<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/NCT02187042</url>
  </required_header>
  <id_info>
    <org_study_id>A6181213</org_study_id>
    <secondary_id>RENACALL</secondary_id>
    <nct_id>NCT02187042</nct_id>
  </id_info>
  <brief_title>Evaluation Of The Impact Of A Call Center In Management Of Metastatic And/Or Advanced Renal Cell Carcinoma Patients Treated With Sunitinib (Sutent) In First Line</brief_title>
  <acronym>RENACALL</acronym>
  <official_title>EVALUATION OF THE IMPACT OF A THERAPY MANAGEMENT PLATFORM ON THE MANAGEMENT OF PATIENTS SUFFERING FROM ADVANCED/METASTATIC RENAL CELL CARCINOMA AND RECEIVING FIRST LINE TREATMENT WITH SUNITINIB, VERSUS STANDARD FOLLOW-UP</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      100 patients with metastatic and/or advanced renal cell carcinoma treated with sunitinib&#xD;
      (Sutent) will be inclued and followed with standard care plus a call center&#xD;
&#xD;
      Principal assumption : the proportion of patients presenting with at least one grade 3 or 4&#xD;
      AE (whether related to sunitinib or not).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      RENACALL is a prospective intermediate care study whose main aim is to evaluate the impact of&#xD;
      a therapy management platform on the management of patients suffering from&#xD;
      advanced/metastatic renal cell carcinoma and receiving first line treatment with Sutent®.&#xD;
&#xD;
      100 mRCC patients treated receiving first line Sutent® treatment shall be included in the&#xD;
      study, and shall benefit both from conventional follow-up and from additional therapy&#xD;
      management platform-based follow-up. Platform follow-up shall consist in regular phone calls&#xD;
      to accompany patients in their real life home management of their treatment with sunitinib&#xD;
      (prevention, advice and guidance of patients towards options)..&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 7, 2015</start_date>
  <completion_date type="Actual">July 25, 2018</completion_date>
  <primary_completion_date type="Actual">July 25, 2018</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>Number of Participants With at Least 1 Adverse Event (AE) of Grade 3 or 4 Based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03</measure>
    <time_frame>Baseline up to 6 months</time_frame>
    <description>An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. The severity was graded by NCI CTCAE v.4.03. Grade 1 was mild AE. Grade 2 was moderate AE. Grade 3 was severe AE. Grade 4 was life-threatening consequences and urgent intervention AE. Grade 5 was death related to AE.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With at Least 1 Sunitinib Dose Reduction</measure>
    <time_frame>Baseline up to 6 months</time_frame>
    <description>Number of participants treated with sunitinib having had at least 1 dose reduction relative to the initial dose are reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Involved in at Least 1 Occasion For Each of the Reasons for a Sunitinib Dose Reduction</measure>
    <time_frame>Baseline up to 6 months</time_frame>
    <description>Number of participants treated with sunitinib having had at least 1 dose reduction relative to the initial dose according to the reasons for dose reductions are reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Sunitinib Dose Reduction</measure>
    <time_frame>Baseline up to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With at Least 1 Temporary Interruption of Sunitinib Treatment</measure>
    <time_frame>Baseline up to 6 months</time_frame>
    <description>Reason for temporary dose interruptions included: who had AEs that were intolerable, surgery, omission, doctor choice and any other reason judged by doctor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Duration (in Days) of Temporary Interruption to Sunitinib Treatment</measure>
    <time_frame>Baseline up to 6 months</time_frame>
    <description>Reason for temporary dose interruptions included: who had AEs that were intolerable, surgery, omission, doctor choice and any other reason judged by doctor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Involved on at Least 1 Occasion for Each of the Reasons for a Sunitinib Temporary Treatment Interruption</measure>
    <time_frame>Baseline up to 6 months</time_frame>
    <description>Reason for temporary dose interruptions included: who had AEs that were intolerable, surgery, omission, doctor choice and any other reason judged by doctor. Participants were counted in more than 1 category.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Permanently Discontinued Sunitinib Treatment</measure>
    <time_frame>Baseline up to 6 months</time_frame>
    <description>Reason for permanent discontinuation of sunitinib treatment included: progressive disease, toxicity, participant's choice, doctor's choice and death of participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Involved on At Least 1 Occasion for Each of the Reasons for a Permanent Sunitinib Treatment Discontinuation</measure>
    <time_frame>Baseline up to 6 months</time_frame>
    <description>Reason for permanent discontinuation of sunitinib treatment included: progressive disease, toxicity, participant's choice, doctor's choice and death of participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Duration of Sunitinib Treatment</measure>
    <time_frame>Baseline up to 6 months</time_frame>
    <description>Total mean duration (in months) of sunitinib treatment is reported in this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Classified on the Basis of Number of Sunitinib Treatment Cycles</measure>
    <time_frame>Baseline up to 6 months</time_frame>
    <description>Last treatment cycle was declared by doctor either on the notified date to discontinue sunitinib or on the date of the last consultation if sunitinib treatment was not stopped</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With At Least 1 Unplanned Hospitalization</measure>
    <time_frame>Baseline up to 6 months</time_frame>
    <description>Number of participants with at least 1 unplanned hospitalizations either related or unrelated to sunitinib were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With At Least 1 Unplanned Consultation</measure>
    <time_frame>Baseline up to 6 months</time_frame>
    <description>Number of participants with at least 1 unplanned consultations either related or unrelated to sunitinib were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Were &quot;Adherent&quot; as Per 4- Item Morisky Medication Adherence Scale (MMAS-4)</measure>
    <time_frame>Baseline up to 6 months</time_frame>
    <description>MMAS-4 is a self-reported measure of medication taking behavior, consisting of 4 questions based on forgetting taking medication, carelessness about taking medication, stopping medication when feeling better, or stopping medication when feeling worse. Each question has answer either &quot;Yes&quot; or &quot;No&quot;; &quot;Yes&quot; =1 and &quot;No&quot; =0. The sum of answer to all 4 questions resulted in total MMAS-4 score. Total MMAS-4 score ranges from 0 (best adherence) to 4 (worst adherence), a low score representing improved adherence. Adherent participants were defined as participants with an MMAS-4 score of 0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean 4-Item Morisky Medication Adherence Scale (MMAS-4) Score</measure>
    <time_frame>Baseline up to 6 months</time_frame>
    <description>MMAS-4 is a self-reported measure of medication taking behavior, consisting of 4 questions based on forgetting taking medication, carelessness about taking medication, stopping medication when feeling better, or stopping medication when feeling worse. Each question has answer either &quot;Yes&quot; or &quot;No&quot;; &quot;Yes&quot; =1 and &quot;No&quot; =0. The sum of answer to all 4 questions resulted in total MMAS-4 score. Total MMAS-4 score ranges from 0 (best adherence) to 4 (worst adherence), a low score representing improved adherence. High adherence: score of 0, average adherence: score of 1 or 2, poor adherence: score of 3 or 4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate (ORR): Percentage of Participants With a Complete or Partial Best Response</measure>
    <time_frame>Baseline up to 6 months</time_frame>
    <description>ORR used for the assessment of response to treatment. As per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1: Complete response (CR) was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [&lt;] 10 millimetre [mm]). No new lesions. Partial response (PR) was defined as greater than or equal to (&gt;=) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Scores for Each Dimension on the Participant's Satisfaction (With the Management By the Telephone Call Center) Questionnaire</measure>
    <time_frame>At the end of the study (At Month 6)</time_frame>
    <description>Participants' satisfaction with call center was assessed via the self-administered questionnaire completed at the end of the study. Questionnaire evaluated 4 dimensions with total of 8 items. Dimensions were: 1) Satisfaction with advice: 3 item, 2) Satisfaction with care, 3) Satisfaction concerning the service: 3 items and 4) Overall satisfaction with support in management of sunitinib treatment: 1 item. Each item had 5 responses: very satisfied, satisfied, not very satisfied, not satisfied and no opinion equivalent to score of +2, +1, 1, -2 and no score respectively. A score was calculated for each dimension by calculating the mean scores obtained for each item if at least 50% of the items for the dimension had been completed (and are not &quot;no opinion&quot;). Overall possible mean score range for each dimension was +2 to -2, where higher scores signified higher satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Reported Themselves Being &quot;Satisfied&quot; or &quot;Very Satisfied&quot; With the Management By the Telephone Call Center</measure>
    <time_frame>At the end of the study (At Month 6)</time_frame>
    <description>Participants' satisfaction with call center was assessed via the self-administered questionnaire completed at the end of the study. Questionnaire evaluated 4 dimensions with total of 8 items. Dimensions were: 1) Satisfaction concerning advice: have 3 item, 2) Satisfaction concerning management: 1 items, 3) Satisfaction concerning the service: 3 items and 4) Overall satisfaction with support in management of sunitinib treatment: 1 item. Each item had 5 responses: very satisfied, satisfied, not very satisfied, not satisfied and no opinion. In this outcome measure number of participants who were either &quot;Satisfied&quot; or &quot;Very Satisfied&quot; for overall satisfaction were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Scores for Each Dimension on the Physician's Satisfaction (With the Management By the Telephone Call Center) Questionnaire</measure>
    <time_frame>At the end of the study (At Month 6)</time_frame>
    <description>Physician's satisfaction with call center service for participants' follow-up was assessed via the self-administered questionnaire completed at the end of the study. Questionnaire evaluated 3 dimensions with total of 5 items. Dimensions were: 1) Satisfaction concerning advice: had 3 items, 2) Satisfaction concerning management: 1 items and 3) Overall satisfaction: 1 item. Each item had 5 responses: very satisfied, satisfied, not very satisfied, not satisfied and no opinion equivalent to score of +2, +1, 1, -2 and no score respectively. A score was calculated for each dimension by calculating the mean scores obtained for each item if at least 50% of the items for the dimension have been completed (and are not &quot;no opinion&quot;). Overall possible mean score range for each dimension was +2 to -2, where higher scores signified higher satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Investigating Physicians Who Reported Themselves Being &quot;Satisfied&quot; or &quot;Very Satisfied&quot; With the Management By the Telephone Call Center</measure>
    <time_frame>Baseline up to 6 months</time_frame>
    <description>Physicians' satisfaction with call center service for participants' follow-up was assessed via the self-administered questionnaire completed at the end of the study. Questionnaire evaluated 3 dimensions with total of 5 item. Dimensions were: 1) Satisfaction concerning advice: had 3 items, 2) Satisfaction concerning management: 1 items and 3) Overall satisfaction: 1 item. Each item had 5 responses: very satisfied, satisfied, not very satisfied, not satisfied and no opinion. In this outcome measure number of physicians who were either &quot;Satisfied&quot; or &quot;Very Satisfied&quot; for overall satisfaction were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Number of Calls (Planned and Unplanned)</measure>
    <time_frame>Baseline up to 6 months</time_frame>
    <description>1 participant can call more than once during the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Were Taking Sunitinib as Told to Call Center During the First Call</measure>
    <time_frame>First call made anytime from baseline up to 6 months</time_frame>
    <description>Participants were followed up for taking their medication and they were supposed to respond either &quot;yes&quot; or &quot;no&quot;. In this outcome measure participants who responded &quot;Yes&quot; are reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Their Responses as &quot;Yes&quot; Against the Actions of Investigating Physicians, as Told to Call Center During the First Call</measure>
    <time_frame>First call made anytime from baseline up to 6 months</time_frame>
    <description>Actions of investigating doctors/physicians: did doctor clearly explained how to take treatment, were participants given documentation about treatment by doctor or medical team, did doctor explained how to manage any side effects due to treatment which could occur and were prescriptions or orders for supportive medical treatments given by doctor. Participants responded either &quot;Yes&quot; or &quot;No&quot;. In this outcome measure participants who responded &quot;Yes&quot; to each action are reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Telephone Calls Describing Actions Taken by Call Center</measure>
    <time_frame>Baseline up to 6 months</time_frame>
    <description>In this outcome measure number of telephone calls against each action taken/or described by the call center to the participants are reported. Actions taken by the call center included: 1) Given advice about managing the treatment: a) advice about taking Sunitinib, b) advice about using the Sunitinib follow-up diary, c) reporting any AE; 2) Given general preventative advice: a) advice about taking preventative systemic treatments, b) lifestyle advice, c) food/dietetic advice, d) oro-dental hygiene advice; 3) Given specific preventative advice for a type of AE: a) prevention of skin toxicities, b) prevention of gastrointestinal disorders, c) prevention of cardiac disorders, d) prevention of infectious/inflammatory problems, e)other preventative advice; 4) Actions recommended to participant: a) do not forget the planned consultation with the oncologist, b) get the additional investigations requested performed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Telephone Calls Where Participants Declared Adverse Events</measure>
    <time_frame>Baseline up to 6 months</time_frame>
    <description>In this outcome measure total number of telephone calls where participants declared of any AE are reported. Participants could call more than once to declare AE.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">70</enrollment>
  <condition>Metastatic/Advanced Renal Cell Carcinoma</condition>
  <arm_group>
    <arm_group_label>All patients</arm_group_label>
    <description>Metastatic and/or advanced renal cell carcinoma patients treated with sunitinib in first line and followed by standard care plus call center</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Best supportive care</intervention_name>
    <description>BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life</description>
    <arm_group_label>All patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>call center</intervention_name>
    <description>Nurses from a call center will call the patients at regular time to help patients in the management of their cancer, with some dietetic advices, medical advices etc.</description>
    <arm_group_label>All patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The 100 metastatic and/or advanced patients of the study will come from the population of&#xD;
        patients under the care of French renal cell carcinoma oncologists&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Man or woman aged 18 or over;&#xD;
&#xD;
          -  Patient suffering from a/mRCC, receiving sunitinib first-line treatment, as per SPC&#xD;
             recommendations;&#xD;
&#xD;
          -  Resolution (grade ≤ 1 according to CTCAE version 4.03 of June 2010) of all acute toxic&#xD;
             effects due to radiotherapy or surgical procedure prior to initiation of sunitinib;&#xD;
&#xD;
          -  Patient who can be monitored for 6 months.&#xD;
&#xD;
          -  Female patient of child-bearing age using a form of contraception during treatment&#xD;
             with Sunitinib and for at least 28 days after termination of treatment with Sunitinib;&#xD;
&#xD;
          -  Patient having signed his/her consent form;&#xD;
&#xD;
          -  Patient affiliated with a social security scheme.&#xD;
&#xD;
        Non-inclusion criteria&#xD;
&#xD;
          -  Patient participating in a clinical trial during sunitinib treatment;&#xD;
&#xD;
          -  Patient managed by a home hospitalisation service during sunitinib treatment;&#xD;
&#xD;
          -  Patient taking part in therapeutic education programmes, or benefiting from nursing&#xD;
             consultation, or from any other significant treatment support and likely to impact&#xD;
             adverse event management.&#xD;
&#xD;
          -  Patient untreated and/or symptomatic brain metastases prior to sunitinib initiation;&#xD;
&#xD;
          -  Patient refusing the use of his/her personal data.&#xD;
&#xD;
          -  Patient with an ECOG performance status upon inclusion &gt; 2;&#xD;
&#xD;
          -  Patient presenting with a serum creatinine level &gt;1.5 times the upper limit of the&#xD;
             normal level;&#xD;
&#xD;
          -  Patient presenting with a bilirubin level &gt; 2 mg/dl, aspartate transaminase (ASAT) or&#xD;
             alanine transaminase (ALAT) &gt;2.5 times the upper limit of the normal value, or &gt;5&#xD;
             times the upper limit of the normal value in the presence of liver metastases upon&#xD;
             initiation of sunitinib treatment.&#xD;
&#xD;
          -  Patients who are staff members of a centre involved in the study, or close to one of&#xD;
             the staff members of a centre directly involved in conducting the study, or patients&#xD;
             employed by Pfizer and involved in conducting the study&#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>
  <location>
    <facility>
      <name>CHU de la Timone</name>
      <address>
        <city>Marseille</city>
        <state>Cedex 5</state>
        <zip>13335</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Strasbourg</name>
      <address>
        <city>Strasbourg</city>
        <state>Cedex</state>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier d'Annecy</name>
      <address>
        <city>Annecy Cedex</city>
        <zip>74011</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Catalan Urologie Andrologie</name>
      <address>
        <city>Cabestany</city>
        <zip>66330</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre hospitalier de Chambery</name>
      <address>
        <city>Chambery</city>
        <zip>73000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital prive La Louviere</name>
      <address>
        <city>Lille</city>
        <zip>59042</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Claude Bernard Chimiotherapie Ambulatoire</name>
      <address>
        <city>Metz</city>
        <zip>57000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CRLC Val d'Aurelle</name>
      <address>
        <city>Montpellier cedex 05</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Polyclinique Gentilly</name>
      <address>
        <city>Nancy</city>
        <zip>54000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Polyclinique de Gentilly Service Oncologie Médicale</name>
      <address>
        <city>Nancy</city>
        <zip>54100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHI de Cornouailles - Oncologie hospitalisation</name>
      <address>
        <city>Quimper Cedex</city>
        <zip>29107</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Jean BERNARD - Tours - 7eme etage</name>
      <address>
        <city>Valenciennes</city>
        <zip>59300</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Alexis Vautrin</name>
      <address>
        <city>Vandoeuvre les Nancy</city>
        <zip>54511</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6181213&amp;StudyName=Evaluation%20Of%20The%20Impact%20Of%20A%20Call%20Center%20In%20Management%20Of%20Metastatic%20And/Or%20Advanced%20Renal%20Cell%20Carcinoma%20Patients%20Treated%20With%20Sunit</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>July 8, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <results_first_submitted>July 25, 2019</results_first_submitted>
  <results_first_submitted_qc>October 1, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">October 24, 2019</results_first_posted>
  <last_update_submitted>October 1, 2019</last_update_submitted>
  <last_update_submitted_qc>October 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>sunitinib</keyword>
  <keyword>call center</keyword>
  <keyword>management of patients</keyword>
  <keyword>nurses</keyword>
  <keyword>metastatic renal carcinoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Renal Cell</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>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 6, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT02187042/SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 21, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT02187042/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Call Center</title>
          <description>Participants with advanced/metastatic renal cell carcinoma (a/mRCC) being treated first line with sunitinib (dose as per the recommendations in the summary or product characteristics [SmPC]) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.</description>
        </group>
        <group group_id="P2">
          <title>Standard of Care</title>
          <description>Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Toxicity</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant choice</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Doctor choice</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Progressive disease</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety population included participants treated with Sunitinib.</population>
      <group_list>
        <group group_id="B1">
          <title>Call Center</title>
          <description>Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.</description>
        </group>
        <group group_id="B2">
          <title>Standard of Care</title>
          <description>Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="42"/>
            <count group_id="B2" value="27"/>
            <count group_id="B3" value="69"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="42"/>
                    <count group_id="B2" value="27"/>
                    <count group_id="B3" value="69"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67.2" spread="10.3"/>
                    <measurement group_id="B2" value="65.6" spread="9.2"/>
                    <measurement group_id="B3" value="66.6" spread="9.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="42"/>
                    <count group_id="B2" value="27"/>
                    <count group_id="B3" value="69"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With at Least 1 Adverse Event (AE) of Grade 3 or 4 Based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03</title>
        <description>An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. The severity was graded by NCI CTCAE v.4.03. Grade 1 was mild AE. Grade 2 was moderate AE. Grade 3 was severe AE. Grade 4 was life-threatening consequences and urgent intervention AE. Grade 5 was death related to AE.</description>
        <time_frame>Baseline up to 6 months</time_frame>
        <population>Safety population included participants treated with Sunitinib.</population>
        <group_list>
          <group group_id="O1">
            <title>Call Center</title>
            <description>Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With at Least 1 Adverse Event (AE) of Grade 3 or 4 Based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03</title>
          <description>An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. The severity was graded by NCI CTCAE v.4.03. Grade 1 was mild AE. Grade 2 was moderate AE. Grade 3 was severe AE. Grade 4 was life-threatening consequences and urgent intervention AE. Grade 5 was death related to AE.</description>
          <population>Safety population included participants treated with Sunitinib.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With at Least 1 Sunitinib Dose Reduction</title>
        <description>Number of participants treated with sunitinib having had at least 1 dose reduction relative to the initial dose are reported.</description>
        <time_frame>Baseline up to 6 months</time_frame>
        <population>Safety population included participants treated with Sunitinib.</population>
        <group_list>
          <group group_id="O1">
            <title>Call Center</title>
            <description>Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With at Least 1 Sunitinib Dose Reduction</title>
          <description>Number of participants treated with sunitinib having had at least 1 dose reduction relative to the initial dose are reported.</description>
          <population>Safety population included participants treated with Sunitinib.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Involved in at Least 1 Occasion For Each of the Reasons for a Sunitinib Dose Reduction</title>
        <description>Number of participants treated with sunitinib having had at least 1 dose reduction relative to the initial dose according to the reasons for dose reductions are reported.</description>
        <time_frame>Baseline up to 6 months</time_frame>
        <population>Safety population included participants treated with Sunitinib. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Call Center</title>
            <description>Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Involved in at Least 1 Occasion For Each of the Reasons for a Sunitinib Dose Reduction</title>
          <description>Number of participants treated with sunitinib having had at least 1 dose reduction relative to the initial dose according to the reasons for dose reductions are reported.</description>
          <population>Safety population included participants treated with Sunitinib. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Adverse Event</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Sunitinib Dose Reduction</title>
        <time_frame>Baseline up to 6 months</time_frame>
        <population>Safety population included participants treated with Sunitinib. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Call Center</title>
            <description>Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Sunitinib Dose Reduction</title>
          <population>Safety population included participants treated with Sunitinib. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>milligram per day (mg/day)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.5" spread="0"/>
                    <measurement group_id="O2" value="12.5" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With at Least 1 Temporary Interruption of Sunitinib Treatment</title>
        <description>Reason for temporary dose interruptions included: who had AEs that were intolerable, surgery, omission, doctor choice and any other reason judged by doctor.</description>
        <time_frame>Baseline up to 6 months</time_frame>
        <population>Safety population included participants treated with Sunitinib.</population>
        <group_list>
          <group group_id="O1">
            <title>Call Center</title>
            <description>Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With at Least 1 Temporary Interruption of Sunitinib Treatment</title>
          <description>Reason for temporary dose interruptions included: who had AEs that were intolerable, surgery, omission, doctor choice and any other reason judged by doctor.</description>
          <population>Safety population included participants treated with Sunitinib.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Duration (in Days) of Temporary Interruption to Sunitinib Treatment</title>
        <description>Reason for temporary dose interruptions included: who had AEs that were intolerable, surgery, omission, doctor choice and any other reason judged by doctor.</description>
        <time_frame>Baseline up to 6 months</time_frame>
        <population>Safety population included participants treated with Sunitinib. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Call Center</title>
            <description>Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Duration (in Days) of Temporary Interruption to Sunitinib Treatment</title>
          <description>Reason for temporary dose interruptions included: who had AEs that were intolerable, surgery, omission, doctor choice and any other reason judged by doctor.</description>
          <population>Safety population included participants treated with Sunitinib. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.5" spread="11.5"/>
                    <measurement group_id="O2" value="16.6" spread="19.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Involved on at Least 1 Occasion for Each of the Reasons for a Sunitinib Temporary Treatment Interruption</title>
        <description>Reason for temporary dose interruptions included: who had AEs that were intolerable, surgery, omission, doctor choice and any other reason judged by doctor. Participants were counted in more than 1 category.</description>
        <time_frame>Baseline up to 6 months</time_frame>
        <population>Safety population included participants treated with Sunitinib. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Call Center</title>
            <description>Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Involved on at Least 1 Occasion for Each of the Reasons for a Sunitinib Temporary Treatment Interruption</title>
          <description>Reason for temporary dose interruptions included: who had AEs that were intolerable, surgery, omission, doctor choice and any other reason judged by doctor. Participants were counted in more than 1 category.</description>
          <population>Safety population included participants treated with Sunitinib. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Surgery</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Omission</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Doctor choice</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Permanently Discontinued Sunitinib Treatment</title>
        <description>Reason for permanent discontinuation of sunitinib treatment included: progressive disease, toxicity, participant's choice, doctor's choice and death of participant.</description>
        <time_frame>Baseline up to 6 months</time_frame>
        <population>Safety population included participants treated with Sunitinib.</population>
        <group_list>
          <group group_id="O1">
            <title>Call Center</title>
            <description>Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Permanently Discontinued Sunitinib Treatment</title>
          <description>Reason for permanent discontinuation of sunitinib treatment included: progressive disease, toxicity, participant's choice, doctor's choice and death of participant.</description>
          <population>Safety population included participants treated with Sunitinib.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Involved on At Least 1 Occasion for Each of the Reasons for a Permanent Sunitinib Treatment Discontinuation</title>
        <description>Reason for permanent discontinuation of sunitinib treatment included: progressive disease, toxicity, participant's choice, doctor's choice and death of participant.</description>
        <time_frame>Baseline up to 6 months</time_frame>
        <population>Safety population included participants treated with Sunitinib. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Call Center</title>
            <description>Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Involved on At Least 1 Occasion for Each of the Reasons for a Permanent Sunitinib Treatment Discontinuation</title>
          <description>Reason for permanent discontinuation of sunitinib treatment included: progressive disease, toxicity, participant's choice, doctor's choice and death of participant.</description>
          <population>Safety population included participants treated with Sunitinib. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Progressive Disease</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Toxicity</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Participant Choice</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Doctor's Choice</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Death</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Duration of Sunitinib Treatment</title>
        <description>Total mean duration (in months) of sunitinib treatment is reported in this outcome measure.</description>
        <time_frame>Baseline up to 6 months</time_frame>
        <population>Safety population included participants treated with Sunitinib.</population>
        <group_list>
          <group group_id="O1">
            <title>Call Center</title>
            <description>Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Duration of Sunitinib Treatment</title>
          <description>Total mean duration (in months) of sunitinib treatment is reported in this outcome measure.</description>
          <population>Safety population included participants treated with Sunitinib.</population>
          <units>Months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8" spread="1.9"/>
                    <measurement group_id="O2" value="4.2" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Classified on the Basis of Number of Sunitinib Treatment Cycles</title>
        <description>Last treatment cycle was declared by doctor either on the notified date to discontinue sunitinib or on the date of the last consultation if sunitinib treatment was not stopped</description>
        <time_frame>Baseline up to 6 months</time_frame>
        <population>Safety population included participants treated with Sunitinib.</population>
        <group_list>
          <group group_id="O1">
            <title>Call Center</title>
            <description>Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Classified on the Basis of Number of Sunitinib Treatment Cycles</title>
          <description>Last treatment cycle was declared by doctor either on the notified date to discontinue sunitinib or on the date of the last consultation if sunitinib treatment was not stopped</description>
          <population>Safety population included participants treated with Sunitinib.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>1 Cycle</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2 Cycles</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3 Cycles</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4 Cycles</title>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With At Least 1 Unplanned Hospitalization</title>
        <description>Number of participants with at least 1 unplanned hospitalizations either related or unrelated to sunitinib were reported.</description>
        <time_frame>Baseline up to 6 months</time_frame>
        <population>Analysis population included participants who were treated with Sunitinib and had follow up by call center along with conventional method. Data was collected only for the reporting arm &quot;call center&quot; as per the planned analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Call Center</title>
            <description>Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With At Least 1 Unplanned Hospitalization</title>
          <description>Number of participants with at least 1 unplanned hospitalizations either related or unrelated to sunitinib were reported.</description>
          <population>Analysis population included participants who were treated with Sunitinib and had follow up by call center along with conventional method. Data was collected only for the reporting arm &quot;call center&quot; as per the planned analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With At Least 1 Unplanned Consultation</title>
        <description>Number of participants with at least 1 unplanned consultations either related or unrelated to sunitinib were reported.</description>
        <time_frame>Baseline up to 6 months</time_frame>
        <population>Analysis population included included participants who were treated with sunitinib and had follow up by call center along with conventional method. Data was collected only for the reporting arm &quot;call center&quot; as per the planned analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Call Center</title>
            <description>Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With At Least 1 Unplanned Consultation</title>
          <description>Number of participants with at least 1 unplanned consultations either related or unrelated to sunitinib were reported.</description>
          <population>Analysis population included included participants who were treated with sunitinib and had follow up by call center along with conventional method. Data was collected only for the reporting arm &quot;call center&quot; as per the planned analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Were &quot;Adherent&quot; as Per 4- Item Morisky Medication Adherence Scale (MMAS-4)</title>
        <description>MMAS-4 is a self-reported measure of medication taking behavior, consisting of 4 questions based on forgetting taking medication, carelessness about taking medication, stopping medication when feeling better, or stopping medication when feeling worse. Each question has answer either &quot;Yes&quot; or &quot;No&quot;; &quot;Yes&quot; =1 and &quot;No&quot; =0. The sum of answer to all 4 questions resulted in total MMAS-4 score. Total MMAS-4 score ranges from 0 (best adherence) to 4 (worst adherence), a low score representing improved adherence. Adherent participants were defined as participants with an MMAS-4 score of 0.</description>
        <time_frame>Baseline up to 6 months</time_frame>
        <population>Safety population included participants treated with Sunitinib. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Call Center</title>
            <description>Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Were &quot;Adherent&quot; as Per 4- Item Morisky Medication Adherence Scale (MMAS-4)</title>
          <description>MMAS-4 is a self-reported measure of medication taking behavior, consisting of 4 questions based on forgetting taking medication, carelessness about taking medication, stopping medication when feeling better, or stopping medication when feeling worse. Each question has answer either &quot;Yes&quot; or &quot;No&quot;; &quot;Yes&quot; =1 and &quot;No&quot; =0. The sum of answer to all 4 questions resulted in total MMAS-4 score. Total MMAS-4 score ranges from 0 (best adherence) to 4 (worst adherence), a low score representing improved adherence. Adherent participants were defined as participants with an MMAS-4 score of 0.</description>
          <population>Safety population included participants treated with Sunitinib. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean 4-Item Morisky Medication Adherence Scale (MMAS-4) Score</title>
        <description>MMAS-4 is a self-reported measure of medication taking behavior, consisting of 4 questions based on forgetting taking medication, carelessness about taking medication, stopping medication when feeling better, or stopping medication when feeling worse. Each question has answer either &quot;Yes&quot; or &quot;No&quot;; &quot;Yes&quot; =1 and &quot;No&quot; =0. The sum of answer to all 4 questions resulted in total MMAS-4 score. Total MMAS-4 score ranges from 0 (best adherence) to 4 (worst adherence), a low score representing improved adherence. High adherence: score of 0, average adherence: score of 1 or 2, poor adherence: score of 3 or 4.</description>
        <time_frame>Baseline up to 6 months</time_frame>
        <population>Safety population included participants treated with Sunitinib. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Call Center</title>
            <description>Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean 4-Item Morisky Medication Adherence Scale (MMAS-4) Score</title>
          <description>MMAS-4 is a self-reported measure of medication taking behavior, consisting of 4 questions based on forgetting taking medication, carelessness about taking medication, stopping medication when feeling better, or stopping medication when feeling worse. Each question has answer either &quot;Yes&quot; or &quot;No&quot;; &quot;Yes&quot; =1 and &quot;No&quot; =0. The sum of answer to all 4 questions resulted in total MMAS-4 score. Total MMAS-4 score ranges from 0 (best adherence) to 4 (worst adherence), a low score representing improved adherence. High adherence: score of 0, average adherence: score of 1 or 2, poor adherence: score of 3 or 4.</description>
          <population>Safety population included participants treated with Sunitinib. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.5"/>
                    <measurement group_id="O2" value="0.2" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Objective Response Rate (ORR): Percentage of Participants With a Complete or Partial Best Response</title>
        <description>ORR used for the assessment of response to treatment. As per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1: Complete response (CR) was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [&lt;] 10 millimetre [mm]). No new lesions. Partial response (PR) was defined as greater than or equal to (&gt;=) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.</description>
        <time_frame>Baseline up to 6 months</time_frame>
        <population>Analysis population included all participants who were investigated by the doctors, who met the study eligibility criteria, had received at least 1 dose of Sunitinib and who had telephone calls with call center. Data was collected only for the reporting arm &quot;call center&quot; as per the planned analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Call Center</title>
            <description>Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Response Rate (ORR): Percentage of Participants With a Complete or Partial Best Response</title>
          <description>ORR used for the assessment of response to treatment. As per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1: Complete response (CR) was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [&lt;] 10 millimetre [mm]). No new lesions. Partial response (PR) was defined as greater than or equal to (&gt;=) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.</description>
          <population>Analysis population included all participants who were investigated by the doctors, who met the study eligibility criteria, had received at least 1 dose of Sunitinib and who had telephone calls with call center. Data was collected only for the reporting arm &quot;call center&quot; as per the planned analysis.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Scores for Each Dimension on the Participant's Satisfaction (With the Management By the Telephone Call Center) Questionnaire</title>
        <description>Participants' satisfaction with call center was assessed via the self-administered questionnaire completed at the end of the study. Questionnaire evaluated 4 dimensions with total of 8 items. Dimensions were: 1) Satisfaction with advice: 3 item, 2) Satisfaction with care, 3) Satisfaction concerning the service: 3 items and 4) Overall satisfaction with support in management of sunitinib treatment: 1 item. Each item had 5 responses: very satisfied, satisfied, not very satisfied, not satisfied and no opinion equivalent to score of +2, +1, 1, -2 and no score respectively. A score was calculated for each dimension by calculating the mean scores obtained for each item if at least 50% of the items for the dimension had been completed (and are not &quot;no opinion&quot;). Overall possible mean score range for each dimension was +2 to -2, where higher scores signified higher satisfaction.</description>
        <time_frame>At the end of the study (At Month 6)</time_frame>
        <population>Analysis population: participants who were investigated by the doctors, who met study eligibility criteria, had received at least 1 dose of Sunitinib and were followed up by call center and completed a self-administered satisfaction questionnaire about management by call center. Here, 'Number analyzed' = participants evaluable for specified rows.</population>
        <group_list>
          <group group_id="O1">
            <title>Call Center</title>
            <description>Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Scores for Each Dimension on the Participant's Satisfaction (With the Management By the Telephone Call Center) Questionnaire</title>
          <description>Participants' satisfaction with call center was assessed via the self-administered questionnaire completed at the end of the study. Questionnaire evaluated 4 dimensions with total of 8 items. Dimensions were: 1) Satisfaction with advice: 3 item, 2) Satisfaction with care, 3) Satisfaction concerning the service: 3 items and 4) Overall satisfaction with support in management of sunitinib treatment: 1 item. Each item had 5 responses: very satisfied, satisfied, not very satisfied, not satisfied and no opinion equivalent to score of +2, +1, 1, -2 and no score respectively. A score was calculated for each dimension by calculating the mean scores obtained for each item if at least 50% of the items for the dimension had been completed (and are not &quot;no opinion&quot;). Overall possible mean score range for each dimension was +2 to -2, where higher scores signified higher satisfaction.</description>
          <population>Analysis population: participants who were investigated by the doctors, who met study eligibility criteria, had received at least 1 dose of Sunitinib and were followed up by call center and completed a self-administered satisfaction questionnaire about management by call center. Here, 'Number analyzed' = participants evaluable for specified rows.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Satisfaction with the advice</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Satisfaction with care</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Satisfaction with the service</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall satisfaction with support in management</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Reported Themselves Being &quot;Satisfied&quot; or &quot;Very Satisfied&quot; With the Management By the Telephone Call Center</title>
        <description>Participants' satisfaction with call center was assessed via the self-administered questionnaire completed at the end of the study. Questionnaire evaluated 4 dimensions with total of 8 items. Dimensions were: 1) Satisfaction concerning advice: have 3 item, 2) Satisfaction concerning management: 1 items, 3) Satisfaction concerning the service: 3 items and 4) Overall satisfaction with support in management of sunitinib treatment: 1 item. Each item had 5 responses: very satisfied, satisfied, not very satisfied, not satisfied and no opinion. In this outcome measure number of participants who were either &quot;Satisfied&quot; or &quot;Very Satisfied&quot; for overall satisfaction were reported.</description>
        <time_frame>At the end of the study (At Month 6)</time_frame>
        <population>Analysis population included all participants who were investigated by the doctors, who met the study eligibility criteria, had received at least 1 dose of Sunitinib and who were followed up by call center and completed a self-administered satisfaction questionnaire about management by call center.</population>
        <group_list>
          <group group_id="O1">
            <title>Call Center</title>
            <description>Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Reported Themselves Being &quot;Satisfied&quot; or &quot;Very Satisfied&quot; With the Management By the Telephone Call Center</title>
          <description>Participants' satisfaction with call center was assessed via the self-administered questionnaire completed at the end of the study. Questionnaire evaluated 4 dimensions with total of 8 items. Dimensions were: 1) Satisfaction concerning advice: have 3 item, 2) Satisfaction concerning management: 1 items, 3) Satisfaction concerning the service: 3 items and 4) Overall satisfaction with support in management of sunitinib treatment: 1 item. Each item had 5 responses: very satisfied, satisfied, not very satisfied, not satisfied and no opinion. In this outcome measure number of participants who were either &quot;Satisfied&quot; or &quot;Very Satisfied&quot; for overall satisfaction were reported.</description>
          <population>Analysis population included all participants who were investigated by the doctors, who met the study eligibility criteria, had received at least 1 dose of Sunitinib and who were followed up by call center and completed a self-administered satisfaction questionnaire about management by call center.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Scores for Each Dimension on the Physician's Satisfaction (With the Management By the Telephone Call Center) Questionnaire</title>
        <description>Physician's satisfaction with call center service for participants' follow-up was assessed via the self-administered questionnaire completed at the end of the study. Questionnaire evaluated 3 dimensions with total of 5 items. Dimensions were: 1) Satisfaction concerning advice: had 3 items, 2) Satisfaction concerning management: 1 items and 3) Overall satisfaction: 1 item. Each item had 5 responses: very satisfied, satisfied, not very satisfied, not satisfied and no opinion equivalent to score of +2, +1, 1, -2 and no score respectively. A score was calculated for each dimension by calculating the mean scores obtained for each item if at least 50% of the items for the dimension have been completed (and are not &quot;no opinion&quot;). Overall possible mean score range for each dimension was +2 to -2, where higher scores signified higher satisfaction.</description>
        <time_frame>At the end of the study (At Month 6)</time_frame>
        <population>Analysis population included all investigating doctors/physicians who completed a satisfaction questionnaire to assess the management of follow-up of participants by the call center. For this outcome measure 'Participant' refers to 'investigating physician'.</population>
        <group_list>
          <group group_id="O1">
            <title>Physicians</title>
            <description>Physicians who were investigating the participants being followed up by call center along with conventional method in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Scores for Each Dimension on the Physician's Satisfaction (With the Management By the Telephone Call Center) Questionnaire</title>
          <description>Physician's satisfaction with call center service for participants' follow-up was assessed via the self-administered questionnaire completed at the end of the study. Questionnaire evaluated 3 dimensions with total of 5 items. Dimensions were: 1) Satisfaction concerning advice: had 3 items, 2) Satisfaction concerning management: 1 items and 3) Overall satisfaction: 1 item. Each item had 5 responses: very satisfied, satisfied, not very satisfied, not satisfied and no opinion equivalent to score of +2, +1, 1, -2 and no score respectively. A score was calculated for each dimension by calculating the mean scores obtained for each item if at least 50% of the items for the dimension have been completed (and are not &quot;no opinion&quot;). Overall possible mean score range for each dimension was +2 to -2, where higher scores signified higher satisfaction.</description>
          <population>Analysis population included all investigating doctors/physicians who completed a satisfaction questionnaire to assess the management of follow-up of participants by the call center. For this outcome measure 'Participant' refers to 'investigating physician'.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Satisfaction with the advice</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Satisfaction with care</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.6" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall satisfaction of participant care</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Investigating Physicians Who Reported Themselves Being &quot;Satisfied&quot; or &quot;Very Satisfied&quot; With the Management By the Telephone Call Center</title>
        <description>Physicians' satisfaction with call center service for participants' follow-up was assessed via the self-administered questionnaire completed at the end of the study. Questionnaire evaluated 3 dimensions with total of 5 item. Dimensions were: 1) Satisfaction concerning advice: had 3 items, 2) Satisfaction concerning management: 1 items and 3) Overall satisfaction: 1 item. Each item had 5 responses: very satisfied, satisfied, not very satisfied, not satisfied and no opinion. In this outcome measure number of physicians who were either &quot;Satisfied&quot; or &quot;Very Satisfied&quot; for overall satisfaction were reported.</description>
        <time_frame>Baseline up to 6 months</time_frame>
        <population>Analysis population included all investigating doctors/physicians who completed a satisfaction questionnaire to assess the management of follow-up of participants by the call center. For this outcome measure 'Participant' refers to 'investigating physician'</population>
        <group_list>
          <group group_id="O1">
            <title>Physicians</title>
            <description>Physicians who were investigating the participants being followed up by call center along with conventional method in the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Investigating Physicians Who Reported Themselves Being &quot;Satisfied&quot; or &quot;Very Satisfied&quot; With the Management By the Telephone Call Center</title>
          <description>Physicians' satisfaction with call center service for participants' follow-up was assessed via the self-administered questionnaire completed at the end of the study. Questionnaire evaluated 3 dimensions with total of 5 item. Dimensions were: 1) Satisfaction concerning advice: had 3 items, 2) Satisfaction concerning management: 1 items and 3) Overall satisfaction: 1 item. Each item had 5 responses: very satisfied, satisfied, not very satisfied, not satisfied and no opinion. In this outcome measure number of physicians who were either &quot;Satisfied&quot; or &quot;Very Satisfied&quot; for overall satisfaction were reported.</description>
          <population>Analysis population included all investigating doctors/physicians who completed a satisfaction questionnaire to assess the management of follow-up of participants by the call center. For this outcome measure 'Participant' refers to 'investigating physician'</population>
          <units>Physicians</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Number of Calls (Planned and Unplanned)</title>
        <description>1 participant can call more than once during the study.</description>
        <time_frame>Baseline up to 6 months</time_frame>
        <population>Analysis population included all participants who were investigated by the doctors, who met the study eligibility criteria, had received at least 1 dose of Sunitinib and who had telephone calls with call center. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Call Center</title>
            <description>Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Number of Calls (Planned and Unplanned)</title>
          <description>1 participant can call more than once during the study.</description>
          <population>Analysis population included all participants who were investigated by the doctors, who met the study eligibility criteria, had received at least 1 dose of Sunitinib and who had telephone calls with call center. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>Calls</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="431"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Were Taking Sunitinib as Told to Call Center During the First Call</title>
        <description>Participants were followed up for taking their medication and they were supposed to respond either &quot;yes&quot; or &quot;no&quot;. In this outcome measure participants who responded &quot;Yes&quot; are reported.</description>
        <time_frame>First call made anytime from baseline up to 6 months</time_frame>
        <population>Analysis population included all participants who were investigated by the doctors, who met the study eligibility criteria, had received at least 1 dose of Sunitinib and who had telephone calls with call center. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Call Center</title>
            <description>Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Were Taking Sunitinib as Told to Call Center During the First Call</title>
          <description>Participants were followed up for taking their medication and they were supposed to respond either &quot;yes&quot; or &quot;no&quot;. In this outcome measure participants who responded &quot;Yes&quot; are reported.</description>
          <population>Analysis population included all participants who were investigated by the doctors, who met the study eligibility criteria, had received at least 1 dose of Sunitinib and who had telephone calls with call center. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Their Responses as &quot;Yes&quot; Against the Actions of Investigating Physicians, as Told to Call Center During the First Call</title>
        <description>Actions of investigating doctors/physicians: did doctor clearly explained how to take treatment, were participants given documentation about treatment by doctor or medical team, did doctor explained how to manage any side effects due to treatment which could occur and were prescriptions or orders for supportive medical treatments given by doctor. Participants responded either &quot;Yes&quot; or &quot;No&quot;. In this outcome measure participants who responded &quot;Yes&quot; to each action are reported.</description>
        <time_frame>First call made anytime from baseline up to 6 months</time_frame>
        <population>Analysis population included all participants who were investigated by the doctors, who met the study eligibility criteria, had received at least 1 dose of Sunitinib and who had telephone calls with call center. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Call Center</title>
            <description>Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Their Responses as &quot;Yes&quot; Against the Actions of Investigating Physicians, as Told to Call Center During the First Call</title>
          <description>Actions of investigating doctors/physicians: did doctor clearly explained how to take treatment, were participants given documentation about treatment by doctor or medical team, did doctor explained how to manage any side effects due to treatment which could occur and were prescriptions or orders for supportive medical treatments given by doctor. Participants responded either &quot;Yes&quot; or &quot;No&quot;. In this outcome measure participants who responded &quot;Yes&quot; to each action are reported.</description>
          <population>Analysis population included all participants who were investigated by the doctors, who met the study eligibility criteria, had received at least 1 dose of Sunitinib and who had telephone calls with call center. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Doctor clearly explained how to take treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants given documentation about treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Doctor explain manage side effect due to treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prescriptions for supportive medical treatments</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Telephone Calls Describing Actions Taken by Call Center</title>
        <description>In this outcome measure number of telephone calls against each action taken/or described by the call center to the participants are reported. Actions taken by the call center included: 1) Given advice about managing the treatment: a) advice about taking Sunitinib, b) advice about using the Sunitinib follow-up diary, c) reporting any AE; 2) Given general preventative advice: a) advice about taking preventative systemic treatments, b) lifestyle advice, c) food/dietetic advice, d) oro-dental hygiene advice; 3) Given specific preventative advice for a type of AE: a) prevention of skin toxicities, b) prevention of gastrointestinal disorders, c) prevention of cardiac disorders, d) prevention of infectious/inflammatory problems, e)other preventative advice; 4) Actions recommended to participant: a) do not forget the planned consultation with the oncologist, b) get the additional investigations requested performed.</description>
        <time_frame>Baseline up to 6 months</time_frame>
        <population>Analysis population included all participants who were investigated by the doctors, who met the study eligibility criteria, had received at least 1 dose of Sunitinib and who had telephone calls with call center. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Call Center</title>
            <description>Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Telephone Calls Describing Actions Taken by Call Center</title>
          <description>In this outcome measure number of telephone calls against each action taken/or described by the call center to the participants are reported. Actions taken by the call center included: 1) Given advice about managing the treatment: a) advice about taking Sunitinib, b) advice about using the Sunitinib follow-up diary, c) reporting any AE; 2) Given general preventative advice: a) advice about taking preventative systemic treatments, b) lifestyle advice, c) food/dietetic advice, d) oro-dental hygiene advice; 3) Given specific preventative advice for a type of AE: a) prevention of skin toxicities, b) prevention of gastrointestinal disorders, c) prevention of cardiac disorders, d) prevention of infectious/inflammatory problems, e)other preventative advice; 4) Actions recommended to participant: a) do not forget the planned consultation with the oncologist, b) get the additional investigations requested performed.</description>
          <population>Analysis population included all participants who were investigated by the doctors, who met the study eligibility criteria, had received at least 1 dose of Sunitinib and who had telephone calls with call center. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>Telephone calls</units>
          <param>Number</param>
          <units_analyzed>Telephone calls</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Telephone calls</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="431"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Advice about managing treatment: taking Sunitinib</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="266"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Advice about managing treatment:Sunitinib followup</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="281"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Advice about managing treatment: Reporting any AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="341"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>General preventative advice: taking treatments</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="263"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>General preventative advice: Lifestyle advice</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="278"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>General preventative advice: Food/dietetic advice</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="222"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>General preventative advice: Orodental hygiene</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="272"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Specific advice for type of AE: skin toxicities</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="270"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Specific advice for type of AE: GI disorders</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="271"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Specific advice for type of AE: cardiac disorders</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="317"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Specific advice for type of AE: infectious problem</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="233"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Specific advice for type of AE:preventative advice</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="289"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Actions to participants:Do not forget consultation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="134"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Actions to participants: additional investigation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="137"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Telephone Calls Where Participants Declared Adverse Events</title>
        <description>In this outcome measure total number of telephone calls where participants declared of any AE are reported. Participants could call more than once to declare AE.</description>
        <time_frame>Baseline up to 6 months</time_frame>
        <population>Call center full analysis set (FAS) population included all participants who were investigated by doctors, who met the study eligibility criteria and had received at least 1 dose of Sunitinib and were followed up by call center. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Call Center</title>
            <description>Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Telephone Calls Where Participants Declared Adverse Events</title>
          <description>In this outcome measure total number of telephone calls where participants declared of any AE are reported. Participants could call more than once to declare AE.</description>
          <population>Call center full analysis set (FAS) population included all participants who were investigated by doctors, who met the study eligibility criteria and had received at least 1 dose of Sunitinib and were followed up by call center. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>Telephone calls</units>
          <param>Number</param>
          <units_analyzed>Telephone calls</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Telephone calls</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="431"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="280"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline up to 6 months</time_frame>
      <desc>Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.</desc>
      <group_list>
        <group group_id="E1">
          <title>Call Center</title>
          <description>Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks.</description>
        </group>
        <group group_id="E2">
          <title>Standard of Care</title>
          <description>Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA v15</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac Failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Adrenal Insufficiency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>General Physical Health Deterioration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>General Symptom</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Anti-Platelet Antibody Positive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Weight Decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Neoplasm Progression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Aphasia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Cerebral Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Cerebrovascular Accident</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Clonus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Hemiparesis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Ischaemic Stroke</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Paralysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Sensorimotor Disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusional State</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Renal Failure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Purpura</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_vocab>MedDRA v15</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="42" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="27" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Blood Disorder</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Platelet Disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Endocrine Disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Dark Circles Under Eyes</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Eyelid Oedema</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Lacrimation Increased</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Distension</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Abdominal Pain Upper</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Anal Inflammation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Anorectal Disorder</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Aphthous Ulcer</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Cheilitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Dry Mouth</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Eructation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Disorder</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal Reflux Disease</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Gingival Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Gingivitis</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Glossitis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Glossodynia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Lip Pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Oral Pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Proctalgia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Rectal Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Chest Pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>General Physical Health Deterioration</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>General Symptom</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Inflammation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Mucosal Dryness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Mucosal Inflammation</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Oedema</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Oedema Peripheral</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Xerosis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatocellular Injury</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Jaundice</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Blood Albumin Abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Blood Creatinine Increased</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Blood Lactate Dehydrogenase</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Blood Pressure Increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Blood Thyroid Stimulating Hormone Decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Blood Thyroid Stimulating Hormone Increased</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Liver Function Test Abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Prothrombin Time Ratio</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Weight Decreased</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>White Blood Cell Count Decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased Appetite</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Hypertriglyceridaemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Bone Pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Muscle Spasms</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Musculoskeletal Pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Neck Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Pain In Extremity</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Hyperaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Neuropathy Peripheral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Food Aversion</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Chromaturia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Renal Failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Balanitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Scrotal Erythema</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Hiccups</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Nasal Obstruction</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Oropharyngeal Pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Throat Irritation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Dry Skin</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Hair Colour Changes</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Hyperkeratosis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Intertrigo</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Palmar-Plantar Erythrodysaesthesia Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Rash Erythematous</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Skin Chapped</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Skin Discolouration</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Skin Fissures</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Skin Irritation</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Skin Reaction</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Yellow Skin</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Tooth Extraction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hot Flush</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Pfizer ClinicalTrials.gov Call Center</name_or_title>
      <organization>Pfizer Inc.</organization>
      <phone>1-800-718-1021</phone>
      <email>ClinicalTrials.gov_Inquiries@pfizer.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02187042
org study id: A6181213
secondary id: RENACALL
nct id: NCT02187042
lead sponsor: 
has dmc: No
100 patients with metastatic and/or advanced renal cell carcinoma treated with sunitinib
      (Sutent) will be inclued and followed with standard care plus a call center

      Principal assumption : the proportion of patients presenting with at least one grade 3 or 4
      AE (whether related to sunitinib or not).
RENACALL is a prospective intermediate care study whose main aim is to evaluate the impact of
      a therapy management platform on the management of patients suffering from
      advanced/metastatic renal cell carcinoma and receiving first line treatment with Sutent®.

      100 mRCC patients treated receiving first line Sutent® treatment shall be included in the
      study, and shall benefit both from conventional follow-up and from additional therapy
      management platform-based follow-up. Platform follow-up shall consist in regular phone calls
      to accompany patients in their real life home management of their treatment with sunitinib
      (prevention, advice and guidance of patients towards options)..
observational model: Cohort
time perspective: Prospective
measure: Number of Participants With at Least 1 Adverse Event (AE) of Grade 3 or 4 Based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03
time frame: Baseline up to 6 months
description: An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. The severity was graded by NCI CTCAE v.4.03. Grade 1 was mild AE. Grade 2 was moderate AE. Grade 3 was severe AE. Grade 4 was life-threatening consequences and urgent intervention AE. Grade 5 was death related to AE.
measure: Number of Participants With at Least 1 Sunitinib Dose Reduction
time frame: Baseline up to 6 months
description: Number of participants treated with sunitinib having had at least 1 dose reduction relative to the initial dose are reported.
measure: Number of Participants Involved in at Least 1 Occasion For Each of the Reasons for a Sunitinib Dose Reduction
time frame: Baseline up to 6 months
description: Number of participants treated with sunitinib having had at least 1 dose reduction relative to the initial dose according to the reasons for dose reductions are reported.
measure: Average Sunitinib Dose Reduction
time frame: Baseline up to 6 months
measure: Number of Participants With at Least 1 Temporary Interruption of Sunitinib Treatment
time frame: Baseline up to 6 months
description: Reason for temporary dose interruptions included: who had AEs that were intolerable, surgery, omission, doctor choice and any other reason judged by doctor.
measure: Mean Duration (in Days) of Temporary Interruption to Sunitinib Treatment
time frame: Baseline up to 6 months
description: Reason for temporary dose interruptions included: who had AEs that were intolerable, surgery, omission, doctor choice and any other reason judged by doctor.
measure: Number of Participants Involved on at Least 1 Occasion for Each of the Reasons for a Sunitinib Temporary Treatment Interruption
time frame: Baseline up to 6 months
description: Reason for temporary dose interruptions included: who had AEs that were intolerable, surgery, omission, doctor choice and any other reason judged by doctor. Participants were counted in more than 1 category.
measure: Number of Participants Who Permanently Discontinued Sunitinib Treatment
time frame: Baseline up to 6 months
description: Reason for permanent discontinuation of sunitinib treatment included: progressive disease, toxicity, participant's choice, doctor's choice and death of participant.
measure: Number of Participants Involved on At Least 1 Occasion for Each of the Reasons for a Permanent Sunitinib Treatment Discontinuation
time frame: Baseline up to 6 months
description: Reason for permanent discontinuation of sunitinib treatment included: progressive disease, toxicity, participant's choice, doctor's choice and death of participant.
measure: Mean Duration of Sunitinib Treatment
time frame: Baseline up to 6 months
description: Total mean duration (in months) of sunitinib treatment is reported in this outcome measure.
measure: Number of Participants Classified on the Basis of Number of Sunitinib Treatment Cycles
time frame: Baseline up to 6 months
description: Last treatment cycle was declared by doctor either on the notified date to discontinue sunitinib or on the date of the last consultation if sunitinib treatment was not stopped
measure: Number of Participants With At Least 1 Unplanned Hospitalization
time frame: Baseline up to 6 months
description: Number of participants with at least 1 unplanned hospitalizations either related or unrelated to sunitinib were reported.
measure: Number of Participants With At Least 1 Unplanned Consultation
time frame: Baseline up to 6 months
description: Number of participants with at least 1 unplanned consultations either related or unrelated to sunitinib were reported.
measure: Number of Participants Who Were "Adherent" as Per 4- Item Morisky Medication Adherence Scale (MMAS-4)
time frame: Baseline up to 6 months
description: MMAS-4 is a self-reported measure of medication taking behavior, consisting of 4 questions based on forgetting taking medication, carelessness about taking medication, stopping medication when feeling better, or stopping medication when feeling worse. Each question has answer either "Yes" or "No"; "Yes" =1 and "No" =0. The sum of answer to all 4 questions resulted in total MMAS-4 score. Total MMAS-4 score ranges from 0 (best adherence) to 4 (worst adherence), a low score representing improved adherence. Adherent participants were defined as participants with an MMAS-4 score of 0.
measure: Mean 4-Item Morisky Medication Adherence Scale (MMAS-4) Score
time frame: Baseline up to 6 months
description: MMAS-4 is a self-reported measure of medication taking behavior, consisting of 4 questions based on forgetting taking medication, carelessness about taking medication, stopping medication when feeling better, or stopping medication when feeling worse. Each question has answer either "Yes" or "No"; "Yes" =1 and "No" =0. The sum of answer to all 4 questions resulted in total MMAS-4 score. Total MMAS-4 score ranges from 0 (best adherence) to 4 (worst adherence), a low score representing improved adherence. High adherence: score of 0, average adherence: score of 1 or 2, poor adherence: score of 3 or 4.
measure: Objective Response Rate (ORR): Percentage of Participants With a Complete or Partial Best Response
time frame: Baseline up to 6 months
description: ORR used for the assessment of response to treatment. As per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1: Complete response (CR) was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 millimetre [mm]). No new lesions. Partial response (PR) was defined as greater than or equal to (>=) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.
measure: Mean Scores for Each Dimension on the Participant's Satisfaction (With the Management By the Telephone Call Center) Questionnaire
time frame: At the end of the study (At Month 6)
description: Participants' satisfaction with call center was assessed via the self-administered questionnaire completed at the end of the study. Questionnaire evaluated 4 dimensions with total of 8 items. Dimensions were: 1) Satisfaction with advice: 3 item, 2) Satisfaction with care, 3) Satisfaction concerning the service: 3 items and 4) Overall satisfaction with support in management of sunitinib treatment: 1 item. Each item had 5 responses: very satisfied, satisfied, not very satisfied, not satisfied and no opinion equivalent to score of +2, +1, 1, -2 and no score respectively. A score was calculated for each dimension by calculating the mean scores obtained for each item if at least 50% of the items for the dimension had been completed (and are not "no opinion"). Overall possible mean score range for each dimension was +2 to -2, where higher scores signified higher satisfaction.
measure: Number of Participants Who Reported Themselves Being "Satisfied" or "Very Satisfied" With the Management By the Telephone Call Center
time frame: At the end of the study (At Month 6)
description: Participants' satisfaction with call center was assessed via the self-administered questionnaire completed at the end of the study. Questionnaire evaluated 4 dimensions with total of 8 items. Dimensions were: 1) Satisfaction concerning advice: have 3 item, 2) Satisfaction concerning management: 1 items, 3) Satisfaction concerning the service: 3 items and 4) Overall satisfaction with support in management of sunitinib treatment: 1 item. Each item had 5 responses: very satisfied, satisfied, not very satisfied, not satisfied and no opinion. In this outcome measure number of participants who were either "Satisfied" or "Very Satisfied" for overall satisfaction were reported.
measure: Mean Scores for Each Dimension on the Physician's Satisfaction (With the Management By the Telephone Call Center) Questionnaire
time frame: At the end of the study (At Month 6)
description: Physician's satisfaction with call center service for participants' follow-up was assessed via the self-administered questionnaire completed at the end of the study. Questionnaire evaluated 3 dimensions with total of 5 items. Dimensions were: 1) Satisfaction concerning advice: had 3 items, 2) Satisfaction concerning management: 1 items and 3) Overall satisfaction: 1 item. Each item had 5 responses: very satisfied, satisfied, not very satisfied, not satisfied and no opinion equivalent to score of +2, +1, 1, -2 and no score respectively. A score was calculated for each dimension by calculating the mean scores obtained for each item if at least 50% of the items for the dimension have been completed (and are not "no opinion"). Overall possible mean score range for each dimension was +2 to -2, where higher scores signified higher satisfaction.
measure: Number of Investigating Physicians Who Reported Themselves Being "Satisfied" or "Very Satisfied" With the Management By the Telephone Call Center
time frame: Baseline up to 6 months
description: Physicians' satisfaction with call center service for participants' follow-up was assessed via the self-administered questionnaire completed at the end of the study. Questionnaire evaluated 3 dimensions with total of 5 item. Dimensions were: 1) Satisfaction concerning advice: had 3 items, 2) Satisfaction concerning management: 1 items and 3) Overall satisfaction: 1 item. Each item had 5 responses: very satisfied, satisfied, not very satisfied, not satisfied and no opinion. In this outcome measure number of physicians who were either "Satisfied" or "Very Satisfied" for overall satisfaction were reported.
measure: Total Number of Calls (Planned and Unplanned)
time frame: Baseline up to 6 months
description: 1 participant can call more than once during the study.
measure: Number of Participants Who Were Taking Sunitinib as Told to Call Center During the First Call
time frame: First call made anytime from baseline up to 6 months
description: Participants were followed up for taking their medication and they were supposed to respond either "yes" or "no". In this outcome measure participants who responded "Yes" are reported.
measure: Number of Participants With Their Responses as "Yes" Against the Actions of Investigating Physicians, as Told to Call Center During the First Call
time frame: First call made anytime from baseline up to 6 months
description: Actions of investigating doctors/physicians: did doctor clearly explained how to take treatment, were participants given documentation about treatment by doctor or medical team, did doctor explained how to manage any side effects due to treatment which could occur and were prescriptions or orders for supportive medical treatments given by doctor. Participants responded either "Yes" or "No". In this outcome measure participants who responded "Yes" to each action are reported.
measure: Number of Telephone Calls Describing Actions Taken by Call Center
time frame: Baseline up to 6 months
description: In this outcome measure number of telephone calls against each action taken/or described by the call center to the participants are reported. Actions taken by the call center included: 1) Given advice about managing the treatment: a) advice about taking Sunitinib, b) advice about using the Sunitinib follow-up diary, c) reporting any AE; 2) Given general preventative advice: a) advice about taking preventative systemic treatments, b) lifestyle advice, c) food/dietetic advice, d) oro-dental hygiene advice; 3) Given specific preventative advice for a type of AE: a) prevention of skin toxicities, b) prevention of gastrointestinal disorders, c) prevention of cardiac disorders, d) prevention of infectious/inflammatory problems, e)other preventative advice; 4) Actions recommended to participant: a) do not forget the planned consultation with the oncologist, b) get the additional investigations requested performed.
measure: Number of Telephone Calls Where Participants Declared Adverse Events
time frame: Baseline up to 6 months
description: In this outcome measure total number of telephone calls where participants declared of any AE are reported. Participants could call more than once to declare AE.
arm group label: All patients
description: Metastatic and/or advanced renal cell carcinoma patients treated with sunitinib in first line and followed by standard care plus call center
intervention type: Other
intervention name: Best supportive care
description: BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life
arm group label: All patients
intervention type: Other
intervention name: call center
description: Nurses from a call center will call the patients at regular time to help patients in the management of their cancer, with some dietetic advices, medical advices etc.
arm group label: All patients
study pop: 
sampling method: 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
facility: 
facility: 
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facility: 
country: France
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6181213&StudyName=Evaluation%20Of%20The%20Impact%20Of%20A%20Call%20Center%20In%20Management%20Of%20Metastatic%20And/Or%20Advanced%20Renal%20Cell%20Carcinoma%20Patients%20Treated%20With%20Sunit
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Renal Cell
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.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 