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  <outcomeMeasures/>
  <reportedEvents>
    <allCauseMortComment>all-cause mortality</allCauseMortComment>
    <assessmentType>Non-Systematic Assessment</assessmentType>
    <frequencyReportingThreshold>0.0</frequencyReportingThreshold>
    <frequentAdverseEvents>
      <frequentEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>11</numEvents>
            <numSubjectsAffected>7</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>16</numEvents>
            <numSubjectsAffected>8</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>13</numEvents>
            <numSubjectsAffected>7</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Abdominal distension</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Abdominal distension</term>
      </frequentEvent>
      <frequentEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>9</numEvents>
            <numSubjectsAffected>4</numSubjectsAffected>
            <numSubjects>20</numSubjects>
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          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>14</numEvents>
            <numSubjectsAffected>4</numSubjectsAffected>
            <numSubjects>22</numSubjects>
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          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>4</numEvents>
            <numSubjectsAffected>3</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Abdominal infection</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Abdominal infection</term>
      </frequentEvent>
      <frequentEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>10</numEvents>
            <numSubjectsAffected>4</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>11</numEvents>
            <numSubjectsAffected>3</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>11</numEvents>
            <numSubjectsAffected>9</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Abdominal soft tissue necrosis</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Abdominal soft tissue necrosis</term>
      </frequentEvent>
      <frequentEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>17</numEvents>
            <numSubjectsAffected>7</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>11</numEvents>
            <numSubjectsAffected>8</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>18</numEvents>
            <numSubjectsAffected>8</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Abducens nerve disorder</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Abducens nerve disorder</term>
      </frequentEvent>
      <frequentEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>14</numEvents>
            <numSubjectsAffected>6</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>8</numEvents>
            <numSubjectsAffected>5</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>18</numEvents>
            <numSubjectsAffected>11</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Acidosis</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Acidosis</term>
      </frequentEvent>
      <frequentEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>8</numEvents>
            <numSubjectsAffected>6</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>14</numEvents>
            <numSubjectsAffected>6</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>7</numEvents>
            <numSubjectsAffected>2</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Activated partial thromboplastin time prolonged</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Activated partial thromboplastin time prolonged</term>
      </frequentEvent>
      <frequentEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>12</numEvents>
            <numSubjectsAffected>4</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>15</numEvents>
            <numSubjectsAffected>11</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>6</numEvents>
            <numSubjectsAffected>3</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Acute coronary syndrome</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Acute coronary syndrome</term>
      </frequentEvent>
      <frequentEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>7</numEvents>
            <numSubjectsAffected>2</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>21</numEvents>
            <numSubjectsAffected>11</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>11</numEvents>
            <numSubjectsAffected>5</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Acute kidney injury</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Acute kidney injury</term>
      </frequentEvent>
      <frequentEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>18</numEvents>
            <numSubjectsAffected>10</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>11</numEvents>
            <numSubjectsAffected>5</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>4</numEvents>
            <numSubjectsAffected>4</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Adrenal insufficiency</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Adrenal insufficiency</term>
      </frequentEvent>
      <frequentEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>7</numEvents>
            <numSubjectsAffected>4</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>6</numEvents>
            <numSubjectsAffected>3</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>14</numEvents>
            <numSubjectsAffected>8</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Adult respiratory distress syndrome</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Adult respiratory distress syndrome</term>
      </frequentEvent>
      <frequentEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>5</numEvents>
            <numSubjectsAffected>5</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>7</numEvents>
            <numSubjectsAffected>4</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>8</numEvents>
            <numSubjectsAffected>7</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Agitation</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Agitation</term>
      </frequentEvent>
      <frequentEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>5</numEvents>
            <numSubjectsAffected>4</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>17</numEvents>
            <numSubjectsAffected>9</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>8</numEvents>
            <numSubjectsAffected>3</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Allergic reaction</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Allergic reaction</term>
      </frequentEvent>
      <frequentEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>5</numEvents>
            <numSubjectsAffected>4</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>11</numEvents>
            <numSubjectsAffected>5</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>15</numEvents>
            <numSubjectsAffected>5</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Alopecia</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Alopecia</term>
      </frequentEvent>
      <frequentEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>10</numEvents>
            <numSubjectsAffected>3</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>14</numEvents>
            <numSubjectsAffected>6</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>11</numEvents>
            <numSubjectsAffected>5</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Anemia</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Anemia</term>
      </frequentEvent>
      <frequentEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>9</numEvents>
            <numSubjectsAffected>5</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>14</numEvents>
            <numSubjectsAffected>4</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>17</numEvents>
            <numSubjectsAffected>8</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Ankle fracture</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Ankle fracture</term>
      </frequentEvent>
      <frequentEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>16</numEvents>
            <numSubjectsAffected>8</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>15</numEvents>
            <numSubjectsAffected>6</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>11</numEvents>
            <numSubjectsAffected>6</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Azoospermia</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Azoospermia</term>
      </frequentEvent>
      <frequentEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>7</numEvents>
            <numSubjectsAffected>4</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>16</numEvents>
            <numSubjectsAffected>8</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>9</numEvents>
            <numSubjectsAffected>3</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Bile duct stenosis</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Bile duct stenosis</term>
      </frequentEvent>
      <frequentEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>7</numEvents>
            <numSubjectsAffected>2</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>9</numEvents>
            <numSubjectsAffected>6</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>16</numEvents>
            <numSubjectsAffected>8</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Blurred vision</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Blurred vision</term>
      </frequentEvent>
      <frequentEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>8</numEvents>
            <numSubjectsAffected>2</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>5</numEvents>
            <numSubjectsAffected>5</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>8</numEvents>
            <numSubjectsAffected>7</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Capillary leak syndrome</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Capillary leak syndrome</term>
      </frequentEvent>
      <frequentEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>6</numEvents>
            <numSubjectsAffected>3</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>8</numEvents>
            <numSubjectsAffected>5</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>15</numEvents>
            <numSubjectsAffected>10</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Chills</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Chills</term>
      </frequentEvent>
      <frequentEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>4</numEvents>
            <numSubjectsAffected>2</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>11</numEvents>
            <numSubjectsAffected>6</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>7</numEvents>
            <numSubjectsAffected>7</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Congenital, familial and genetic disorders - Other, specify</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Congenital, familial and genetic disorders - Other, specify</term>
      </frequentEvent>
      <frequentEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>18</numEvents>
            <numSubjectsAffected>8</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>16</numEvents>
            <numSubjectsAffected>7</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>8</numEvents>
            <numSubjectsAffected>5</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Ear pain</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Ear pain</term>
      </frequentEvent>
      <frequentEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>7</numEvents>
            <numSubjectsAffected>4</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>22</numEvents>
            <numSubjectsAffected>14</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>7</numEvents>
            <numSubjectsAffected>6</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Fetal death</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Fetal death</term>
      </frequentEvent>
      <frequentEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>5</numEvents>
            <numSubjectsAffected>4</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>13</numEvents>
            <numSubjectsAffected>4</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>14</numEvents>
            <numSubjectsAffected>5</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Leukemia secondary to oncology chemotherapy</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Leukemia secondary to oncology chemotherapy</term>
      </frequentEvent>
      <frequentEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>14</numEvents>
            <numSubjectsAffected>8</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>7</numEvents>
            <numSubjectsAffected>7</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>3</numEvents>
            <numSubjectsAffected>1</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Menopause</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Menopause</term>
      </frequentEvent>
      <frequentEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>15</numEvents>
            <numSubjectsAffected>6</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>10</numEvents>
            <numSubjectsAffected>4</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>14</numEvents>
            <numSubjectsAffected>4</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Surgical and medical procedures - Other, specify</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Surgical and medical procedures - Other, specify</term>
      </frequentEvent>
    </frequentAdverseEvents>
    <interventionGroups>
      <interventionGroup id="idm711497520">
        <description>Group A</description>
        <numDeaths>3</numDeaths>
        <numSubjectsFrequentEvents>10</numSubjectsFrequentEvents>
        <numSubjectsSeriousEvents>10</numSubjectsSeriousEvents>
        <partAtRiskAllCauseMort>20</partAtRiskAllCauseMort>
        <partAtRiskFrequentEvents>20</partAtRiskFrequentEvents>
        <partAtRiskSeriousEvents>20</partAtRiskSeriousEvents>
        <title>Group A</title>
      </interventionGroup>
      <interventionGroup id="idm711485744">
        <description>Group B</description>
        <numDeaths>6</numDeaths>
        <numSubjectsFrequentEvents>14</numSubjectsFrequentEvents>
        <numSubjectsSeriousEvents>13</numSubjectsSeriousEvents>
        <partAtRiskAllCauseMort>22</partAtRiskAllCauseMort>
        <partAtRiskFrequentEvents>22</partAtRiskFrequentEvents>
        <partAtRiskSeriousEvents>22</partAtRiskSeriousEvents>
        <title>Group B</title>
      </interventionGroup>
      <interventionGroup id="idm711487920">
        <description>Group C</description>
        <numDeaths>2</numDeaths>
        <numSubjectsFrequentEvents>11</numSubjectsFrequentEvents>
        <numSubjectsSeriousEvents>9</numSubjectsSeriousEvents>
        <partAtRiskAllCauseMort>18</partAtRiskAllCauseMort>
        <partAtRiskFrequentEvents>18</partAtRiskFrequentEvents>
        <partAtRiskSeriousEvents>18</partAtRiskSeriousEvents>
        <title>Group C</title>
      </interventionGroup>
    </interventionGroups>
    <notes/>
    <seriousAdverseEvents>
      <seriousEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>8</numEvents>
            <numSubjectsAffected>7</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>4</numEvents>
            <numSubjectsAffected>3</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>8</numEvents>
            <numSubjectsAffected>2</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Abdominal distension</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Abdominal distension</term>
      </seriousEvent>
      <seriousEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>7</numEvents>
            <numSubjectsAffected>3</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>8</numEvents>
            <numSubjectsAffected>5</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>10</numEvents>
            <numSubjectsAffected>4</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Abdominal infection</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Abdominal infection</term>
      </seriousEvent>
      <seriousEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>12</numEvents>
            <numSubjectsAffected>5</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>10</numEvents>
            <numSubjectsAffected>4</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>9</numEvents>
            <numSubjectsAffected>6</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Abdominal soft tissue necrosis</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Abdominal soft tissue necrosis</term>
      </seriousEvent>
      <seriousEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>8</numEvents>
            <numSubjectsAffected>5</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>8</numEvents>
            <numSubjectsAffected>6</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>7</numEvents>
            <numSubjectsAffected>3</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Abducens nerve disorder</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Abducens nerve disorder</term>
      </seriousEvent>
      <seriousEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>10</numEvents>
            <numSubjectsAffected>8</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>15</numEvents>
            <numSubjectsAffected>5</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>9</numEvents>
            <numSubjectsAffected>2</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Acidosis</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Acidosis</term>
      </seriousEvent>
      <seriousEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>8</numEvents>
            <numSubjectsAffected>4</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>11</numEvents>
            <numSubjectsAffected>6</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>9</numEvents>
            <numSubjectsAffected>5</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Activated partial thromboplastin time prolonged</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Activated partial thromboplastin time prolonged</term>
      </seriousEvent>
      <seriousEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>4</numEvents>
            <numSubjectsAffected>3</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>9</numEvents>
            <numSubjectsAffected>4</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>15</numEvents>
            <numSubjectsAffected>9</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Acute coronary syndrome</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Acute coronary syndrome</term>
      </seriousEvent>
      <seriousEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>5</numEvents>
            <numSubjectsAffected>4</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>9</numEvents>
            <numSubjectsAffected>5</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>0</numEvents>
            <numSubjectsAffected>0</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Acute kidney injury</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Acute kidney injury</term>
      </seriousEvent>
      <seriousEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>12</numEvents>
            <numSubjectsAffected>5</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>17</numEvents>
            <numSubjectsAffected>12</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>8</numEvents>
            <numSubjectsAffected>3</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Adrenal insufficiency</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Adrenal insufficiency</term>
      </seriousEvent>
      <seriousEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>17</numEvents>
            <numSubjectsAffected>7</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>22</numEvents>
            <numSubjectsAffected>12</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>12</numEvents>
            <numSubjectsAffected>5</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Adult respiratory distress syndrome</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Adult respiratory distress syndrome</term>
      </seriousEvent>
      <seriousEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>8</numEvents>
            <numSubjectsAffected>6</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>15</numEvents>
            <numSubjectsAffected>10</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>12</numEvents>
            <numSubjectsAffected>2</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Agitation</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Agitation</term>
      </seriousEvent>
      <seriousEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>10</numEvents>
            <numSubjectsAffected>7</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>13</numEvents>
            <numSubjectsAffected>8</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>11</numEvents>
            <numSubjectsAffected>7</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Allergic reaction</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Allergic reaction</term>
      </seriousEvent>
      <seriousEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>6</numEvents>
            <numSubjectsAffected>3</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>10</numEvents>
            <numSubjectsAffected>8</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>3</numEvents>
            <numSubjectsAffected>2</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Alopecia</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Alopecia</term>
      </seriousEvent>
      <seriousEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>6</numEvents>
            <numSubjectsAffected>6</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>16</numEvents>
            <numSubjectsAffected>7</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>13</numEvents>
            <numSubjectsAffected>3</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Anemia</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Anemia</term>
      </seriousEvent>
      <seriousEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>6</numEvents>
            <numSubjectsAffected>5</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>9</numEvents>
            <numSubjectsAffected>6</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>14</numEvents>
            <numSubjectsAffected>7</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Ankle fracture</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Ankle fracture</term>
      </seriousEvent>
      <seriousEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>11</numEvents>
            <numSubjectsAffected>5</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>5</numEvents>
            <numSubjectsAffected>3</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>9</numEvents>
            <numSubjectsAffected>4</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Azoospermia</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Azoospermia</term>
      </seriousEvent>
      <seriousEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>5</numEvents>
            <numSubjectsAffected>5</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>16</numEvents>
            <numSubjectsAffected>9</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>6</numEvents>
            <numSubjectsAffected>1</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Bile duct stenosis</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Bile duct stenosis</term>
      </seriousEvent>
      <seriousEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>16</numEvents>
            <numSubjectsAffected>6</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>6</numEvents>
            <numSubjectsAffected>3</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>7</numEvents>
            <numSubjectsAffected>4</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Blurred vision</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Blurred vision</term>
      </seriousEvent>
      <seriousEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>12</numEvents>
            <numSubjectsAffected>4</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>11</numEvents>
            <numSubjectsAffected>6</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>16</numEvents>
            <numSubjectsAffected>9</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Capillary leak syndrome</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Capillary leak syndrome</term>
      </seriousEvent>
      <seriousEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>20</numEvents>
            <numSubjectsAffected>10</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>17</numEvents>
            <numSubjectsAffected>7</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>14</numEvents>
            <numSubjectsAffected>6</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Chills</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Chills</term>
      </seriousEvent>
      <seriousEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>5</numEvents>
            <numSubjectsAffected>5</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>11</numEvents>
            <numSubjectsAffected>4</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>14</numEvents>
            <numSubjectsAffected>9</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Congenital, familial and genetic disorders - Other, specify</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Congenital, familial and genetic disorders - Other, specify</term>
      </seriousEvent>
      <seriousEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>9</numEvents>
            <numSubjectsAffected>2</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>9</numEvents>
            <numSubjectsAffected>6</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>10</numEvents>
            <numSubjectsAffected>4</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Ear pain</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Ear pain</term>
      </seriousEvent>
      <seriousEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>7</numEvents>
            <numSubjectsAffected>3</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>14</numEvents>
            <numSubjectsAffected>5</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>8</numEvents>
            <numSubjectsAffected>4</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Fetal death</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Fetal death</term>
      </seriousEvent>
      <seriousEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>8</numEvents>
            <numSubjectsAffected>5</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>6</numEvents>
            <numSubjectsAffected>4</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>12</numEvents>
            <numSubjectsAffected>8</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Leukemia secondary to oncology chemotherapy</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Leukemia secondary to oncology chemotherapy</term>
      </seriousEvent>
      <seriousEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>12</numEvents>
            <numSubjectsAffected>8</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>12</numEvents>
            <numSubjectsAffected>6</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>6</numEvents>
            <numSubjectsAffected>6</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Menopause</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Menopause</term>
      </seriousEvent>
      <seriousEvent>
        <adverseEventStats>
          <eventStats>
            <reportingGroupId>idm711497520</reportingGroupId>
            <numEvents>5</numEvents>
            <numSubjectsAffected>5</numSubjectsAffected>
            <numSubjects>20</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711485744</reportingGroupId>
            <numEvents>16</numEvents>
            <numSubjectsAffected>9</numSubjectsAffected>
            <numSubjects>22</numSubjects>
          </eventStats>
          <eventStats>
            <reportingGroupId>idm711487920</reportingGroupId>
            <numEvents>7</numEvents>
            <numSubjectsAffected>3</numSubjectsAffected>
            <numSubjects>18</numSubjects>
          </eventStats>
        </adverseEventStats>
        <assessmentType>Non-Systematic Assessment</assessmentType>
        <notes>Surgical and medical procedures - Other, specify</notes>
        <organSystemName/>
        <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
        <term>Surgical and medical procedures - Other, specify</term>
      </seriousEvent>
    </seriousAdverseEvents>
    <sourceVocabulary>MedDRA 22.0</sourceVocabulary>
    <timeFrame>Timeframe for AE</timeFrame>
  </reportedEvents>
</tns:result>
