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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02573324
Other study ID # M13-813
Secondary ID 2015-001166-26
Status Completed
Phase Phase 3
First received
Last updated
Start date January 4, 2015
Est. completion date April 4, 2022

Study information

Verified date May 2023
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study seeks to determine whether the addition of ABT-414 to concomitant radiotherapy and temozolomide (TMZ) followed by combination of ABT-414 with adjuvant TMZ prolongs overall survival (OS) among participants with newly diagnosed glioblastoma (GBM) with epidermal growth factor receptor (EGFR) amplification. In addition, there is a Phase 1, open-label, multicenter sub-study to assess the pharmacokinetics, safety and tolerability of ABT-414 in participants with newly diagnosed EGFR-amplified GBM who have mild or moderate hepatic impairment.


Recruitment information / eligibility

Status Completed
Enrollment 691
Est. completion date April 4, 2022
Est. primary completion date April 4, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - Must have a clinical diagnosis of glioblastoma (GBM). - Must have a confirmed epidermal growth factor receptor amplification in tumor tissue. - Must have a Karnofsky Performance Status (KPS) >= 70 at assessment <= 14 days prior to randomization (N/A to the sub-study). - Must have recovered from effects of surgery, postoperative infection and other complications of surgery. - Must have adequate bone marrow, renal, and hepatic function (For the sub-study, the participant must have adequate bone marrow and renal function and have mild-to-moderate hepatic impairment). Exclusion Criteria: - Multifocal, recurrent or metastatic GBM or gliomatosis cerebri (For the sub-study, the participant can have multifocal GBM and glimatosis cerebri but can't have recurrent or metastatic GBM). - Prior chemo therapy or radiosensitizer for head and neck cancer. - Prior radiotherapy to the head or neck in overlap of radiation fields. - Prior therapy for glioblastoma or other invasive malignancy. - Prior, concomitant or planned treatment with Novo Tumor Treatment Fields (Novo-TTF), EGFR-targeted therapy, bevacizumab, Gliadel wafers or other intratumoral or intracavity anti-neoplastic therapy.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Temozolomide
Oral Capsule
Depatuxizumab mafodotin
Intravenous (IV) Infusion
Radiation:
Radiation

Drug:
Placebo for ABT-414
IV Infusion (IV)

Locations

Country Name City State
Argentina Duplicate_Instituto Med Alex Flem /ID# 142884 Buenos Aires
Argentina Sanatorio Parque /ID# 142825 Rosario Santa Fe
Australia Calvary North Adelaide Hospita /ID# 143866 Adelaide South Australia
Australia Royal Adelaide Hospital /ID# 143867 Adelaide South Australia
Australia St Vincent's Hospital Melbourne /ID# 143858 Fitzroy Melbourne Victoria
Australia Duplicate_Austin Hospital /ID# 143859 Heidelberg Victoria
Australia Liverpool Hospital /ID# 144392 Liverpool New South Wales
Australia Duplicate_The Prince of Wales Hospital /ID# 144882 Randwick New South Wales
Australia Royal North Shore Hospital /ID# 143870 St Leonards New South Wales
Australia St John Of God Subiaco Hospital /ID# 143869 Subiaco Western Australia
Australia Calvary Mater Newcastle /ID# 143860 Waratah New South Wales
Australia Southern Medical Day Care Centre /ID# 143868 Wollongong New South Wales
Australia Princess Alexandra Hospital /ID# 143857 Woolloongabba Queensland
Austria Medizinische Universitaet Graz /ID# 141982 Graz Steiermark
Austria Duplicate_Medizinische Universitat Innsbruck,Universitatsklinik fur Innere Mediz /ID# 141984 Innsbruck
Austria Kepler Universitätsklinikum GmbH - Neuromed Campus /ID# 141983 Linz
Austria Medizinische Universitaet Wien /ID# 141981 Vienna Wien
Belgium Grand Hopital de Charleroi /ID# 141645 Charleroi Hainaut
Belgium UZ Gent /ID# 141647 Gent Oost-Vlaanderen
Belgium Duplicate_Centre Hospitalier Jolimont /ID# 143873 La Louvière
Belgium Universitair Ziekenhuis Leuven /ID# 143872 Leuven Vlaams-Brabant
Belgium CHU de Liege /ID# 162860 Liege
Belgium UCL Saint-Luc /ID# 141648 Woluwe-Saint-Lambert Bruxelles-Capitale
Belgium Duplicate_UCL Mont Godinne /ID# 141644 Yvoir
Brazil Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 143876 Barretos Sao Paulo
Brazil Liga Norte Riograndense Contra o Câncer /ID# 143878 Natal Rio Grande Do Norte
Brazil Hospital Sao Lucas da PUCRS /ID# 143879 Porto Alegre Rio Grande Do Sul
Brazil Instituto Nacional de Câncer José Alencar Gomes da Silva (INCA) /ID# 143877 Rio de Janeiro
Brazil Instituto do Câncer do Estado de São Paulo - ICESP /ID# 144031 São Paulo Sao Paulo
Canada QE II Health Sciences Centre /ID# 151600 Halifax Nova Scotia
Canada Juravinski Cancer Centre /ID# 152117 Hamilton Ontario
Canada Victoria Hospital /ID# 144184 London Ontario
Canada Duplicate_Hospital Maisonneuve-Rosemont /ID# 149315 Montreal Quebec
Canada Duplicate_Jewish General Hospital /ID# 144029 Montreal Quebec
Canada Royal Victoria Hospital / McGill University Health Centre /ID# 144187 Montreal Quebec
Canada CHUM - Notre-Dame Hospital /ID# 144027 Montréal Quebec
Canada Ottawa Hospital Research Institute /ID# 150120 Ottawa Ontario
Canada CHU de Quebec-Universite Laval /ID# 144189 Quebec City Quebec
Canada CHUS - Hopital Fleurimont /ID# 149771 Sherbrooke Quebec
Canada Princess Margaret Cancer Centre /ID# 166277 Toronto Ontario
Canada Duplicate_Cancer Care Manitoba /ID# 149253 Winnipeg Manitoba
China Beijing Tian Tan Hospital, Capital Medical University /ID# 167160 Beijing
China Peking Union Medical College Hospital /ID# 157430 Beijing Beijing
China SanboBrain Hospital Capital Medical University /ID# 166422 Beijing Beijing
China Duplicate_Xiangya Hospital Central South University /ID# 166791 Changsha Hunan
China The First Affiliated Hospital of Fujian Medical University /ID# 159166 Fuzhou
China Sun Yat-Sen University Cancer Center /ID# 143919 Guangzhou Guangdong
China Duplicate_The Second Affiliated Hospital of ZUSM /ID# 165593 Hangzhou Zhejiang
China Anhui Provincial Hospital /ID# 166320 Hefei Anhui
China Duplicate_Huashan Hospital of Fudan University /ID# 159999 Shanghai Shanghai
China Duplicate_Shengjing Hospital of China Medical University /ID# 167016 Shenyang
China The First Affiliated Hospital of Soochow University /ID# 165596 Suzhou Jiangsu
China Duplicate_Tianjin Med Univ General Hosp /ID# 143923 Tianjin
China Tongji Hospital Tongji Medical College of HUST /ID# 163820 Wuhan Hubei
China Duplicate_Tangdu Hospital /ID# 143920 Xi'an Shaanxi
Colombia Administradora del Country_S.A-Clinica Del Country /ID# 143881 Bogota Cundinamarca
Colombia Centro Medico Imbanaco de Cali /ID# 143882 Cali
Colombia Hospital Pablo Tobon Uribe /ID# 143780 Medellín Antioquia
Colombia Instituto Medico de Alta Tecnologia Oncomédica S.A /ID# 147223 Monteria Cordoba
Colombia Oncologos del Occidente S.A /ID# 147713 Pereira Risaralda
Czechia Masarykuv onkologicky ustav /ID# 143884 Brno
Czechia Duplicate_FN Hradec Kralove /ID# 143885 Hradec Kralove
Czechia Krajska nemocnice Liberec, a.s. /ID# 142024 Liberec
Czechia Duplicate_Univ Hosp Ostrava-Poruba /ID# 143883 Ostrava
Czechia Fakultni Nemocnice v Motole /ID# 142023 Praha
France Insititut de Cancerologie /ID# 143908 Angers
France Hopital Avicenne - APHP /ID# 143910 Bobigny Ile-de-France
France CHRU Lille - Hopital Claude Huriez /ID# 143915 Lille Hauts-de-France
France AP-HM - Hopital de la Timone /ID# 143911 Marseille CEDEX 05 Bouches-du-Rhone
France CHU Nice -Hopital Pasteur /ID# 143916 Nice CEDEX 1 Provence-Alpes-Cote-d Azur
France Hopital Pitie Salpetriere /ID# 143917 Paris
France Institut de Cancérologie de l'Ouest René Gauducheau /ID# 143914 St Herblain CEDEX Loire-Atlantique
France Duplicate_Gustave Roussy /ID# 143912 Villejuif Cedex Ile-de-France
Germany Universitaetsklinikum Knappschaftskrankenhaus Bochum GmbH /ID# 143961 Bochum
Germany Universitaetsklinik Heidelberg /ID# 143927 Heidelberg Baden-Wuerttemberg
Germany Universitaetsklinikum Leipzig /ID# 143962 Leipzig Sachsen
Germany Universitaetsklinikum Tuebingen /ID# 143926 Tubingen Baden-Wuerttemberg
Hong Kong Prince of Wales Hospital /ID# 143952 Hong Kong
Ireland Beaumont Hospital /ID# 142969 Beaumont Dublin
Israel Rambam Health Care Campus /ID# 143959 Haifa
Israel Gastroenterology Institute, Division of Medicine /ID# 143958 Jerusalem
Israel Rabin Medical Center /ID# 143957 Petakh Tikva
Israel The Chaim Sheba Medical Center /ID# 143960 Ramat Gan Tel-Aviv
Israel Tel Aviv Sourasky Medical Center /ID# 143956 Tel Aviv-Yafo Tel-Aviv
Italy Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 141800 Milan
Italy Istituto Oncologico Veneto /ID# 143821 Padova
Italy Duplicate_Regina Elena National Cancer I /ID# 141795 Rome
Italy Duplicate_Duplicate_AOU Citta della Salute Scienza /ID# 141801 Turin Piemonte
Korea, Republic of National Cancer Center /ID# 141845 Goyang Gyeonggido
Korea, Republic of Duplicate_Yonsei University Health System, Severance hospital. /ID# 141846 Seoul Seoul Teugbyeolsi
Korea, Republic of Samsung Medical Center /ID# 143887 Seoul
Korea, Republic of Seoul National University Hospital /ID# 143886 Seoul
Korea, Republic of The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 141844 Seoul
Mexico Centro Medico Zambrano Hellion /ID# 143845 San Pedro Garza Garcia Nuevo Leon
Netherlands Vrije Universiteit Medisch Centrum /ID# 143889 Amsterdam
Netherlands Haaglanden Medisch Centrum /ID# 141405 Den Haag
Netherlands Universitair Medisch Centrum Groningen /ID# 141408 Groningen
Netherlands Maastricht Universitair Medisch Centrum /ID# 143585 Maastricht
Netherlands Universitair Medisch Centrum Utrecht /ID# 141406 Utrecht
New Zealand Duplicate_Canterbury District Health Boa /ID# 143861 Christchurch
New Zealand Duplicate_Wellington Hospital (Capital and Coast District Health Board) /ID# 143890 Wellington
Portugal CCA Braga - Hospital de Braga /ID# 141940 Braga
Portugal Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 141939 Faro
Portugal Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 141941 Lisboa
Portugal IPO Lisboa FG, EPE /ID# 141938 Lisboa
Portugal Centro Hospitalar Universitario de Sao Joao, EPE /ID# 142830 Porto
Russian Federation Regional Clinical Hospital of Kaliningrad region /ID# 141702 Kaliningrad Kaliningradskaya Oblast
Russian Federation Federal State Budgetary Scientific Institution N.N. Blokhin /ID# 141707 Moscow Moskva
Russian Federation Federal State Treatment and Rehabilitation center /ID# 141704 Moscow Moskva
Russian Federation GEMC - European Medical Center /ID# 141703 Moscow Moskovskaya Oblast
Russian Federation National Medical Research Center for Neurosurgery n.a. N. N. Burdenko /ID# 141701 Moscow Moskva
Russian Federation State budgetary healthcare institution Republican Clinical Oncology Dispensary /ID# 141706 Ufa Kirovskaya Oblast
Russian Federation Sverdlovsk Regional Oncology Dispensary /ID# 141700 Yekaterinburg Sverdlovskaya Oblast
Singapore National Cancer Ctr Singapore /ID# 143932 Singapore
Singapore National University Hospital /ID# 143933 Singapore
South Africa University of Free State, Universitas Annex (National Hospital Grounds) /ID# 144064 Bloemfontein Free State
South Africa Netcare Oncology Intervent Ctr /ID# 143951 Cape Town Western Cape
South Africa Rondebosch Oncology Center /ID# 143949 Cape Town Western Cape
South Africa Netcare Unitas Hospital /ID# 152936 Centurion Gauteng
South Africa The Oncology Centre /ID# 143950 Durban Kwazulu-Natal
South Africa Cape Town Oncology Trials /ID# 143948 Kraaifontein Western Cape
Spain Hospital Clinic de Barcelona /ID# 143906 Barcelona
Spain Hospital Santa Creu i Sant Pau /ID# 143900 Barcelona
Spain Hospital Clinico Universitario San Carlos /ID# 143901 Madrid
Spain Hospital Universitario 12 de Octubre /ID# 143930 Madrid
Spain Hospital Universitario HM Sanchinarro /ID# 143496 Madrid
Spain Hospital Regional de Malaga /ID# 143902 Málaga Malaga
Spain Hospital General Universitario de Valencia /ID# 143903 Valencia
Switzerland Kantonsspital Aarau AG /ID# 141885 Aarau Aargau
Switzerland Duplicate_EOC Ospedale Regionale di Bellinzona e Valli /ID# 143936 Bellinzona
Switzerland Inselspital, Universitätsspital Bern /ID# 141886 Bern
Switzerland Universitatsspital Zurich /ID# 141887 Zurich Zuerich
Taiwan National Taiwan University Hospital /ID# 143940 Taipei City
Taiwan Taipei Veterans General Hosp /ID# 143955 Taipei City
Taiwan Linkou Chang Gung Memorial Hospital /ID# 143941 Taoyuan City
United Kingdom University Hospitals Birmingham NHS Foundation Trust /ID# 154592 Birmingham
United Kingdom Velindre University NHS Trust /ID# 141996 Cardiff
United Kingdom Duplicate_NHS Tayside /ID# 141651 Dundee
United Kingdom NHS Lothian /ID# 141802 Edinburgh
United Kingdom Leeds Teaching Hospitals NHS Trust /ID# 141653 Leeds
United Kingdom Guys and St Thomas NHS Foundation Trust /ID# 142652 London London, City Of
United Kingdom University College London Hospitals NHS Foundation Trust /ID# 142658 London
United Kingdom Duplicate_The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 141999 Newcastle Upon Tyne
United Kingdom Royal Marsden Hospital /ID# 142827 Sutton
United States Emory Midtown Infectious Disease Clinic /ID# 144015 Atlanta Georgia
United States Piedmont Hospital /ID# 145892 Atlanta Georgia
United States Univ of Colorado Cancer Center /ID# 148194 Aurora Colorado
United States Austin Cancer Centers /ID# 151061 Austin Texas
United States St. Luke's Hospital /ID# 148191 Bethlehem Pennsylvania
United States Boca Raton Regional Hospital /ID# 163659 Boca Raton Florida
United States Dana-Farber Cancer Institute /ID# 148475 Boston Massachusetts
United States Massachusetts General Hospital /ID# 144145 Boston Massachusetts
United States Tufts Medical Center /ID# 145897 Boston Massachusetts
United States MD Anderson Cancer Center at Cooper - Camden /ID# 145891 Camden New Jersey
United States Medical University of South Carolina /ID# 144141 Charleston South Carolina
United States Levine Cancer Ins, Carolina Me /ID# 144124 Charlotte North Carolina
United States Northwestern University Feinberg School of Medicine /ID# 147895 Chicago Illinois
United States The University of Chicago Medical Center /ID# 144158 Chicago Illinois
United States University of Cincinnati /ID# 144164 Cincinnati Ohio
United States Cleveland Clinic Main Campus /ID# 144023 Cleveland Ohio
United States Duplicate_Univ Hosp Cleveland /ID# 144153 Cleveland Ohio
United States The Ohio State University /ID# 144016 Columbus Ohio
United States Baylor Sammons Cancer Center /ID# 155542 Dallas Texas
United States Henry Ford Health System /ID# 145896 Detroit Michigan
United States Wayne State University /ID# 145890 Detroit Michigan
United States NorthShore University HealthSystem /ID# 144017 Evanston Illinois
United States Associated Neurologists of Sou /ID# 147701 Fairfield Connecticut
United States Inova Health System /ID# 152956 Falls Church Virginia
United States Holy Cross Hospital /ID# 156764 Fort Lauderdale Florida
United States Parkview Research Ctr, Hosp /ID# 144150 Fort Wayne Indiana
United States Penn State University and Milton S. Hershey Medical Center /ID# 147525 Hershey Pennsylvania
United States The University of Texas Health Science Center at Houston /ID# 144013 Houston Texas
United States University of Texas MD Anderson Cancer Center /ID# 144018 Houston Texas
United States University of California, Los Angeles /ID# 149239 Los Angeles California
United States University of Southern California /ID# 147543 Los Angeles California
United States Univ of Wisconsin Hosp/Clinics /ID# 144167 Madison Wisconsin
United States Baptist Hospital Miami /ID# 152451 Miami Florida
United States Froedtert Memorial Lutheran Hospital /ID# 144139 Milwaukee Wisconsin
United States Intermountain Medical Center /ID# 144142 Murray Utah
United States Rutgers Cancer Institute of New Jersey /ID# 148190 New Brunswick New Jersey
United States Yale University /ID# 144170 New Haven Connecticut
United States Columbia University Medical Center /ID# 144020 New York New York
United States Christiana Care Health Service /ID# 144127 Newark Delaware
United States Univ Oklahoma HSC /ID# 144161 Oklahoma City Oklahoma
United States Nebraska Methodist Hospital /ID# 144140 Omaha Nebraska
United States University of Nebraska Medical Center /ID# 145899 Omaha Nebraska
United States Advent Health /ID# 144128 Orlando Florida
United States Fox Chase Cancer Center /ID# 145893 Philadelphia Pennsylvania
United States Thomas Jefferson University /ID# 144191 Philadelphia Pennsylvania
United States University of Pennsylvania /ID# 157623 Philadelphia Pennsylvania
United States St. Josephs Hospital and Med Center /ID# 144149 Phoenix Arizona
United States Allegheny General Hospital /ID# 144126 Pittsburgh Pennsylvania
United States University of Pennsylvania Medical Center - Shadyside /ID# 144159 Pittsburgh Pennsylvania
United States Virginia Commonwealth University Medical Center Main Hospital /ID# 149014 Richmond Virginia
United States University of Rochester Medical Center /ID# 144166 Rochester New York
United States Washington University-School of Medicine /ID# 144174 Saint Louis Missouri
United States Mmcorc /Id# 144146 Saint Louis Park Minnesota
United States University of Utah /ID# 144160 Salt Lake City Utah
United States Sharp Memorial Hospital /ID# 148193 San Diego California
United States Univ California, San Francisco /ID# 145889 San Francisco California
United States Duplicate_St. John's Health Center /ID# 148192 Santa Monica California
United States Maine Medical Partners Neurolo /ID# 160864 Scarborough Maine
United States University of Washington /ID# 144162 Seattle Washington
United States Virginia Mason Medical Center /ID# 144022 Seattle Washington
United States Highlands Oncology Group, PA /ID# 142050 Springdale Arkansas
United States Moffitt Cancer Center /ID# 144130 Tampa Florida
United States Duplicate_Scott and White Medical Center /ID# 160743 Temple Texas
United States University of Toledo /ID# 156763 Toledo Ohio
United States Northwestern Medicine Cancer Center - Warrenville /ID# 148476 Warrenville Illinois
United States Cedars-Sinai Medical Center-West Hollywood /ID# 148472 West Hollywood California
United States Univ Kansas Cancer Ctr - Overl /ID# 145895 Westwood Kansas
United States Duplicate_St. Joseph Mercy Hospital /ID# 144143 Ypsilanti Michigan

Sponsors (2)

Lead Sponsor Collaborator
AbbVie Radiation Therapy Oncology Group

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  China,  Colombia,  Czechia,  France,  Germany,  Hong Kong,  Ireland,  Israel,  Italy,  Korea, Republic of,  Mexico,  Netherlands,  New Zealand,  Portugal,  Russian Federation,  Singapore,  South Africa,  Spain,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Survival (OS) Time to OS is defined as the number of days from the date of randomization to the date of death due to any cause. Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
Secondary OS for the O6-methylguaninemethlytransferese (MGMT) Unmethylated Group Time to OS is defined as the number of days from the date of randomization to the date of death due to any cause.
Unmethylated MGMT promoter is associated with a worse prognosis in GBM
Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
Secondary OS for the MGMT Methylated Group Time to OS is defined as the number of days from the date of randomization to the date of death due to any cause. Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
Secondary OS for the Epidermal Growth Factor Receptor (EGFR)vIII-Mutated Tumor Subgroup Time to OS is defined as the number of days from the date of randomization to the date of death due to any cause. Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
Secondary Progression-Free Survival (PFS) PFS will be defined as the number of days from the date of randomization to the date of earliest disease progression based on Response Assessment in Neuro-Oncology (RANO) criteria (see Wen et al. J Clin Oncol. 2010 Apr 10;28(11):1963-72) or to the date of death, if disease progression does not occur. Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
Secondary PFS for EGFRvIII-Mutated Tumor Subgroup PFS will be defined as the number of days from the date of randomization to the date of earliest disease progression based on Response Assessment in Neuro-Oncology (RANO) criteria or to the date of death, if disease progression does not occur. Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
Secondary Deterioration Free Survival in M.D. Anderson Symptom Inventory Brain Tumor Module (MDASI-BT) Symptom Severity Score The MDASI-BT assesses the severity of multiple brain tumor-related symptoms and the impact of these symptoms on daily functioning in the last 24 hours. It consists of 22 symptom items and 6 interference items, each rated from 0 to 10. MDASI-BT symptom severity score is defined as average over 13 core symptom items and 9 brain tumor symptom items, with a total score of 0 to 10, with higher score indicating worse symptoms/interference. Changes in symptom severity score were classified into 3 categories: improved (= -1), stable (> -1 and < 1), and deteriorated (= 1). Deterioration is defined as satisfying the deterioration criteria (i.e., increase in symptom severity score by = 1 unit) without further improvement (i.e., failing to satisfy deterioration criteria) within 8 weeks or occurrence of death. Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
Secondary Deterioration Free Survival in MDASI-BT Symptom Interference Score The MDASI-BT assesses the severity of multiple brain tumor-related symptoms and the impact of these symptoms on daily functioning in the last 24 hours. It consists of 22 symptom items and 6 interference items, each rated from 0 to 10. MDASI-BT symptom interference score is defined as an average of 6 interference items, with a total score of 0 to 10, where higher scores indicate worse interference. Changes in symptom interference score were classified into 3 categories: improved (= -1), stable (> -1 and < 1), and deteriorated (= 1). Deterioration is defined as satisfying the deterioration criteria (i.e., increase in symptom interference score by = 1 unit) without further improvement (i.e., failing to satisfy deterioration criteria) within 8 weeks or occurrence of death. Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
Secondary Deterioration Free Survival in Neurocognitive Functioning on the Hopkins Verbal Learning Test Revised (HVLT-R) Total Recall Score The HVLT-R consists of 3 parts. Free call has a range of 0 to 36, delayed recall has a range from 0 to 12, and delayed recognition has a range of -12 to 12. Higher scores indicating better function in all 3 parts. When scoring the HVLT-R, the 3 learning trials are combined to calculate a total recall score (range -12 to 60). Deterioration is defined as satisfying the deterioration criteria (i.e., decrease in HVLT-R total recall score by 5 units) without further improvement within 8 weeks or occurrence of death. Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).
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