<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/NCT03812835</url>
  </required_header>
  <id_info>
    <org_study_id>B0661104</org_study_id>
    <nct_id>NCT03812835</nct_id>
  </id_info>
  <brief_title>A Study of Adverse Events and Suspected Adverse Drug Reactions of Patients Under Treatment of Apixaban for Venous Thomboembolism (VTE) Treatment</brief_title>
  <official_title>A PHASE IV NON-INTERVENTIONAL STUDY. REGISTRY OF ADVERSE EVENTS (AES)/SUSPECTED ADVERSE DRUG REACTIONS (SADRS) OF ADULT PATIENTS UNDER TREATMENT OF DEEP VEIN THROMBOSIS (DVT) AND PULMONARY EMBOLISM (PE); PREVENTION OF RECURRENT DVT AND PE WITH ELICUIS REGISTERED (APIXABAN)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <brief_summary>
    <textblock>
      Number, type and incidence of adverse events/suspected adverse drug reactions in patients&#xD;
      treated with apixaban, according to therapeutic indications approved in Mexico.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Company decision to not conduct study and was cancelled prior to any enrollment.&#xD;
  </why_stopped>
  <start_date type="Anticipated">August 23, 2021</start_date>
  <completion_date type="Anticipated">August 23, 2023</completion_date>
  <primary_completion_date type="Anticipated">August 23, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The number, type and incidence of adverse events/suspected adverse drug reactions in patients treated with apixaban, according to therapeutic indications approved in Mexico.</measure>
    <time_frame>12 up to 24 months</time_frame>
    <description>Data will be collected for at least 12 months and until 24 months in 3 sites in Mexico using an electronic case report form</description>
  </primary_outcome>
  <enrollment type="Actual">0</enrollment>
  <condition>Thrombosis, Deep Vein</condition>
  <condition>Pulmonary Embolism</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients who have received at least one dose of apixaban for treatment of deep vein&#xD;
        thrombosis (DVT) and pulmonary embolism (PE); prevention of recurrent DVT and PE.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients must meet all of the following inclusion criteria to be eligible for inclusion in&#xD;
        the study:&#xD;
&#xD;
          1. Evidence a personally signed and dated informed consent document indicating that the&#xD;
             patient (or a legally acceptable representative) has been informed of all pertinent&#xD;
             aspects of the study.&#xD;
&#xD;
          2. Patients (men and women) &gt;18 years old.&#xD;
&#xD;
          3. Patients who have received at least one dose of apixaban for treatment of deep vein&#xD;
             thrombosis (DVT) and pulmonary embolism (PE); prevention of recurrent DVT and PE&#xD;
&#xD;
             -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients meeting any of the following criteria will not be included in the study:&#xD;
&#xD;
          1. Patients who are participating in a clinical trial.&#xD;
&#xD;
          2. Hypersensitivity to the active substance or to any of the excipients.&#xD;
&#xD;
          3. Active clinically significant bleeding.&#xD;
&#xD;
          4. Hepatic disease associated with coagulopathy and clinically relevant bleeding risk,&#xD;
             based on hepatic function tests.&#xD;
&#xD;
          5. Lesion or condition if considered a significant risk factor for major bleeding. This&#xD;
             may include current or recent gastrointestinal ulceration, presence of malignant&#xD;
             neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain,&#xD;
             spinal or ophthalmic surgery, recent intracranial hemorrhage, known or suspected&#xD;
             esophageal varices, arteriovenous malformations, vascular aneurysms or major&#xD;
             intraspinal or intracerebral vascular abnormalities.&#xD;
&#xD;
          6. Concomitant treatment with any other anticoagulant agent e.g. unfractionated heparin&#xD;
             (UFH), low molecular weight heparins (enoxaparin, dalteparin, etc.), heparin&#xD;
             derivatives (fondaparinux, etc.), and oral anticoagulants (warfarin, acenocoumarin,&#xD;
             rivaroxaban, dabigatran, etc.) except under specific circumstances of switching&#xD;
             anticoagulant therapy.&#xD;
&#xD;
          7. Pregnancy and breast-feeding.&#xD;
&#xD;
          8. Severe acute or chronic psychiatric condition and other significant medical condition.&#xD;
&#xD;
             -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>January 4, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>November 9, 2021</last_update_submitted>
  <last_update_submitted_qc>November 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Embolism</mesh_term>
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Embolism</mesh_term>
    <mesh_term>Venous Thrombosis</mesh_term>
    <mesh_term>Drug-Related Side Effects and Adverse Reactions</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.</ipd_description>
  </patient_data>
  <!-- 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/NCT03812835
org study id: B0661104
nct id: NCT03812835
lead sponsor: 
Number, type and incidence of adverse events/suspected adverse drug reactions in patients
      treated with apixaban, according to therapeutic indications approved in Mexico.
observational model: Other
time perspective: Prospective
measure: The number, type and incidence of adverse events/suspected adverse drug reactions in patients treated with apixaban, according to therapeutic indications approved in Mexico.
time frame: 12 up to 24 months
description: Data will be collected for at least 12 months and until 24 months in 3 sites in Mexico using an electronic case report form
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
responsible party type: Sponsor
mesh term: Pulmonary Embolism
mesh term: Thrombosis
mesh term: Embolism
mesh term: Venous Thrombosis
mesh term: Drug-Related Side Effects and Adverse Reactions
sharing ipd: No
ipd description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.