<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04484935</url>
  </required_header>
  <id_info>
    <org_study_id>D5290C00008</org_study_id>
    <nct_id>NCT04484935</nct_id>
  </id_info>
  <brief_title>Evaluate the Safety and Tolerability, for Nirsevimab in Immunocompromised Children</brief_title>
  <acronym>MUSIC</acronym>
  <official_title>A Phase 2, Open-label, Uncontrolled, Single-dose Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Occurrence of Antidrug Antibody for Nirsevimab in Immunocompromised Children ≤ 24 Months of Age</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Iqvia Pty Ltd</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>AstraZeneca</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study D5290C00008 is a Phase 2, open-label, uncontrolled, single-dose study to evaluate the&#xD;
      safety and tolerability, pharmacokinetic(s) (PK), occurrence of antidrug antibody (ADA), and&#xD;
      efficacy of nirsevimab in immunocompromised children who are ≤ 24 months of age at the time&#xD;
      of dose administration. Approximately 100 subjects will be enrolled. Subjects will be&#xD;
      followed for approximately 1 year after dose administration.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract&#xD;
      infection (LRTI) among infants and young children, resulting in annual epidemics in Japan.&#xD;
      Children with congenital or acquired immunodeficiencies, transplant recipients, and those&#xD;
      receiving immunosuppressive therapy are at increased risk for severe RSV-associated LRTI with&#xD;
      prolonged viral shedding and higher viral loads, resulting in prolonged hospitalizations,&#xD;
      admissions to the intensive care unit (ICU), and the need for mechanical ventilation.&#xD;
      Palivizumab (Synagis®) is the only approved agent for RSV prophylaxis, and its half-life&#xD;
      (t1/2) is approximately 1 month, infants and young children need to receive monthly&#xD;
      intramuscular doses of palivizumab throughout the RSV season to maintain protection. This&#xD;
      constitutes a significant burden on healthcare providers as well as the infants/children and&#xD;
      their families.&#xD;
&#xD;
      Nirsevimab may provide a cost-effective opportunity to protect all infants from RSV disease&#xD;
      based on an improvement in potency and the extended t1/2 that is expected to support&#xD;
      once-per-RSV-season dosing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2, 2020</start_date>
  <completion_date type="Actual">February 17, 2023</completion_date>
  <primary_completion_date type="Actual">February 17, 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Open: no masking is used. All involved know the identity of the intervention assignment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Safety and tolerability of nirsevimab when administered to immunocompromised children ≤ 24 months of age</measure>
    <time_frame>Through 360 days post dose.</time_frame>
    <description>All treatment-emergent adverse event (TEAEs), treatment-emergent serious adverse event (TESAEs), adverse event of special interest (AESIs), new onset chronic disease (NOCDs)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To evaluate the PK of nirsevimab</measure>
    <time_frame>Through 360 days post dose.</time_frame>
    <description>Summary of nirsevimab serum concentrations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate ADA responses to nirsevimab in serum</measure>
    <time_frame>Through 360 days post dose.</time_frame>
    <description>Incidence of ADA to nirsevimab in serum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess the efficacy of nirsevimab when administered as a single intramuscular (IM) dose to infants ≤ 24 months of age</measure>
    <time_frame>Through 360 days post dose</time_frame>
    <description>Incidence of medically attended lower respiratory tract infection (LRTI; inpatient and outpatient) and hospitalizations due to reverse transcriptase-polymerase chain reaction (RT-PCR)-confirmed respiratory syncytial virus (RSV) through 150 days after administration of nirsevimab</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>RSV Infection</condition>
  <arm_group>
    <arm_group_label>Nirsevimab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1st RSV season: 50mg nirsevimab&#xD;
st RSV season: 100mg nirsevimab&#xD;
nd RSV season: 200mg nirsevimab</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nirsevimab</intervention_name>
    <description>Single fixed IM dose of nirsevimab 50 mg if body weight &lt; 5 kg or 100 mg if body weight ≥ 5 kg, and subjects entering their second RSV season will receive a single fixed IM dose of nirsevimab 200 mg</description>
    <arm_group_label>Nirsevimab</arm_group_label>
    <other_name>Nirsevimab (MEDI8897)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Neonate, infant, or young child ≤ 24 months of age at the time of dose administration&#xD;
             who, per investigator judgement, are:&#xD;
&#xD;
               1. In their first year of life AND entering their first RSV season at the time of&#xD;
                  dose administration OR&#xD;
&#xD;
               2. In their second year of life AND entering their second RSV season at the time of&#xD;
                  dose administration&#xD;
&#xD;
          -  The subject must meet at least 1 of the following conditions at the time of informed&#xD;
             consent.&#xD;
&#xD;
               1. Diagnosed with combined immunodeficiency (severe combined immunodeficiency,&#xD;
                  X-linked hyper-immunoglobulin M [IgM] syndrome, etc); antibody deficiency (X&#xD;
                  linked agammaglobulinemia, common variable immunodeficiency, non-X-linked&#xD;
                  hyper-IgM syndromes, etc); or other immunodeficiency (Wiskott-Aldrich syndrome,&#xD;
                  DiGeorge syndrome, etc), or&#xD;
&#xD;
               2. Diagnosed with human immunodeficiency virus infection, or&#xD;
&#xD;
               3. History of organ or bone marrow transplantation, or&#xD;
&#xD;
               4. Subject is receiving immunosuppressive chemotherapy, or&#xD;
&#xD;
               5. Subject is receiving systemic high-dose corticosteroid therapy (prednisone&#xD;
                  equivalents ≥ 0.5 mg/kg every other day, other than inhaler or topical use), or&#xD;
&#xD;
               6. Subject is receiving other immunosuppressive therapy (eg, azathioprine,&#xD;
                  methotrexate, mizoribine, mycophenolate mofetil, cyclophosphamide, cyclosporine,&#xD;
                  tacrolimus, cytokine inhibitors, etc)&#xD;
&#xD;
          -  Written informed consent and any locally required authorization obtained from the&#xD;
             subject's parent(s)/legal representative(s) prior to performing any protocol-related&#xD;
             procedures, including screening evaluations.&#xD;
&#xD;
          -  Subject's parent(s)/legal representative(s) able to understand and comply with the&#xD;
             requirements of the protocol including follow-up visits as judged by the investigator.&#xD;
&#xD;
          -  Subject is available to complete the follow-up period, which will be approximately 1&#xD;
             year after receipt of nirsevimab&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject who meets any of the palivizumab indications approved in Japan other than&#xD;
             immunocompromised condition.&#xD;
&#xD;
               1. Subject born at ≤ 28 weeks gestation and is ≤ 12 months of age&#xD;
&#xD;
               2. Subject born at 29 to 35 weeks gestation and is ≤ 6 months of age&#xD;
&#xD;
               3. Age ≤ 24 months with a history of bronchopulmonary dysplasia requiring medical&#xD;
                  management within the past 6 months&#xD;
&#xD;
               4. Age ≤ 24 months with current hemodynamically significant congenital heart disease&#xD;
                  (CHD)&#xD;
&#xD;
               5. Age ≤ 24 months with Down syndrome&#xD;
&#xD;
          -  Requirement for oxygen supplementation, mechanical ventilation, extracorporeal&#xD;
             membrane oxygenation, continuous positive airway pressure, or other mechanical&#xD;
             respiratory or cardiac support at screening&#xD;
&#xD;
          -  A current, active infection, including RSV infection, at the time of screening or at&#xD;
             the time of investigational product administration.&#xD;
&#xD;
          -  Any fever (≥ 100.4°F [≥ 38.0°C], regardless of route) or acute illness within 7 days&#xD;
             prior to investigational product administration.&#xD;
&#xD;
          -  Any serious concurrent medical condition (renal failure, hepatic dysfunction,&#xD;
             suspected active or chronic hepatitis infection, seizure disorder, unstable neurologic&#xD;
             disorder, etc), except those resulting in an immune deficiency condition.&#xD;
&#xD;
          -  Clinically significant congenital anomaly of the respiratory tract.&#xD;
&#xD;
          -  Receipt of palivizumab.&#xD;
&#xD;
          -  Any known allergy or history of allergic reaction to any component of nirsevimab.&#xD;
&#xD;
          -  Any known allergy or history of allergic reaction to immunoglobulin products, blood&#xD;
             products, or other foreign proteins.&#xD;
&#xD;
          -  Concurrent enrollment in another interventional study, or prior receipt of any&#xD;
             investigational agent.&#xD;
&#xD;
          -  Anticipated survival of less than 1 year at the time of informed consent.&#xD;
&#xD;
          -  Any condition that, in the opinion of the investigator, would interfere with&#xD;
             evaluation of the investigational product or interpretation of study results.&#xD;
&#xD;
          -  Children of employees of the sponsor, clinical study site, or any other individuals&#xD;
             involved with the conduct of the study, or immediate family members of such&#xD;
             individuals.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>0 Years</minimum_age>
    <maximum_age>2 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>North Charleston</city>
        <state>South Carolina</state>
        <zip>29406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bruxelles</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bunkyo-ku</city>
        <zip>113-8519</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Fuchu-shi</city>
        <zip>183-8561</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kawasaki-shi</city>
        <zip>216-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kurume-shi</city>
        <zip>830-0011</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kyoto-shi</city>
        <zip>606-8507</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nagasaki-shi</city>
        <zip>852-8501</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Setagaya-ku</city>
        <zip>157-8535</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tsukuba-shi</city>
        <zip>305-8576</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Yokohama-shi</city>
        <zip>232 8555</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85-048</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Parktown</city>
        <zip>2193</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Soweto</city>
        <zip>2013</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Barcelona</city>
        <zip>8035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Granada</city>
        <zip>18014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Dnipro</city>
        <zip>49006</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kharkiv</city>
        <zip>61075</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nottingham</city>
        <zip>NG7 2UH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Japan</country>
    <country>Poland</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>March 16, 2023</last_update_submitted>
  <last_update_submitted_qc>March 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>LRTI by RSV infection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Syncytial Virus Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.&#xD;
All request will be evaluated as per the AstraZeneca (AZ) disclosure commitment:&#xD;
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AstraZeneca (AZ) are accepting requests for Individual Participant Data (IPD), but this does not mean all requests will be shared.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>AstraZeneca will meet or exceed data availability as per the commitments made to the European Federation of Pharmaceutical Industries and Associations (EFPIA) Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.</ipd_time_frame>
    <ipd_access_criteria>When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.</ipd_access_criteria>
    <ipd_url>https://astrazenecagroup-dt.pharmacm.com/DT/Home</ipd_url>
  </patient_data>
  <pending_results>
    <submitted>August 29, 2023</submitted>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04484935
org study id: D5290C00008
nct id: NCT04484935
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Study D5290C00008 is a Phase 2, open-label, uncontrolled, single-dose study to evaluate the
      safety and tolerability, pharmacokinetic(s) (PK), occurrence of antidrug antibody (ADA), and
      efficacy of nirsevimab in immunocompromised children who are ≤ 24 months of age at the time
      of dose administration. Approximately 100 subjects will be enrolled. Subjects will be
      followed for approximately 1 year after dose administration.
Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract
      infection (LRTI) among infants and young children, resulting in annual epidemics in Japan.
      Children with congenital or acquired immunodeficiencies, transplant recipients, and those
      receiving immunosuppressive therapy are at increased risk for severe RSV-associated LRTI with
      prolonged viral shedding and higher viral loads, resulting in prolonged hospitalizations,
      admissions to the intensive care unit (ICU), and the need for mechanical ventilation.
      Palivizumab (Synagis®) is the only approved agent for RSV prophylaxis, and its half-life
      (t1/2) is approximately 1 month, infants and young children need to receive monthly
      intramuscular doses of palivizumab throughout the RSV season to maintain protection. This
      constitutes a significant burden on healthcare providers as well as the infants/children and
      their families.

      Nirsevimab may provide a cost-effective opportunity to protect all infants from RSV disease
      based on an improvement in potency and the extended t1/2 that is expected to support
      once-per-RSV-season dosing.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
masking description: Open: no masking is used. All involved know the identity of the intervention assignment.
measure: Safety and tolerability of nirsevimab when administered to immunocompromised children ≤ 24 months of age
time frame: Through 360 days post dose.
description: All treatment-emergent adverse event (TEAEs), treatment-emergent serious adverse event (TESAEs), adverse event of special interest (AESIs), new onset chronic disease (NOCDs)
measure: To evaluate the PK of nirsevimab
time frame: Through 360 days post dose.
description: Summary of nirsevimab serum concentrations
measure: To evaluate ADA responses to nirsevimab in serum
time frame: Through 360 days post dose.
description: Incidence of ADA to nirsevimab in serum
measure: To assess the efficacy of nirsevimab when administered as a single intramuscular (IM) dose to infants ≤ 24 months of age
time frame: Through 360 days post dose
description: Incidence of medically attended lower respiratory tract infection (LRTI; inpatient and outpatient) and hospitalizations due to reverse transcriptase-polymerase chain reaction (RT-PCR)-confirmed respiratory syncytial virus (RSV) through 150 days after administration of nirsevimab
arm group label: Nirsevimab
arm group type: Experimental
description: 1st RSV season: 50mg nirsevimab
st RSV season: 100mg nirsevimab
nd RSV season: 200mg nirsevimab
intervention type: Drug
intervention name: Nirsevimab
description: Single fixed IM dose of nirsevimab 50 mg if body weight < 5 kg or 100 mg if body weight ≥ 5 kg, and subjects entering their second RSV season will receive a single fixed IM dose of nirsevimab 200 mg
arm group label: Nirsevimab
other name: Nirsevimab (MEDI8897)
criteria: 
gender: All
minimum age: 0 Years
maximum age: 2 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: Japan
country: Poland
country: South Africa
country: Spain
country: Ukraine
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Respiratory Syncytial Virus Infections
sharing ipd: Yes
ipd description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.
All request will be evaluated as per the AstraZeneca (AZ) disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AstraZeneca (AZ) are accepting requests for Individual Participant Data (IPD), but this does not mean all requests will be shared.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the European Federation of Pharmaceutical Industries and Associations (EFPIA) Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
ipd access criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
ipd url: https://astrazenecagroup-dt.pharmacm.com/DT/Home
submitted: August 29, 2023