna | Warsaw | |
Portugal | IPO do Porto; Servico de Oncologia Medica | Porto | |
Romania | Institutul Oncologic Prof. Dr. Al. Trestioreanu Bucuresti | Bucuresti | |
Romania | Prof. Dr. I. Chiricuta Institute of Oncology | Cluj Napoca | |
Romania | Oncology Center Sf. Nectarie | Craiova | |
Romania | Spital Clinic Judetean Mures; Oncologie | Targu Mures | |
Romania | S.C. Life Search S.R.L; Medical Oncology Clinic | Timisoara | |
Russian Federation | FSBI "National Medical Research Center of Oncology N.N. Blokhin" | Moscow | |
Russian Federation | Moscow city oncology hospital #62 of Moscow Healthcare Department | Moscow | |
Russian Federation | FSBI"National Medical Research Center of Oncology named after N.N.Petrov" MHRF | St Petersburg | Leningrad |
Russian Federation | Saint-Petersburg City Clinical Oncology Dispensary | St Petersburg | |
Serbia | Institute for Oncology and Radiology of Serbia; Medical Oncology | Belgrade | |
Serbia | Military Medical Academy | Belgrade | |
Slovakia | Fakultna Nemocnica Roosevelta | Banska Bystrica | |
Slovenia | Institute of Oncology Ljubljana | Ljubljana | |
Spain | Fundacion Hospital de Alcorcon; Servicio de Dermatologia | Alcorcon | Madrid |
Spain | Hospital Universitario del Sureste; Servicio de Dermatologia | Arganda del Rey | Madrid |
Spain | Hospital Clinic i Provincial; Servicio de dermatología | Barcelona | |
Spain | Hospital de la Santa Creu i Sant Pau; Servicio de Dermatologia | Barcelona | |
Spain | Hospital de Cruces; Servicio de Oncologia | Bilbao | Vizcaya |
Spain | Hospital Reina Sofia; Servicio de dermatología | Cordoba | |
Spain | Hospital Universitario Virgen de las Nieves; Servicio de Oncologia | Granada | |
Spain | Hospital General Universitario de Guadalajara; Servicio de Dermatologia | Guadalajara | |
Spain | Hospital de Gran Canaria Dr. Negrin; Servicio de Dermatologia | Las Palmas de Gran Canaria | LAS Palmas |
Spain | Complejo Asistencial Universitario de Leon; Servicio de Oncologia | Leon | |
Spain | Hospital General Universitario Gregorio Marañon; Servicio de Oncologia | Madrid | |
Spain | Hospital Universitario 12 de Octubre; Servicio de Oncologia | Madrid | |
Spain | Hospital General Universitario J.M Morales Meseguer; Servicio de Dermatologia | Murcia | |
Spain | Hospital Univ. Central de Asturias; Servicio de Dermatologia | Oviedo | Asturias |
Spain | Hospital Universitario Son Espases; Servicio de Oncologia | Palma De Mallorca | Islas Baleares |
Spain | Clinica Universitaria de Navarra; Servicio de Dermatologia | Pamplona | Navarra |
Spain | Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Dermatologia | Santa Cruz de Tenerife | Tenerife |
Spain | Hospital Universitario Virgen Macarena; Servicio de Oncologia | Sevilla | |
Spain | Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Dermatologia | Toledo | |
Spain | Hospital General Universitario de Valencia; Servicio de oncologia | Valencia | |
Spain | Instituto Valenciano Oncologia; Oncologia Medica | Valencia | |
Spain | Hospital Universitario Miguel Servet; Servicio Dermatologia | Zaragoza | |
Sweden | Skånes Onkologiska Klinik, Universitetssjukhuset | Lund | |
Sweden | Karolinska Universitetssjukhuset, Solna | Stockholm | |
Switzerland | Universitätsspital Zürich; Dermatologische Klinik | Zürich | |
Turkey | Ankara Numune Training and Research Hospital; Dermatology | Ankara | |
Turkey | Gazi Universitesi Tip Facultesi; Dept. of Dermatology | Ankara | |
Turkey | Istanbul Uni of Medicine Faculty; Oncology Dept | Istanbul | |
Turkey | Dokuz Eylul University Medicine Faculty; Dermatology | Izmir | |
Turkey | Hacettepe Uni Medical Faculty Hospital; Oncology Dept | Sihhiye, Ankara | |
United Kingdom | Addenbrookes Hospital; Cambridge Cancer Trials Centre, S4 Box 279 | Cambridge | |
United Kingdom | Western Infirmary; Division of Cardiovascular and Medical Sciences | Glasgow | |
United Kingdom | Royal Marsden Hospital - London | London | |
United Kingdom | St Thomas Hospital | London | |
United Kingdom | Freeman Hospital; Northern Centre For Cancer Care | New Castle Upon Tyne | |
United Kingdom | Salford Royal NHS Foundation Trust | Salford | |
United Kingdom | The Royal Marsden Hospital | Sutton |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Colombia, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Lithuania, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants Who Experienced Any Adverse Events (AEs), AEs Grade 3 or 4, AEs Leading to Drug Interruptions or Discontinuations and Any Serious Adverse Events (SAEs) | Adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activity of daily living with inability to perform bathing, dressing and undressing, feeding self, using the toilet, taking medications but not bedridden. Grade 4: An immediate threat to life. Urgent medical intervention is required in order to maintain survival. | Baseline to the data cut-off of 14 June 2017 (up to 6 years) | |
Primary | Percentage of Participants Who Died Due to Adverse Events, Disease Progression or Other Reasons | Reasons for "other" included "unknown," "natural causes," "cardiac decompensation," "general state alteration," "deterioration of general state," "clinical deterioration taking into consideration patient's age," "old age," and "disease progression of mediastinal squamous cell carcinoma (SCC)." | Baseline to the data cut-off of 14 June 2017 (up to 6 years) | |
Primary | Percentage of Participants Who Report a Shift in NCI CTCAE Grades to 3/4 in Hematology and Biochemistry Laboratory Parameters | Baseline to the data cut-off of 14 June 2017 (up to 6 years) | ||
Primary | Exposure to Study Treatment: Duration on Treatment | Duration on treatment was the number of days between first and last dose of study treatment. | Baseline to the data cut-off of 14 June 2017 (up to 6 years) | |
Primary | Exposure to Study Treatment - Dose Intensity | Dose intensity was defined as the percentage of actual number of doses received versus planned. | Baseline to the data cut-off of 14 June 2017 (up to 6 years) | |
Secondary | Best Overall Response Rate (BORR) | BORR was defined as the percentage of participants achieving either a complete response (CR) or a partial response (PR) as assessed by the Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) required a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | Baseline to the data cut-off of 14 June 2017 (up to 6 years) | |
Secondary | Duration of Response | Duration of response was defined as the time interval between the date of the earliest qualifying response (CR or PR) and the date of disease progression or death for any cause. Median duration of response was estimated using Kaplan-Meier estimates. | Baseline to the data cut-off of 14 June 2017 (up to 6 years) | |
Secondary | Time to Response | Time to response was defined as the interval between the date of first treatment and the date of first documentation of confirmed CR or PR (whichever occur first). | Baseline to the data cut-off of 14 June 2017 (up to 6 years) | |
Secondary | Progression-Free Survival (PFS) | PFS was defined as the time interval between the date of the first therapy and the date of progression or death for any causes, whichever occurs first. Disease progression was assessed by the investigator. | Baseline to the data cut-off of 14 June 2017 (up to 6 years) | |
Secondary | Overall Survival (OS) | OS was defined as the time from the date of first treatment to the date of death, regardless of the cause of death. | Baseline to the data cut-off of 14 June 2017 (up to 6 years) | |
Secondary | Change From Baseline Scores of Skindex-16 Questionnaire Domains of Emotion, Function and Symptom | The Skindex-16 questionnaire includes three domains for the assessment of the effects of skin disease on participants' quality of life: symptoms, emotions and function. For each domain, responses from the questionnaire were transformed to a linear scale of 100 varying from 0 (never bothered, i.e., best) to 100 (always bothers, i.e., worst). | Baseline to the data cut-off date of 14 June 2017 (up to 6 years). | |
Secondary | Percentage of Participants With a = 30% Reduction in Disease-Related Symptoms According to MDASI Scale | M.D. Anderson Symptom Inventory (MDASI) scale. The MDASI core instrument is a 19-item patient self-report questionnaire whose items comprise two scales, symptom severity and symptom interference. For 13 items (i.e., pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, difficulty remembering things, lack of appetite, drowsiness, dry mouth, sadness, vomiting, and numbness or tingling), participants were asked to rate how severe the symptoms were when "at their worst" in the last 24 hours. For the remaining 6 items, participants were asked to rate how much the symptoms have interfered with 6 areas of functioning (i.e., general activity, walking, work, mood, relations with other people, and enjoyment of life) in the last 24 hours. | 08-May-2013 (Protocol Version = 4) to the data cut-off date of 14 June 2017 (approximately 4 years and 1 month). | |
Secondary | Percentage of Participants With a = 30% Reduction in Composite Symptom Severity Score According to MDASI Scale | M.D. Anderson Symptom Inventory (MDASI) scale. The MDASI core instrument is a 19-item patient self-report questionnaire whose items comprise two scales, symptom severity and symptom interference. For 13 items (i.e., pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, difficulty remembering things, lack of appetite, drowsiness, dry mouth, sadness, vomiting, and numbness or tingling), participants were asked to rate how severe the symptoms were when "at their worst" in the last 24 hours. For the remaining 6 items, participants were asked to rate how much the symptoms have interfered with 6 areas of functioning (i.e., general activity, walking, work, mood, relations with other people, and enjoyment of life) in the last 24 hours. | 08-May-2013 (Protocol Version = 4) to the data cut-off date of 14 June 2017 (approximately 4 years and 1 month). |
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