<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/NCT01723826</url>
  </required_header>
  <id_info>
    <org_study_id>GN28525</org_study_id>
    <secondary_id>2012-003242-33</secondary_id>
    <nct_id>NCT01723826</nct_id>
  </id_info>
  <brief_title>A Long-Term Safety Extension of Studies ABE4869g and ABE4955g in Participants With Mild to Moderate Alzheimer's Disease Treated With Crenezumab</brief_title>
  <official_title>A Multicenter, Open-Label, Long-Term Safety Extension of Phase II Studies ABE4869g and ABE4955g in Patients With Mild to Moderate Alzheimer's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Genentech, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Genentech, Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This Phase II, open-label extension (OLE), multicenter study will evaluate the long-term&#xD;
      safety and tolerability of crenezumab in participants with mild to moderate Alzheimer's&#xD;
      disease who have participated in and completed the treatment period of the Phase II Study&#xD;
      ABE4869g (NCT01343966) or ABE4955g (NCT01397578). Participants who received placebo in Study&#xD;
      ABE4869g (NCT01343966) or ABE4955g (NCT01397578) will receive crenezumab. Anticipated time on&#xD;
      study treatment is 144 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 7, 2012</start_date>
  <completion_date type="Actual">February 8, 2017</completion_date>
  <primary_completion_date type="Actual">February 8, 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Adverse Events (AEs)</measure>
    <time_frame>Up to 50 months</time_frame>
    <description>An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. . An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants by Nature of AEs</measure>
    <time_frame>Up to 50 months</time_frame>
    <description>A serious adverse event (SAE) is any AE that meets any of the following criteria: fatal, life threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in a neonate/infant. Non-SAE of special interest for this study include the following: cerebral vascular edema, Superficial siderosis of central nervous system, cerebral micro-hemorrhages or macro-hemorrhages, pneumonia, liver injury.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants by Severity of AEs</measure>
    <time_frame>Up to 50 months</time_frame>
    <description>AE severity grading scale for the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 was used for assessing adverse event severity. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on the following general guideline: Grade 1) mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated, Grade 2) moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL), Grade 3) severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL, Grade 4) life-threatening consequences; urgent intervention indicated, Grade 5) death related to AE.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Human Anti-Therapeutic Antibody (ATA) Formation</measure>
    <time_frame>Pre-dose (Day-14), predose at Week 25, 49, 97, Follow-up Week 8 (Week 153) and 12 (Week 157)</time_frame>
    <description>ATA is a measurement to explore the potential relationship of immunogenicity response with pharmacokinetics, safety and efficacy. Percentage of participants at post-baseline with positive results for ATA against crenezumab are reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Amyloid-Related Imaging Abnormalities Edema/Effusions (ARIA-E)</measure>
    <time_frame>Baseline, Weeks 23, 47, 71, 97, 121 and 153</time_frame>
    <description>Alzheimer's disease (AD) is associated with ARIA. The occurrence of imaging abnormalities believed to represent cerebral vasogenic edema, has been reported in association with the investigational use of compounds that are intended to treat Alzheimer's disease by reducing Abeta in the brain. Here, the percentage of participants with symptomatic and asymptomatic ARIA-E were reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Amyloid-Related Imaging Abnormalities-Hemorrhage (ARIA-H)</measure>
    <time_frame>Baseline, Weeks 23, 47, 71, 97, 121 and 153</time_frame>
    <description>AD is associated with ARIA. Cerebral micro-hemorrhages (microbleeds [MBs]) are radiologically defined as small dot-like foci of signal loss observed on magnetic resonance imaging (MRI) sequences sensitive for paramagnetic tissue properties. The occurrence of MBs has also been identified as an adverse event in anti-amyloid vaccination trials, and together with superficial siderosis, they have been termed ARIA-H.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">360</enrollment>
  <condition>Alzheimer's Disease</condition>
  <arm_group>
    <arm_group_label>Crenezumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive intravenous infusion of crenezumab every 4 weeks for 144 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Crenezumab</intervention_name>
    <description>Participants will receive intravenous infusion of crenezumab every 4 weeks for 144 weeks.</description>
    <arm_group_label>Crenezumab</arm_group_label>
    <other_name>RO5490245</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Previous participation in Study ABE4869g or ABE4955g and completion of the Week 73&#xD;
             visit&#xD;
&#xD;
          -  Adequate visual and auditory acuity, in the investigator's judgment, to allow for&#xD;
             neuropsychological testing&#xD;
&#xD;
          -  Availability of a person (&quot;caregiver&quot;) who can provide information on activities of&#xD;
             daily living and behavior in order to complete the study-specific assessments&#xD;
&#xD;
          -  Diagnosis of probable Alzheimer's disease according to the National Institute on&#xD;
             Neurological and Communication Disease and Stroke/Alzheimer's Disease and Related&#xD;
             Disorders Association (NINCDS-ADRDA) criteria (McKhann et al. 1984)&#xD;
&#xD;
          -  Mini-Mental State Examination (MMSE) score of 10 or more at screening (Folstein et al.&#xD;
             1975)&#xD;
&#xD;
          -  For male participants with partners with reproductive potential, agreement to use a&#xD;
             reliable means of contraception (e.g., condoms) during the study and for at least 8&#xD;
             weeks following the last dose of study drug&#xD;
&#xD;
          -  For female participants, a negative pregnancy test at screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Early treatment and/or study discontinuation prior to completion of the Week 73 visit&#xD;
             of Genentech Study ABE4869g or ABE4955g&#xD;
&#xD;
          -  Early discontinuation from the treatment schedule of a prior version of Study GN28525&#xD;
             for safety reasons. If treatment discontinuation occurred for safety reasons,&#xD;
             participants may not re-start dosing on extended treatment schedules offered in&#xD;
             amendments to Study GN28525&#xD;
&#xD;
          -  Inability to tolerate Magnetic Resonance Imaging (MRI) procedures or contraindication&#xD;
             to MRI&#xD;
&#xD;
          -  Female participants with reproductive potential: Female participants must either have&#xD;
             undergone documented surgical sterilization or have not experienced menstruation for&#xD;
             at least 12 consecutive months&#xD;
&#xD;
          -  Severe or unstable medical condition that, in the opinion of the investigator or&#xD;
             Sponsor, would interfere with the participant's ability to complete the study&#xD;
             assessments or would require the equivalent of institutional or hospital care&#xD;
&#xD;
          -  History or presence of clinically evident vascular disease potentially affecting the&#xD;
             brain&#xD;
&#xD;
          -  History of severe, clinically significant central nervous system trauma&#xD;
&#xD;
          -  History or presence of clinically relevant intracranial tumor&#xD;
&#xD;
          -  Presence of infections that affect the brain function or history of infections that&#xD;
             resulted in neurologic sequelae&#xD;
&#xD;
          -  History or presence of systemic autoimmune disorders potentially causing progressive&#xD;
             neurologic disease&#xD;
&#xD;
          -  History or presence of a neurologic disease other than Alzheimer's disease that may&#xD;
             affect cognition&#xD;
&#xD;
          -  History of severe allergic, anaphylactic, or other hypersensitivity reactions to&#xD;
             chimeric, human, or humanized antibodies or fusion proteins&#xD;
&#xD;
          -  Evidence of malignancies (except squamous cell cancer or basal cell cancer of the&#xD;
             skin), acute infections, renal failure that requires dialysis, or other unstable&#xD;
             medical disease not related to Alzheimer's disease that, in the investigator's&#xD;
             opinion, would preclude participant's participation. Cancer that is not being actively&#xD;
             treated with anti-cancer therapy or radiotherapy as well as cancers which are&#xD;
             considered to have low probability of recurrence are allowed&#xD;
&#xD;
          -  History or presence of atrial fibrillation that, in the investigator's judgment, poses&#xD;
             a risk for future stroke&#xD;
&#xD;
          -  Chronic kidney disease of Stage greater than or equal to (&gt;=) 4, according to the&#xD;
             National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF KDOQI)&#xD;
             guidelines for chronic kidney disease (CKD)&#xD;
&#xD;
          -  Impaired hepatic function&#xD;
&#xD;
          -  Impaired coagulation (activated partial thromboplastin time [aPTT] greater than [&gt;]&#xD;
             1.2 times upper limit of normal [ULN])&#xD;
&#xD;
          -  Platelet count less than (&lt;) 100,000 per microliter (mcL)&#xD;
&#xD;
          -  Presence at screening of superficial siderosis of central nervous system, more than 8&#xD;
             cerebral microhemorrhages, or evidence of a prior cerebral macrohemorrhage&#xD;
&#xD;
          -  Presence at screening of any other significant cerebral abnormalities, including&#xD;
             ARIA-E&#xD;
&#xD;
          -  Treatment with anticoagulation medications within 2 weeks prior to enrollment.&#xD;
             Clopidogrel, dipyridamole, and aspirin are permitted&#xD;
&#xD;
          -  Treatment with anticholinergic antidepressants, typical antipsychotics, or&#xD;
             barbiturates within 2 weeks prior to enrollment. All other antidepressants and&#xD;
             atypical antipsychotics are allowed with certain restrictions as defined in the&#xD;
             protocol&#xD;
&#xD;
          -  Chronic use of opiates, opioids, or benzodiazepines&#xD;
&#xD;
          -  Any biologic therapy within 75 weeks prior to enrollment&#xD;
&#xD;
          -  Any investigational agent (other than crenezumab) within 75 weeks prior to enrollment&#xD;
&#xD;
          -  Treatment with anticholinergic antidepressants, typical antipsychotics, barbiturates,&#xD;
             or narcotics within 5 half-lives or 3 months prior to screening, whichever is longer.&#xD;
             All other antidepressants and atypical antipsychotics are allowed. Chronic use of&#xD;
             benzodiazepines is not allowed; however, the intermittent use of benzodiazepines is&#xD;
             allowed, except within 2 days prior to any neurocognitive assessment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Genentech, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Banner Alzheimer's Institute</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85259</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Banner Sun Health Research Insitute</name>
      <address>
        <city>Sun City</city>
        <state>Arizona</state>
        <zip>85351</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharmacology Research Inst</name>
      <address>
        <city>Encino</city>
        <state>California</state>
        <zip>91316</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Margolin Brain Institute</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univ of CA San Diego; Neurosciences Comp.Alzheimer's</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>USC School of Medicine</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California Los Angeles (UCLA)</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharmacology Research Inst</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pacific Neuroscience Med Grp</name>
      <address>
        <city>Oxnard</city>
        <state>California</state>
        <zip>93030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford Univ Medical Center</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California Davis Medical System</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pacific Research Network - PRN</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uni of California San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Redwood Regional Medical Group</name>
      <address>
        <city>Santa Rosa</city>
        <state>California</state>
        <zip>95403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Atlantic University; College of Medicine</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33431</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridien Research</name>
      <address>
        <city>Brooksville</city>
        <state>Florida</state>
        <zip>34601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brain Matters Research, Inc.</name>
      <address>
        <city>Delray Beach</city>
        <state>Florida</state>
        <zip>33445</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Miami Jewish Health Systems; Clinical Research</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33137</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Collier Neurologic Specialists</name>
      <address>
        <city>Naples</city>
        <state>Florida</state>
        <zip>34105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bioclinica Research</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Axiom Clinical Research of Florida</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Premiere Research Institute</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dekalb Neurology Associates</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush Alzheimer's Disease Cntr.</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alexian Brothers Neurosci Inst</name>
      <address>
        <city>Elk Grove Village</city>
        <state>Illinois</state>
        <zip>60007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana Univ School of Med</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Louisiana Research Associates</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hattiesburg Clinic</name>
      <address>
        <city>Hattiesburg</city>
        <state>Mississippi</state>
        <zip>39401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Millennium Psychiatric Associates, LLC</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Lou Ruvo; Center for Brain Research</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memory Enhancement Center of America, Inc.</name>
      <address>
        <city>Eatontown</city>
        <state>New Jersey</state>
        <zip>07724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NeuroCognitive Institute</name>
      <address>
        <city>Mount Arlington</city>
        <state>New Jersey</state>
        <zip>07856</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Empire Neurology, PC</name>
      <address>
        <city>Latham</city>
        <state>New York</state>
        <zip>12210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Litwin Zucker Research Ctr.; Feinstein Inst. Med. Rsch.</name>
      <address>
        <city>Manhasset</city>
        <state>New York</state>
        <zip>11030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Rochester Medical Center; Monroe Community Hospital</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14627</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Drug Service; Univ of Rochester Medical Ctr</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Raleigh Neurology Associates</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27607-6520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Summit Research Network Inc.</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Clinical Trial Center, LLC</name>
      <address>
        <city>Jenkintown</city>
        <state>Pennsylvania</state>
        <zip>19046</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rhode Island Mood &amp; Memory Research Institute</name>
      <address>
        <city>East Providence</city>
        <state>Rhode Island</state>
        <zip>02914</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Butler Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02906</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Uni of South Carolina</name>
      <address>
        <city>North Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alzheimers Disease &amp; Memory Disorders Center; Department of Neurology Baylor College of Medicine</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Neuroscience Research Associates, Inc.</name>
      <address>
        <city>Bennington</city>
        <state>Vermont</state>
        <zip>05201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Med Arts Health Rsrch Grp</name>
      <address>
        <city>Kelowna</city>
        <state>British Columbia</state>
        <zip>V1Y 3G8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of British Columbia Hospital; Division of Neurology</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6T 2B5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Capitol District Health Authority</name>
      <address>
        <city>Halilfax</city>
        <state>Nova Scotia</state>
        <zip>B3H 2E1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jbn Medical Diagnostic Services Inc.</name>
      <address>
        <city>Burlington</city>
        <state>Ontario</state>
        <zip>L7M 4Y1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hotel Dieu Hospital</name>
      <address>
        <city>Kingston</city>
        <state>Ontario</state>
        <zip>K7L 2V7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Joseph's HC-Parkwood Hosp</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6C 5J1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bruyere Continuing Care</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1N 5C8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kawartha Centre - Redefining Healthy Aging</name>
      <address>
        <city>Peterborough</city>
        <state>Ontario</state>
        <zip>K9H 2P4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toronto Memory Program (Neurology Research Inc.)</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M3B 2S7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Neuro Rive-Sud</name>
      <address>
        <city>Greenfield Park</city>
        <state>Quebec</state>
        <zip>J4V 2J2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Maisonneuve-Rosemont/Polyclinique;Recherche Clinique</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H1T 2M4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHAUQ Hopital Enfant-Jesus</name>
      <address>
        <city>Quebec City</city>
        <state>Quebec</state>
        <zip>G1J 1Z4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McGill Univeristy; Douglas Mental Health University Institute; Neurological and Psychiatric</name>
      <address>
        <city>Verdun</city>
        <state>Quebec</state>
        <zip>H4H 1R3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie</name>
      <address>
        <city>Bron</city>
        <zip>69677</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Limoges Hopital Dupuytren; Service de Medecine Geriatrique</name>
      <address>
        <city>Limoges</city>
        <zip>87042</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Central; Neurologie</name>
      <address>
        <city>Nancy</city>
        <zip>54035</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Nord Laennec</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Rouen Hopital; Service de Neurologie</name>
      <address>
        <city>Rouen</city>
        <zip>76031</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Civil de Strasbourg</name>
      <address>
        <city>Strasbourg</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univ Berlin; Klin fur Psychi &amp; Psycho Charite</name>
      <address>
        <city>Berlin</city>
        <zip>12203</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bezirkskrankenhaus Günzburg</name>
      <address>
        <city>Günzburg</city>
        <zip>89312</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zentralinstitut fuer Seelische Gesundheit</name>
      <address>
        <city>Mannheim</city>
        <zip>68159</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ludwig-Maximilians-Univ.</name>
      <address>
        <city>Munchen</city>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum rechts der Isar der Technischen Universität München</name>
      <address>
        <city>Munchen</city>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinik Tübingen; Psychiatrie und Psychotherapie</name>
      <address>
        <city>Tubingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundació ACE</name>
      <address>
        <city>BArcelon</city>
        <state>Barcelona</state>
        <zip>08034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General de Catalunya</name>
      <address>
        <city>San Cugat Del Valles</city>
        <state>Barcelona</state>
        <zip>08195</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinica Guipuzcoa</name>
      <address>
        <city>San Sebastian</city>
        <state>Guipuzcoa</state>
        <zip>20009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Cruces; Servicio de Neurologia</name>
      <address>
        <city>Barakaldo</city>
        <state>Vizcaya</state>
        <zip>48903</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario Universitario de Albacete</name>
      <address>
        <city>Albacete</city>
        <zip>2006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Ruber, 4 planta; Servicio de Neurologia</name>
      <address>
        <city>Madrid</city>
        <zip>28006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Rice Centre; Royal United Hospital</name>
      <address>
        <city>Bath</city>
        <zip>BA1 3NG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West London Research Unit; Brentford Lodge</name>
      <address>
        <city>Brentford</city>
        <zip>TW8 8DS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Sussex County Hospital, CIRU Level 5</name>
      <address>
        <city>Brighton</city>
        <zip>BN2 5BE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Glasgow Memory Clinic</name>
      <address>
        <city>Glasgow</city>
        <zip>G20 0XA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The National Hospital for Neurology &amp; Neurosurgery; Dementia Research Center</name>
      <address>
        <city>London, GT LON</city>
        <zip>WC1N 3BG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southampton General Hospital; Pharmacy</name>
      <address>
        <city>Southampton</city>
        <zip>SO16 6YD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moorgreen Hospital; Memory Assessment &amp; Rsch Ctr</name>
      <address>
        <city>Southampton</city>
        <zip>SO30 3JB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Great Western Hosp.; Kingshill Research Ctr</name>
      <address>
        <city>Swindon</city>
        <zip>SN3 6BW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>France</country>
    <country>Germany</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
  </removed_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>November 6, 2012</study_first_submitted>
  <study_first_submitted_qc>November 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 8, 2012</study_first_posted>
  <results_first_submitted>January 24, 2020</results_first_submitted>
  <results_first_submitted_qc>February 10, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">February 12, 2020</results_first_posted>
  <disposition_first_submitted>January 26, 2018</disposition_first_submitted>
  <disposition_first_submitted_qc>January 26, 2018</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">January 29, 2018</disposition_first_posted>
  <last_update_submitted>February 18, 2020</last_update_submitted>
  <last_update_submitted_qc>February 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 22, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/26/NCT01723826/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 360 participants were enrolled at 83 sites across 6 countries.</recruitment_details>
      <pre_assignment_details>Participants who completed either Phase II Study NCT01343966 (ABE4869g) or NCT01397578 (ABE4955g) and had Mini-Mental State Examination (MMSE) score of 10 or more at the time of screening were included. Participant flow is represented based on the safety population by treatment received.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>PCP PL - OLE CREN SC - OLE CREN IV</title>
          <description>Participants who on their placebo-controlled portion [PCP]/parent study received placebo (PL) and who on this open-label extension (OLE) study initially received crenezumab (CREN) subcutaneously (SC) and after the protocol amendment received CREN intravenously (IV).</description>
        </group>
        <group group_id="P2">
          <title>PCP PL - OLE CREN IV</title>
          <description>Participants who on their PCP/parent study received placebo and who on this OLE study received CREN IV.</description>
        </group>
        <group group_id="P3">
          <title>PCP CREN SC - OLE CREN SC - OLE CREN IV</title>
          <description>Participants who on their PCP/parent study received CREN and who on this OLE study initially received CREN SC and after the protocol amendment received CREN IV.</description>
        </group>
        <group group_id="P4">
          <title>PCP CREN IV - OLE CREN IV</title>
          <description>Participants who on their PCP/parent study received CREN IV and who on this OLE study received CREN IV.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="47"/>
                <participants group_id="P2" count="63"/>
                <participants group_id="P3" count="101"/>
                <participants group_id="P4" count="149"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="27"/>
                <participants group_id="P3" count="44"/>
                <participants group_id="P4" count="59"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="36"/>
                <participants group_id="P3" count="57"/>
                <participants group_id="P4" count="90"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death according to AE eCRF</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-compliance</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-compliance With Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other Reason</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="12"/>
                <participants group_id="P4" count="14"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="17"/>
                <participants group_id="P3" count="27"/>
                <participants group_id="P4" count="48"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>PCP PL - OLE CREN SC - OLE CREN IV</title>
          <description>Participants who on their placebo-controlled portion [PCP]/parent study received placebo (PL) and who on this open-label extension (OLE) study initially received crenezumab (CREN) subcutaneously (SC) and after the protocol amendment received CREN intravenously (IV).</description>
        </group>
        <group group_id="B2">
          <title>PCP PL - OLE CREN IV</title>
          <description>Participants who on their PCP/parent study received placebo and who on this OLE study received CREN IV.</description>
        </group>
        <group group_id="B3">
          <title>PCP CREN SC - OLE CREN SC - OLE CREN IV</title>
          <description>Participants who on their PCP/parent study received CREN and who on this OLE study initially received CREN SC and after the protocol amendment received CREN IV.</description>
        </group>
        <group group_id="B4">
          <title>PCP CREN IV - OLE CREN IV</title>
          <description>Participants who on their PCP/parent study received CREN IV and who on this OLE study received CREN IV.</description>
        </group>
        <group group_id="B5">
          <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="47"/>
            <count group_id="B2" value="63"/>
            <count group_id="B3" value="101"/>
            <count group_id="B4" value="149"/>
            <count group_id="B5" value="360"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70.9" spread="7.4"/>
                    <measurement group_id="B2" value="71.9" spread="7.4"/>
                    <measurement group_id="B3" value="72.3" spread="7.2"/>
                    <measurement group_id="B4" value="72.2" spread="6.7"/>
                    <measurement group_id="B5" value="72.0" spread="7.0"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="58"/>
                    <measurement group_id="B4" value="79"/>
                    <measurement group_id="B5" value="199"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="43"/>
                    <measurement group_id="B4" value="70"/>
                    <measurement group_id="B5" value="161"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="61"/>
                    <measurement group_id="B3" value="98"/>
                    <measurement group_id="B4" value="145"/>
                    <measurement group_id="B5" value="349"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Stated</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                    <measurement group_id="B2" value="63"/>
                    <measurement group_id="B3" value="97"/>
                    <measurement group_id="B4" value="144"/>
                    <measurement group_id="B5" value="351"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Adverse Events (AEs)</title>
        <description>An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. . An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.</description>
        <time_frame>Up to 50 months</time_frame>
        <population>Safety Analysis population included all participants who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>PCP PL - OLE CREN SC - OLE CREN IV</title>
            <description>Participants who on their placebo-controlled portion [PCP]/parent study received placebo (PL) and who on this open-label extension (OLE) study initially received crenezumab (CREN) subcutaneously (SC) and after the protocol amendment received CREN intravenously (IV).</description>
          </group>
          <group group_id="O2">
            <title>PCP PL - OLE CREN IV</title>
            <description>Participants who on their PCP/parent study received placebo and who on this OLE study received CREN IV.</description>
          </group>
          <group group_id="O3">
            <title>PCP CREN - OLE CREN SC -OLE CREN IV</title>
            <description>Participants who on their PCP/parent study received CREN and who on this OLE study initially received CREN SC and after the protocol amendment received CREN IV.</description>
          </group>
          <group group_id="O4">
            <title>PCP CREN - OLE CREN IV</title>
            <description>Participants who on their PCP/parent study received CREN IV and who on this OLE study received CREN IV.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Adverse Events (AEs)</title>
          <description>An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. . An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.</description>
          <population>Safety Analysis population included all participants who received at least one dose of study drug.</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="47"/>
                <count group_id="O2" value="63"/>
                <count group_id="O3" value="101"/>
                <count group_id="O4" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.4"/>
                    <measurement group_id="O2" value="90.5"/>
                    <measurement group_id="O3" value="96.0"/>
                    <measurement group_id="O4" value="87.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants by Nature of AEs</title>
        <description>A serious adverse event (SAE) is any AE that meets any of the following criteria: fatal, life threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in a neonate/infant. Non-SAE of special interest for this study include the following: cerebral vascular edema, Superficial siderosis of central nervous system, cerebral micro-hemorrhages or macro-hemorrhages, pneumonia, liver injury.</description>
        <time_frame>Up to 50 months</time_frame>
        <population>Safety Analysis population included all participants who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>PCP PL - OLE CREN SC - OLE CREN IV</title>
            <description>Participants who on their placebo-controlled portion [PCP]/parent study received placebo (PL) and who on this open-label extension (OLE) study initially received crenezumab (CREN) subcutaneously (SC) and after the protocol amendment received CREN intravenously (IV).</description>
          </group>
          <group group_id="O2">
            <title>PCP PL - OLE CREN IV</title>
            <description>Participants who on their PCP/parent study received placebo and who on this OLE study received CREN IV.</description>
          </group>
          <group group_id="O3">
            <title>PCP CREN - OLE CREN SC -OLE CREN IV</title>
            <description>Participants who on their PCP/parent study received CREN and who on this OLE study initially received CREN SC and after the protocol amendment received CREN IV.</description>
          </group>
          <group group_id="O4">
            <title>PCP CREN - OLE CREN IV</title>
            <description>Participants who on their PCP/parent study received CREN IV and who on this OLE study received CREN IV.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants by Nature of AEs</title>
          <description>A serious adverse event (SAE) is any AE that meets any of the following criteria: fatal, life threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in a neonate/infant. Non-SAE of special interest for this study include the following: cerebral vascular edema, Superficial siderosis of central nervous system, cerebral micro-hemorrhages or macro-hemorrhages, pneumonia, liver injury.</description>
          <population>Safety Analysis population included all participants who received at least one dose of study drug.</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="47"/>
                <count group_id="O2" value="63"/>
                <count group_id="O3" value="101"/>
                <count group_id="O4" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.1"/>
                    <measurement group_id="O2" value="22.2"/>
                    <measurement group_id="O3" value="21.8"/>
                    <measurement group_id="O4" value="23.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.2"/>
                    <measurement group_id="O2" value="88.9"/>
                    <measurement group_id="O3" value="94.1"/>
                    <measurement group_id="O4" value="87.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants by Severity of AEs</title>
        <description>AE severity grading scale for the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 was used for assessing adverse event severity. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on the following general guideline: Grade 1) mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated, Grade 2) moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL), Grade 3) severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL, Grade 4) life-threatening consequences; urgent intervention indicated, Grade 5) death related to AE.</description>
        <time_frame>Up to 50 months</time_frame>
        <population>Safety Analysis population included all participants who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>PCP PL - OLE CREN SC - OLE CREN IV</title>
            <description>Participants who on their placebo-controlled portion [PCP]/parent study received placebo (PL) and who on this open-label extension (OLE) study initially received crenezumab (CREN) subcutaneously (SC) and after the protocol amendment received CREN intravenously (IV).</description>
          </group>
          <group group_id="O2">
            <title>PCP PL - OLE CREN IV</title>
            <description>Participants who on their PCP/parent study received placebo and who on this OLE study received CREN IV.</description>
          </group>
          <group group_id="O3">
            <title>PCP CREN - OLE CREN SC -OLE CREN IV</title>
            <description>Participants who on their PCP/parent study received CREN and who on this OLE study initially received CREN SC and after the protocol amendment received CREN IV.</description>
          </group>
          <group group_id="O4">
            <title>PCP CREN - OLE CREN IV</title>
            <description>Participants who on their PCP/parent study received CREN IV and who on this OLE study received CREN IV.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants by Severity of AEs</title>
          <description>AE severity grading scale for the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 was used for assessing adverse event severity. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on the following general guideline: Grade 1) mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated, Grade 2) moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL), Grade 3) severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL, Grade 4) life-threatening consequences; urgent intervention indicated, Grade 5) death related to AE.</description>
          <population>Safety Analysis population included all participants who received at least one dose of study drug.</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="47"/>
                <count group_id="O2" value="63"/>
                <count group_id="O3" value="101"/>
                <count group_id="O4" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.1"/>
                    <measurement group_id="O2" value="34.9"/>
                    <measurement group_id="O3" value="29.7"/>
                    <measurement group_id="O4" value="22.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.7"/>
                    <measurement group_id="O2" value="31.7"/>
                    <measurement group_id="O3" value="43.6"/>
                    <measurement group_id="O4" value="40.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.8"/>
                    <measurement group_id="O2" value="17.5"/>
                    <measurement group_id="O3" value="16.8"/>
                    <measurement group_id="O4" value="19.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.5"/>
                    <measurement group_id="O2" value="1.6"/>
                    <measurement group_id="O3" value="3.0"/>
                    <measurement group_id="O4" value="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3"/>
                    <measurement group_id="O2" value="4.8"/>
                    <measurement group_id="O3" value="3.0"/>
                    <measurement group_id="O4" value="4.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Human Anti-Therapeutic Antibody (ATA) Formation</title>
        <description>ATA is a measurement to explore the potential relationship of immunogenicity response with pharmacokinetics, safety and efficacy. Percentage of participants at post-baseline with positive results for ATA against crenezumab are reported.</description>
        <time_frame>Pre-dose (Day-14), predose at Week 25, 49, 97, Follow-up Week 8 (Week 153) and 12 (Week 157)</time_frame>
        <population>Safety Analysis population included all participants who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>PCP PL - OLE CREN SC - OLE CREN IV</title>
            <description>Participants who on their placebo-controlled portion [PCP]/parent study received placebo (PL) and who on this open-label extension (OLE) study initially received crenezumab (CREN) subcutaneously (SC) and after the protocol amendment received CREN intravenously (IV).</description>
          </group>
          <group group_id="O2">
            <title>PCP PL - OLE CREN IV</title>
            <description>Participants who on their PCP/parent study received placebo and who on this OLE study received CREN IV.</description>
          </group>
          <group group_id="O3">
            <title>PCP CREN - OLE CREN SC -OLE CREN IV</title>
            <description>Participants who on their PCP/parent study received CREN and who on this OLE study initially received CREN SC and after the protocol amendment received CREN IV.</description>
          </group>
          <group group_id="O4">
            <title>PCP CREN - OLE CREN IV</title>
            <description>Participants who on their PCP/parent study received CREN IV and who on this OLE study received CREN IV.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Human Anti-Therapeutic Antibody (ATA) Formation</title>
          <description>ATA is a measurement to explore the potential relationship of immunogenicity response with pharmacokinetics, safety and efficacy. Percentage of participants at post-baseline with positive results for ATA against crenezumab are reported.</description>
          <population>Safety Analysis population included all participants who received at least one dose of study drug.</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="47"/>
                <count group_id="O2" value="63"/>
                <count group_id="O3" value="101"/>
                <count group_id="O4" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.1"/>
                    <measurement group_id="O2" value="3.4"/>
                    <measurement group_id="O3" value="9.1"/>
                    <measurement group_id="O4" value="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Amyloid-Related Imaging Abnormalities Edema/Effusions (ARIA-E)</title>
        <description>Alzheimer's disease (AD) is associated with ARIA. The occurrence of imaging abnormalities believed to represent cerebral vasogenic edema, has been reported in association with the investigational use of compounds that are intended to treat Alzheimer's disease by reducing Abeta in the brain. Here, the percentage of participants with symptomatic and asymptomatic ARIA-E were reported.</description>
        <time_frame>Baseline, Weeks 23, 47, 71, 97, 121 and 153</time_frame>
        <population>Safety Analysis population included all participants who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>PCP PL - OLE CREN SC - OLE CREN IV</title>
            <description>Participants who on their placebo-controlled portion [PCP]/parent study received placebo (PL) and who on this open-label extension (OLE) study initially received crenezumab (CREN) subcutaneously (SC) and after the protocol amendment received CREN intravenously (IV).</description>
          </group>
          <group group_id="O2">
            <title>PCP PL - OLE CREN IV</title>
            <description>Participants who on their PCP/parent study received placebo and who on this OLE study received CREN IV.</description>
          </group>
          <group group_id="O3">
            <title>PCP CREN - OLE CREN SC -OLE CREN IV</title>
            <description>Participants who on their PCP/parent study received CREN and who on this OLE study initially received CREN SC and after the protocol amendment received CREN IV.</description>
          </group>
          <group group_id="O4">
            <title>PCP CREN - OLE CREN IV</title>
            <description>Participants who on their PCP/parent study received CREN IV and who on this OLE study received CREN IV.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Amyloid-Related Imaging Abnormalities Edema/Effusions (ARIA-E)</title>
          <description>Alzheimer's disease (AD) is associated with ARIA. The occurrence of imaging abnormalities believed to represent cerebral vasogenic edema, has been reported in association with the investigational use of compounds that are intended to treat Alzheimer's disease by reducing Abeta in the brain. Here, the percentage of participants with symptomatic and asymptomatic ARIA-E were reported.</description>
          <population>Safety Analysis population included all participants who received at least one dose of study drug.</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="47"/>
                <count group_id="O2" value="63"/>
                <count group_id="O3" value="101"/>
                <count group_id="O4" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Symptomatic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asymptomatic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Amyloid-Related Imaging Abnormalities-Hemorrhage (ARIA-H)</title>
        <description>AD is associated with ARIA. Cerebral micro-hemorrhages (microbleeds [MBs]) are radiologically defined as small dot-like foci of signal loss observed on magnetic resonance imaging (MRI) sequences sensitive for paramagnetic tissue properties. The occurrence of MBs has also been identified as an adverse event in anti-amyloid vaccination trials, and together with superficial siderosis, they have been termed ARIA-H.</description>
        <time_frame>Baseline, Weeks 23, 47, 71, 97, 121 and 153</time_frame>
        <population>Safety Analysis population included all participants who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>PCP PL - OLE CREN SC - OLE CREN IV</title>
            <description>Participants who on their placebo-controlled portion [PCP]/parent study received placebo (PL) and who on this open-label extension (OLE) study initially received crenezumab (CREN) subcutaneously (SC) and after the protocol amendment received CREN intravenously (IV).</description>
          </group>
          <group group_id="O2">
            <title>PCP PL - OLE CREN IV</title>
            <description>Participants who on their PCP/parent study received placebo and who on this OLE study received CREN IV.</description>
          </group>
          <group group_id="O3">
            <title>PCP CREN - OLE CREN SC -OLE CREN IV</title>
            <description>Participants who on their PCP/parent study received CREN and who on this OLE study initially received CREN SC and after the protocol amendment received CREN IV.</description>
          </group>
          <group group_id="O4">
            <title>PCP CREN - OLE CREN IV</title>
            <description>Participants who on their PCP/parent study received CREN IV and who on this OLE study received CREN IV.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Amyloid-Related Imaging Abnormalities-Hemorrhage (ARIA-H)</title>
          <description>AD is associated with ARIA. Cerebral micro-hemorrhages (microbleeds [MBs]) are radiologically defined as small dot-like foci of signal loss observed on magnetic resonance imaging (MRI) sequences sensitive for paramagnetic tissue properties. The occurrence of MBs has also been identified as an adverse event in anti-amyloid vaccination trials, and together with superficial siderosis, they have been termed ARIA-H.</description>
          <population>Safety Analysis population included all participants who received at least one dose of study drug.</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="47"/>
                <count group_id="O2" value="63"/>
                <count group_id="O3" value="101"/>
                <count group_id="O4" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Superficial Siderosis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3.0"/>
                    <measurement group_id="O4" value="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>New Micro-hemorrhage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.4"/>
                    <measurement group_id="O2" value="9.5"/>
                    <measurement group_id="O3" value="4.0"/>
                    <measurement group_id="O4" value="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 50 months</time_frame>
      <desc>Safety Analysis population included all participants who received at least one dose of study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>PCP PL - OLE CREN SC - OLE CREN IV</title>
          <description>Participants who on their placebo-controlled portion [PCP]/parent study received placebo (PL) and who on this open-label extension (OLE) study initially received crenezumab (CREN) subcutaneously (SC) and after the protocol amendment received CREN intravenously (IV).</description>
        </group>
        <group group_id="E2">
          <title>PCP PL - OLE CREN IV</title>
          <description>Participants who on their PCP/parent study received placebo and who on this OLE study received CREN IV.</description>
        </group>
        <group group_id="E3">
          <title>PCP CREN SC - OLE CREN SC - OLE CREN IV</title>
          <description>Participants who on their PCP/parent study received CREN and who on this OLE study initially received CREN SC and after the protocol amendment received CREN IV.</description>
        </group>
        <group group_id="E4">
          <title>PCP CREN IV - OLE CREN IV</title>
          <description>Participants who on their PCP/parent study received CREN IV and who on this OLE study received CREN IV.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA version 20.0</default_vocab>
        <default_assessment>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="47"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="101"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="47"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="22" subjects_at_risk="101"/>
                <counts group_id="E4" subjects_affected="35" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>ANAEMIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>NEUTROPENIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>ACUTE MYOCARDIAL INFARCTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>ATRIAL FIBRILLATION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>ATRIAL FLUTTER</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>CARDIO-RESPIRATORY ARREST</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>MYOCARDIAL INFARCTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>SINUS TACHYCARDIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>VERTIGO</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>ABDOMINAL PAIN</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>INGUINAL HERNIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>INTESTINAL OBSTRUCTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>NAUSEA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>SMALL INTESTINAL OBSTRUCTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>VOMITING</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>ASTHENIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>CHEST PAIN</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>DEATH</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>GAIT DISTURBANCE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>INCARCERATED HERNIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>BILIARY COLIC</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>CHOLELITHIASIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>BACTERAEMIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>DIVERTICULITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>ESCHERICHIA URINARY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="101"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>GASTROENTERITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>INFLUENZA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>OSTEOMYELITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>PNEUMONIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E4" events="5" subjects_affected="3" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>PNEUMONIA BACTERIAL</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>PNEUMONIA ESCHERICHIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>PNEUMONIA VIRAL</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>POST PROCEDURAL INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>SEPSIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>SEPTIC SHOCK</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>UPPER RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>URINARY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>UROSEPSIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>ANKLE FRACTURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>CERVICAL VERTEBRAL FRACTURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>FACIAL BONES FRACTURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>FALL</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>FEMORAL NECK FRACTURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>FEMUR FRACTURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>FRACTURE DISPLACEMENT</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>FRACTURED SACRUM</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>HIP FRACTURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>HUMERUS FRACTURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>LACERATION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>LIMB INJURY</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>PELVIC FRACTURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>SUBARACHNOID HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>SUBDURAL HAEMATOMA</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>THORACIC VERTEBRAL FRACTURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>WRIST FRACTURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>ADULT FAILURE TO THRIVE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>DEHYDRATION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>BACK PAIN</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>OSTEOARTHRITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>BASAL CELL CARCINOMA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>COLON CANCER</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>INTESTINAL ADENOCARCINOMA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>METASTATIC NEOPLASM</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>PROSTATE CANCER</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>BASILAR ARTERY STENOSIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>CEREBROVASCULAR ACCIDENT</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>DEMENTIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="63"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>DEMENTIA ALZHEIMER'S TYPE</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>DEMENTIA WITH LEWY BODIES</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>DEPRESSED LEVEL OF CONSCIOUSNESS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>DIZZINESS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>ENCEPHALOPATHY</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>EPILEPSY</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>GENERALISED TONIC-CLONIC SEIZURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>HYDROCEPHALUS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>ISCHAEMIC STROKE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>METABOLIC ENCEPHALOPATHY</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>PARAESTHESIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>PRESYNCOPE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="101"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>SEIZURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>SYNCOPE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="63"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="101"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>TRANSIENT ISCHAEMIC ATTACK</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>DEVICE DISLOCATION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>DEVICE FAILURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>ABNORMAL BEHAVIOUR</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>AGGRESSION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>AGITATION</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>DELIRIUM</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>DISORIENTATION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>MENTAL STATUS CHANGES</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="101"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>PSYCHOTIC DISORDER</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>ACUTE PRERENAL FAILURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>URINARY RETENTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>ACUTE RESPIRATORY FAILURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>PULMONARY GRANULOMA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>TACHYPNOEA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>AORTIC ANEURYSM</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>DEEP VEIN THROMBOSIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>EXSANGUINATION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>HYPERTENSION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>HYPOTENSION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="101"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>PHLEBITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA version 20.0</default_vocab>
        <default_assessment>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="37" subjects_at_risk="47"/>
                <counts group_id="E2" subjects_affected="51" subjects_at_risk="63"/>
                <counts group_id="E3" subjects_affected="80" subjects_at_risk="101"/>
                <counts group_id="E4" subjects_affected="97" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>CONSTIPATION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="63"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="101"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>DIARRHOEA</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="47"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="63"/>
                <counts group_id="E3" events="12" subjects_affected="11" subjects_at_risk="101"/>
                <counts group_id="E4" events="23" subjects_affected="14" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>VOMITING</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="5" subjects_affected="3" subjects_at_risk="63"/>
                <counts group_id="E3" events="6" subjects_affected="5" subjects_at_risk="101"/>
                <counts group_id="E4" events="11" subjects_affected="8" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>FATIGUE</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="8" subjects_affected="8" subjects_at_risk="101"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>INJECTION SITE ERYTHEMA</sub_title>
                <counts group_id="E1" events="13" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" events="10" subjects_affected="8" subjects_at_risk="101"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>INJECTION SITE EXTRAVASATION</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" events="7" subjects_affected="3" subjects_at_risk="101"/>
                <counts group_id="E4" events="16" subjects_affected="4" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>BRONCHITIS</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="63"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="101"/>
                <counts group_id="E4" events="9" subjects_affected="9" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>UPPER RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="47"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="63"/>
                <counts group_id="E3" events="20" subjects_affected="15" subjects_at_risk="101"/>
                <counts group_id="E4" events="15" subjects_affected="13" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>URINARY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="47"/>
                <counts group_id="E2" events="13" subjects_affected="9" subjects_at_risk="63"/>
                <counts group_id="E3" events="23" subjects_affected="16" subjects_at_risk="101"/>
                <counts group_id="E4" events="34" subjects_affected="18" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>VIRAL UPPER RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="7" subjects_affected="5" subjects_at_risk="47"/>
                <counts group_id="E2" events="14" subjects_affected="11" subjects_at_risk="63"/>
                <counts group_id="E3" events="11" subjects_affected="10" subjects_at_risk="101"/>
                <counts group_id="E4" events="13" subjects_affected="13" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>CONTUSION</sub_title>
                <counts group_id="E1" events="6" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="63"/>
                <counts group_id="E3" events="8" subjects_affected="6" subjects_at_risk="101"/>
                <counts group_id="E4" events="10" subjects_affected="8" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>FALL</sub_title>
                <counts group_id="E1" events="10" subjects_affected="7" subjects_at_risk="47"/>
                <counts group_id="E2" events="11" subjects_affected="8" subjects_at_risk="63"/>
                <counts group_id="E3" events="42" subjects_affected="26" subjects_at_risk="101"/>
                <counts group_id="E4" events="28" subjects_affected="18" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>LACERATION</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="47"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="63"/>
                <counts group_id="E3" events="11" subjects_affected="10" subjects_at_risk="101"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>SKIN ABRASION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="63"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="101"/>
                <counts group_id="E4" events="5" subjects_affected="3" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>WEIGHT DECREASED</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="47"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="63"/>
                <counts group_id="E3" events="11" subjects_affected="8" subjects_at_risk="101"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>ARTHRALGIA</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="63"/>
                <counts group_id="E3" events="10" subjects_affected="8" subjects_at_risk="101"/>
                <counts group_id="E4" events="10" subjects_affected="8" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>BACK PAIN</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="47"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="63"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="101"/>
                <counts group_id="E4" events="8" subjects_affected="8" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>MUSCLE SPASMS</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="6" subjects_affected="4" subjects_at_risk="101"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>TENDONITIS</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="47"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="63"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>SQUAMOUS CELL CARCINOMA</sub_title>
                <counts group_id="E1" events="8" subjects_affected="3" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="101"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>CEREBRAL MICROHAEMORRHAGE</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="47"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="63"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="101"/>
                <counts group_id="E4" events="7" subjects_affected="6" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>DIZZINESS</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="63"/>
                <counts group_id="E3" events="14" subjects_affected="11" subjects_at_risk="101"/>
                <counts group_id="E4" events="11" subjects_affected="10" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>HEADACHE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="63"/>
                <counts group_id="E3" events="10" subjects_affected="8" subjects_at_risk="101"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>AGITATION</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="47"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="63"/>
                <counts group_id="E3" events="20" subjects_affected="13" subjects_at_risk="101"/>
                <counts group_id="E4" events="14" subjects_affected="13" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>ANXIETY</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="63"/>
                <counts group_id="E3" events="9" subjects_affected="8" subjects_at_risk="101"/>
                <counts group_id="E4" events="16" subjects_affected="15" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>CONFUSIONAL STATE</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="101"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>DELUSION</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="101"/>
                <counts group_id="E4" events="6" subjects_affected="4" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>DEPRESSION</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="47"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="63"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="101"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="149"/>
              </event>
              <event>
                <sub_title>INSOMNIA</sub_title>
                <counts group_id="E1" events="6" subjects_affected="3" subjects_at_risk="47"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E3" events="10" subjects_affected="8" subjects_at_risk="101"/>
                <counts group_id="E4" events="9" subjects_affected="8" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>URINARY INCONTINENCE</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="47"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E3" events="6" subjects_affected="5" subjects_at_risk="101"/>
                <counts group_id="E4" events="8" subjects_affected="8" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>COUGH</sub_title>
                <counts group_id="E1" events="11" subjects_affected="5" subjects_at_risk="47"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="63"/>
                <counts group_id="E3" events="9" subjects_affected="8" subjects_at_risk="101"/>
                <counts group_id="E4" events="13" subjects_affected="11" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>RASH</sub_title>
                <counts group_id="E1" events="7" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="63"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="101"/>
                <counts group_id="E4" events="7" subjects_affected="6" subjects_at_risk="149"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>HAEMATOMA</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="47"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="63"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="101"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="149"/>
              </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>The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Communications</name_or_title>
      <organization>Hoffmann-La Roche</organization>
      <phone>800 821-8590</phone>
      <email>genentech@druginfo.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/NCT01723826
org study id: GN28525
secondary id: 2012-003242-33
nct id: NCT01723826
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
This Phase II, open-label extension (OLE), multicenter study will evaluate the long-term
      safety and tolerability of crenezumab in participants with mild to moderate Alzheimer's
      disease who have participated in and completed the treatment period of the Phase II Study
      ABE4869g (NCT01343966) or ABE4955g (NCT01397578). Participants who received placebo in Study
      ABE4869g (NCT01343966) or ABE4955g (NCT01397578) will receive crenezumab. Anticipated time on
      study treatment is 144 weeks.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants With Adverse Events (AEs)
time frame: Up to 50 months
description: An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. . An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
measure: Percentage of Participants by Nature of AEs
time frame: Up to 50 months
description: A serious adverse event (SAE) is any AE that meets any of the following criteria: fatal, life threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in a neonate/infant. Non-SAE of special interest for this study include the following: cerebral vascular edema, Superficial siderosis of central nervous system, cerebral micro-hemorrhages or macro-hemorrhages, pneumonia, liver injury.
measure: Percentage of Participants by Severity of AEs
time frame: Up to 50 months
description: AE severity grading scale for the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 was used for assessing adverse event severity. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on the following general guideline: Grade 1) mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated, Grade 2) moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL), Grade 3) severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL, Grade 4) life-threatening consequences; urgent intervention indicated, Grade 5) death related to AE.
measure: Percentage of Participants With Human Anti-Therapeutic Antibody (ATA) Formation
time frame: Pre-dose (Day-14), predose at Week 25, 49, 97, Follow-up Week 8 (Week 153) and 12 (Week 157)
description: ATA is a measurement to explore the potential relationship of immunogenicity response with pharmacokinetics, safety and efficacy. Percentage of participants at post-baseline with positive results for ATA against crenezumab are reported.
measure: Percentage of Participants With Amyloid-Related Imaging Abnormalities Edema/Effusions (ARIA-E)
time frame: Baseline, Weeks 23, 47, 71, 97, 121 and 153
description: Alzheimer's disease (AD) is associated with ARIA. The occurrence of imaging abnormalities believed to represent cerebral vasogenic edema, has been reported in association with the investigational use of compounds that are intended to treat Alzheimer's disease by reducing Abeta in the brain. Here, the percentage of participants with symptomatic and asymptomatic ARIA-E were reported.
measure: Percentage of Participants With Amyloid-Related Imaging Abnormalities-Hemorrhage (ARIA-H)
time frame: Baseline, Weeks 23, 47, 71, 97, 121 and 153
description: AD is associated with ARIA. Cerebral micro-hemorrhages (microbleeds [MBs]) are radiologically defined as small dot-like foci of signal loss observed on magnetic resonance imaging (MRI) sequences sensitive for paramagnetic tissue properties. The occurrence of MBs has also been identified as an adverse event in anti-amyloid vaccination trials, and together with superficial siderosis, they have been termed ARIA-H.
arm group label: Crenezumab
arm group type: Experimental
description: Participants will receive intravenous infusion of crenezumab every 4 weeks for 144 weeks.
intervention type: Drug
intervention name: Crenezumab
description: Participants will receive intravenous infusion of crenezumab every 4 weeks for 144 weeks.
arm group label: Crenezumab
other name: RO5490245
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Genentech, Inc.
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country: Canada
country: France
country: Germany
country: Spain
country: United Kingdom
country: United States
country: Czech Republic
responsible party type: Sponsor
mesh term: Alzheimer Disease
provided document: 
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point of contact: 