<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/NCT03031938</url>
  </required_header>
  <id_info>
    <org_study_id>A4091065</org_study_id>
    <secondary_id>2013-002548-10</secondary_id>
    <secondary_id>INFANT SAFETY FOLLOW-UP #2</secondary_id>
    <secondary_id>NEONATAL MONITORING STUDY #2</secondary_id>
    <nct_id>NCT03031938</nct_id>
  </id_info>
  <brief_title>Protocol to Monitor the Neurological Development of Infants With Exposure in Utero From Birth to 15 Months in Tanezumab Clinical Studies</brief_title>
  <official_title>A PROTOCOL TO MONITOR FROM BIRTH TO AGE 15 MONTHS THE NEUROLOGICAL DEVELOPMENT OF INFANTS WITH EXPOSURE IN-UTERO IN TANEZUMAB CLINICAL STUDIES AT ALL INVESTIGATIONAL SITES</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A4091065 is a multicenter, prospective, cohort study with enhance physical an&#xD;
      neurodevelopmental surveillance to characterize the outcomes related to the development of&#xD;
      infants up to the age of 15 months who were potentially exposed to tanezumab, placebo or&#xD;
      comparator via maternal exposure or in utero in any tanezumb study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A4091065 is a long term observational follow up study of subjects from tanezumab&#xD;
      interventional studies A4091056, A4091057, A4091058, A4091059, A4091061 or A4091063&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 3, 2017</start_date>
  <completion_date type="Actual">June 4, 2020</completion_date>
  <primary_completion_date type="Actual">June 4, 2020</primary_completion_date>
  <phase>Phase 3</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Occipital-frontal Head Circumference During 0 to Less Than or Equal to (&lt;=) 2 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age from 0 to 2 Months</time_frame>
    <description>Occipital-frontal head circumference of participants in centimeter (cm) was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Occipital-frontal Head Circumference at 8 Months of Participant's Age</measure>
    <time_frame>At 8 Months of participants' age</time_frame>
    <description>Occipital-frontal head circumference of participants in centimeter (cm) was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Occipital-frontal Head Circumference at 15 Months of Participant's Age</measure>
    <time_frame>At 15 Months of participants' age</time_frame>
    <description>Occipital-frontal head circumference of participants in centimeter (cm) was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Occipital-frontal Head Circumference During 0 to Less Than or Equal to (&lt;=) 3 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age from 0 to 3 Months</time_frame>
    <description>Occipital-frontal head circumference of participants in centimeter (cm) was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Occipital-frontal Head Circumference During Greater Than (&gt;) 3 to &lt;=6 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age above 3 Months and up to 6 Months</time_frame>
    <description>Occipital-frontal head circumference of participants in cm was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Occipital-frontal Head Circumference During &gt;6 to &lt;=9 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age above 6 Months and up to 9 Months</time_frame>
    <description>Occipital-frontal head circumference of participants in cm was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Occipital-frontal Head Circumference During &gt;15 to &lt;=18 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age above 15 Months and up to 18 Months</time_frame>
    <description>Occipital-frontal head circumference of participants in cm was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Occipital-frontal Head Circumference During &gt;21 to &lt;=24 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age above 21 Months and up to 24 Months</time_frame>
    <description>Occipital-frontal head circumference of participants in cm was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Occipital-frontal Head Circumference During &gt;24 to &lt;=30 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age above 24 Months and up to 30 Months</time_frame>
    <description>Occipital-frontal head circumference of participants in cm was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body Length During 0 to Less Than or Equal to (&lt;=) 2 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age from 0 to 2 Months</time_frame>
    <description>Body length of participants in cm was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body Length at 8 Months of Participant's Age</measure>
    <time_frame>At 8 Months of participant's age</time_frame>
    <description>Body length of participants in cm was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body Length at 15 Months of Participant's Age</measure>
    <time_frame>At 15 Months of participant's age</time_frame>
    <description>Body length of participants in cm was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body Length During 0 to &lt;=3 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age from 0 to 3 Months</time_frame>
    <description>Body length of participants in cm was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body Length During &gt;3 to &lt;=6 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age above 3 Months and up to 6 Months</time_frame>
    <description>Body length of participants in cm was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body Length During &gt;6 to &lt;=9 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age above 6 Months and up to 9 Months</time_frame>
    <description>Body length of participants in cm was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body Length During &gt;15 to &lt;=18 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age above 15 Months and up to 18 Months</time_frame>
    <description>Body length of participants in cm was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body Length During &gt;21 to &lt;=24 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age above 21 Months and up to 24 Months</time_frame>
    <description>Body length of participants in cm was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body Length During &gt;24 to &lt;=30 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age above 24 Months and up to 30 Months</time_frame>
    <description>Body length of participants in cm was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body Weight During 0 to Less Than or Equal to (&lt;=) 2 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age from 0 to 2 Months</time_frame>
    <description>Body weight of participants in kilogram (kg) was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body Weight at 8 Months of Participant's Age</measure>
    <time_frame>At 8 Months of participants' age</time_frame>
    <description>Body weight of participants in kilogram (kg) was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body Weight at 15 Months of Participant's Age</measure>
    <time_frame>At 15 Months of participants' age</time_frame>
    <description>Body weight of participants in kilogram (kg) was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body Weight During 0 to &lt;=3 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age from 0 to 3 Months</time_frame>
    <description>Body weight of participants in kilogram (kg) was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body Weight During &gt;3 to &lt;=6 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age above 3 Months and up to 6 Months</time_frame>
    <description>Body weight of participants in kg was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body Weight During &gt;6 to &lt;=9 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age above 6 Months and up to 9 Months</time_frame>
    <description>Body weight of participants in kg was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body Weight During &gt;15 to &lt;=18 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age above 15 Months and up to 18 Months</time_frame>
    <description>Body weight of participants in kg was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body Weight During &gt;21 to &lt;=24 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age above 21 Months and up to 24 Months</time_frame>
    <description>Body weight of participants in kg was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body Weight During &gt;24 to &lt;=30 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age above 24 Months up to 30 Months</time_frame>
    <description>Body weight of participants in kg was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Systolic and Diastolic Blood Pressure During 0 to Less Than or Equal to (&lt;=) 2 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age from 0 to 2 Months</time_frame>
    <description>Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Systolic and Diastolic Blood Pressure at 8 Months of Participant's Age</measure>
    <time_frame>At 8 Months of participants' age</time_frame>
    <description>Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Systolic and Diastolic Blood Pressure at 15 Months of Participant's Age</measure>
    <time_frame>At 15 Months participants' age</time_frame>
    <description>Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Systolic and Diastolic Blood Pressure During 0 to &lt;=3 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age from 0 to 3 Months</time_frame>
    <description>Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Systolic and Diastolic Blood Pressure During &gt;3 to &lt;=6 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age above 3 Months and up to 6 Months</time_frame>
    <description>Systolic and diastolic blood pressure of participants in mmHg was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Systolic and Diastolic Blood Pressure During &gt;6 to &lt;=9 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age above 6 Months and up to 9 Months</time_frame>
    <description>Systolic and diastolic blood pressure of participants in mmHg was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Systolic and Diastolic Blood Pressure During &gt;15 to &lt;=18 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age above 15 Months and up to 18 Months</time_frame>
    <description>Systolic and diastolic blood pressure of participants in mmHg was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Systolic and Diastolic Blood Pressure During &gt;21 to &lt;=24 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age above 21 Months and up to 24 Months</time_frame>
    <description>Systolic and diastolic blood pressure of participants in mmHg was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Systolic and Diastolic Blood Pressure During &gt;24 to &lt;=30 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age above 24 Months and up to 30 Months</time_frame>
    <description>Systolic and diastolic blood pressure of participants in mmHg was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pulse Rate During 0 to Less Than or Equal to (&lt;=) 2 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age from 0 to 2 Months</time_frame>
    <description>Pulse rate of participants in beats per minute was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pulse Rate at 8 Months of Participant's Age</measure>
    <time_frame>At 8 Months of participants' age</time_frame>
    <description>Pulse rate of participants in beats per minute was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pulse Rate at 15 Months of Participant's Age</measure>
    <time_frame>At 15 Months of participants' age</time_frame>
    <description>Pulse rate of participants in beats per minute was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pulse Rate During 0 to &lt;=3 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age from 0 to 3 Months</time_frame>
    <description>Pulse rate of participants in beats per minute was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pulse Rate During &gt;3 to &lt;=6 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age above 3 Months and up to 6 Months</time_frame>
    <description>Pulse rate of participants in beats per minute was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pulse Rate During &gt;6 to &lt;=9 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age above 6 Months and up to 9 Months</time_frame>
    <description>Pulse rate of participants in beats per minute was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pulse Rate During &gt;15 to &lt;=18 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age above 15 Months and up to 18 Months</time_frame>
    <description>Pulse rate of participants in beats per minute was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pulse Rate During &gt;21 to &lt;=24 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age above 21 Months and up to 24 Months</time_frame>
    <description>Pulse rate of participants in beats per minute was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pulse Rate During &gt;24 to &lt;=30 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age above 24 Months and up to 30 Months</time_frame>
    <description>Pulse rate of participants in beats per minute was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Temperature During 0 to Less Than or Equal to (&lt;=) 2 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age from 0 to 2 Months</time_frame>
    <description>Temperature of participants in degree Celsius was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Temperature at 8 Months of Participant's Age</measure>
    <time_frame>At 8 Months of participants' age</time_frame>
    <description>Temperature of participants in degree Celsius was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Temperature at 15 Months of Participant's Age</measure>
    <time_frame>At 15 Months of participants' age</time_frame>
    <description>Temperature of participants in degree Celsius was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Temperature During 0 to &lt;=3 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age from 0 to 3 Months</time_frame>
    <description>Temperature of participants in degree Celsius was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Temperature During &gt;3 to &lt;=6 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age above 3 Months and up to 6 Months</time_frame>
    <description>Temperature of participants in degree Celsius was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Temperature During &gt;6 to &lt;=9 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age above 6 Months and up to 9 Months</time_frame>
    <description>Temperature of participants in degree Celsius was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Temperature During &gt;15 to &lt;=18 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age above 15 Months and up to 18 Months</time_frame>
    <description>Temperature of participants in degree Celsius was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Temperature During &gt;21 to &lt;=24 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age above 21 Months and up to 24 Months</time_frame>
    <description>Temperature of participants in degree Celsius was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Temperature During &gt;24 to &lt;=30 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age above 24 Months and up to 30 Months</time_frame>
    <description>Temperature of participants in degree Celsius was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Respiratory Rate During 0 to Less Than or Equal to (&lt;=) 2 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age from 0 to 2 Months</time_frame>
    <description>Respiratory rate of participants in breaths per minute was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Respiratory Rate at 8 Months of Participant's Age</measure>
    <time_frame>At 8 Months of participants' age</time_frame>
    <description>Respiratory rate of participants in breaths per minute was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Respiratory Rate at 15 Months of Participant's Age</measure>
    <time_frame>At 15 Months participants' age</time_frame>
    <description>Respiratory rate of participants in breaths per minute was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Respiratory Rate During 0 to &lt;=3 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age from 0 to 3 Months</time_frame>
    <description>Respiratory rate of participants in breaths per minute was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Respiratory Rate During &gt;3 to &lt;=6 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age above 3 Months and up to 6 Months</time_frame>
    <description>Respiratory rate of participants in breaths per minute was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Respiratory Rate During &gt;6 to &lt;=9 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age above 6 Months and up to 9 Months</time_frame>
    <description>Respiratory rate of participants in breaths per minute was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Respiratory Rate During &gt;15 to &lt;=18 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age above 15 Months and up to 18 Months</time_frame>
    <description>Respiratory rate of participants in breaths per minute was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Respiratory Rate During &gt;21 to &lt;=24 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age above 21 Months and up to 24 Months</time_frame>
    <description>Respiratory rate of participants in breaths per minute was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Respiratory Rate During &gt;24 to &lt;=30 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age above 24 Months and up to 30 Months</time_frame>
    <description>Respiratory rate of participants in breaths per minute was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Abnormal Neurological Examination Findings During 0 to Less Than or Equal to (&lt;=) 2 Months of Participant's Age</measure>
    <time_frame>Any visit during participants' age from 0 to 2 Months</time_frame>
    <description>Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Abnormal Neurological Examination Findings at 8 Months of Participant's Age</measure>
    <time_frame>At 8 Months of participants' age</time_frame>
    <description>Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Abnormal Neurological Examination Findings at 15 Months of Participant's Age</measure>
    <time_frame>At 15 Months of participants' age</time_frame>
    <description>Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Abnormal Neurological Examination Findings at Follow-up Visit 1 (Month 20 of Participant's Age)</measure>
    <time_frame>Follow-up Visit 1 (At the age of Month 20)</time_frame>
    <description>Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Abnormal Neurological Examination Findings at Follow-up Visit 2 (Month 26 of Participant's Age)</measure>
    <time_frame>Follow-up Visit 2 (At the age of 26 Months)</time_frame>
    <description>Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Month 8 of Participant's Age</measure>
    <time_frame>At 8 Months of participants' age</time_frame>
    <description>BINS: a validated instrument designed specifically for a high-risk infant population. It consisted of 11-13 items for different age levels (11 items for participants aged from 3-4 months, 11-15 months, 16-20 months; 13 items for participants aged from 5-6 months, 7-10 months, 21-24 months) to assess cognitive, social, language, gross, and fine motor skills. Each item was scored on a range 0 = non-optimal performance to 1 = optimal performance; BINS total score was sum of scores of each item and it ranged for 11 items from 0 (non-optimal performance) to 11 (optimum performance) and for 13 items from 0 (non-optimal performance) to 13 (optimum performance), higher score indicated better performance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Month 15 of Participant's Age</measure>
    <time_frame>At 15 Months of participants' age</time_frame>
    <description>BINS: a validated instrument designed specifically for a high-risk infant population. It consisted of 11-13 items for different age levels (11 items for participants aged from 3-4 months, 11-15 months, 16-20 months; 13 items for participants aged from 5-6 months, 7-10 months, 21-24 months) to assess cognitive, social, language, gross, and fine motor skills. Each item was scored on a range 0 = non-optimal performance to 1 = optimal performance; BINS total score was sum of scores of each item and it ranged for 11 items from 0 (non-optimal performance) to 11 (optimum performance) and for 13 items from 0 (non-optimal performance) to 13 (optimum performance), higher score indicated better performance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Follow-up Visit 1 (Month 20 of Participant's Age)</measure>
    <time_frame>Follow-up Visit 1 (At the age of Month 20)</time_frame>
    <description>BINS: a validated instrument designed specifically for a high-risk infant population. It consisted of 11-13 items for different age levels (11 items for participants aged from 3-4 months, 11-15 months, 16-20 months; 13 items for participants aged from 5-6 months, 7-10 months, 21-24 months) to assess cognitive, social, language, gross, and fine motor skills. Each item was scored on a range 0 = non-optimal performance to 1 = optimal performance; BINS total score was sum of scores of each item and it ranged for 11 items from 0 (non-optimal performance) to 11 (optimum performance) and for 13 items from 0 (non-optimal performance) to 13 (optimum performance), higher score indicated better performance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Follow-up Visit 2 (Month 26 of Participant's Age)</measure>
    <time_frame>Follow-up Visit 2 (At the age of Month 26)</time_frame>
    <description>BINS: a validated instrument designed specifically for a high-risk infant population. It consisted of 11-13 items for different age levels (11 items for participants aged from 3-4 months, 11-15 months, 16-20 months; 13 items for participants aged from 5-6 months, 7-10 months, 21-24 months) to assess cognitive, social, language, gross, and fine motor skills. Each item was scored on a range 0 = non-optimal performance to 1 = optimal performance; BINS total score was sum of scores of each item and it ranged for 11 items from 0 (non-optimal performance) to 11 (optimum performance) and for 13 items from 0 (non-optimal performance) to 13 (optimum performance), higher score indicated better performance. Data collected at age of 26 months used 24 months' age items.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Month 8 of Participant's Age</measure>
    <time_frame>At 8 Months of participants' age</time_frame>
    <description>REEL-3, was designed to identify infants and toddlers who had language impairments or who had other disabilities that affect language development. Caregiver answered interview questionnaire by pediatrician, pediatric neurologist or clinical psychologist for receptive language and expressive language subtests. Each of these 2 sub tests had 66 questions with answer of 'yes = 1' or 'no = 0'. Sum of receptive and expressive language subtests answers was used to calculate REEL-3 language ability total score, with following ranges: &lt;70 (very poor), 70-79 (poor), 80-89 (below average), 90-110 (average), 111-120 (above average), 121-130 (superior), and &gt;130 (very superior). Higher scores indicated better language ability.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Month 15 of Participant's Age</measure>
    <time_frame>At 15 Months of participants' age</time_frame>
    <description>REEL-3, was designed to identify infants and toddlers who had language impairments or who had other disabilities that affect language development. Caregiver answered interview questionnaire by pediatrician, pediatric neurologist or clinical psychologist for receptive language and expressive language subtests. Each of these 2 sub tests had 66 questions with answer of 'yes = 1' or 'no = 0'. Sum of receptive and expressive language subtests answers was used to calculate REEL-3 language ability total score, with following ranges: &lt;70 (very poor), 70-79 (poor), 80-89 (below average), 90-110 (average), 111-120 (above average), 121-130 (superior), and &gt;130 (very superior). Higher scores indicated better language ability.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Follow-up Visit 1 (Month 20 of Participant's Age)</measure>
    <time_frame>Follow-up Visit 1 (At the age of Month 20)</time_frame>
    <description>REEL-3, was designed to identify infants and toddlers who had language impairments or who had other disabilities that affect language development. Caregiver answered interview questionnaire by pediatrician, pediatric neurologist or clinical psychologist for receptive language and expressive language subtests. Each of these 2 sub tests had 66 questions with answer of 'yes = 1' or 'no = 0'. Sum of receptive and expressive language subtests answers was used to calculate REEL-3 language ability total score, with following ranges: &lt;70 (very poor), 70-79 (poor), 80-89 (below average), 90-110 (average), 111-120 (above average), 121-130 (superior), and &gt;130 (very superior). Higher scores indicated better language ability.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Follow-up Visit 2 (Month 26 of Participant's Age)</measure>
    <time_frame>Follow-up Visit 2 (At the age of Month 26)</time_frame>
    <description>REEL-3, was designed to identify infants and toddlers who had language impairments or who had other disabilities that affect language development. Caregiver answered interview questionnaire by pediatrician, pediatric neurologist or clinical psychologist for receptive language and expressive language subtests. Each of these 2 sub tests had 66 questions with answer of 'yes = 1' or 'no = 0'. Sum of receptive and expressive language subtests answers was used to calculate REEL-3 language ability total score, with following ranges: &lt;70 (very poor), 70-79 (poor), 80-89 (below average), 90-110 (average), 111-120 (above average), 121-130 (superior), and &gt;130 (very superior). Higher scores indicated better language ability.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Osteoarthritis</condition>
  <condition>Cancer Pain</condition>
  <condition>Recurrent Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Long term observational study of subjects from tanezumab parent study</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Investigational medical product (IMP) administered in parent study</intervention_name>
    <description>IMP as administered in parent study. IMP would have been either placebo, tanezumab, celecoxib, naproxen, diclofenac, administered in parent study</description>
    <arm_group_label>Cohort 1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is an infant born to a mother who was exposed to study drug on a tanezumab&#xD;
             clinical study.&#xD;
&#xD;
          -  The infant's mother (who was the tanezumab clinical study participant) must review,&#xD;
             agree and sign an informed consent document explaining the details of the perinatal&#xD;
             and post natal follow up. Where local regulations mandate, the male parent would also&#xD;
             review and sign the informed consent.&#xD;
&#xD;
          -  Parents or legal guardian must be willing and able to comply with scheduled visits and&#xD;
             study procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  There are no exclusion criteria for participating in this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>0 Years</minimum_age>
    <maximum_age>2 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>USC Keck 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>Gulfcoast Research Institute</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kennedy and White Orthopaedic Center</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric Epilepsy &amp; Neurology Specialists</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lafayette Clinical Research Group</name>
      <address>
        <city>Lafayette</city>
        <state>Indiana</state>
        <zip>47905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Preferred Pediatrics</name>
      <address>
        <city>Lafayette</city>
        <state>Indiana</state>
        <zip>47905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://pmiform.com/clinical-trial-info-request?StudyID=A4091065</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <results_first_submitted>June 1, 2021</results_first_submitted>
  <results_first_submitted_qc>June 1, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">June 25, 2021</results_first_posted>
  <last_update_submitted>June 1, 2021</last_update_submitted>
  <last_update_submitted_qc>June 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Exposure in utero in tanezumab program</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Low Back Pain</mesh_term>
    <mesh_term>Cancer Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.</ipd_description>
    <ipd_url>https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 26, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/38/NCT03031938/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 1, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/38/NCT03031938/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Infants to be enrolled were exposed potentially to tanezumab, placebo or comparator via maternal exposure at conception or in-utero during tanezumab clinical program, in any of the following studies: A4091056 (NCT02697773), A4091057 (NCT02709486), A4091058 (NCT02528188), A4091059 (NCT02528253), A4091061 (NCT02609828) or A4091063 (NCT02725411). Total 4 eligible infants were enrolled. Out of 4, 2 had tanezumab exposure, 2 had comparator (tramadol) exposure and none had placebo exposure.</recruitment_details>
      <pre_assignment_details>Protocol defined visits for vital signs were at age of 0-2, 8 and 15 months. Additional visits to collect vital signs, were defined in 3 month intervals for the first 2 years and then 6 month intervals up till as needed. Neurological examination was planned at age of 0-2, 8 and 15 months. Developmental assessments (BINS, REEL-3) were planned at age of 8 and 15 months. As judged by the investigator neurological examination and developmental assessments could be conducted up to an age 36 months.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Maternal Exposure to Tanezumab</title>
          <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
        </group>
        <group group_id="P2">
          <title>Maternal Exposure to Tramadol</title>
          <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety population included all participants who were enrolled into the study.</population>
      <group_list>
        <group group_id="B1">
          <title>Maternal Exposure to Tanezumab</title>
          <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
        </group>
        <group group_id="B2">
          <title>Maternal Exposure to Tramadol</title>
          <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="2"/>
            <count group_id="B2" value="2"/>
            <count group_id="B3" value="4"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Pre-term newborn - gestational age &lt; 37 week</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Newborns (0-27 days)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Infants and toddlers (28 days-23 months)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </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="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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>Race</title>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Occipital-frontal Head Circumference During 0 to Less Than or Equal to (&lt;=) 2 Months of Participant's Age</title>
        <description>Occipital-frontal head circumference of participants in centimeter (cm) was reported.</description>
        <time_frame>Any visit during participants' age from 0 to 2 Months</time_frame>
        <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Occipital-frontal Head Circumference During 0 to Less Than or Equal to (&lt;=) 2 Months of Participant's Age</title>
          <description>Occipital-frontal head circumference of participants in centimeter (cm) was reported.</description>
          <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure.</population>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.7"/>
                    <measurement group_id="O2" value="38.7" spread="1.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Occipital-frontal Head Circumference at 8 Months of Participant's Age</title>
        <description>Occipital-frontal head circumference of participants in centimeter (cm) was reported.</description>
        <time_frame>At 8 Months of participants' age</time_frame>
        <population>Safety population included all participants who were enrolled into the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Occipital-frontal Head Circumference at 8 Months of Participant's Age</title>
          <description>Occipital-frontal head circumference of participants in centimeter (cm) was reported.</description>
          <population>Safety population included all participants who were enrolled into the study.</population>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.0" spread="1.41"/>
                    <measurement group_id="O2" value="47.2" spread="1.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Occipital-frontal Head Circumference at 15 Months of Participant's Age</title>
        <description>Occipital-frontal head circumference of participants in centimeter (cm) was reported.</description>
        <time_frame>At 15 Months of participants' age</time_frame>
        <population>Safety population included all participants who were enrolled into the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Occipital-frontal Head Circumference at 15 Months of Participant's Age</title>
          <description>Occipital-frontal head circumference of participants in centimeter (cm) was reported.</description>
          <population>Safety population included all participants who were enrolled into the study.</population>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.2" spread="2.33"/>
                    <measurement group_id="O2" value="48.9" spread="2.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Occipital-frontal Head Circumference During 0 to Less Than or Equal to (&lt;=) 3 Months of Participant's Age</title>
        <description>Occipital-frontal head circumference of participants in centimeter (cm) was reported.</description>
        <time_frame>Any visit during participants' age from 0 to 3 Months</time_frame>
        <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Occipital-frontal Head Circumference During 0 to Less Than or Equal to (&lt;=) 3 Months of Participant's Age</title>
          <description>Occipital-frontal head circumference of participants in centimeter (cm) was reported.</description>
          <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure.</population>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.7"/>
                    <measurement group_id="O2" value="38.7" spread="1.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Occipital-frontal Head Circumference During Greater Than (&gt;) 3 to &lt;=6 Months of Participant's Age</title>
        <description>Occipital-frontal head circumference of participants in cm was reported.</description>
        <time_frame>Any visit during participants' age above 3 Months and up to 6 Months</time_frame>
        <population>Safety population analyzed. &quot;Overall Number of Participants Analyzed&quot; = number of participants evaluable for this outcome measure. Window period 3 to 6 months was not protocol defined but was an additional window to report data for participants whose initial visit was outside of the protocol defined window of 0-2 months. No participant for reporting arm &quot;Maternal Exposure to Tramadol&quot; had a visit within this window period, hence, for this reporting group no data was collected and reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Occipital-frontal Head Circumference During Greater Than (&gt;) 3 to &lt;=6 Months of Participant's Age</title>
          <description>Occipital-frontal head circumference of participants in cm was reported.</description>
          <population>Safety population analyzed. &quot;Overall Number of Participants Analyzed&quot; = number of participants evaluable for this outcome measure. Window period 3 to 6 months was not protocol defined but was an additional window to report data for participants whose initial visit was outside of the protocol defined window of 0-2 months. No participant for reporting arm &quot;Maternal Exposure to Tramadol&quot; had a visit within this window period, hence, for this reporting group no data was collected and reported.</population>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Occipital-frontal Head Circumference During &gt;6 to &lt;=9 Months of Participant's Age</title>
        <description>Occipital-frontal head circumference of participants in cm was reported.</description>
        <time_frame>Any visit during participants' age above 6 Months and up to 9 Months</time_frame>
        <population>Safety population included all participants who were enrolled into the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Occipital-frontal Head Circumference During &gt;6 to &lt;=9 Months of Participant's Age</title>
          <description>Occipital-frontal head circumference of participants in cm was reported.</description>
          <population>Safety population included all participants who were enrolled into the study.</population>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.0" spread="1.41"/>
                    <measurement group_id="O2" value="47.2" spread="1.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Occipital-frontal Head Circumference During &gt;15 to &lt;=18 Months of Participant's Age</title>
        <description>Occipital-frontal head circumference of participants in cm was reported.</description>
        <time_frame>Any visit during participants' age above 15 Months and up to 18 Months</time_frame>
        <population>Safety population included all participants who were enrolled into the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Occipital-frontal Head Circumference During &gt;15 to &lt;=18 Months of Participant's Age</title>
          <description>Occipital-frontal head circumference of participants in cm was reported.</description>
          <population>Safety population included all participants who were enrolled into the study.</population>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.2" spread="2.33"/>
                    <measurement group_id="O2" value="48.9" spread="2.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Occipital-frontal Head Circumference During &gt;21 to &lt;=24 Months of Participant's Age</title>
        <description>Occipital-frontal head circumference of participants in cm was reported.</description>
        <time_frame>Any visit during participants' age above 21 Months and up to 24 Months</time_frame>
        <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. No participant visited the site for window period &gt;21 to &lt;=24 months for reporting arm &quot;Maternal Exposure to Tramadol&quot;. Hence, for this reporting group no data was collected and reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Occipital-frontal Head Circumference During &gt;21 to &lt;=24 Months of Participant's Age</title>
          <description>Occipital-frontal head circumference of participants in cm was reported.</description>
          <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. No participant visited the site for window period &gt;21 to &lt;=24 months for reporting arm &quot;Maternal Exposure to Tramadol&quot;. Hence, for this reporting group no data was collected and reported.</population>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Occipital-frontal Head Circumference During &gt;24 to &lt;=30 Months of Participant's Age</title>
        <description>Occipital-frontal head circumference of participants in cm was reported.</description>
        <time_frame>Any visit during participants' age above 24 Months and up to 30 Months</time_frame>
        <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. No participant visited the site for window period &gt;24 to &lt;=30 months for reporting arm &quot;Maternal Exposure to Tramadol&quot;. Hence, for this reporting group no data was collected and reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Occipital-frontal Head Circumference During &gt;24 to &lt;=30 Months of Participant's Age</title>
          <description>Occipital-frontal head circumference of participants in cm was reported.</description>
          <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. No participant visited the site for window period &gt;24 to &lt;=30 months for reporting arm &quot;Maternal Exposure to Tramadol&quot;. Hence, for this reporting group no data was collected and reported.</population>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Body Length During 0 to Less Than or Equal to (&lt;=) 2 Months of Participant's Age</title>
        <description>Body length of participants in cm was reported.</description>
        <time_frame>Any visit during participants' age from 0 to 2 Months</time_frame>
        <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Body Length During 0 to Less Than or Equal to (&lt;=) 2 Months of Participant's Age</title>
          <description>Body length of participants in cm was reported.</description>
          <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure.</population>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.6"/>
                    <measurement group_id="O2" value="56.5" spread="1.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Body Length at 8 Months of Participant's Age</title>
        <description>Body length of participants in cm was reported.</description>
        <time_frame>At 8 Months of participant's age</time_frame>
        <population>Safety population included all participants who were enrolled into the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Body Length at 8 Months of Participant's Age</title>
          <description>Body length of participants in cm was reported.</description>
          <population>Safety population included all participants who were enrolled into the study.</population>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.6" spread="3.45"/>
                    <measurement group_id="O2" value="73.7" spread="1.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Body Length at 15 Months of Participant's Age</title>
        <description>Body length of participants in cm was reported.</description>
        <time_frame>At 15 Months of participant's age</time_frame>
        <population>Safety population included all participants who were enrolled into the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Body Length at 15 Months of Participant's Age</title>
          <description>Body length of participants in cm was reported.</description>
          <population>Safety population included all participants who were enrolled into the study.</population>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.3" spread="3.95"/>
                    <measurement group_id="O2" value="81.3" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Body Length During 0 to &lt;=3 Months of Participant's Age</title>
        <description>Body length of participants in cm was reported.</description>
        <time_frame>Any visit during participants' age from 0 to 3 Months</time_frame>
        <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Body Length During 0 to &lt;=3 Months of Participant's Age</title>
          <description>Body length of participants in cm was reported.</description>
          <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure.</population>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.6"/>
                    <measurement group_id="O2" value="56.5" spread="1.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Body Length During &gt;3 to &lt;=6 Months of Participant's Age</title>
        <description>Body length of participants in cm was reported.</description>
        <time_frame>Any visit during participants' age above 3 Months and up to 6 Months</time_frame>
        <population>Safety population analyzed. &quot;Overall Number of Participants Analyzed&quot; = number of participants evaluable for this outcome measure. Window period 3 to 6 months was not protocol defined but was an additional window to report data for participants whose initial visit was outside of the protocol defined window of 0-2 months. No participant for reporting arm &quot;Maternal Exposure to Tramadol&quot; had a visit within this window period, hence, for this reporting group no data was collected and reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Body Length During &gt;3 to &lt;=6 Months of Participant's Age</title>
          <description>Body length of participants in cm was reported.</description>
          <population>Safety population analyzed. &quot;Overall Number of Participants Analyzed&quot; = number of participants evaluable for this outcome measure. Window period 3 to 6 months was not protocol defined but was an additional window to report data for participants whose initial visit was outside of the protocol defined window of 0-2 months. No participant for reporting arm &quot;Maternal Exposure to Tramadol&quot; had a visit within this window period, hence, for this reporting group no data was collected and reported.</population>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Body Length During &gt;6 to &lt;=9 Months of Participant's Age</title>
        <description>Body length of participants in cm was reported.</description>
        <time_frame>Any visit during participants' age above 6 Months and up to 9 Months</time_frame>
        <population>Safety population included all participants who were enrolled into the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Body Length During &gt;6 to &lt;=9 Months of Participant's Age</title>
          <description>Body length of participants in cm was reported.</description>
          <population>Safety population included all participants who were enrolled into the study.</population>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.6" spread="3.45"/>
                    <measurement group_id="O2" value="73.7" spread="1.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Body Length During &gt;15 to &lt;=18 Months of Participant's Age</title>
        <description>Body length of participants in cm was reported.</description>
        <time_frame>Any visit during participants' age above 15 Months and up to 18 Months</time_frame>
        <population>Safety population included all participants who were enrolled into the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Body Length During &gt;15 to &lt;=18 Months of Participant's Age</title>
          <description>Body length of participants in cm was reported.</description>
          <population>Safety population included all participants who were enrolled into the study.</population>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.3" spread="3.95"/>
                    <measurement group_id="O2" value="81.3" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Body Length During &gt;21 to &lt;=24 Months of Participant's Age</title>
        <description>Body length of participants in cm was reported.</description>
        <time_frame>Any visit during participants' age above 21 Months and up to 24 Months</time_frame>
        <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. No participant visited the site for window period &gt;21 to &lt;=24 months for reporting arm &quot;Maternal Exposure to Tramadol&quot;. Hence, for this reporting group no data was collected and reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Body Length During &gt;21 to &lt;=24 Months of Participant's Age</title>
          <description>Body length of participants in cm was reported.</description>
          <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. No participant visited the site for window period &gt;21 to &lt;=24 months for reporting arm &quot;Maternal Exposure to Tramadol&quot;. Hence, for this reporting group no data was collected and reported.</population>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Body Length During &gt;24 to &lt;=30 Months of Participant's Age</title>
        <description>Body length of participants in cm was reported.</description>
        <time_frame>Any visit during participants' age above 24 Months and up to 30 Months</time_frame>
        <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. No participant visited the site for window period &gt;24 to &lt;=30 months for reporting arm &quot;Maternal Exposure to Tramadol&quot;. Hence, for this reporting group no data was collected and reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Body Length During &gt;24 to &lt;=30 Months of Participant's Age</title>
          <description>Body length of participants in cm was reported.</description>
          <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. No participant visited the site for window period &gt;24 to &lt;=30 months for reporting arm &quot;Maternal Exposure to Tramadol&quot;. Hence, for this reporting group no data was collected and reported.</population>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Body Weight During 0 to Less Than or Equal to (&lt;=) 2 Months of Participant's Age</title>
        <description>Body weight of participants in kilogram (kg) was reported.</description>
        <time_frame>Any visit during participants' age from 0 to 2 Months</time_frame>
        <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Body Weight During 0 to Less Than or Equal to (&lt;=) 2 Months of Participant's Age</title>
          <description>Body weight of participants in kilogram (kg) was reported.</description>
          <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure.</population>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4"/>
                    <measurement group_id="O2" value="5.8" spread="1.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Body Weight at 8 Months of Participant's Age</title>
        <description>Body weight of participants in kilogram (kg) was reported.</description>
        <time_frame>At 8 Months of participants' age</time_frame>
        <population>Safety population included all participants who were enrolled into the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Body Weight at 8 Months of Participant's Age</title>
          <description>Body weight of participants in kilogram (kg) was reported.</description>
          <population>Safety population included all participants who were enrolled into the study.</population>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.3" spread="2.50"/>
                    <measurement group_id="O2" value="11.6" spread="0.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Body Weight at 15 Months of Participant's Age</title>
        <description>Body weight of participants in kilogram (kg) was reported.</description>
        <time_frame>At 15 Months of participants' age</time_frame>
        <population>Safety population included all participants who were enrolled into the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Body Weight at 15 Months of Participant's Age</title>
          <description>Body weight of participants in kilogram (kg) was reported.</description>
          <population>Safety population included all participants who were enrolled into the study.</population>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.6" spread="2.53"/>
                    <measurement group_id="O2" value="13.1" spread="1.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Body Weight During 0 to &lt;=3 Months of Participant's Age</title>
        <description>Body weight of participants in kilogram (kg) was reported.</description>
        <time_frame>Any visit during participants' age from 0 to 3 Months</time_frame>
        <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Body Weight During 0 to &lt;=3 Months of Participant's Age</title>
          <description>Body weight of participants in kilogram (kg) was reported.</description>
          <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure.</population>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4"/>
                    <measurement group_id="O2" value="5.8" spread="1.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Body Weight During &gt;3 to &lt;=6 Months of Participant's Age</title>
        <description>Body weight of participants in kg was reported.</description>
        <time_frame>Any visit during participants' age above 3 Months and up to 6 Months</time_frame>
        <population>Safety population analyzed. &quot;Overall Number of Participants Analyzed&quot; = number of participants evaluable for this outcome measure. Window period 3 to 6 months was not protocol defined but was an additional window to report data for participants whose initial visit was outside of the protocol defined window of 0-2 months. No participant for reporting arm &quot;Maternal Exposure to Tramadol&quot; had a visit within this window period, hence, for this reporting group no data was collected and reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Body Weight During &gt;3 to &lt;=6 Months of Participant's Age</title>
          <description>Body weight of participants in kg was reported.</description>
          <population>Safety population analyzed. &quot;Overall Number of Participants Analyzed&quot; = number of participants evaluable for this outcome measure. Window period 3 to 6 months was not protocol defined but was an additional window to report data for participants whose initial visit was outside of the protocol defined window of 0-2 months. No participant for reporting arm &quot;Maternal Exposure to Tramadol&quot; had a visit within this window period, hence, for this reporting group no data was collected and reported.</population>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Body Weight During &gt;6 to &lt;=9 Months of Participant's Age</title>
        <description>Body weight of participants in kg was reported.</description>
        <time_frame>Any visit during participants' age above 6 Months and up to 9 Months</time_frame>
        <population>Safety population included all participants who were enrolled into the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Body Weight During &gt;6 to &lt;=9 Months of Participant's Age</title>
          <description>Body weight of participants in kg was reported.</description>
          <population>Safety population included all participants who were enrolled into the study.</population>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.3" spread="2.50"/>
                    <measurement group_id="O2" value="11.6" spread="0.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Body Weight During &gt;15 to &lt;=18 Months of Participant's Age</title>
        <description>Body weight of participants in kg was reported.</description>
        <time_frame>Any visit during participants' age above 15 Months and up to 18 Months</time_frame>
        <population>Safety population included all participants who were enrolled into the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Body Weight During &gt;15 to &lt;=18 Months of Participant's Age</title>
          <description>Body weight of participants in kg was reported.</description>
          <population>Safety population included all participants who were enrolled into the study.</population>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.6" spread="2.53"/>
                    <measurement group_id="O2" value="13.1" spread="1.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Body Weight During &gt;21 to &lt;=24 Months of Participant's Age</title>
        <description>Body weight of participants in kg was reported.</description>
        <time_frame>Any visit during participants' age above 21 Months and up to 24 Months</time_frame>
        <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. No participant visited the site for window period &gt;21 to &lt;=24 months for reporting arm &quot;Maternal Exposure to Tramadol&quot;. Hence, for this reporting group no data was collected and reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Body Weight During &gt;21 to &lt;=24 Months of Participant's Age</title>
          <description>Body weight of participants in kg was reported.</description>
          <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. No participant visited the site for window period &gt;21 to &lt;=24 months for reporting arm &quot;Maternal Exposure to Tramadol&quot;. Hence, for this reporting group no data was collected and reported.</population>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Body Weight During &gt;24 to &lt;=30 Months of Participant's Age</title>
        <description>Body weight of participants in kg was reported.</description>
        <time_frame>Any visit during participants' age above 24 Months up to 30 Months</time_frame>
        <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. No participant visited the site for window period &gt;24 to &lt;=30 months for reporting arm &quot;Maternal Exposure to Tramadol&quot;. Hence, for this reporting group no data was collected and reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Body Weight During &gt;24 to &lt;=30 Months of Participant's Age</title>
          <description>Body weight of participants in kg was reported.</description>
          <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. No participant visited the site for window period &gt;24 to &lt;=30 months for reporting arm &quot;Maternal Exposure to Tramadol&quot;. Hence, for this reporting group no data was collected and reported.</population>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Systolic and Diastolic Blood Pressure During 0 to Less Than or Equal to (&lt;=) 2 Months of Participant's Age</title>
        <description>Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.</description>
        <time_frame>Any visit during participants' age from 0 to 2 Months</time_frame>
        <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Systolic and Diastolic Blood Pressure During 0 to Less Than or Equal to (&lt;=) 2 Months of Participant's Age</title>
          <description>Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.</description>
          <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Systolic Blood Pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.0"/>
                    <measurement group_id="O2" value="NA" spread="NA">Investigator tried to measure infants blood pressure but could not obtain measurements, hence no data available to report.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic Blood Pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.0"/>
                    <measurement group_id="O2" value="NA" spread="NA">Investigator tried to measure infants blood pressure but could not obtain measurements, hence no data available to report.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Systolic and Diastolic Blood Pressure at 8 Months of Participant's Age</title>
        <description>Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.</description>
        <time_frame>At 8 Months of participants' age</time_frame>
        <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Systolic and Diastolic Blood Pressure at 8 Months of Participant's Age</title>
          <description>Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.</description>
          <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Systolic Blood Pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.5" spread="19.09"/>
                    <measurement group_id="O2" value="82.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic Blood Pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.0" spread="8.49"/>
                    <measurement group_id="O2" value="40.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Systolic and Diastolic Blood Pressure at 15 Months of Participant's Age</title>
        <description>Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.</description>
        <time_frame>At 15 Months participants' age</time_frame>
        <population>Safety population included all participants who were enrolled into the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Systolic and Diastolic Blood Pressure at 15 Months of Participant's Age</title>
          <description>Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.</description>
          <population>Safety population included all participants who were enrolled into the study.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Systolic Blood Pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.5" spread="7.78"/>
                    <measurement group_id="O2" value="80.0" spread="2.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic Blood Pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.5" spread="2.12"/>
                    <measurement group_id="O2" value="43.0" spread="4.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Systolic and Diastolic Blood Pressure During 0 to &lt;=3 Months of Participant's Age</title>
        <description>Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.</description>
        <time_frame>Any visit during participants' age from 0 to 3 Months</time_frame>
        <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Systolic and Diastolic Blood Pressure During 0 to &lt;=3 Months of Participant's Age</title>
          <description>Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.</description>
          <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Systolic Blood Pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.0"/>
                    <measurement group_id="O2" value="NA" spread="NA">Investigator tried to measure infants blood pressure but could not obtain measurements, hence no data available to report.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic Blood Pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.0"/>
                    <measurement group_id="O2" value="NA" spread="NA">Investigator tried to measure infants blood pressure but could not obtain measurements, hence no data available to report.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Systolic and Diastolic Blood Pressure During &gt;3 to &lt;=6 Months of Participant's Age</title>
        <description>Systolic and diastolic blood pressure of participants in mmHg was reported.</description>
        <time_frame>Any visit during participants' age above 3 Months and up to 6 Months</time_frame>
        <population>Safety population analyzed. Window period 3 to 6 months was not protocol defined but was an additional window to report data for participants whose initial visit was outside of the protocol defined window of 0-2 months. No participant for &quot;Maternal Exposure to Tramadol&quot; had a visit within this window period; for &quot;Maternal Exposure to Tanezumab&quot; site missed to take participants' measurement. Thus, no data was collected and reported for both reporting arms.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Systolic and Diastolic Blood Pressure During &gt;3 to &lt;=6 Months of Participant's Age</title>
          <description>Systolic and diastolic blood pressure of participants in mmHg was reported.</description>
          <population>Safety population analyzed. Window period 3 to 6 months was not protocol defined but was an additional window to report data for participants whose initial visit was outside of the protocol defined window of 0-2 months. No participant for &quot;Maternal Exposure to Tramadol&quot; had a visit within this window period; for &quot;Maternal Exposure to Tanezumab&quot; site missed to take participants' measurement. Thus, no data was collected and reported for both reporting arms.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Systolic and Diastolic Blood Pressure During &gt;6 to &lt;=9 Months of Participant's Age</title>
        <description>Systolic and diastolic blood pressure of participants in mmHg was reported.</description>
        <time_frame>Any visit during participants' age above 6 Months and up to 9 Months</time_frame>
        <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Systolic and Diastolic Blood Pressure During &gt;6 to &lt;=9 Months of Participant's Age</title>
          <description>Systolic and diastolic blood pressure of participants in mmHg was reported.</description>
          <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Systolic Blood Pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.5" spread="19.09"/>
                    <measurement group_id="O2" value="82.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic Blood Pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.0" spread="8.49"/>
                    <measurement group_id="O2" value="40.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Systolic and Diastolic Blood Pressure During &gt;15 to &lt;=18 Months of Participant's Age</title>
        <description>Systolic and diastolic blood pressure of participants in mmHg was reported.</description>
        <time_frame>Any visit during participants' age above 15 Months and up to 18 Months</time_frame>
        <population>Safety population included all participants who were enrolled into the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Systolic and Diastolic Blood Pressure During &gt;15 to &lt;=18 Months of Participant's Age</title>
          <description>Systolic and diastolic blood pressure of participants in mmHg was reported.</description>
          <population>Safety population included all participants who were enrolled into the study.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Systolic Blood Pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.5" spread="7.78"/>
                    <measurement group_id="O2" value="80.0" spread="2.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic Blood Pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.5" spread="2.12"/>
                    <measurement group_id="O2" value="43.0" spread="4.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Systolic and Diastolic Blood Pressure During &gt;21 to &lt;=24 Months of Participant's Age</title>
        <description>Systolic and diastolic blood pressure of participants in mmHg was reported.</description>
        <time_frame>Any visit during participants' age above 21 Months and up to 24 Months</time_frame>
        <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. No participant visited the site for window period &gt;21 to &lt;=24 months for reporting arm &quot;Maternal Exposure to Tramadol&quot;. Hence, for this reporting group no data was collected and reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Systolic and Diastolic Blood Pressure During &gt;21 to &lt;=24 Months of Participant's Age</title>
          <description>Systolic and diastolic blood pressure of participants in mmHg was reported.</description>
          <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. No participant visited the site for window period &gt;21 to &lt;=24 months for reporting arm &quot;Maternal Exposure to Tramadol&quot;. Hence, for this reporting group no data was collected and reported.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Systolic Blood Pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="123.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic Blood Pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Systolic and Diastolic Blood Pressure During &gt;24 to &lt;=30 Months of Participant's Age</title>
        <description>Systolic and diastolic blood pressure of participants in mmHg was reported.</description>
        <time_frame>Any visit during participants' age above 24 Months and up to 30 Months</time_frame>
        <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. No participant visited the site for window period &gt;24 to &lt;=30 months for reporting arm &quot;Maternal Exposure to Tramadol&quot;. Hence, for this reporting group no data was collected and reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Systolic and Diastolic Blood Pressure During &gt;24 to &lt;=30 Months of Participant's Age</title>
          <description>Systolic and diastolic blood pressure of participants in mmHg was reported.</description>
          <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. No participant visited the site for window period &gt;24 to &lt;=30 months for reporting arm &quot;Maternal Exposure to Tramadol&quot;. Hence, for this reporting group no data was collected and reported.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Systolic Blood Pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="101.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic Blood Pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pulse Rate During 0 to Less Than or Equal to (&lt;=) 2 Months of Participant's Age</title>
        <description>Pulse rate of participants in beats per minute was reported.</description>
        <time_frame>Any visit during participants' age from 0 to 2 Months</time_frame>
        <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Pulse Rate During 0 to Less Than or Equal to (&lt;=) 2 Months of Participant's Age</title>
          <description>Pulse rate of participants in beats per minute was reported.</description>
          <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.</population>
          <units>beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="124.0"/>
                    <measurement group_id="O2" value="144.0" spread="15.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pulse Rate at 8 Months of Participant's Age</title>
        <description>Pulse rate of participants in beats per minute was reported.</description>
        <time_frame>At 8 Months of participants' age</time_frame>
        <population>Safety population included all participants who were enrolled into the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Pulse Rate at 8 Months of Participant's Age</title>
          <description>Pulse rate of participants in beats per minute was reported.</description>
          <population>Safety population included all participants who were enrolled into the study.</population>
          <units>beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="117.0" spread="15.56"/>
                    <measurement group_id="O2" value="121.0" spread="4.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pulse Rate at 15 Months of Participant's Age</title>
        <description>Pulse rate of participants in beats per minute was reported.</description>
        <time_frame>At 15 Months of participants' age</time_frame>
        <population>Safety population included all participants who were enrolled into the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Pulse Rate at 15 Months of Participant's Age</title>
          <description>Pulse rate of participants in beats per minute was reported.</description>
          <population>Safety population included all participants who were enrolled into the study.</population>
          <units>beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="108.5" spread="20.51"/>
                    <measurement group_id="O2" value="116.0" spread="5.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pulse Rate During 0 to &lt;=3 Months of Participant's Age</title>
        <description>Pulse rate of participants in beats per minute was reported.</description>
        <time_frame>Any visit during participants' age from 0 to 3 Months</time_frame>
        <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Pulse Rate During 0 to &lt;=3 Months of Participant's Age</title>
          <description>Pulse rate of participants in beats per minute was reported.</description>
          <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.</population>
          <units>beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="124.0"/>
                    <measurement group_id="O2" value="144.0" spread="15.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pulse Rate During &gt;3 to &lt;=6 Months of Participant's Age</title>
        <description>Pulse rate of participants in beats per minute was reported.</description>
        <time_frame>Any visit during participants' age above 3 Months and up to 6 Months</time_frame>
        <population>Safety population analyzed. &quot;Overall Number of Participants Analyzed&quot; = number of participants evaluable for this outcome measure. Window period 3 to 6 months was not protocol defined but was an additional window to report data for participants whose initial visit was outside of the protocol defined window of 0-2 months. No participant for reporting arm &quot;Maternal Exposure to Tramadol&quot; had a visit within this window period, hence, for this reporting group no data was collected and reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Pulse Rate During &gt;3 to &lt;=6 Months of Participant's Age</title>
          <description>Pulse rate of participants in beats per minute was reported.</description>
          <population>Safety population analyzed. &quot;Overall Number of Participants Analyzed&quot; = number of participants evaluable for this outcome measure. Window period 3 to 6 months was not protocol defined but was an additional window to report data for participants whose initial visit was outside of the protocol defined window of 0-2 months. No participant for reporting arm &quot;Maternal Exposure to Tramadol&quot; had a visit within this window period, hence, for this reporting group no data was collected and reported.</population>
          <units>beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="128.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pulse Rate During &gt;6 to &lt;=9 Months of Participant's Age</title>
        <description>Pulse rate of participants in beats per minute was reported.</description>
        <time_frame>Any visit during participants' age above 6 Months and up to 9 Months</time_frame>
        <population>Safety population included all participants who were enrolled into the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Pulse Rate During &gt;6 to &lt;=9 Months of Participant's Age</title>
          <description>Pulse rate of participants in beats per minute was reported.</description>
          <population>Safety population included all participants who were enrolled into the study.</population>
          <units>beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="117.0" spread="15.56"/>
                    <measurement group_id="O2" value="121.0" spread="4.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pulse Rate During &gt;15 to &lt;=18 Months of Participant's Age</title>
        <description>Pulse rate of participants in beats per minute was reported.</description>
        <time_frame>Any visit during participants' age above 15 Months and up to 18 Months</time_frame>
        <population>Safety population included all participants who were enrolled into the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Pulse Rate During &gt;15 to &lt;=18 Months of Participant's Age</title>
          <description>Pulse rate of participants in beats per minute was reported.</description>
          <population>Safety population included all participants who were enrolled into the study.</population>
          <units>beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="108.5" spread="20.51"/>
                    <measurement group_id="O2" value="116.0" spread="5.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pulse Rate During &gt;21 to &lt;=24 Months of Participant's Age</title>
        <description>Pulse rate of participants in beats per minute was reported.</description>
        <time_frame>Any visit during participants' age above 21 Months and up to 24 Months</time_frame>
        <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. No participant visited the site for window period &gt;21 to &lt;=24 months for reporting arm &quot;Maternal Exposure to Tramadol&quot;. Hence, for this reporting group no data was collected and reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Pulse Rate During &gt;21 to &lt;=24 Months of Participant's Age</title>
          <description>Pulse rate of participants in beats per minute was reported.</description>
          <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. No participant visited the site for window period &gt;21 to &lt;=24 months for reporting arm &quot;Maternal Exposure to Tramadol&quot;. Hence, for this reporting group no data was collected and reported.</population>
          <units>beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="118.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pulse Rate During &gt;24 to &lt;=30 Months of Participant's Age</title>
        <description>Pulse rate of participants in beats per minute was reported.</description>
        <time_frame>Any visit during participants' age above 24 Months and up to 30 Months</time_frame>
        <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. No participant visited the site for window period &gt;24 to &lt;=30 months for reporting arm &quot;Maternal Exposure to Tramadol&quot;. Hence, for this reporting group no data was collected and reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Pulse Rate During &gt;24 to &lt;=30 Months of Participant's Age</title>
          <description>Pulse rate of participants in beats per minute was reported.</description>
          <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. No participant visited the site for window period &gt;24 to &lt;=30 months for reporting arm &quot;Maternal Exposure to Tramadol&quot;. Hence, for this reporting group no data was collected and reported.</population>
          <units>beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="118.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Temperature During 0 to Less Than or Equal to (&lt;=) 2 Months of Participant's Age</title>
        <description>Temperature of participants in degree Celsius was reported.</description>
        <time_frame>Any visit during participants' age from 0 to 2 Months</time_frame>
        <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Temperature During 0 to Less Than or Equal to (&lt;=) 2 Months of Participant's Age</title>
          <description>Temperature of participants in degree Celsius was reported.</description>
          <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure.</population>
          <units>degree Celsius</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.2"/>
                    <measurement group_id="O2" value="36.6" spread="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Temperature at 8 Months of Participant's Age</title>
        <description>Temperature of participants in degree Celsius was reported.</description>
        <time_frame>At 8 Months of participants' age</time_frame>
        <population>Safety population included all participants who were enrolled into the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Temperature at 8 Months of Participant's Age</title>
          <description>Temperature of participants in degree Celsius was reported.</description>
          <population>Safety population included all participants who were enrolled into the study.</population>
          <units>degree Celsius</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.3" spread="0.27"/>
                    <measurement group_id="O2" value="36.7" spread="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Temperature at 15 Months of Participant's Age</title>
        <description>Temperature of participants in degree Celsius was reported.</description>
        <time_frame>At 15 Months of participants' age</time_frame>
        <population>Safety population included all participants who were enrolled into the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Temperature at 15 Months of Participant's Age</title>
          <description>Temperature of participants in degree Celsius was reported.</description>
          <population>Safety population included all participants who were enrolled into the study.</population>
          <units>degree Celsius</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.1" spread="0.47"/>
                    <measurement group_id="O2" value="36.5" spread="0.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Temperature During 0 to &lt;=3 Months of Participant's Age</title>
        <description>Temperature of participants in degree Celsius was reported.</description>
        <time_frame>Any visit during participants' age from 0 to 3 Months</time_frame>
        <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Temperature During 0 to &lt;=3 Months of Participant's Age</title>
          <description>Temperature of participants in degree Celsius was reported.</description>
          <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure.</population>
          <units>degree Celsius</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.2"/>
                    <measurement group_id="O2" value="36.6" spread="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Temperature During &gt;3 to &lt;=6 Months of Participant's Age</title>
        <description>Temperature of participants in degree Celsius was reported.</description>
        <time_frame>Any visit during participants' age above 3 Months and up to 6 Months</time_frame>
        <population>Safety population analyzed. &quot;Overall Number of Participants Analyzed&quot; = number of participants evaluable for this outcome measure. Window period 3 to 6 months was not protocol defined but was an additional window to report data for participants whose initial visit was outside of the protocol defined window of 0-2 months. No participant for reporting arm &quot;Maternal Exposure to Tramadol&quot; had a visit within this window period, hence, for this reporting group no data was collected and reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Temperature During &gt;3 to &lt;=6 Months of Participant's Age</title>
          <description>Temperature of participants in degree Celsius was reported.</description>
          <population>Safety population analyzed. &quot;Overall Number of Participants Analyzed&quot; = number of participants evaluable for this outcome measure. Window period 3 to 6 months was not protocol defined but was an additional window to report data for participants whose initial visit was outside of the protocol defined window of 0-2 months. No participant for reporting arm &quot;Maternal Exposure to Tramadol&quot; had a visit within this window period, hence, for this reporting group no data was collected and reported.</population>
          <units>degree Celsius</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Temperature During &gt;6 to &lt;=9 Months of Participant's Age</title>
        <description>Temperature of participants in degree Celsius was reported.</description>
        <time_frame>Any visit during participants' age above 6 Months and up to 9 Months</time_frame>
        <population>Safety population included all participants who were enrolled into the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Temperature During &gt;6 to &lt;=9 Months of Participant's Age</title>
          <description>Temperature of participants in degree Celsius was reported.</description>
          <population>Safety population included all participants who were enrolled into the study.</population>
          <units>degree Celsius</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.3" spread="0.27"/>
                    <measurement group_id="O2" value="36.7" spread="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Temperature During &gt;15 to &lt;=18 Months of Participant's Age</title>
        <description>Temperature of participants in degree Celsius was reported.</description>
        <time_frame>Any visit during participants' age above 15 Months and up to 18 Months</time_frame>
        <population>Safety population included all participants who were enrolled into the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Temperature During &gt;15 to &lt;=18 Months of Participant's Age</title>
          <description>Temperature of participants in degree Celsius was reported.</description>
          <population>Safety population included all participants who were enrolled into the study.</population>
          <units>degree Celsius</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.1" spread="0.47"/>
                    <measurement group_id="O2" value="36.5" spread="0.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Temperature During &gt;21 to &lt;=24 Months of Participant's Age</title>
        <description>Temperature of participants in degree Celsius was reported.</description>
        <time_frame>Any visit during participants' age above 21 Months and up to 24 Months</time_frame>
        <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. No participant visited the site for window period &gt;21 to &lt;=24 months for reporting arm &quot;Maternal Exposure to Tramadol&quot;. Hence, for this reporting group no data was collected and reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Temperature During &gt;21 to &lt;=24 Months of Participant's Age</title>
          <description>Temperature of participants in degree Celsius was reported.</description>
          <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. No participant visited the site for window period &gt;21 to &lt;=24 months for reporting arm &quot;Maternal Exposure to Tramadol&quot;. Hence, for this reporting group no data was collected and reported.</population>
          <units>degree Celsius</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Temperature During &gt;24 to &lt;=30 Months of Participant's Age</title>
        <description>Temperature of participants in degree Celsius was reported.</description>
        <time_frame>Any visit during participants' age above 24 Months and up to 30 Months</time_frame>
        <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. No participant visited the site for window period &gt;24 to &lt;=30 months for reporting arm &quot;Maternal Exposure to Tramadol&quot;. Hence, for this reporting group no data was collected and reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Temperature During &gt;24 to &lt;=30 Months of Participant's Age</title>
          <description>Temperature of participants in degree Celsius was reported.</description>
          <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. No participant visited the site for window period &gt;24 to &lt;=30 months for reporting arm &quot;Maternal Exposure to Tramadol&quot;. Hence, for this reporting group no data was collected and reported.</population>
          <units>degree Celsius</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Respiratory Rate During 0 to Less Than or Equal to (&lt;=) 2 Months of Participant's Age</title>
        <description>Respiratory rate of participants in breaths per minute was reported.</description>
        <time_frame>Any visit during participants' age from 0 to 2 Months</time_frame>
        <population>Safety population included all participants who were enrolled into the study. Here &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Respiratory Rate During 0 to Less Than or Equal to (&lt;=) 2 Months of Participant's Age</title>
          <description>Respiratory rate of participants in breaths per minute was reported.</description>
          <population>Safety population included all participants who were enrolled into the study. Here &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure.</population>
          <units>breaths per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.0"/>
                    <measurement group_id="O2" value="57.0" spread="9.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Respiratory Rate at 8 Months of Participant's Age</title>
        <description>Respiratory rate of participants in breaths per minute was reported.</description>
        <time_frame>At 8 Months of participants' age</time_frame>
        <population>Safety population included all participants who were enrolled into the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Respiratory Rate at 8 Months of Participant's Age</title>
          <description>Respiratory rate of participants in breaths per minute was reported.</description>
          <population>Safety population included all participants who were enrolled into the study.</population>
          <units>breaths per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.0" spread="1.41"/>
                    <measurement group_id="O2" value="34.0" spread="2.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Respiratory Rate at 15 Months of Participant's Age</title>
        <description>Respiratory rate of participants in breaths per minute was reported.</description>
        <time_frame>At 15 Months participants' age</time_frame>
        <population>Safety population included all participants who were enrolled into the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Respiratory Rate at 15 Months of Participant's Age</title>
          <description>Respiratory rate of participants in breaths per minute was reported.</description>
          <population>Safety population included all participants who were enrolled into the study.</population>
          <units>breaths per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.0" spread="14.14"/>
                    <measurement group_id="O2" value="27.0" spread="1.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Respiratory Rate During 0 to &lt;=3 Months of Participant's Age</title>
        <description>Respiratory rate of participants in breaths per minute was reported.</description>
        <time_frame>Any visit during participants' age from 0 to 3 Months</time_frame>
        <population>Safety population included all participants who were enrolled into the study. Here &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Respiratory Rate During 0 to &lt;=3 Months of Participant's Age</title>
          <description>Respiratory rate of participants in breaths per minute was reported.</description>
          <population>Safety population included all participants who were enrolled into the study. Here &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure.</population>
          <units>breaths per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.0"/>
                    <measurement group_id="O2" value="57.0" spread="9.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Respiratory Rate During &gt;3 to &lt;=6 Months of Participant's Age</title>
        <description>Respiratory rate of participants in breaths per minute was reported.</description>
        <time_frame>Any visit during participants' age above 3 Months and up to 6 Months</time_frame>
        <population>Safety population analyzed. &quot;Overall Number of Participants Analyzed&quot; = number of participants evaluable for this outcome measure. Window period 3 to 6 months was not protocol defined but was an additional window to report data for participants whose initial visit was outside of the protocol defined window of 0-2 months. No participant for reporting arm &quot;Maternal Exposure to Tramadol&quot; had a visit within this window period, hence, for this reporting group no data was collected and reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Respiratory Rate During &gt;3 to &lt;=6 Months of Participant's Age</title>
          <description>Respiratory rate of participants in breaths per minute was reported.</description>
          <population>Safety population analyzed. &quot;Overall Number of Participants Analyzed&quot; = number of participants evaluable for this outcome measure. Window period 3 to 6 months was not protocol defined but was an additional window to report data for participants whose initial visit was outside of the protocol defined window of 0-2 months. No participant for reporting arm &quot;Maternal Exposure to Tramadol&quot; had a visit within this window period, hence, for this reporting group no data was collected and reported.</population>
          <units>breaths per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Respiratory Rate During &gt;6 to &lt;=9 Months of Participant's Age</title>
        <description>Respiratory rate of participants in breaths per minute was reported.</description>
        <time_frame>Any visit during participants' age above 6 Months and up to 9 Months</time_frame>
        <population>Safety population included all participants who were enrolled into the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Respiratory Rate During &gt;6 to &lt;=9 Months of Participant's Age</title>
          <description>Respiratory rate of participants in breaths per minute was reported.</description>
          <population>Safety population included all participants who were enrolled into the study.</population>
          <units>breaths per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.0" spread="1.41"/>
                    <measurement group_id="O2" value="34.0" spread="2.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Respiratory Rate During &gt;15 to &lt;=18 Months of Participant's Age</title>
        <description>Respiratory rate of participants in breaths per minute was reported.</description>
        <time_frame>Any visit during participants' age above 15 Months and up to 18 Months</time_frame>
        <population>Safety population included all participants who were enrolled into the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Respiratory Rate During &gt;15 to &lt;=18 Months of Participant's Age</title>
          <description>Respiratory rate of participants in breaths per minute was reported.</description>
          <population>Safety population included all participants who were enrolled into the study.</population>
          <units>breaths per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.0" spread="14.14"/>
                    <measurement group_id="O2" value="27.0" spread="1.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Respiratory Rate During &gt;21 to &lt;=24 Months of Participant's Age</title>
        <description>Respiratory rate of participants in breaths per minute was reported.</description>
        <time_frame>Any visit during participants' age above 21 Months and up to 24 Months</time_frame>
        <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. No participant visited the site for window period &gt;21 to &lt;=24 months for reporting arm &quot;Maternal Exposure to Tramadol&quot;. Hence, for this reporting group no data was collected and reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Respiratory Rate During &gt;21 to &lt;=24 Months of Participant's Age</title>
          <description>Respiratory rate of participants in breaths per minute was reported.</description>
          <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. No participant visited the site for window period &gt;21 to &lt;=24 months for reporting arm &quot;Maternal Exposure to Tramadol&quot;. Hence, for this reporting group no data was collected and reported.</population>
          <units>breaths per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Respiratory Rate During &gt;24 to &lt;=30 Months of Participant's Age</title>
        <description>Respiratory rate of participants in breaths per minute was reported.</description>
        <time_frame>Any visit during participants' age above 24 Months and up to 30 Months</time_frame>
        <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. No participant visited the site for window period &gt;24 to &lt;=30 months for reporting arm &quot;Maternal Exposure to Tramadol&quot;. Hence, for this reporting group no data was collected and reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Respiratory Rate During &gt;24 to &lt;=30 Months of Participant's Age</title>
          <description>Respiratory rate of participants in breaths per minute was reported.</description>
          <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. No participant visited the site for window period &gt;24 to &lt;=30 months for reporting arm &quot;Maternal Exposure to Tramadol&quot;. Hence, for this reporting group no data was collected and reported.</population>
          <units>breaths per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Abnormal Neurological Examination Findings During 0 to Less Than or Equal to (&lt;=) 2 Months of Participant's Age</title>
        <description>Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.</description>
        <time_frame>Any visit during participants' age from 0 to 2 Months</time_frame>
        <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Neurological Examination Findings During 0 to Less Than or Equal to (&lt;=) 2 Months of Participant's Age</title>
          <description>Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.</description>
          <population>Safety population included all participants who were enrolled into the study. Here, &quot;Overall Number of Participants Analyzed&quot; signifies number of participants evaluable for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Abnormal Neurological Examination Findings at 8 Months of Participant's Age</title>
        <description>Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.</description>
        <time_frame>At 8 Months of participants' age</time_frame>
        <population>Safety population included all participants who were enrolled into the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Neurological Examination Findings at 8 Months of Participant's Age</title>
          <description>Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.</description>
          <population>Safety population included all participants who were enrolled into the study.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Abnormal Neurological Examination Findings at 15 Months of Participant's Age</title>
        <description>Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.</description>
        <time_frame>At 15 Months of participants' age</time_frame>
        <population>Safety population included all participants who were enrolled into the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Neurological Examination Findings at 15 Months of Participant's Age</title>
          <description>Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.</description>
          <population>Safety population included all participants who were enrolled into the study.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Abnormal Neurological Examination Findings at Follow-up Visit 1 (Month 20 of Participant's Age)</title>
        <description>Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.</description>
        <time_frame>Follow-up Visit 1 (At the age of Month 20)</time_frame>
        <population>Safety population analyzed. &quot;Overall Number of Participants Analyzed&quot; = number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. Investigator upon previous assessment suggested only 1 participant of reporting arm &quot;Maternal Exposure to Tanezumab&quot; to have follow up visit for neurological examination. No participant of reporting arm &quot;Maternal Exposure to Tramadol&quot; was suggested for follow up visit, thus no data reported for this arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Neurological Examination Findings at Follow-up Visit 1 (Month 20 of Participant's Age)</title>
          <description>Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.</description>
          <population>Safety population analyzed. &quot;Overall Number of Participants Analyzed&quot; = number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. Investigator upon previous assessment suggested only 1 participant of reporting arm &quot;Maternal Exposure to Tanezumab&quot; to have follow up visit for neurological examination. No participant of reporting arm &quot;Maternal Exposure to Tramadol&quot; was suggested for follow up visit, thus no data reported for this arm.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Abnormal Neurological Examination Findings at Follow-up Visit 2 (Month 26 of Participant's Age)</title>
        <description>Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.</description>
        <time_frame>Follow-up Visit 2 (At the age of 26 Months)</time_frame>
        <population>Safety population analyzed. &quot;Overall Number of Participants Analyzed&quot; = number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. Investigator upon previous assessment suggested only 1 participant of reporting arm &quot;Maternal Exposure to Tanezumab&quot; to have follow up visit for neurological examination. No participant of reporting arm &quot;Maternal Exposure to Tramadol&quot; was suggested for follow up visit, thus no data reported for this arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Neurological Examination Findings at Follow-up Visit 2 (Month 26 of Participant's Age)</title>
          <description>Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.</description>
          <population>Safety population analyzed. &quot;Overall Number of Participants Analyzed&quot; = number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. Investigator upon previous assessment suggested only 1 participant of reporting arm &quot;Maternal Exposure to Tanezumab&quot; to have follow up visit for neurological examination. No participant of reporting arm &quot;Maternal Exposure to Tramadol&quot; was suggested for follow up visit, thus no data reported for this arm.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Month 8 of Participant's Age</title>
        <description>BINS: a validated instrument designed specifically for a high-risk infant population. It consisted of 11-13 items for different age levels (11 items for participants aged from 3-4 months, 11-15 months, 16-20 months; 13 items for participants aged from 5-6 months, 7-10 months, 21-24 months) to assess cognitive, social, language, gross, and fine motor skills. Each item was scored on a range 0 = non-optimal performance to 1 = optimal performance; BINS total score was sum of scores of each item and it ranged for 11 items from 0 (non-optimal performance) to 11 (optimum performance) and for 13 items from 0 (non-optimal performance) to 13 (optimum performance), higher score indicated better performance.</description>
        <time_frame>At 8 Months of participants' age</time_frame>
        <population>Safety population included all participants who were enrolled into the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Month 8 of Participant's Age</title>
          <description>BINS: a validated instrument designed specifically for a high-risk infant population. It consisted of 11-13 items for different age levels (11 items for participants aged from 3-4 months, 11-15 months, 16-20 months; 13 items for participants aged from 5-6 months, 7-10 months, 21-24 months) to assess cognitive, social, language, gross, and fine motor skills. Each item was scored on a range 0 = non-optimal performance to 1 = optimal performance; BINS total score was sum of scores of each item and it ranged for 11 items from 0 (non-optimal performance) to 11 (optimum performance) and for 13 items from 0 (non-optimal performance) to 13 (optimum performance), higher score indicated better performance.</description>
          <population>Safety population included all participants who were enrolled into the study.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Summarized data was not available, individual BINS total score for 2 participants were 13 and 11 respectively.</measurement>
                    <measurement group_id="O2" value="NA" spread="NA">Summarized data was not available, individual BINS total score for 2 participants were 11 and 9 respectively.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Month 15 of Participant's Age</title>
        <description>BINS: a validated instrument designed specifically for a high-risk infant population. It consisted of 11-13 items for different age levels (11 items for participants aged from 3-4 months, 11-15 months, 16-20 months; 13 items for participants aged from 5-6 months, 7-10 months, 21-24 months) to assess cognitive, social, language, gross, and fine motor skills. Each item was scored on a range 0 = non-optimal performance to 1 = optimal performance; BINS total score was sum of scores of each item and it ranged for 11 items from 0 (non-optimal performance) to 11 (optimum performance) and for 13 items from 0 (non-optimal performance) to 13 (optimum performance), higher score indicated better performance.</description>
        <time_frame>At 15 Months of participants' age</time_frame>
        <population>Safety population included all participants who were enrolled into the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Month 15 of Participant's Age</title>
          <description>BINS: a validated instrument designed specifically for a high-risk infant population. It consisted of 11-13 items for different age levels (11 items for participants aged from 3-4 months, 11-15 months, 16-20 months; 13 items for participants aged from 5-6 months, 7-10 months, 21-24 months) to assess cognitive, social, language, gross, and fine motor skills. Each item was scored on a range 0 = non-optimal performance to 1 = optimal performance; BINS total score was sum of scores of each item and it ranged for 11 items from 0 (non-optimal performance) to 11 (optimum performance) and for 13 items from 0 (non-optimal performance) to 13 (optimum performance), higher score indicated better performance.</description>
          <population>Safety population included all participants who were enrolled into the study.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Summarized data was not available, individual BINS total score for 2 participants were 11 and 7 respectively.</measurement>
                    <measurement group_id="O2" value="NA" spread="NA">Summarized data was not available, individual BINS total score for 2 participants were 11 and 10 respectively.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Follow-up Visit 1 (Month 20 of Participant's Age)</title>
        <description>BINS: a validated instrument designed specifically for a high-risk infant population. It consisted of 11-13 items for different age levels (11 items for participants aged from 3-4 months, 11-15 months, 16-20 months; 13 items for participants aged from 5-6 months, 7-10 months, 21-24 months) to assess cognitive, social, language, gross, and fine motor skills. Each item was scored on a range 0 = non-optimal performance to 1 = optimal performance; BINS total score was sum of scores of each item and it ranged for 11 items from 0 (non-optimal performance) to 11 (optimum performance) and for 13 items from 0 (non-optimal performance) to 13 (optimum performance), higher score indicated better performance.</description>
        <time_frame>Follow-up Visit 1 (At the age of Month 20)</time_frame>
        <population>Safety population analyzed. &quot;Overall Number of Participants Analyzed&quot; = number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. Investigator upon previous assessment suggested only 1 participant of reporting arm &quot;Maternal Exposure to Tanezumab&quot; to have follow up visit for BINS assessment. No participant of reporting arm &quot;Maternal Exposure to Tramadol&quot; was suggested for follow up visit, thus no data reported for this arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Follow-up Visit 1 (Month 20 of Participant's Age)</title>
          <description>BINS: a validated instrument designed specifically for a high-risk infant population. It consisted of 11-13 items for different age levels (11 items for participants aged from 3-4 months, 11-15 months, 16-20 months; 13 items for participants aged from 5-6 months, 7-10 months, 21-24 months) to assess cognitive, social, language, gross, and fine motor skills. Each item was scored on a range 0 = non-optimal performance to 1 = optimal performance; BINS total score was sum of scores of each item and it ranged for 11 items from 0 (non-optimal performance) to 11 (optimum performance) and for 13 items from 0 (non-optimal performance) to 13 (optimum performance), higher score indicated better performance.</description>
          <population>Safety population analyzed. &quot;Overall Number of Participants Analyzed&quot; = number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. Investigator upon previous assessment suggested only 1 participant of reporting arm &quot;Maternal Exposure to Tanezumab&quot; to have follow up visit for BINS assessment. No participant of reporting arm &quot;Maternal Exposure to Tramadol&quot; was suggested for follow up visit, thus no data reported for this arm.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Follow-up Visit 2 (Month 26 of Participant's Age)</title>
        <description>BINS: a validated instrument designed specifically for a high-risk infant population. It consisted of 11-13 items for different age levels (11 items for participants aged from 3-4 months, 11-15 months, 16-20 months; 13 items for participants aged from 5-6 months, 7-10 months, 21-24 months) to assess cognitive, social, language, gross, and fine motor skills. Each item was scored on a range 0 = non-optimal performance to 1 = optimal performance; BINS total score was sum of scores of each item and it ranged for 11 items from 0 (non-optimal performance) to 11 (optimum performance) and for 13 items from 0 (non-optimal performance) to 13 (optimum performance), higher score indicated better performance. Data collected at age of 26 months used 24 months' age items.</description>
        <time_frame>Follow-up Visit 2 (At the age of Month 26)</time_frame>
        <population>Safety population analyzed. &quot;Overall Number of Participants Analyzed&quot; = number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. Investigator upon previous assessment suggested only 1 participant of reporting arm &quot;Maternal Exposure to Tanezumab&quot; to have follow up visit for BINS assessment. No participant of reporting arm &quot;Maternal Exposure to Tramadol&quot; was suggested for follow up visit, thus no data reported for this arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Follow-up Visit 2 (Month 26 of Participant's Age)</title>
          <description>BINS: a validated instrument designed specifically for a high-risk infant population. It consisted of 11-13 items for different age levels (11 items for participants aged from 3-4 months, 11-15 months, 16-20 months; 13 items for participants aged from 5-6 months, 7-10 months, 21-24 months) to assess cognitive, social, language, gross, and fine motor skills. Each item was scored on a range 0 = non-optimal performance to 1 = optimal performance; BINS total score was sum of scores of each item and it ranged for 11 items from 0 (non-optimal performance) to 11 (optimum performance) and for 13 items from 0 (non-optimal performance) to 13 (optimum performance), higher score indicated better performance. Data collected at age of 26 months used 24 months' age items.</description>
          <population>Safety population analyzed. &quot;Overall Number of Participants Analyzed&quot; = number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. Investigator upon previous assessment suggested only 1 participant of reporting arm &quot;Maternal Exposure to Tanezumab&quot; to have follow up visit for BINS assessment. No participant of reporting arm &quot;Maternal Exposure to Tramadol&quot; was suggested for follow up visit, thus no data reported for this arm.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Month 8 of Participant's Age</title>
        <description>REEL-3, was designed to identify infants and toddlers who had language impairments or who had other disabilities that affect language development. Caregiver answered interview questionnaire by pediatrician, pediatric neurologist or clinical psychologist for receptive language and expressive language subtests. Each of these 2 sub tests had 66 questions with answer of 'yes = 1' or 'no = 0'. Sum of receptive and expressive language subtests answers was used to calculate REEL-3 language ability total score, with following ranges: &lt;70 (very poor), 70-79 (poor), 80-89 (below average), 90-110 (average), 111-120 (above average), 121-130 (superior), and &gt;130 (very superior). Higher scores indicated better language ability.</description>
        <time_frame>At 8 Months of participants' age</time_frame>
        <population>Safety population included all participants who were enrolled into the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Month 8 of Participant's Age</title>
          <description>REEL-3, was designed to identify infants and toddlers who had language impairments or who had other disabilities that affect language development. Caregiver answered interview questionnaire by pediatrician, pediatric neurologist or clinical psychologist for receptive language and expressive language subtests. Each of these 2 sub tests had 66 questions with answer of 'yes = 1' or 'no = 0'. Sum of receptive and expressive language subtests answers was used to calculate REEL-3 language ability total score, with following ranges: &lt;70 (very poor), 70-79 (poor), 80-89 (below average), 90-110 (average), 111-120 (above average), 121-130 (superior), and &gt;130 (very superior). Higher scores indicated better language ability.</description>
          <population>Safety population included all participants who were enrolled into the study.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Summarized data was not available, individual REEL-3 language ability total score for 2 participants were 95 and 91 respectively.</measurement>
                    <measurement group_id="O2" value="NA" spread="NA">Summarized data was not available, individual REEL-3 language ability total score for 2 participants were 97 and 93 respectively.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Month 15 of Participant's Age</title>
        <description>REEL-3, was designed to identify infants and toddlers who had language impairments or who had other disabilities that affect language development. Caregiver answered interview questionnaire by pediatrician, pediatric neurologist or clinical psychologist for receptive language and expressive language subtests. Each of these 2 sub tests had 66 questions with answer of 'yes = 1' or 'no = 0'. Sum of receptive and expressive language subtests answers was used to calculate REEL-3 language ability total score, with following ranges: &lt;70 (very poor), 70-79 (poor), 80-89 (below average), 90-110 (average), 111-120 (above average), 121-130 (superior), and &gt;130 (very superior). Higher scores indicated better language ability.</description>
        <time_frame>At 15 Months of participants' age</time_frame>
        <population>Safety population included all participants who were enrolled into the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Month 15 of Participant's Age</title>
          <description>REEL-3, was designed to identify infants and toddlers who had language impairments or who had other disabilities that affect language development. Caregiver answered interview questionnaire by pediatrician, pediatric neurologist or clinical psychologist for receptive language and expressive language subtests. Each of these 2 sub tests had 66 questions with answer of 'yes = 1' or 'no = 0'. Sum of receptive and expressive language subtests answers was used to calculate REEL-3 language ability total score, with following ranges: &lt;70 (very poor), 70-79 (poor), 80-89 (below average), 90-110 (average), 111-120 (above average), 121-130 (superior), and &gt;130 (very superior). Higher scores indicated better language ability.</description>
          <population>Safety population included all participants who were enrolled into the study.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Summarized data was not available, individual REEL-3 language ability total score for 2 participants were 86 and 89 respectively.</measurement>
                    <measurement group_id="O2" value="NA" spread="NA">Summarized data was not available, individual REEL-3 language ability total score for 2 participants were 99 and 97 respectively.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Follow-up Visit 1 (Month 20 of Participant's Age)</title>
        <description>REEL-3, was designed to identify infants and toddlers who had language impairments or who had other disabilities that affect language development. Caregiver answered interview questionnaire by pediatrician, pediatric neurologist or clinical psychologist for receptive language and expressive language subtests. Each of these 2 sub tests had 66 questions with answer of 'yes = 1' or 'no = 0'. Sum of receptive and expressive language subtests answers was used to calculate REEL-3 language ability total score, with following ranges: &lt;70 (very poor), 70-79 (poor), 80-89 (below average), 90-110 (average), 111-120 (above average), 121-130 (superior), and &gt;130 (very superior). Higher scores indicated better language ability.</description>
        <time_frame>Follow-up Visit 1 (At the age of Month 20)</time_frame>
        <population>Safety population analyzed. &quot;Overall Number of Participants Analyzed&quot; = number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. Investigator upon previous assessment suggested only 1 participant of reporting arm &quot;Maternal Exposure to Tanezumab&quot; to have follow up visit for REEL-3 assessment. No participant of reporting arm &quot;Maternal Exposure to Tramadol&quot; was suggested for follow up visit, thus no data reported for this arm</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Follow-up Visit 1 (Month 20 of Participant's Age)</title>
          <description>REEL-3, was designed to identify infants and toddlers who had language impairments or who had other disabilities that affect language development. Caregiver answered interview questionnaire by pediatrician, pediatric neurologist or clinical psychologist for receptive language and expressive language subtests. Each of these 2 sub tests had 66 questions with answer of 'yes = 1' or 'no = 0'. Sum of receptive and expressive language subtests answers was used to calculate REEL-3 language ability total score, with following ranges: &lt;70 (very poor), 70-79 (poor), 80-89 (below average), 90-110 (average), 111-120 (above average), 121-130 (superior), and &gt;130 (very superior). Higher scores indicated better language ability.</description>
          <population>Safety population analyzed. &quot;Overall Number of Participants Analyzed&quot; = number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. Investigator upon previous assessment suggested only 1 participant of reporting arm &quot;Maternal Exposure to Tanezumab&quot; to have follow up visit for REEL-3 assessment. No participant of reporting arm &quot;Maternal Exposure to Tramadol&quot; was suggested for follow up visit, thus no data reported for this arm</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Follow-up Visit 2 (Month 26 of Participant's Age)</title>
        <description>REEL-3, was designed to identify infants and toddlers who had language impairments or who had other disabilities that affect language development. Caregiver answered interview questionnaire by pediatrician, pediatric neurologist or clinical psychologist for receptive language and expressive language subtests. Each of these 2 sub tests had 66 questions with answer of 'yes = 1' or 'no = 0'. Sum of receptive and expressive language subtests answers was used to calculate REEL-3 language ability total score, with following ranges: &lt;70 (very poor), 70-79 (poor), 80-89 (below average), 90-110 (average), 111-120 (above average), 121-130 (superior), and &gt;130 (very superior). Higher scores indicated better language ability.</description>
        <time_frame>Follow-up Visit 2 (At the age of Month 26)</time_frame>
        <population>Safety population analyzed. &quot;Overall Number of Participants Analyzed&quot; = number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. Investigator upon previous assessment suggested only 1 participant of reporting arm &quot;Maternal Exposure to Tanezumab&quot; to have follow up visit for REEL-3 assessment. No participant of reporting arm &quot;Maternal Exposure to Tramadol&quot; was suggested for follow up visit, thus no data reported for this arm</population>
        <group_list>
          <group group_id="O1">
            <title>Maternal Exposure to Tanezumab</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
          </group>
          <group group_id="O2">
            <title>Maternal Exposure to Tramadol</title>
            <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
          </group>
        </group_list>
        <measure>
          <title>Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Follow-up Visit 2 (Month 26 of Participant's Age)</title>
          <description>REEL-3, was designed to identify infants and toddlers who had language impairments or who had other disabilities that affect language development. Caregiver answered interview questionnaire by pediatrician, pediatric neurologist or clinical psychologist for receptive language and expressive language subtests. Each of these 2 sub tests had 66 questions with answer of 'yes = 1' or 'no = 0'. Sum of receptive and expressive language subtests answers was used to calculate REEL-3 language ability total score, with following ranges: &lt;70 (very poor), 70-79 (poor), 80-89 (below average), 90-110 (average), 111-120 (above average), 121-130 (superior), and &gt;130 (very superior). Higher scores indicated better language ability.</description>
          <population>Safety population analyzed. &quot;Overall Number of Participants Analyzed&quot; = number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. Investigator upon previous assessment suggested only 1 participant of reporting arm &quot;Maternal Exposure to Tanezumab&quot; to have follow up visit for REEL-3 assessment. No participant of reporting arm &quot;Maternal Exposure to Tramadol&quot; was suggested for follow up visit, thus no data reported for this arm</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From the participants' age of 0 month to maximum of 36 months</time_frame>
      <desc>Same event may appear as both adverse event (AE) and serious adverse event (SAE). An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE.</desc>
      <group_list>
        <group group_id="E1">
          <title>Maternal Exposure to Tanezumab</title>
          <description>Infants in this reporting arm were those who had potential maternal exposure to tanezumab.</description>
        </group>
        <group group_id="E2">
          <title>Maternal Exposure to Tramadol</title>
          <description>Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA v23.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Drowning</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA v23.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Speech disorder/ Language development delay</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Speech disorder developmental / Speech developmental delay</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Pfizer ClinicalTrials.gov Call Center</name_or_title>
      <organization>Pfizer Inc.</organization>
      <phone>1-800-718-1021</phone>
      <email>ClinicalTrials.gov_Inquiries@pfizer.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03031938
org study id: A4091065
secondary id: 2013-002548-10
secondary id: INFANT SAFETY FOLLOW-UP #2
secondary id: NEONATAL MONITORING STUDY #2
nct id: NCT03031938
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
A4091065 is a multicenter, prospective, cohort study with enhance physical an
      neurodevelopmental surveillance to characterize the outcomes related to the development of
      infants up to the age of 15 months who were potentially exposed to tanezumab, placebo or
      comparator via maternal exposure or in utero in any tanezumb study.
A4091065 is a long term observational follow up study of subjects from tanezumab
      interventional studies A4091056, A4091057, A4091058, A4091059, A4091061 or A4091063
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Occipital-frontal Head Circumference During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
time frame: Any visit during participants' age from 0 to 2 Months
description: Occipital-frontal head circumference of participants in centimeter (cm) was reported.
measure: Occipital-frontal Head Circumference at 8 Months of Participant's Age
time frame: At 8 Months of participants' age
description: Occipital-frontal head circumference of participants in centimeter (cm) was reported.
measure: Occipital-frontal Head Circumference at 15 Months of Participant's Age
time frame: At 15 Months of participants' age
description: Occipital-frontal head circumference of participants in centimeter (cm) was reported.
measure: Occipital-frontal Head Circumference During 0 to Less Than or Equal to (<=) 3 Months of Participant's Age
time frame: Any visit during participants' age from 0 to 3 Months
description: Occipital-frontal head circumference of participants in centimeter (cm) was reported.
measure: Occipital-frontal Head Circumference During Greater Than (>) 3 to <=6 Months of Participant's Age
time frame: Any visit during participants' age above 3 Months and up to 6 Months
description: Occipital-frontal head circumference of participants in cm was reported.
measure: Occipital-frontal Head Circumference During >6 to <=9 Months of Participant's Age
time frame: Any visit during participants' age above 6 Months and up to 9 Months
description: Occipital-frontal head circumference of participants in cm was reported.
measure: Occipital-frontal Head Circumference During >15 to <=18 Months of Participant's Age
time frame: Any visit during participants' age above 15 Months and up to 18 Months
description: Occipital-frontal head circumference of participants in cm was reported.
measure: Occipital-frontal Head Circumference During >21 to <=24 Months of Participant's Age
time frame: Any visit during participants' age above 21 Months and up to 24 Months
description: Occipital-frontal head circumference of participants in cm was reported.
measure: Occipital-frontal Head Circumference During >24 to <=30 Months of Participant's Age
time frame: Any visit during participants' age above 24 Months and up to 30 Months
description: Occipital-frontal head circumference of participants in cm was reported.
measure: Body Length During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
time frame: Any visit during participants' age from 0 to 2 Months
description: Body length of participants in cm was reported.
measure: Body Length at 8 Months of Participant's Age
time frame: At 8 Months of participant's age
description: Body length of participants in cm was reported.
measure: Body Length at 15 Months of Participant's Age
time frame: At 15 Months of participant's age
description: Body length of participants in cm was reported.
measure: Body Length During 0 to <=3 Months of Participant's Age
time frame: Any visit during participants' age from 0 to 3 Months
description: Body length of participants in cm was reported.
measure: Body Length During >3 to <=6 Months of Participant's Age
time frame: Any visit during participants' age above 3 Months and up to 6 Months
description: Body length of participants in cm was reported.
measure: Body Length During >6 to <=9 Months of Participant's Age
time frame: Any visit during participants' age above 6 Months and up to 9 Months
description: Body length of participants in cm was reported.
measure: Body Length During >15 to <=18 Months of Participant's Age
time frame: Any visit during participants' age above 15 Months and up to 18 Months
description: Body length of participants in cm was reported.
measure: Body Length During >21 to <=24 Months of Participant's Age
time frame: Any visit during participants' age above 21 Months and up to 24 Months
description: Body length of participants in cm was reported.
measure: Body Length During >24 to <=30 Months of Participant's Age
time frame: Any visit during participants' age above 24 Months and up to 30 Months
description: Body length of participants in cm was reported.
measure: Body Weight During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
time frame: Any visit during participants' age from 0 to 2 Months
description: Body weight of participants in kilogram (kg) was reported.
measure: Body Weight at 8 Months of Participant's Age
time frame: At 8 Months of participants' age
description: Body weight of participants in kilogram (kg) was reported.
measure: Body Weight at 15 Months of Participant's Age
time frame: At 15 Months of participants' age
description: Body weight of participants in kilogram (kg) was reported.
measure: Body Weight During 0 to <=3 Months of Participant's Age
time frame: Any visit during participants' age from 0 to 3 Months
description: Body weight of participants in kilogram (kg) was reported.
measure: Body Weight During >3 to <=6 Months of Participant's Age
time frame: Any visit during participants' age above 3 Months and up to 6 Months
description: Body weight of participants in kg was reported.
measure: Body Weight During >6 to <=9 Months of Participant's Age
time frame: Any visit during participants' age above 6 Months and up to 9 Months
description: Body weight of participants in kg was reported.
measure: Body Weight During >15 to <=18 Months of Participant's Age
time frame: Any visit during participants' age above 15 Months and up to 18 Months
description: Body weight of participants in kg was reported.
measure: Body Weight During >21 to <=24 Months of Participant's Age
time frame: Any visit during participants' age above 21 Months and up to 24 Months
description: Body weight of participants in kg was reported.
measure: Body Weight During >24 to <=30 Months of Participant's Age
time frame: Any visit during participants' age above 24 Months up to 30 Months
description: Body weight of participants in kg was reported.
measure: Systolic and Diastolic Blood Pressure During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
time frame: Any visit during participants' age from 0 to 2 Months
description: Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.
measure: Systolic and Diastolic Blood Pressure at 8 Months of Participant's Age
time frame: At 8 Months of participants' age
description: Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.
measure: Systolic and Diastolic Blood Pressure at 15 Months of Participant's Age
time frame: At 15 Months participants' age
description: Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.
measure: Systolic and Diastolic Blood Pressure During 0 to <=3 Months of Participant's Age
time frame: Any visit during participants' age from 0 to 3 Months
description: Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.
measure: Systolic and Diastolic Blood Pressure During >3 to <=6 Months of Participant's Age
time frame: Any visit during participants' age above 3 Months and up to 6 Months
description: Systolic and diastolic blood pressure of participants in mmHg was reported.
measure: Systolic and Diastolic Blood Pressure During >6 to <=9 Months of Participant's Age
time frame: Any visit during participants' age above 6 Months and up to 9 Months
description: Systolic and diastolic blood pressure of participants in mmHg was reported.
measure: Systolic and Diastolic Blood Pressure During >15 to <=18 Months of Participant's Age
time frame: Any visit during participants' age above 15 Months and up to 18 Months
description: Systolic and diastolic blood pressure of participants in mmHg was reported.
measure: Systolic and Diastolic Blood Pressure During >21 to <=24 Months of Participant's Age
time frame: Any visit during participants' age above 21 Months and up to 24 Months
description: Systolic and diastolic blood pressure of participants in mmHg was reported.
measure: Systolic and Diastolic Blood Pressure During >24 to <=30 Months of Participant's Age
time frame: Any visit during participants' age above 24 Months and up to 30 Months
description: Systolic and diastolic blood pressure of participants in mmHg was reported.
measure: Pulse Rate During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
time frame: Any visit during participants' age from 0 to 2 Months
description: Pulse rate of participants in beats per minute was reported.
measure: Pulse Rate at 8 Months of Participant's Age
time frame: At 8 Months of participants' age
description: Pulse rate of participants in beats per minute was reported.
measure: Pulse Rate at 15 Months of Participant's Age
time frame: At 15 Months of participants' age
description: Pulse rate of participants in beats per minute was reported.
measure: Pulse Rate During 0 to <=3 Months of Participant's Age
time frame: Any visit during participants' age from 0 to 3 Months
description: Pulse rate of participants in beats per minute was reported.
measure: Pulse Rate During >3 to <=6 Months of Participant's Age
time frame: Any visit during participants' age above 3 Months and up to 6 Months
description: Pulse rate of participants in beats per minute was reported.
measure: Pulse Rate During >6 to <=9 Months of Participant's Age
time frame: Any visit during participants' age above 6 Months and up to 9 Months
description: Pulse rate of participants in beats per minute was reported.
measure: Pulse Rate During >15 to <=18 Months of Participant's Age
time frame: Any visit during participants' age above 15 Months and up to 18 Months
description: Pulse rate of participants in beats per minute was reported.
measure: Pulse Rate During >21 to <=24 Months of Participant's Age
time frame: Any visit during participants' age above 21 Months and up to 24 Months
description: Pulse rate of participants in beats per minute was reported.
measure: Pulse Rate During >24 to <=30 Months of Participant's Age
time frame: Any visit during participants' age above 24 Months and up to 30 Months
description: Pulse rate of participants in beats per minute was reported.
measure: Temperature During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
time frame: Any visit during participants' age from 0 to 2 Months
description: Temperature of participants in degree Celsius was reported.
measure: Temperature at 8 Months of Participant's Age
time frame: At 8 Months of participants' age
description: Temperature of participants in degree Celsius was reported.
measure: Temperature at 15 Months of Participant's Age
time frame: At 15 Months of participants' age
description: Temperature of participants in degree Celsius was reported.
measure: Temperature During 0 to <=3 Months of Participant's Age
time frame: Any visit during participants' age from 0 to 3 Months
description: Temperature of participants in degree Celsius was reported.
measure: Temperature During >3 to <=6 Months of Participant's Age
time frame: Any visit during participants' age above 3 Months and up to 6 Months
description: Temperature of participants in degree Celsius was reported.
measure: Temperature During >6 to <=9 Months of Participant's Age
time frame: Any visit during participants' age above 6 Months and up to 9 Months
description: Temperature of participants in degree Celsius was reported.
measure: Temperature During >15 to <=18 Months of Participant's Age
time frame: Any visit during participants' age above 15 Months and up to 18 Months
description: Temperature of participants in degree Celsius was reported.
measure: Temperature During >21 to <=24 Months of Participant's Age
time frame: Any visit during participants' age above 21 Months and up to 24 Months
description: Temperature of participants in degree Celsius was reported.
measure: Temperature During >24 to <=30 Months of Participant's Age
time frame: Any visit during participants' age above 24 Months and up to 30 Months
description: Temperature of participants in degree Celsius was reported.
measure: Respiratory Rate During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
time frame: Any visit during participants' age from 0 to 2 Months
description: Respiratory rate of participants in breaths per minute was reported.
measure: Respiratory Rate at 8 Months of Participant's Age
time frame: At 8 Months of participants' age
description: Respiratory rate of participants in breaths per minute was reported.
measure: Respiratory Rate at 15 Months of Participant's Age
time frame: At 15 Months participants' age
description: Respiratory rate of participants in breaths per minute was reported.
measure: Respiratory Rate During 0 to <=3 Months of Participant's Age
time frame: Any visit during participants' age from 0 to 3 Months
description: Respiratory rate of participants in breaths per minute was reported.
measure: Respiratory Rate During >3 to <=6 Months of Participant's Age
time frame: Any visit during participants' age above 3 Months and up to 6 Months
description: Respiratory rate of participants in breaths per minute was reported.
measure: Respiratory Rate During >6 to <=9 Months of Participant's Age
time frame: Any visit during participants' age above 6 Months and up to 9 Months
description: Respiratory rate of participants in breaths per minute was reported.
measure: Respiratory Rate During >15 to <=18 Months of Participant's Age
time frame: Any visit during participants' age above 15 Months and up to 18 Months
description: Respiratory rate of participants in breaths per minute was reported.
measure: Respiratory Rate During >21 to <=24 Months of Participant's Age
time frame: Any visit during participants' age above 21 Months and up to 24 Months
description: Respiratory rate of participants in breaths per minute was reported.
measure: Respiratory Rate During >24 to <=30 Months of Participant's Age
time frame: Any visit during participants' age above 24 Months and up to 30 Months
description: Respiratory rate of participants in breaths per minute was reported.
measure: Number of Participants With Abnormal Neurological Examination Findings During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
time frame: Any visit during participants' age from 0 to 2 Months
description: Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.
measure: Number of Participants With Abnormal Neurological Examination Findings at 8 Months of Participant's Age
time frame: At 8 Months of participants' age
description: Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.
measure: Number of Participants With Abnormal Neurological Examination Findings at 15 Months of Participant's Age
time frame: At 15 Months of participants' age
description: Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.
measure: Number of Participants With Abnormal Neurological Examination Findings at Follow-up Visit 1 (Month 20 of Participant's Age)
time frame: Follow-up Visit 1 (At the age of Month 20)
description: Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.
measure: Number of Participants With Abnormal Neurological Examination Findings at Follow-up Visit 2 (Month 26 of Participant's Age)
time frame: Follow-up Visit 2 (At the age of 26 Months)
description: Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.
measure: Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Month 8 of Participant's Age
time frame: At 8 Months of participants' age
description: BINS: a validated instrument designed specifically for a high-risk infant population. It consisted of 11-13 items for different age levels (11 items for participants aged from 3-4 months, 11-15 months, 16-20 months; 13 items for participants aged from 5-6 months, 7-10 months, 21-24 months) to assess cognitive, social, language, gross, and fine motor skills. Each item was scored on a range 0 = non-optimal performance to 1 = optimal performance; BINS total score was sum of scores of each item and it ranged for 11 items from 0 (non-optimal performance) to 11 (optimum performance) and for 13 items from 0 (non-optimal performance) to 13 (optimum performance), higher score indicated better performance.
measure: Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Month 15 of Participant's Age
time frame: At 15 Months of participants' age
description: BINS: a validated instrument designed specifically for a high-risk infant population. It consisted of 11-13 items for different age levels (11 items for participants aged from 3-4 months, 11-15 months, 16-20 months; 13 items for participants aged from 5-6 months, 7-10 months, 21-24 months) to assess cognitive, social, language, gross, and fine motor skills. Each item was scored on a range 0 = non-optimal performance to 1 = optimal performance; BINS total score was sum of scores of each item and it ranged for 11 items from 0 (non-optimal performance) to 11 (optimum performance) and for 13 items from 0 (non-optimal performance) to 13 (optimum performance), higher score indicated better performance.
measure: Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Follow-up Visit 1 (Month 20 of Participant's Age)
time frame: Follow-up Visit 1 (At the age of Month 20)
description: BINS: a validated instrument designed specifically for a high-risk infant population. It consisted of 11-13 items for different age levels (11 items for participants aged from 3-4 months, 11-15 months, 16-20 months; 13 items for participants aged from 5-6 months, 7-10 months, 21-24 months) to assess cognitive, social, language, gross, and fine motor skills. Each item was scored on a range 0 = non-optimal performance to 1 = optimal performance; BINS total score was sum of scores of each item and it ranged for 11 items from 0 (non-optimal performance) to 11 (optimum performance) and for 13 items from 0 (non-optimal performance) to 13 (optimum performance), higher score indicated better performance.
measure: Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Follow-up Visit 2 (Month 26 of Participant's Age)
time frame: Follow-up Visit 2 (At the age of Month 26)
description: BINS: a validated instrument designed specifically for a high-risk infant population. It consisted of 11-13 items for different age levels (11 items for participants aged from 3-4 months, 11-15 months, 16-20 months; 13 items for participants aged from 5-6 months, 7-10 months, 21-24 months) to assess cognitive, social, language, gross, and fine motor skills. Each item was scored on a range 0 = non-optimal performance to 1 = optimal performance; BINS total score was sum of scores of each item and it ranged for 11 items from 0 (non-optimal performance) to 11 (optimum performance) and for 13 items from 0 (non-optimal performance) to 13 (optimum performance), higher score indicated better performance. Data collected at age of 26 months used 24 months' age items.
measure: Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Month 8 of Participant's Age
time frame: At 8 Months of participants' age
description: REEL-3, was designed to identify infants and toddlers who had language impairments or who had other disabilities that affect language development. Caregiver answered interview questionnaire by pediatrician, pediatric neurologist or clinical psychologist for receptive language and expressive language subtests. Each of these 2 sub tests had 66 questions with answer of 'yes = 1' or 'no = 0'. Sum of receptive and expressive language subtests answers was used to calculate REEL-3 language ability total score, with following ranges: <70 (very poor), 70-79 (poor), 80-89 (below average), 90-110 (average), 111-120 (above average), 121-130 (superior), and >130 (very superior). Higher scores indicated better language ability.
measure: Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Month 15 of Participant's Age
time frame: At 15 Months of participants' age
description: REEL-3, was designed to identify infants and toddlers who had language impairments or who had other disabilities that affect language development. Caregiver answered interview questionnaire by pediatrician, pediatric neurologist or clinical psychologist for receptive language and expressive language subtests. Each of these 2 sub tests had 66 questions with answer of 'yes = 1' or 'no = 0'. Sum of receptive and expressive language subtests answers was used to calculate REEL-3 language ability total score, with following ranges: <70 (very poor), 70-79 (poor), 80-89 (below average), 90-110 (average), 111-120 (above average), 121-130 (superior), and >130 (very superior). Higher scores indicated better language ability.
measure: Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Follow-up Visit 1 (Month 20 of Participant's Age)
time frame: Follow-up Visit 1 (At the age of Month 20)
description: REEL-3, was designed to identify infants and toddlers who had language impairments or who had other disabilities that affect language development. Caregiver answered interview questionnaire by pediatrician, pediatric neurologist or clinical psychologist for receptive language and expressive language subtests. Each of these 2 sub tests had 66 questions with answer of 'yes = 1' or 'no = 0'. Sum of receptive and expressive language subtests answers was used to calculate REEL-3 language ability total score, with following ranges: <70 (very poor), 70-79 (poor), 80-89 (below average), 90-110 (average), 111-120 (above average), 121-130 (superior), and >130 (very superior). Higher scores indicated better language ability.
measure: Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Follow-up Visit 2 (Month 26 of Participant's Age)
time frame: Follow-up Visit 2 (At the age of Month 26)
description: REEL-3, was designed to identify infants and toddlers who had language impairments or who had other disabilities that affect language development. Caregiver answered interview questionnaire by pediatrician, pediatric neurologist or clinical psychologist for receptive language and expressive language subtests. Each of these 2 sub tests had 66 questions with answer of 'yes = 1' or 'no = 0'. Sum of receptive and expressive language subtests answers was used to calculate REEL-3 language ability total score, with following ranges: <70 (very poor), 70-79 (poor), 80-89 (below average), 90-110 (average), 111-120 (above average), 121-130 (superior), and >130 (very superior). Higher scores indicated better language ability.
arm group label: Cohort 1
arm group type: Other
description: Long term observational study of subjects from tanezumab parent study
intervention type: Drug
intervention name: Investigational medical product (IMP) administered in parent study
description: IMP as administered in parent study. IMP would have been either placebo, tanezumab, celecoxib, naproxen, diclofenac, administered in parent study
arm group label: Cohort 1
criteria: 
gender: All
minimum age: 0 Years
maximum age: 2 Months
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
url: https://pmiform.com/clinical-trial-info-request?StudyID=A4091065
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Low Back Pain
mesh term: Cancer Pain
sharing ipd: Yes
ipd description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
ipd url: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 