<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/NCT02200666</url>
  </required_header>
  <id_info>
    <org_study_id>D1692C00014</org_study_id>
    <nct_id>NCT02200666</nct_id>
  </id_info>
  <brief_title>Forxiga Tablets Specific Clinical Experience Investigation for Long-term Use</brief_title>
  <official_title>Forxiga Tablets Specific Clinical Experience Investigation for Long-term Use</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AstraZeneca</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the investigation is to confirm the following under the post-marketing actual&#xD;
      use of Forxiga Tablets (hereinafter referred to as Forxiga)&#xD;
&#xD;
        -  Development of ADRs specified as Key Investigation Items and the risk factors&#xD;
&#xD;
        -  Contributing factors possibly having an impact on the safety and efficacy&#xD;
&#xD;
        -  Development of ADRs unexpected from the Precautions for use and ADRs under actual drug&#xD;
           use&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 3, 2014</start_date>
  <completion_date type="Actual">September 9, 2019</completion_date>
  <primary_completion_date type="Actual">September 9, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse event incidence</measure>
    <time_frame>from baseline to 3 years</time_frame>
  </primary_outcome>
  <enrollment type="Actual">7793</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients treated with Forxiga for the first time due to type 2 diabetes mellitus, which is&#xD;
        the indication of the drug.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients treated with Forxiga for the first time due to type 2 diabetes mellitus, which is&#xD;
        the indication of the drug.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        N/A&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Aichi</city>
        <zip>D1692C00014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Akita</city>
        <zip>D1692C00014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Aomori</city>
        <zip>D1692C00014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chiba</city>
        <zip>D1692C00014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ehime</city>
        <zip>D1692C00014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Fukui</city>
        <zip>D1692C00014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Fukuoka</city>
        <zip>D1692C00014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Fukushima</city>
        <zip>D1692C00014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Gifu</city>
        <zip>D1692C00014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Gunma</city>
        <zip>D1692C00014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hiroshima</city>
        <zip>D1692C00014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hokkaido</city>
        <zip>D1692C00014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hyogo</city>
        <zip>D1692C00014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ibaraki</city>
        <zip>D1692C00014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ishikawa</city>
        <zip>D1692C00014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Iwate</city>
        <zip>D1692C00014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kagawa</city>
        <zip>D1692C00014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kagoshima</city>
        <zip>D1692C00014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kanagawa</city>
        <zip>D1692C00014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kochi</city>
        <zip>D1692C00014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kumamoto</city>
        <zip>D1692C00014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kyoto</city>
        <zip>D1692C00014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mie</city>
        <zip>D1692C00014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miyagi</city>
        <zip>D1692C00014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miyazaki</city>
        <zip>D1692C00014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nagano</city>
        <zip>D1692C00014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nagasaki</city>
        <zip>D1692C00014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nara</city>
        <zip>D1692C00014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Niigata</city>
        <zip>D1692C00014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Oita</city>
        <zip>D1692C00014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Okayama</city>
        <zip>D1692C00014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Okinawa</city>
        <zip>D1692C00014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Osaka</city>
        <zip>D1692C00014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Saga</city>
        <zip>D1692C00014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Saitama</city>
        <zip>D1692C00014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shiga</city>
        <zip>D1692C00014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shimane</city>
        <zip>D1692C00014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shizuoka</city>
        <zip>D1692C00014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tochigi</city>
        <zip>D1692C00014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tokushima</city>
        <zip>D1692C00014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tokyo</city>
        <zip>D1692C00014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tottori</city>
        <zip>D1692C00014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Toyama</city>
        <zip>D1692C00014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Wakayama</city>
        <zip>D1692C00014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Yamagata</city>
        <zip>D1692C00014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Yamaguchi</city>
        <zip>D1692C00014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Yamanashi</city>
        <zip>D1692C00014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <removed_countries>
    <country>India</country>
  </removed_countries>
  <link>
    <url>http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&amp;studyid=3067&amp;filename=JP_PMS%20Protocol_FXG_D1692C00014_E_Redacted.pdf</url>
    <description>Redacted Protocol</description>
  </link>
  <link>
    <url>https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D1692C00014&amp;attachmentIdentifier=28022cf7-726c-4258-b5cc-d32639730783&amp;fileName=CSR_synopsis_D1692C00014.pdf&amp;versionIdentifier=</url>
    <description>CSR Synopsis</description>
  </link>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>February 21, 2020</last_update_submitted>
  <last_update_submitted_qc>February 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Type 2 diabetes mellitus</keyword>
  <keyword>Diabetes</keyword>
  <keyword>Forxiga</keyword>
  <keyword>Long-term use</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <!-- 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/NCT02200666
org study id: D1692C00014
nct id: NCT02200666
lead sponsor: 
has dmc: No
The purpose of the investigation is to confirm the following under the post-marketing actual
      use of Forxiga Tablets (hereinafter referred to as Forxiga)

        -  Development of ADRs specified as Key Investigation Items and the risk factors

        -  Contributing factors possibly having an impact on the safety and efficacy

        -  Development of ADRs unexpected from the Precautions for use and ADRs under actual drug
           use
observational model: Cohort
time perspective: Prospective
measure: Adverse event incidence
time frame: from baseline to 3 years
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
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country: Japan
country: India
url: http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3067&filename=JP_PMS%20Protocol_FXG_D1692C00014_E_Redacted.pdf
description: Redacted Protocol
url: https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D1692C00014&attachmentIdentifier=28022cf7-726c-4258-b5cc-d32639730783&fileName=CSR_synopsis_D1692C00014.pdf&versionIdentifier=
description: CSR Synopsis
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2