Safety Study to Assess IV Zanamivir for Treatment of Influenza Infection in Patients Who Are in Hospital

NCT01014988 | Completed Phase 2 Results DMC

• 1 other identifier: 113678
• Study Type: interventional
• Target: 202
• Locations: 13 countries
• Sites: 110

Brief Summary

The purpose of this study is to determine whether zanamivir aqueous solution given by intravenous injection is safe in treating hospitalized patients with confirmed influenza infection. A single arm open-label design has been selected to achieve the primary objective of providing regulatory authorities with safety data on IV zanamivir.

Conditions

Influenza, Human

Keywords

pandemic; seasonal influenza; Influenza B virus; H1N1; zanamivir; Influenza A virus, H1N1 Subtype; Relenza; influenza; neuraminidase inhibitor

Outcome Measures

Primary Outcomes (16)

• Number of Participants With Any Adverse Event (AE) Considered to be Related to Study Treatment

  An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. All AEs were assesed by the Investigateor as related or not related to the study treatment.

  Up to post-treatment (PT) + 23 days

• Number of Participants With Any Severe or Grade 3/4 AEs

  An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. AEs that occured during the study were evaluated by the Investigator and graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) table for grading the severity of adult and pediatric AEs. Grade 3=severe; Grade 4=potentially life threatening.

  Up to post-treatment (PT) + 23 days

• Number of Participants With Any Severe or Grade 3/4 Treatment-related AE

  An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. AEs that occured during the study were evaluated by the Investigator and graded according to the DAIDS table for grading the severity of adult and pediatric AEs. Grade 3=severe; Grade 4=potentially life threatening. All AEs were assesed by the Investigateor as related or not related to the study treatment.

  Up to post-treatment (PT) + 23 days

• Number of Participants Who Permanently Discontinued the Study Treatment Due to an AE

  An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.

  Up to 10 days

• Number of Participants Who Were Permanently Discontinued From the Study Due to an AE

  An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.

  Up to post-treatment (PT) + 23 days

• Number of Participants With the Indicated Clinical Chemistry Values Relative to the Normal Range at Baseline (Day 1) and Day 5

  Blood samples for laboratory assessments were collected at Baseline (Day \[D\] 1), Days 3 and 5, and on post-treatment +2 days (if hospitalized) and post-treatment +23 days. Clinical chemistry parameters included alanine aminotransferase (ALT), direct bilirubin (DB), total bilirubin (TB), and creatinine. The number of participants with values that were high (H)/normal (N)/low (L) relative to the normal range at Baseline (D 1) and D 5 for the indicated clinical chemistry parameters are summarized. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

  Baseline (Day 1) and Day 5

• Number of Participants With the Indicated Hematology Values Relative to the Normal Range at Baseline (Day 1) and Day 5

  Blood samples for laboratory assessments were collected at Baseline (Day \[D\] 1), Days 3 and 5, and on post-treatment +2 days (if hospitalized) and post-treatment +23 days. Hematology parameters included hemoglobin, total neutrophils (TN), and white blood cell (WBC) count. The number of participants with values that were high (H)/normal (N)/low (L) relative to the normal range at Baseline (D 1) and D 5 for the indicated hematology parameters are summarized. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

  Baseline (Day 1) and Day 5

• Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Toxicities

  A toxicity was considered to be TE if it was greater than the Baseline grade, and if it had developed or increased post-Baseline in intensity (and prior to the last dose of investigational product). Clinical chemistry parameters included ALT, TB, and creatinine. Per the DAIDS table for grading the severity of adult and pediatric AEs, Grade 3=severe and Grade 4=potentially life threatening. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

  Up to post-treatment (PT) + 23 days

• Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Hematology Toxicities

  A toxicity was considered to be TE if it was greater than the Baseline grade, and if it had developed or increased post-Baseline in intensity (and prior to the last dose of investigational product). The hematology parameters included hemoglobin, TN, and WBC count. Per the DAIDS table for grading the severity of adult and pediatric AEs, Grade 3=severe and Grade 4=potentially life threatening. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

  Up to post-treatment (PT) + 23 days

• Median Heart Rate at Baseline (Day 1) and Day 5

  Heart rate was measured at Baseline (Day 1); Days 2, 3, 4, 5, 6, 7, 8, 9, and 10; post-treatment +2 days, +5 days, +9 days, +16 days (assessments to be done if participant remained hospitalized), and +23 days. Heart rate was assessed once daily during inpatient or outpatient follow-up visits. Heart rate values at Baseline (Day 1) and Day 5 are summarized. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X, X in the category titles).

  Baseline (Day 1) and Day 5

• Median Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Baseline (Day 1) and Day 5

  SBP and DBP were measured at Baseline (Day 1), Days 2, 3, 4, 5, 6, 7, 8, 9, and 10; post-treatment +2 days, +5 days, +9 days, +16 days (assessments to be done if participant remained hospitalized), and +23 days. SBP and DBP were assessed once daily during inpatient or outpatient follow-up visits. SBP and DBP values at Baseline (Day 1) and Day 5 are summarized. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X, X in the category titles).

  Baseline (Day 1) and Day 5

• Median Oxygen Saturation Measured Via Transcutaneous Oximetry (TCPO2) at Baseline (Day 1) and Day 5

  TCPO2 is a noninvasive test that directly measures the oxygen level of tissue beneath the skin. Because oxygen is carried to tissues by blood flow in the arteries, TCPO2 is an indirect measure of blood flow. The percent (%) oxygen saturation was measured at Baseline (Day 1), Days 2, 3, 4, 5, 6, 7, 8, 9, and 10; and post-treatment +2 days, +5 days, +9 days, +16 days (assessments to be done if participant remained hospitalized), and +23 days. Oxygen saturation was assessed once daily during inpatient follow-up visits. The median oxygen saturation values at Baseline (Day 1) and Day 5 are summarized. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X, X in the category titles).

  Baseline (Day 1) and Day 5

• Median Respiration Rate at Baseline (Day 1) and Day 5

  Respiration rate was measured at Baseline (Day 1), Days 2, 3, 4, 5, 6, 7, 8, 9, and 10; and post-treatment +2 days, +5 days, +9 days, +16 days (assessments to be done if participant remained hospitalized), and +23 days. Respiration rate was assessed once daily during inpatient or outpatient follow-up visits. The median respiration rate at Baseline (Day 1) and Day 5 is summarized. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X, X in the category titles).

  Baseline (Day 1) and Day 5

• Median Body Temperature at Baseline (Day 1) and Day 5

  Body temperature was recorded at Baseline (Day 1), Days 2, 3, 4, 5, 6, 7, 8, 9, and 10; and post-treatment +2 days, +5 days, +9 days, +16 days (assessments to be done if participant remained hospitalized), and +23 days. Body temperature was recorded once daily during inpatient or outpatient follow-up visits. Median body temperature at Baseline (Day 1) and Day 5 is summarized. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X, X in the category titles).

  Baseline (Day 1) and Day 5

• Number of Participants Assessed as Normal/Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at Baseline (Day 1)

  The number of participants with an ECG status of normal and abnormal CS or NCS, as determined by the Investigator, is reported. Normal=all ECG parameters within the accepted normal ranges. Abnormal=ECG findings outside of normal ranges. CS=ECG with a CS abnormality that meets exclusion criteria. NCS=ECG with an abnormality that is not CS nor meets exclusion criteria, per Investigator, based on reasonable standards of clinical judgment. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X in the category titles).

  Baseline (Day 1)

• Median Corrected QT Interval (QTc) for Heart Rate by Fridericia's Formula (QTcF) and Bazett's Formula (QTcB) at Baseline (Day 1) and Day 5

  Twelve-lead ECGs were recorded for the parameters of QTcF and QTcB. The first set of pre-dose ECG values at Baseline (Day 1) and the pre-dose ECG values at Day 5 are presented. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X, X in the category titles). "NA" indicates that data are not available/analysis was not performed. Cohort 1 QTcF and QTcB minimum values of 0.0 were data entry errors that could not be addressed after Data Base Freeze.

  Baseline (Day 1) and Day 5

Secondary Outcomes (18)

• Median Time to Virologic Improvement

  Up to post-treatment (PT) + 23 days

• Median Change From Baseline (Influenza A or B Quantitative PCR, as Appropriate) in Viral Load at the Indicated Time Points

  Baseline (Day 1); Days 2, 3, 4, 5, 7, and 10; and post-treatment +2, +5, +9, +16, +23 days

• Mean Viral Susceptibility to Zanamivir at Baseline (Day 1) and All Post-Baseline Visits Collectively

  Baseline and up to post-treatment (PT) + 23 days

• Number of Participants With Treatment-emergent (TE) Mutations

  Baseline and up to post-treatment (PT) + 23 days

• Median Time to Resolution of Individual Vital Signs

  Up to post-treatment (PT) + 23 days

Study Arms (1)

Single Arm

OTHER

A single arm open-label design has been selected to achieve the primary objective of providing regulatory authorities with safety data on IV zanamivir in an expedited manner. This study design also facilitates the provision of safety data on a real-time basis, if necessary.

Drug: zanamivir aqueous solution

Interventions

zanamivir aqueous solution DRUG

Zanamivir aqueous solution 10mg/mL is a clear, colorless, single use, sterile non-preserved preparation containing 10mg of zanamivir in each milliliter, and made isotonic with sodium chloride. It is presented in 20mL clear glass vials closed with rubber stoppers. Each vial contains 200mg of zanamivir.

Single Arm

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged greater than or equal to 6 months of age; a female is eligible to enter and participate in the study if she is:
• of non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal); or,
• of child-bearing potential, has a negative pregnancy test at Baseline, and agrees to one of the following methods for avoidance of pregnancy during the study and until the Post-Treatment +23 Days Follow-up Assessment:
• Abstinence; or,
• Oral contraceptive, either combined or progestogen alone; or,
• Injectable progestogen; or,
• Implants of levonorgestrel; or,
• Estrogenic vaginal ring; or,
• Percutaneous contraceptive patches; or
• Intrauterine device (IUD) or intrauterine system (IUS) showing that the expected failure rate is less than 1% per year as stated in the IUD or IUS Product Label; or,
• Has a male partner who is sterilized; or,
• Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository).
• Subjects who have confirmed influenza as determined by a positive result in a rapid test for influenza A or influenza B, or a laboratory test for influenza including influenza virus antigen test, virus culture or RT-PCR test. Subjects with negative rapid test result suspected of having influenza can be enrolled following confirmatory testing by RT-PCR, antigen test or culture.
• Hospitalized subjects with symptomatic influenza
• Subjects who are able to receive their first dose of study medication within seven days of experiencing influenza-like symptoms.

You may not qualify if:

• Subjects who, in the opinion of the investigator, are not likely to survive the next 48 hours beyond Baseline.
• Subjects who require concurrent therapy with another influenza antiviral drug.
• Subjects who have participated in a study using an investigational influenza antiviral drug within 30 days prior to Baseline.
• Subjects who are known or suspected to be hypersensitive to any component of the study medication.
• Subjects who meet the following criteria at Baseline:
• ALT greater than or equal to 3xULN and bilirubin greater than or equal to 2xULN or ALT greater than or equal to 5xULN
• History of cardiac disease or clinically significant arrhythmia (either on ECG or by history) which, in the opinion of the Investigator, will interfere with the safety of the individual subject.
• Child in care (CiC) as defined below:
• A child who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation.
• The definition of a CiC can include a child cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. The definition of a CiC does not include a child who is adopted or has an appointed legal guardian.
• French subjects: the French subject has participated in any study using an investigational drug during the previous 30 days.
• Females who are pregnant (positive urine or serum pregnancy test at Baseline) or are breastfeeding.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (110)

GSK Investigational Site

Birmingham, Alabama, 35233, United States

Location

GSK Investigational Site

Phoenix, Arizona, 85023, United States

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GSK Investigational Site

Little Rock, Arkansas, 72202, United States

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GSK Investigational Site

San Diego, California, 92123, United States

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GSK Investigational Site

Stamford, Connecticut, 06902, United States

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GSK Investigational Site

Washington D.C., District of Columbia, 20007, United States

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GSK Investigational Site

Washington D.C., District of Columbia, 20010, United States

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GSK Investigational Site

Gainesville, Florida, 32608, United States

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GSK Investigational Site

Tampa, Florida, 33606, United States

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GSK Investigational Site

Atlanta, Georgia, 30322, United States

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GSK Investigational Site

Decatur, Georgia, 30033, United States

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GSK Investigational Site

Indianapolis, Indiana, 46202, United States

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GSK Investigational Site

Topeka, Kansas, 66604, United States

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GSK Investigational Site

Louisville, Kentucky, 40202, United States

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GSK Investigational Site

New Orleans, Louisiana, 70112, United States

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GSK Investigational Site

Boston, Massachusetts, 02115-5724, United States

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GSK Investigational Site

Boston, Massachusetts, 02115, United States

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GSK Investigational Site

Saint Paul, Minnesota, 55102, United States

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GSK Investigational Site

Kansas City, Missouri, 64108, United States

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GSK Investigational Site

St Louis, Missouri, 63110, United States

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GSK Investigational Site

Butte, Montana, 59701, United States

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GSK Investigational Site

Camden, New Jersey, 08103, United States

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GSK Investigational Site

New Hyde Park, New York, 11040, United States

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GSK Investigational Site

Chapel Hill, North Carolina, 27514, United States

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GSK Investigational Site

Charlotte, North Carolina, 28203, United States

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GSK Investigational Site

Cleveland, Ohio, 44106, United States

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GSK Investigational Site

Columbus, Ohio, 43205, United States

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GSK Investigational Site

Toledo, Ohio, 43606, United States

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GSK Investigational Site

Portland, Oregon, 97239, United States

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GSK Investigational Site

Philadelphia, Pennsylvania, 19102, United States

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GSK Investigational Site

Pittsburgh, Pennsylvania, 15224, United States

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GSK Investigational Site

Memphis, Tennessee, 38103, United States

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GSK Investigational Site

Memphis, Tennessee, 38105, United States

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GSK Investigational Site

Dallas, Texas, 75231, United States

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GSK Investigational Site

Dallas, Texas, 75235, United States

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GSK Investigational Site

Fort Worth, Texas, 76104, United States

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GSK Investigational Site

Houston, Texas, 77030, United States

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GSK Investigational Site

Salt Lake City, Utah, 84113, United States

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GSK Investigational Site

Richmond, Virginia, 23249, United States

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GSK Investigational Site

Milwaukee, Wisconsin, 53201, United States

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GSK Investigational Site

Garran, Australian Capital Territory, 2606, Australia

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GSK Investigational Site

Chermside, Queensland, 4032, Australia

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GSK Investigational Site

Herston, Queensland, 4029, Australia

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GSK Investigational Site

Adelaide, South Australia, 5000, Australia

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GSK Investigational Site

Bedford Park, South Australia, 5043, Australia

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GSK Investigational Site

Heidelberg, Victoria, 3084, Australia

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GSK Investigational Site

Perth, Western Australia, 6000, Australia

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GSK Investigational Site

Subiaco, Western Australia, 6008, Australia

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GSK Investigational Site

Rio de Janeiro, Rio de Janeiro, 21941-590, Brazil

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GSK Investigational Site

São Paulo, São Paulo, 01308060, Brazil

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GSK Investigational Site

Winnipeg, Manitoba, R3E 0J9, Canada

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GSK Investigational Site

Halifax, Nova Scotia, B3K 6R8, Canada

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GSK Investigational Site

Toronto, Ontario, M5G 1X5, Canada

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GSK Investigational Site

Chicoutimi, Quebec, G7H 5H6, Canada

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GSK Investigational Site

Montreal, Quebec, H1T 2M4, Canada

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GSK Investigational Site

Montreal, Quebec, H3T 1C5, Canada

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GSK Investigational Site

Québec, Quebec, G1V 4G2, Canada

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GSK Investigational Site

Bron, 69677, France

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GSK Investigational Site

Grenoble, 38043, France

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GSK Investigational Site

Limoges, 87042, France

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GSK Investigational Site

Nancy, 54035, France

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GSK Investigational Site

Nice, 06200, France

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GSK Investigational Site

Nîmes, 30029, France

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GSK Investigational Site

Orléans, 45067, France

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GSK Investigational Site

Paris, 75018, France

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GSK Investigational Site

Paris, 75679, France

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GSK Investigational Site

Tours, 37044, France

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GSK Investigational Site

Shatin, Hong Kong

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GSK Investigational Site

Fukuoka, 830-8543, Japan

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GSK Investigational Site

Hokkaido, 062-0931, Japan

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GSK Investigational Site

Kanagawa, 247-8533, Japan

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GSK Investigational Site

Osaka, 534-0021, Japan

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GSK Investigational Site

Osaka, 596-8522, Japan

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GSK Investigational Site

Yamanashi, 400-8506, Japan

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GSK Investigational Site

Bergen, 5021, Norway

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GSK Investigational Site

Trondheim, 7030, Norway

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GSK Investigational Site

Smolensk, 214006, Russia

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GSK Investigational Site

Yekaterinburg, 620102, Russia

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GSK Investigational Site

Middelburg, Mpumalanga, 1055, South Africa

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GSK Investigational Site

Bellville, 7530, South Africa

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GSK Investigational Site

Observatory, 7925, South Africa

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GSK Investigational Site

Panorama, 7500, South Africa

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GSK Investigational Site

Rondebosch, 7700, South Africa

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GSK Investigational Site

Tygerberg, 7505, South Africa

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GSK Investigational Site

Worcester, 6850, South Africa

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GSK Investigational Site

(Móstoles) Madrid, 28935, Spain

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GSK Investigational Site

Badalona, 08916, Spain

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GSK Investigational Site

Barcelona, 08003, Spain

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GSK Investigational Site

Barcelona, 08035, Spain

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GSK Investigational Site

Barcelona, 08036, Spain

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GSK Investigational Site

Getafe/Madrid, 28905, Spain

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GSK Investigational Site

L'Hospitalet de Llobregat, 08907, Spain

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GSK Investigational Site

Madrid, 28007, Spain

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GSK Investigational Site

Madrid, 28034, Spain

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GSK Investigational Site

Madrid, 28041, Spain

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GSK Investigational Site

Madrid, 28046, Spain

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GSK Investigational Site

Bangkok, 10330, Thailand

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GSK Investigational Site

Bangkok, 10700, Thailand

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GSK Investigational Site

Glasgow, Lanarkshire, G11 6NT, United Kingdom

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GSK Investigational Site

Liverpool, Merseyside, L7 8XP, United Kingdom

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GSK Investigational Site

Livingston, West Lothian, EH54 6PP, United Kingdom

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GSK Investigational Site

Bristol, BS2 8AE, United Kingdom

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GSK Investigational Site

Bristol, BS2 8HW, United Kingdom

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GSK Investigational Site

Cardiff, CF14 4XW, United Kingdom

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GSK Investigational Site

Leeds, LS1 3EX, United Kingdom

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GSK Investigational Site

Leicester, LE1 5WW, United Kingdom

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GSK Investigational Site

Leicester, LE3 9QP, United Kingdom

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GSK Investigational Site

London, NW1 2BU, United Kingdom

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GSK Investigational Site

Oxford, OX3 9DU, United Kingdom

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GSK Investigational Site

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (1)

• Marty FM, Man CY, van der Horst C, Francois B, Garot D, Manez R, Thamlikitkul V, Lorente JA, Alvarez-Lerma F, Brealey D, Zhao HH, Weller S, Yates PJ, Peppercorn AF. Safety and pharmacokinetics of intravenous zanamivir treatment in hospitalized adults with influenza: an open-label, multicenter, single-arm, phase II study. J Infect Dis. 2014 Feb 15;209(4):542-50. doi: 10.1093/infdis/jit467. Epub 2013 Aug 27.

  PMID: 23983212 DERIVED

Related Links

• FDA information on Influenza (Flu) antiviral drugs and related information
• Centers For Disease Control and Prevention seasonal flu information

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Limitations and Caveats

Two participants who withdrew consent prior to receiving intravenous zanamivir have not been captured in any of the tables.

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2009
• First Posted: November 17, 2009
• Study Start: November 1, 2009
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: March 28, 2017
• Results First Posted: March 28, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share

Locations

TH (2); CA (7); ZA (7); NO (2); JP (6); US (40); RU (2); GB (12); BR (2); AU (8); FR (10); HK (1); ES (11)