A Study of Venetoclax in Combination With Low Dose Cytarabine Versus Low Dose Cytarabine Alone in Treatment Naive Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy

NCT03069352 | Completed Phase 3 Results DMC FDA Drug

• 3 other identifiers: M16-0432016-003900-302024-513630-37-00
• Study Type: interventional
• Target: 211
• Locations: 24 countries
• Sites: 109

Brief Summary

The primary objective of this study is to evaluate if venetoclax when co administered with low-dose cytarabine (LDAC) improves overall survival (OS) versus LDAC and placebo, in treatment-naïve patients with acute myeloid leukemia (AML).

Conditions

Acute Myeloid Leukemia (AML)

Keywords

Acute Myeloid Leukemia; Leukemia; Treatment naïve; Venetoclax; Cytarabine

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Overall survival is defined as the time from the date of randomization to the date of death. Participants who had not died were censored at the date they were last known to be alive on or before the cutoff date. Overall survival was analyzed using Kaplan-Meier methodology.

  From randomization until the primary analysis cut-off date of February 15 2019; the median follow-up time was 12.0 months (range: 0.2-17.0) in the placebo arm and 12.0 months (range: 0.1-17.6) in the venetoclax arm.

Secondary Outcomes (17)

• Percentage of Participants With Complete Remission or Complete Remission With Incomplete Blood Count Recovery (CR + CRi)

  Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively.

• Percentage of Participants With Complete Remission or Complete Remission With Partial Hematologic Recovery (CR + CRh)

  Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively.

• Percentage of Participants With Complete Remission or Complete Remission With Incomplete Blood Count Recovery (CR + CRi) by Initiation of Cycle 2

  Cycle 1, 28 days

• Percentage of Participants With Complete Remission and Complete Remission With Partial Hematologic Recovery (CR + CRh) by Initiation of Cycle 2

  Cycle 1, 28 days

• Percentage of Participants With Complete Remission

  Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively.

Study Arms (2)

Venetoclax + Low Dose Cytarabine (LDAC)

EXPERIMENTAL

Venetoclax 600 mg orally every day (QD) plus LDAC 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle.

Drug: Venetoclax; Drug: Cytarabine

Placebo + LDAC

PLACEBO COMPARATOR

Matching placebo to venetoclax orally QD plus LDAC 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle.

Drug: Placebo; Drug: Cytarabine

Interventions

Placebo DRUG

tablet

Placebo + LDAC

Venetoclax DRUG

tablet

Also known as: ABT-199, Venclexta

Venetoclax + Low Dose Cytarabine (LDAC)

Cytarabine DRUG

Subcutaneous injection

Also known as: Cytosar-U, Ara-C, Arabinosylcytosine

Placebo + LDAC; Venetoclax + Low Dose Cytarabine (LDAC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must have histological confirmation of acute myeloid leukemia (AML) by World Health Organization criteria, be ineligible for intensive induction chemotherapy and either be:
• ≥ 75 years of age OR
• ≥ 18 to 74 years of age and fulfill at least one criteria associated with lack of fitness for intensive induction chemotherapy:
• Eastern Cooperative Oncology Group (ECOG) performance status of 2 - 3
• Cardiac history of congestive heart failure (CHF) requiring treatment or ejection fraction ≤ 50% or chronic stable angina
• Diffusing capacity of the lung for carbon monoxide (DLCO) ≤ 65% or forced expiratory volume in 1 second (FEV1) ≤ 65%
• Creatinine clearance ≥ 30 mL/min to \< 45 ml/min
• Moderate hepatic impairment with total bilirubin \> 1.5 to ≤ 3.0 × upper limit of normal (ULN)
• Other comorbidity that the physician judges to be incompatible with conventional intensive chemotherapy which must be reviewed and approved by the study medical monitor before study enrollment
• Participant must have an ECOG performance status:
• of 0 to 2 for subjects ≥ 75 years of age OR
• of 0 to 3 for subjects between 18 to 74 years of age
• Participant must have a projected life expectancy of at least 12 weeks.
• Participant must have adequate renal function as demonstrated by a creatinine clearance ≥ 30 mL/min; calculated by the Cockcroft Gault formula or measured by 24-hour urine collection.
• Participant must have adequate liver function as demonstrated by:

You may not qualify if:

• Participant has received any prior treatment for AML with the exception of hydroxyurea, allowed through the first cycle of study treatment. Note: Prior treatment for myelodysplastic syndrome is allowed except for use of cytarabine.
• Participant had an antecedent myeloproliferative neoplasm (MPN) including myelofibrosis, essential thrombocytosis, polycythemia vera, or chronic myelogenous leukemia (CML) with or without BCR-ABL 1 translocation and AML with BCR-ABL 1 translocation.
• Participants that have acute promyelocytic leukemia (APL).
• Participant has known central nervous system (CNS) involvement with AML.
• Participant has known human immunodeficiency virus (HIV) infection (due to potential drug-drug interactions between antiretroviral medications and venetoclax). HIV testing will be performed at Screening, if required per local guidelines or institutional standards.
• Participant has received strong or moderate cytochrome P450 3A4 (CYP3A) inducers 7 days prior to the initiation of study treatment.
• Chinese subjects are excluded from receiving strong and/or moderate CYP3A inhibitors 7 days prior to the initiation of study treatment through the end of intensive pharmacokinetic (PK) collection (24 hours post dose on Cycle 1 Day 10).
• Participant has consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or star fruit within 3 days prior to the initiation of study treatment.
• Participant has cardiovascular disability status of New York Heart Association Class \> 2. Class 2 is defined as cardiac disease which subjects are comfortable at rest but ordinary physical activity results in fatigue, palpitations, dyspnea, or angina pain. Class 3 is defined as cardiac disease which subjects are comfortable at rest but less than ordinary activity causes fatigue, palpitation, or dyspnea. Class 4 is defined as cardiac disease which subjects have an inability to carry on any physical activity without discomfort, symptoms of heart failure at rest, and if any physical activity is undertaken then discomfort increases.
• Participant has chronic respiratory disease that requires continuous oxygen, or significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, any other medical condition or known hypersensitivity to any of the study medications including excipients of LDAC that in the opinion of the investigator would adversely affect his/her participating in this study.
• Participant has a malabsorption syndrome or other condition that precludes enteral route of administration.
• Participant exhibits evidence of other clinically significant uncontrolled systemic infection requiring therapy (viral, bacterial or fungal).
• Participant has a history of other malignancies prior to study entry, with the exception of:
• Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast;
• Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;

Sponsors & Collaborators

• AbbVie: lead

Study Sites (109)

H. Lee Moffit Cancer Center /ID# 164273

Tampa, Florida, 33612, United States

Location

Norton Cancer Institute /ID# 158998

Louisville, Kentucky, 40202-3700, United States

Location

Univ of Pittsburgh Med Ctr /ID# 158997

Pittsburgh, Pennsylvania, 15232, United States

Location

Univ TX, MD Anderson /ID# 159678

Houston, Texas, 77030, United States

Location

Swedish Medical Center /ID# 161280

Seattle, Washington, 98104, United States

Location

Gundersen Health System /ID# 164272

La Crosse, Wisconsin, 54601, United States

Location

Cemic /Id# 159676

Buenos Aires, 1431, Argentina

Location

Sanatorio Allende /ID# 159675

Córdoba, 5000, Argentina

Location

Calvary Mater Newcastle /ID# 160123

Waratah, New South Wales, 2298, Australia

Location

Westmead Hospital /ID# 160121

Westmead, New South Wales, 2145, Australia

Location

Alfred Hospital /ID# 160125

Melbourne, Victoria, 3004, Australia

Location

Box Hill Hospital /ID# 162920

Melbourne, Victoria, 3128, Australia

Location

Universitair Ziekenhuis Antwerpen /ID# 159566

Edegem, Antwerpen, 2650, Belgium

Location

Cliniques Universitaires Saint Luc /ID# 159567

Woluwe-Saint-Lambert, Brussels Capital, 1200, Belgium

Location

Centro de Pesquisas Oncologicas /ID# 163567

Florianópolis, Santa Catarina, 88034-000, Brazil

Location

Hospital de Cancer de Barretos /ID# 163568

Barretos, São Paulo, 14784-400, Brazil

Location

Hospital do Cancer Mae de Deus /ID# 163416

Porto Alegre, 90470-150, Brazil

Location

Casa de Saúde Santa Marcelina /ID# 163413

São Paulo, 08270-070, Brazil

Location

University of Alberta Hospital /ID# 159646

Edmonton, Alberta, T6G 2G3, Canada

Location

CISSS de la Monteregie /ID# 159782

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Hospital Maisonneuve-Rosemont /ID# 159780

Montreal, Quebec, H1T 2M4, Canada

Location

Hopital Sacre Coeur Montreal /ID# 160982

Montreal, Quebec, H4J 1C5, Canada

Location

Fujian Medical Univ Union Hosp /ID# 167321

Fuzhou, Fujian, 350001, China

Location

Nanfang Hospital of Southern Medical University /ID# 170147

Guangzhou, Guangdong, 510515, China

Location

Jiangsu Province People's Hospital /ID# 167511

Nanjing, Jiangsu, 210029, China

Location

The First Hosp of Jilin Univ /ID# 167512

Changchun, Jilin, 130021, China

Location

Ruijin Hospital, Shanghai Jiaotong /ID# 167325

Shanghai, Shanghai Municipality, 200025, China

Location

West China Hospital /ID# 167514

Chengdu, Sichuan, 610041, China

Location

Blood disease hosp of Chinese Academy of Med Sciences(Institute of Hematology) /ID# 167509

Tianjin, Tianjin Municipality, 300020, China

Location

The First Affiliated Hospital,College of Medicine, Zhejiang University /ID# 167324

Hangzhou, Zhejiang, 310003, China

Location

Qilu Hospital of Shandong Univ /ID# 167507

Jinan, 250014, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 167515

Wuhan, 430022, China

Location

Henan Cancer Hospital /ID# 167327

Zhengzhou, Henan, 450008, China

Location

Fakultni Nemocnice Brno /ID# 159247

Brno, 625 00, Czechia

Location

Univ Hosp Ostrava-Poruba /ID# 159246

Ostrava, 708 52, Czechia

Location

Fakult Nem Kralovske Vinohrady /ID# 159248

Prague, 100 34, Czechia

Location

Centre Hospitalier Lyon Sud /ID# 159705

Pierre-Bénite, Rhone, 69495, France

Location

Centre Hospitalier Le Mans /ID# 159702

Le Mans, Sarthe, 72037, France

Location

Centre Hospitalier de la Cote /ID# 159697

Bayonne, 64100, France

Location

CHU Bordeaux /ID# 159704

Pessac, 33600, France

Location

CHU De Nancy /ID# 159700

Vandœuvre-lès-Nancy, 54511, France

Location

Schwarzwald-Baar-Klinikum /ID# 159571

Villingen-Schwenningen, Baden-Wurttemberg, 78052, Germany

Location

Vivantes Klinikum Am Urban /ID# 159569

Berlin, 10967, Germany

Location

Universitaetsklinikum Hamburg /ID# 161760

Hamburg, 20246, Germany

Location

General Hospital of Athens Laiko /ID# 157870

Athens, Attica, 115 27, Greece

Location

Gen Univ Hosp Alexandroupolis /ID# 157868

Alexandroupoli, 68100, Greece

Location

General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 157869

Athens, 10676, Greece

Location

University Gen Hosp of Patra /ID# 157871

Pátrai, 26504, Greece

Location

General Hospital of Thessaloniki George Papanikolaou /ID# 157867

Thessaloniki, 57010, Greece

Location

Dél-pesti Centrumkórház- Országos Hematológiai és Infektológiai Intézet /ID# 159127

Budapest IX, Budapest, 1097, Hungary

Location

Pecsi Tudomanyegyetem /ID# 163161

Pécs, Pecs, 7624, Hungary

Location

Semmelweis Egyetem I. Belklini /ID# 158180

Budapest, 1083, Hungary

Location

Debreceni Egyetem Klinikai Koz /ID# 158178

Debrecen, 4032, Hungary

Location

Petz Aladar Megyei Oktato Korh /ID# 161739

Győr, 9023, Hungary

Location

Kaposi Mor Oktato Korhaz /ID# 158175

Kaposvár, 7400, Hungary

Location

Bacs-Kiskun Megyei Korhaz /ID# 160973

Kecskemét, 6000, Hungary

Location

St. James's Hospital /ID# 162730

Dublin, Dublin, D08 E9P6, Ireland

Location

Beaumont Hospital /ID# 162733

Dublin, D09 XR63, Ireland

Location

University Hospital Galway /ID# 162734

Galway, H91 YR71, Ireland

Location

University Hospital Limerick /ID# 162735

Limerick, V94F858, Ireland

Location

University of Fukui Hospital /ID# 159770

Yoshida-gun, Fukui, 910-1193, Japan

Location

Kyushu University Hospital /ID# 159688

Fukuoka, Fukuoka, 812-8582, Japan

Location

Gunmaken Saiseikai Maebashi Hospital /ID# 160597

Maebashi, Gunma, 371-0821, Japan

Location

National Hospital Organization Mito Medical Center /ID# 162988

Higashi Ibaraki-gun, Ibaraki, 3113193, Japan

Location

Kyoto Prefect Univ Med /ID# 160101

Kyoto, Kyoto, 602-8566, Japan

Location

Tohoku University Hospital /ID# 161151

Sendai, Miyagi, 980-8574, Japan

Location

Nagasaki University Hospital /ID# 160233

Nagasaki, Nagasaki, 852-8501, Japan

Location

Osaka City University Hospital /ID# 159722

Osaka, Osaka, 545-0051, Japan

Location

Kinki University -Osakasayama Campus /ID# 160777

Osakasayama-shi, Osaka, 589-8511, Japan

Location

Tokyo Metropolitan Komagome Hospital /ID# 160759

Bunkyo-ku, Tokyo, 113-8677, Japan

Location

Tokyo Jikei Daisan Hospital /ID# 159769

Komae-shi, Tokyo, 201-8601, Japan

Location

NTT Medical Center Tokyo /ID# 160678

Shinagawa-ku, Tokyo, 141-8625, Japan

Location

Yamagata University Hospital /ID# 161223

Yamagata, Yamagata, 990-9585, Japan

Location

Akita University Hospital /ID# 160602

Akita, 100041, Japan

Location

Saitama Med Univ Int Med Ctr /ID# 161308

Hidaka, 350-1241, Japan

Location

NHO Nagoya Medical Center /ID# 159768

Nagoya, 460-0001, Japan

Location

Dokkyo Medical University Hosp /ID# 159650

Shimotsuga, 321-0293, Japan

Location

Juntendo University Hospital /ID# 159781

Tokyo, 113-8431, Japan

Location

Instituto Nacional de Cancerol /ID# 159269

Mexico City, Mexico City, 14080, Mexico

Location

Centro de Invest Clin Chapulte /ID# 162625

Morelia, Michoacán, 58260, Mexico

Location

Hosp. Univ. Dr. Jose E. Gonz /ID# 159268

Monterrey, Nuevo León, 64320, Mexico

Location

North Shore Hospital /ID# 160132

Auckland, 0622, New Zealand

Location

Middlemore Clinical Trials /ID# 160131

Auckland, 2025, New Zealand

Location

Haukeland University Hospital /ID# 165630

Bergen, Hordaland, 5021, Norway

Location

Sykehuset Ostfold Kalnes /ID# 165632

Grålum, 1714, Norway

Location

VA Caribbean Healthcare System /ID# 158999

San Juan, 00921-3201, Puerto Rico

Location

Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev /ID# 162991

Kemerovo, Kemerovo Oblast, 650066, Russia

Location

Nizhniy Novgorod regional clinical hospital named N. A. Semashko /ID# 163186

Nizhny Novgorod, Nizhny Novgorod Oblast, 603126, Russia

Location

State Institution of Health of the Ryazan Regional Clinical Hospital /ID# 163126

Ryazan, Ryazan Oblast, 390039, Russia

Location

City Clinical Hospital Botkina /ID# 164086

Moscow, 125284, Russia

Location

Almazov North-West Federal Med /ID# 162170

Saint Petersburg, 197341, Russia

Location

Saint Petersburg State Institu /ID# 162171

Saint Petersburg, 198205, Russia

Location

Samara State Medical Universit /ID# 164173

Samara, 443099, Russia

Location

saratov state medical /ID# 163130

Saratov, 41002, Russia

Location

Yaroslavl Regional Clinic Hosp /ID# 162172

Yaroslavl, 150062, Russia

Location

Netcare Pretoria East Hospital /ID# 157373

Pretoria, Gauteng, 0001, South Africa

Location

Tshwane District Hospital /ID# 157361

Pretoria, Gauteng, 0001, South Africa

Location

Pusan National University Hosp /ID# 158725

Busan, Busan Gwang Yeogsi, 602-739, South Korea

Location

Chungnam National University Hospital /ID# 158726

Junggu, Daejeon Gwang Yeogsi, 35015, South Korea

Location

Cath Univ Seoul St Mary's Hosp /ID# 158724

Seoul, Seoul Teugbyeolsi, 06591, South Korea

Location

Seoul National University Hospital /ID# 162253

Seoul, 03080, South Korea

Location

Hospital Universitario y Politecnico La Fe /ID# 161181

Valencia, Valenciana, 46026, Spain

Location

Hospital Infanta Leonor /ID# 161180

Madrid, 28031, Spain

Location

National Taiwan Univ Hosp /ID# 162781

Taipei City, Taipei, 10002, Taiwan

Location

Tri-Service General Hospital /ID# 161683

Taipei City, Taipei, 11490, Taiwan

Location

Kaohsiung Medical University /ID# 161693

Kaohsiung City, 80708, Taiwan

Location

Heartlands Hospital /ID# 163534

Birmingham, B9 5SS, United Kingdom

Location

University Hospital of Wales /ID# 162726

Cardiff, CF14 4EN, United Kingdom

Location

Northwick Park Hospital /ID# 162727

Harrow, HA1 3UJ, United Kingdom

Location

Related Publications (4)

• Wei AH, Montesinos P, Ivanov V, DiNardo CD, Novak J, Laribi K, Kim I, Stevens DA, Fiedler W, Pagoni M, Samoilova O, Hu Y, Anagnostopoulos A, Bergeron J, Hou JZ, Murthy V, Yamauchi T, McDonald A, Chyla B, Gopalakrishnan S, Jiang Q, Mendes W, Hayslip J, Panayiotidis P. Venetoclax plus LDAC for newly diagnosed AML ineligible for intensive chemotherapy: a phase 3 randomized placebo-controlled trial. Blood. 2020 Jun 11;135(24):2137-2145. doi: 10.1182/blood.2020004856.

  PMID: 32219442 BACKGROUND

• Wei AH, Panayiotidis P, Montesinos P, Laribi K, Ivanov V, Kim I, Novak J, Champion R, Fiedler W, Pagoni M, Bergeron J, Ting SB, Hou JZ, Yamauchi T, Wang J, Strickland SA, Savona MR, Lin TL, Enjeti AK, Tiong IS, Lee S, Roboz GJ, Popovic R, Jiang Q, Liu Z, Sun Y, Mendes WL, Chyla B, DiNardo CD. Risk stratification of low-dose cytarabine and venetoclax in patients with AML ineligible for intensive chemotherapy. Blood Adv. 2025 Nov 21:bloodadvances.2025017083. doi: 10.1182/bloodadvances.2025017083. Online ahead of print.

  PMID: 41269778 DERIVED

• Badawi M, Chen X, Marroum P, Suleiman AA, Mensing S, Koenigsdorfer A, Schiele JT, Palenski T, Samineni D, Hoffman D, Menon R, Salem AH. Bioavailability Evaluation of Venetoclax Lower-Strength Tablets and Oral Powder Formulations to Establish Interchangeability with the 100 mg Tablet. Clin Drug Investig. 2022 Aug;42(8):657-668. doi: 10.1007/s40261-022-01172-4. Epub 2022 Jul 13.

  PMID: 35829925 DERIVED

• Wei AH, Panayiotidis P, Montesinos P, Laribi K, Ivanov V, Kim I, Novak J, Stevens DA, Fiedler W, Pagoni M, Bergeron J, Ting SB, Hou JZ, Anagnostopoulos A, McDonald A, Murthy V, Yamauchi T, Wang J, Chyla B, Sun Y, Jiang Q, Mendes W, Hayslip J, DiNardo CD. 6-month follow-up of VIALE-C demonstrates improved and durable efficacy in patients with untreated AML ineligible for intensive chemotherapy (141/150). Blood Cancer J. 2021 Oct 1;11(10):163. doi: 10.1038/s41408-021-00555-8.

  PMID: 34599139 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Leukemia

Interventions

venetoclax; Cytarabine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: February 28, 2017
• First Posted: March 3, 2017
• Study Start: May 23, 2017
• Primary Completion: February 15, 2019
• Study Completion: August 21, 2025
• Last Updated: September 30, 2025
• Results First Posted: February 28, 2020

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.

Locations

KR (4); GB (3); BR (4); ZA (2); TW (3); PR (1); GR (5); US (6); IE (4); AR (2); DE (3); RU (9); CN (11); ES (2); BE (2); AU (4); CZ (3); FR (5); HU (7); JP (18); NZ (2); NO (2); ME (3); CA (4)