(QuANTUM-R): An Open-label Study of Quizartinib Monotherapy vs. Salvage Chemotherapy in Acute Myeloid Leukemia (AML) Subjects Who Are FLT3-ITD Positive

A Phase 3 Open-label Randomized Study of Quizartinib (AC220) Monotherapy Versus Salvage Chemotherapy in Subjects With Tyrosine Kinase 3 - Internal Tandem Duplication (FLT3-ITD) Positive Acute Myeloid Leukemia (AML) Refractory to or Relapsed After First-line Treatment With or Without Hematopoietic Stem Cell Transplantation (HSCT) Consolidation

The primary objective of the study is to determine whether quizartinib monotherapy prolongs overall survival (OS) compared to salvage chemotherapy in subjects with FMS-like tyrosine kinase 3 - Internal Tandem Duplication (FLT3-ITD) positive AML who are refractory to or have relapsed within 6 months, after first-line AML therapy.

Study Overview

• Status: Completed
• Conditions: AML
• Intervention / Treatment: Drug: Quizartinib; Drug: Salvage Chemotherapy

• Study Type: Interventional
• Enrollment (Actual): 367
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Garran, New South Wales, Australia, 2605
      • The Canbera Hospital
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital
  • Queensland
    • Brisbane, Queensland, Australia
      • The Princess Alexandra Hospital
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital
    • Woodville, South Australia, Australia, 5011
      • The Queen Elizabeth Hospital
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Alfred Hospital
• Belgium
  • BE
    • Antwerpen, BE, Belgium, 2060
      • ZNA Stuivenberg
    • Brussels, BE, Belgium, 1200
      • UCL St Luc
    • Leuven, BE, Belgium, 3000
      • Leuven UZ Gasthuisberg
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • University of Alberta Hospital
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver General Hospital
  • Ontario
    • Toronto, Ontario, Canada, M5G2M9
      • Princess Margaret Cancer Centre Princess Margaret Hospital
• Croatia
  • Zagreb, Croatia, 10000
    • Klinička Bolinca Merkur
  • Zagreb, Croatia, 10000
    • Kliničko Bolnički Centar Zagreb
• Czechia
  • Brno, Czechia, 62500
    • Fakultni nemocnice Brno
  • Hradec Králové, Czechia, 50005
    • Fakultni nemocnice Hradec Kralove
  • Olomouc, Czechia, 77900
    • Fakultni nemocnice Olomouc
• France
  • Caen, France, 14000
    • CHU de Caen
  • Grenoble, France, 38043
    • Centre Hospitalier Universitaire Grenoble Hopital Michalon
  • Le Chesnay, France, 78157
    • Centre Hospitalier de Versailles
  • Marseille, France, 13385
    • Hôpital de la Conception
  • Nantes, France, 44035
    • Centre Hospitalier Universitaire Nantes
  • Paris, France, 75010
    • Hôpital Saint louis
  • Paris, France, 75571
    • Hôpital Saint-Antoine
  • Pessac, France, 33604
    • Hopital Haut Leveque Centre Francois Magendie
  • Rouen, France, 76038
    • Centre Henri-Becquerel
  • Toulouse, France, 31059
    • Centre Hospitalier Universitaire Purpan
• Germany
  • Berlin, Germany, 12200
    • Charite Universitatsmedizin Berlin
  • Berlin, Germany, 13353
    • Charite Campus Virchow Klinikum
  • Braunschweig, Germany, 38114
    • Klinikum Braunschweig
  • Dresden, Germany, 01307
    • Universitätsklinikum Dresden
  • Frankfurt, Germany, 60590
    • Klinikum der Johann Wolfgang-Goethe-Universität
  • Halle, Germany, 06120
    • Universitätsklinikum Halle
  • Hanover, Germany, 30625
    • Medizinische Hochschule Hannover
  • Heidelberg, Germany, 69120
    • Uniklinik Heidelberg Medizinische Klinik und Poliklinik V
  • Jena, Germany, 07743
    • Universitätsklinikum Jena
  • Leipzig, Germany, 04103
    • Universitatsklinikum Leipzig
  • Mainz, Germany, 55131
    • University Mainz
  • Marburg, Germany, 35043
    • Universitätsklinikum Gießen und Marburg GmbH
  • Munchen, Germany, 81377
    • LMU München Klinikum Großhadern
  • Münster, Germany, 48149
    • Medizinische Klinik A Hämatologie Hämostaseologie Internistische Onkologie und Pneumologie
• Hong Kong
  • Hong Kong, Hong Kong
    • The University of Hong Kong, Queen Mary Hospital
  • Hong Kong, Hong Kong
    • The Chinese University of Hong Kong, Prince of Wales Hospital
• Hungary
  • Csongrad
    • Szeged, Csongrad, Hungary, 6725
      • Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Szent Gyorgyi Albert Klinikai Kozpont
  • Hajdu Bihar
    • Debrecen, Hajdu Bihar, Hungary, 4032
      • Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Intezet
  • Pest
    • Budapest, Pest, Hungary, 1083
      • Semmelweis Egyetem Altalanos Orvostudomanyi Kar I. Belgyogyaszati Klinika
• Italy
  • Bari, Italy, 70124
    • AOU Policlinico Consorziale di Bari
  • Bologna, Italy, 40138
    • Universita di Bologna
  • Cagliari, Italy
    • Unità Operativa di Ematologia e Unità Operativa CTMO
  • Ferrara, Italy, 44124
    • Arcispedale S Anna
  • Firenze, Italy, 50134
    • AOU Careggi
  • Genova, Italy, 16132
    • IRCCS Azienda Ospedaliera Universitaria San Martino
  • Genova, Italy, 16132
    • Opsedale San Martino di Genova
  • Milan, Italy, 20132
    • Ospedale San Raffaele
  • Napoli, Italy, 80131
    • Azienda Ospedaliera Universitaria Federico II
  • Orbassano, Italy, 10043
    • Azienda Ospedaliero Universitaria San Luigi Gonzaga
  • Rome, Italy, 00133
    • L'UOC di Ematologia del Policlinico Tor Vergata
  • Rome, Italy, 00168
    • Policlinico Universitario Agostino Gemelli
  • Siena, Italy, 53100
    • Azienda Ospedaliero Universitaria Senese, Policlinico S. Maria alle Scotte
  • Varese, Italy, 21100
    • Ospedale di Circolo-a Fondazione Macchi
• Korea, Republic of
  • Daegu, Korea, Republic of, 700-721
    • Kyungpook National University Hospital
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 138-736
    • Asan Medical Center
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 137-701
    • The Catholic University of Korea Seoul St. Mary'S Hospital
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
      • Seoul National University Bundang Hospital
• Netherlands
  • Amsterdam, Netherlands, 1081 HV
    • VU Medisch Centrum
  • Groningen, Netherlands, 9713 GZ
    • Universitair Medisch Centrum Groningen
  • Rotterdam, Netherlands, 3015 CE
    • Erasmus Medical Center
• Poland
  • Bialystok, Poland, 15276
    • Uniwersytecki Szpital Kliniczny w Biatymstoku, Klinika Hematologii z Pododzialem Chorob Naczyn
  • Katowice, Poland, 40032
    • Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego w Katowicach Oddzial Hematologii i Transplantacji Szpiku
  • Lublin, Poland, 20081
    • Samodzielny Publiczny Szpital Kliniczny Nr 1, Klinika Hematoonkologii i Transplantacji Szpiku
• Serbia
  • Belgrade, Serbia, 11000
    • Klinicki Centar Srbije
  • Novi Sad, Serbia, 21000
    • Klinicki centar Vojvodine
• Singapore
  • Singapore, Singapore, 169608
    • Singapore General Hospital
  • Singapore, Singapore, 119228
    • National University of Singapore
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic i Provincial de Barcelona
  • Barcelona, Spain, 08916
    • Hospital Universitari Germans Trias i Pujol
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Maranon
  • Pamplona, Spain, 31008
    • Complejo Hospitalario de Navarra
  • Salamanca, Spain, 37007
    • Hospital Clínico Universitario de Salamanca
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio
  • De Mallorca
    • Palma, De Mallorca, Spain, 07120
      • Hospital Son Espases
  • SP
    • Valencia, SP, Spain, 46026
      • Hospital La Fe
• Taiwan
  • Taichung, Taiwan, 404
    • China Medical University Hospital
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital
  • Taipei, Taiwan, 112
    • Taipei Veterans General Hospital
• United Kingdom
  • England
    • Bristol, England, United Kingdom, BS2 8ED
      • Bristol Haematology and Oncology centre
    • Leeds, England, United Kingdom, LS9 7TF
      • Saint James University Hospital
    • London, England, United Kingdom, SE5 9RS
      • King's College Hospital
    • Nottingham, England, United Kingdom, NG51PB
      • Nottingham City Hospital NHS Trust
    • Sutton, England, United Kingdom, SM2 5PT
      • Royal Marsden Hospital Sutton
  • Scotland
    • Aberdeen, Scotland, United Kingdom, AB25 2ZN
      • Aberdeen Royal Infirmary
  • South Glamorgan
    • Cardiff, South Glamorgan, United Kingdom, CF14 4XW
      • University Hospital of Wales
• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope National Medical Center
    • Los Angeles, California, United States, 90095
      • UCLA Medical Center
    • Los Angeles, California, United States, 90033
      • University of Southern California, Norris Comprehensive Cancer Center
    • Sacramento, California, United States, 95817
      • UC Davis Cancer Center
    • Stanford, California, United States, 94305
      • Stanford University Medical Center Stanford Comprehensive Cancer Center
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory Winship Cancer Institute
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
    • Chicago, Illinois, United States, 60607
      • University of Illinois at Chicago
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • Franciscan Alliance
  • Kansas
    • Westwood, Kansas, United States, 66205
      • University of Kansas Medical Center Research Institute Inc
  • Louisiana
    • Shreveport, Louisiana, United States, 71103
      • LSU Health Sciences Center Feist Weiller Cancer Center
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Health System
    • Detroit, Michigan, United States, 48201
      • Barbara Ann Karmanos Cancer Institute
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • John Theurer Cancer Center at Hackensack University Medical Center
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • Rochester, New York, United States, 14642
      • University of Rochester
    • Valhalla, New York, United States, 10595
      • NY Medical College
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC Linebreger Comprehensive Cancer Center
    • Durham, North Carolina, United States, 27710
      • Duke Cancer Institute at Duke University Health System
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Baptist Health
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University Knight Cancer Institute
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S Hershey Medical Center
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Health System
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Avera Cancer Institute
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt-Ingram Cancer Center
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Center, The University of Texas
  • Washington
    • Seattle, Washington, United States, 98104
      • Swedish Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Provision of written informed consent approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) with privacy language in accordance with national regulations (e.g., Health Insurance Portability and Accountability Act [HIPAA] authorization for United States [US] sites) prior to any study related procedures, including withdrawal of prohibited medications if applicable.
2. Age ≥ 18 years or the minimum legal adult age (whichever is greater) at the time of Informed consent.
3. Morphologically documented primary Acute Myeloid Leukemia (AML) or AML secondary to Myelodysplastic Syndrome (MDS), as defined by World Health Organization (WHO) criteria, as determined by pathology review at the study site.
4. In first relapse (with duration of remission of 6 months or less) or refractory after prior therapy, with or without HSCT. Induction therapy must have included at least 1 cycle of an anthracycline/mitoxantrone-containing induction block at a standard dose.
5. Presence of the FLT3-ITD activating mutation in bone marrow or peripheral blood (allelic ratio as determined by a central laboratory with a cutoff of ≥3% FLT3-ITD/total FLT3). If a specimen has been sent for FLT3-ITD testing at the central laboratory but the subject requires treatment for AML before the central FLT3-ITD test result is available, a local test result may be acceptable for randomization after consultation with the Medical Monitor.
6. Eligibility for pre-selected salvage chemotherapy, according to the Investigator's assessment.
7. Eastern Cooperative Oncology Group (ECOG) performance score 0-2.
8. Discontinuation of prior AML treatment before the start of study treatment (except hydroxyurea or other treatment to control leukocytosis) for at least 2 weeks for cytotoxic agents, or for at least 5 half-lives for non cytotoxic agents.
9. Serum creatinine ≤1.5×upper limit of normal (ULN), or glomerular filtration rate >25 mL/min, as calculated with the Cockcroft-Gault formula.
10. Serum potassium, magnesium, and calcium (serum calcium corrected for hypoalbuminemia) within institutional normal limits. Subjects with electrolytes outside the normal range will be eligible if these values are corrected upon retesting following any necessary supplementation.
11. Total serum bilirubin ≤1.5×ULN.
12. Serum aspartate transaminase (AST) and/or alanine transaminase (ALT) ≤2.5×ULN.

Exclusion Criteria:

1. Acute Promyelocytic Leukemia (AML subtype M3).
2. AML secondary to prior chemotherapy for other neoplasms, except AML secondary to prior Myelodysplastic Syndrome (MDS).
3. History of another malignancy, unless the candidate has been disease-free for at least 5 years.
4. Persistent, clinically significant > Grade 1 non-hematologic toxicity from prior AML therapy.
5. Clinically significant graft versus host disease (GVHD) or GVHD requiring initiation of treatment or treatment escalation within 21 days, and/or > Grade 1 persistent or clinically significant non hematologic toxicity related to HSCT.
6. History of or current, central nervous system involvement with AML.
7. Clinically significant coagulation abnormality, such as disseminated intravascular coagulation.
8. Prior treatment with quizartinib or participated in a prior quizartinib study.
9. Prior treatment with a FLT3 targeted therapy including sorafenib or investigational FLT3 inhibitors (not including the multi-kinase inhibitor, midostaurin).
10. Major surgery within 4 weeks prior to screening.
11. Radiation therapy within 4 weeks prior to screening.
12. Uncontrolled or significant cardiovascular disease
13. Active infection not well controlled by antibacterial or antiviral therapy.
14. Known infection with human immunodeficiency virus, or active hepatitis B or C, or other active clinically relevant liver disease.
15. Unwillingness to receive infusion of blood products according to the protocol.
16. In a man whose sexual partner is a woman of childbearing potential, unwillingness or inability of the man or woman to use a highly effective contraceptive method for the entire study treatment period for at least 3 months after study completion. Male subjects must not freeze or donate sperm starting at Screening and throughout the study period, and 105 days after the final study drug administration.
17. In a heterosexually active woman of childbearing potential, unwillingness or inability to use a highly effective contraceptive method for the entire study treatment period and for at least 3 months after study treatment completion. Additionally, for women randomized to chemotherapy, unwillingness to adhere to the restrictions in the respective locally established guidelines and local approved label (prescribing information, Summary of Product Characteristics, or US product insert) from the manufacturer and the Patient Information Leaflet (package insert) as instructed by the Investigator.
18. Pregnancy.
19. Female Subjects must agree to not breastfeed from the time of Screening and throughout the study period, and for 25 days after the final study drug administration.
20. Medical condition, serious intercurrent illness, or other circumstance that, in the Investigator's judgment, could jeopardize the candidate's safety as a study subject, or that could interfere with study objectives.
21. For subjects in the United Kingdom only: Refusal of permission to allow the subject's General Practitioner to be notified of their participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Quizartinib; Participants who were randomized to receive 20 or 30 mg quizartinib tablets administered orally once daily.	Drug: Quizartinib; 20 or 30 mg quizartinib tablets administered orally once daily; Other Names: AC220
Active Comparator: Salvage chemotherapy; Participants who were randomized to receive salvage chemotherapy, such as low dose cytarabine (LoDAC); mitoxantrone, etoposide, and intermediate-dose cytarabine (MEC); or fludarabine, cytarabine, and granulocyte colony stimulating factor (G-CSF) with idarubicin (FLAG-IDA), were administered during 28-day cycles.	Drug: Salvage Chemotherapy; Low dose cytarabine (LoDAC); mitoxantrone, etoposide, and intermediate-dose cytarabine (MEC); or fludarabine, cytarabine, and granulocyte colony stimulating factor (G-CSF) with idarubicin (FLAG-IDA) administered during 28-day cycles; Other Names: Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival in Participants That Received Quizartinib Versus Salvage Chemotherapy	Overall Survival is defined as the time (in weeks) from the date of randomization to the date of death due to any cause. Median and quartiles are calculated using the Kaplan-Meier method.	At approximately 3 years 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Event-free Survival in Participants That Received Quizartinib Versus Salvage Chemotherapy	Event-free survival is defined as the time (in weeks) from randomization until documented refractory disease, relapse after complete composite remission (CRc), or death from any cause, whichever is observed first.	At approximately 3 years 9 months

Collaborators and Investigators

• Sponsor: Daiichi Sankyo, Inc.
• Investigators: Principal Investigator: Jorge E. Cortes, MD, M.D. Anderson Cancer Center

Publications and helpful links

General Publications

• Kang D, Ludwig E, Jaworowicz D, Huang H, Fiedler-Kelly J, Cortes J, Ganguly S, Khaled S, Krämer A, Levis M, Martinelli G, Perl A, Russell N, Abutarif M, Choi Y, Yin O. Concentration-QTc analysis of quizartinib in patients with relapsed/refractory acute myeloid leukemia. Cancer Chemother Pharmacol. 2021 Apr;87(4):513-523. doi: 10.1007/s00280-020-04204-y. Epub 2021 Jan 8.
• Cortes JE, Khaled S, Martinelli G, Perl AE, Ganguly S, Russell N, Kramer A, Dombret H, Hogge D, Jonas BA, Leung AY, Mehta P, Montesinos P, Radsak M, Sica S, Arunachalam M, Holmes M, Kobayashi K, Namuyinga R, Ge N, Yver A, Zhang Y, Levis MJ. Quizartinib versus salvage chemotherapy in relapsed or refractory FLT3-ITD acute myeloid leukaemia (QuANTUM-R): a multicentre, randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2019 Jul;20(7):984-997. doi: 10.1016/S1470-2045(19)30150-0. Epub 2019 Jun 4. Erratum In: Lancet Oncol. 2019 Jul;20(7):e346.
• Cortes J, Perl AE, Dohner H, Kantarjian H, Martinelli G, Kovacsovics T, Rousselot P, Steffen B, Dombret H, Estey E, Strickland S, Altman JK, Baldus CD, Burnett A, Kramer A, Russell N, Shah NP, Smith CC, Wang ES, Ifrah N, Gammon G, Trone D, Lazzaretto D, Levis M. Quizartinib, an FLT3 inhibitor, as monotherapy in patients with relapsed or refractory acute myeloid leukaemia: an open-label, multicentre, single-arm, phase 2 trial. Lancet Oncol. 2018 Jul;19(7):889-903. doi: 10.1016/S1470-2045(18)30240-7. Epub 2018 May 31.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): February 22, 2018
• Study Completion (Actual): September 8, 2020

Study Registration Dates

• First Submitted: January 15, 2014
• First Submitted That Met QC Criteria: January 16, 2014
• First Posted (Estimate): January 20, 2014

Study Record Updates

• Last Update Posted (Actual): February 24, 2021
• Last Update Submitted That Met QC Criteria: February 2, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Acute Myeloid Leukemia; AML; Leukemia; FLT3-ITD; Quizartinib; FMS-like tyrosine kinase 3; Tablets
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
• Other Study ID Numbers: AC220-007; EudraCT Number 2013-004890-28 (Other Identifier: Universal Trial Number (UTN) U1111-1151-8078)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
• IPD Sharing Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• IPD Sharing Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)