Cancer Pain, Osteoarthritis, Recurrent Low Back Pain
Conditions
Keywords
Exposure in utero in tanezumab program
Brief summary
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.
Detailed description
A4091065 is a long term observational follow up study of subjects from tanezumab interventional studies A4091056, A4091057, A4091058, A4091059, A4091061 or A4091063
Interventions
IMP as administered in parent study. IMP would have been either placebo, tanezumab, celecoxib, naproxen, diclofenac, administered in parent study
Sponsors
Eli Lilly and Company
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Years to 2 Months
Healthy volunteers
No
Inclusion criteria
* Subject is an infant born to a mother who was exposed to study drug on a tanezumab clinical study. * The infant's mother (who was the tanezumab clinical study participant) must review, agree and sign an informed consent document explaining the details of the perinatal and post natal follow up. Where local regulations mandate, the male parent would also review and sign the informed consent. * Parents or legal guardian must be willing and able to comply with scheduled visits and study procedures.
Exclusion criteria
* There are no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Weight During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age | Any visit during participants' age from 0 to 2 Months | Body weight of participants in kilogram (kg) was reported. |
| Occipital-frontal Head Circumference During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age | Any visit during participants' age from 0 to 2 Months | Occipital-frontal head circumference of participants in centimeter (cm) was reported. |
| Occipital-frontal Head Circumference at 8 Months of Participant's Age | At 8 Months of participants' age | Occipital-frontal head circumference of participants in centimeter (cm) was reported. |
| Occipital-frontal Head Circumference at 15 Months of Participant's Age | At 15 Months of participants' age | Occipital-frontal head circumference of participants in centimeter (cm) was reported. |
| Occipital-frontal Head Circumference During 0 to Less Than or Equal to (<=) 3 Months of Participant's Age | Any visit during participants' age from 0 to 3 Months | Occipital-frontal head circumference of participants in centimeter (cm) was reported. |
| Occipital-frontal Head Circumference During Greater Than (>) 3 to <=6 Months of Participant's Age | Any visit during participants' age above 3 Months and up to 6 Months | Occipital-frontal head circumference of participants in cm was reported. |
| Occipital-frontal Head Circumference During >6 to <=9 Months of Participant's Age | Any visit during participants' age above 6 Months and up to 9 Months | Occipital-frontal head circumference of participants in cm was reported. |
| Occipital-frontal Head Circumference During >15 to <=18 Months of Participant's Age | Any visit during participants' age above 15 Months and up to 18 Months | Occipital-frontal head circumference of participants in cm was reported. |
| Occipital-frontal Head Circumference During >21 to <=24 Months of Participant's Age | Any visit during participants' age above 21 Months and up to 24 Months | Occipital-frontal head circumference of participants in cm was reported. |
| Occipital-frontal Head Circumference During >24 to <=30 Months of Participant's Age | Any visit during participants' age above 24 Months and up to 30 Months | Occipital-frontal head circumference of participants in cm was reported. |
| Body Length During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age | Any visit during participants' age from 0 to 2 Months | Body length of participants in cm was reported. |
| Body Length at 8 Months of Participant's Age | At 8 Months of participant's age | Body length of participants in cm was reported. |
| Body Length at 15 Months of Participant's Age | At 15 Months of participant's age | Body length of participants in cm was reported. |
| Body Length During 0 to <=3 Months of Participant's Age | Any visit during participants' age from 0 to 3 Months | Body length of participants in cm was reported. |
| Body Length During >3 to <=6 Months of Participant's Age | Any visit during participants' age above 3 Months and up to 6 Months | Body length of participants in cm was reported. |
| Body Length During >6 to <=9 Months of Participant's Age | Any visit during participants' age above 6 Months and up to 9 Months | Body length of participants in cm was reported. |
| Body Length During >15 to <=18 Months of Participant's Age | Any visit during participants' age above 15 Months and up to 18 Months | Body length of participants in cm was reported. |
| Body Length During >21 to <=24 Months of Participant's Age | Any visit during participants' age above 21 Months and up to 24 Months | Body length of participants in cm was reported. |
| Body Length During >24 to <=30 Months of Participant's Age | Any visit during participants' age above 24 Months and up to 30 Months | Body length of participants in cm was reported. |
| Body Weight at 8 Months of Participant's Age | At 8 Months of participants' age | Body weight of participants in kilogram (kg) was reported. |
| Body Weight at 15 Months of Participant's Age | At 15 Months of participants' age | Body weight of participants in kilogram (kg) was reported. |
| Body Weight During 0 to <=3 Months of Participant's Age | Any visit during participants' age from 0 to 3 Months | Body weight of participants in kilogram (kg) was reported. |
| Body Weight During >3 to <=6 Months of Participant's Age | Any visit during participants' age above 3 Months and up to 6 Months | Body weight of participants in kg was reported. |
| Body Weight During >6 to <=9 Months of Participant's Age | Any visit during participants' age above 6 Months and up to 9 Months | Body weight of participants in kg was reported. |
| Body Weight During >15 to <=18 Months of Participant's Age | Any visit during participants' age above 15 Months and up to 18 Months | Body weight of participants in kg was reported. |
| Body Weight During >21 to <=24 Months of Participant's Age | Any visit during participants' age above 21 Months and up to 24 Months | Body weight of participants in kg was reported. |
| Body Weight During >24 to <=30 Months of Participant's Age | Any visit during participants' age above 24 Months up to 30 Months | Body weight of participants in kg was reported. |
| Systolic and Diastolic Blood Pressure During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age | Any visit during participants' age from 0 to 2 Months | Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported. |
| Systolic and Diastolic Blood Pressure at 8 Months of Participant's Age | At 8 Months of participants' age | Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported. |
| Systolic and Diastolic Blood Pressure at 15 Months of Participant's Age | At 15 Months participants' age | Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported. |
| Systolic and Diastolic Blood Pressure During 0 to <=3 Months of Participant's Age | Any visit during participants' age from 0 to 3 Months | Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported. |
| Systolic and Diastolic Blood Pressure During >3 to <=6 Months of Participant's Age | Any visit during participants' age above 3 Months and up to 6 Months | Systolic and diastolic blood pressure of participants in mmHg was reported. |
| Systolic and Diastolic Blood Pressure During >6 to <=9 Months of Participant's Age | Any visit during participants' age above 6 Months and up to 9 Months | Systolic and diastolic blood pressure of participants in mmHg was reported. |
| Systolic and Diastolic Blood Pressure During >15 to <=18 Months of Participant's Age | Any visit during participants' age above 15 Months and up to 18 Months | Systolic and diastolic blood pressure of participants in mmHg was reported. |
| Systolic and Diastolic Blood Pressure During >21 to <=24 Months of Participant's Age | Any visit during participants' age above 21 Months and up to 24 Months | Systolic and diastolic blood pressure of participants in mmHg was reported. |
| Systolic and Diastolic Blood Pressure During >24 to <=30 Months of Participant's Age | Any visit during participants' age above 24 Months and up to 30 Months | Systolic and diastolic blood pressure of participants in mmHg was reported. |
| Pulse Rate During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age | Any visit during participants' age from 0 to 2 Months | Pulse rate of participants in beats per minute was reported. |
| Pulse Rate at 8 Months of Participant's Age | At 8 Months of participants' age | Pulse rate of participants in beats per minute was reported. |
| Pulse Rate at 15 Months of Participant's Age | At 15 Months of participants' age | Pulse rate of participants in beats per minute was reported. |
| Pulse Rate During 0 to <=3 Months of Participant's Age | Any visit during participants' age from 0 to 3 Months | Pulse rate of participants in beats per minute was reported. |
| Pulse Rate During >3 to <=6 Months of Participant's Age | Any visit during participants' age above 3 Months and up to 6 Months | Pulse rate of participants in beats per minute was reported. |
| Pulse Rate During >6 to <=9 Months of Participant's Age | Any visit during participants' age above 6 Months and up to 9 Months | Pulse rate of participants in beats per minute was reported. |
| Pulse Rate During >15 to <=18 Months of Participant's Age | Any visit during participants' age above 15 Months and up to 18 Months | Pulse rate of participants in beats per minute was reported. |
| Pulse Rate During >21 to <=24 Months of Participant's Age | Any visit during participants' age above 21 Months and up to 24 Months | Pulse rate of participants in beats per minute was reported. |
| Pulse Rate During >24 to <=30 Months of Participant's Age | Any visit during participants' age above 24 Months and up to 30 Months | Pulse rate of participants in beats per minute was reported. |
| Temperature During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age | Any visit during participants' age from 0 to 2 Months | Temperature of participants in degree Celsius was reported. |
| Temperature at 8 Months of Participant's Age | At 8 Months of participants' age | Temperature of participants in degree Celsius was reported. |
| Temperature at 15 Months of Participant's Age | At 15 Months of participants' age | Temperature of participants in degree Celsius was reported. |
| Temperature During 0 to <=3 Months of Participant's Age | Any visit during participants' age from 0 to 3 Months | Temperature of participants in degree Celsius was reported. |
| Temperature During >3 to <=6 Months of Participant's Age | Any visit during participants' age above 3 Months and up to 6 Months | Temperature of participants in degree Celsius was reported. |
| Temperature During >6 to <=9 Months of Participant's Age | Any visit during participants' age above 6 Months and up to 9 Months | Temperature of participants in degree Celsius was reported. |
| Temperature During >15 to <=18 Months of Participant's Age | Any visit during participants' age above 15 Months and up to 18 Months | Temperature of participants in degree Celsius was reported. |
| Temperature During >21 to <=24 Months of Participant's Age | Any visit during participants' age above 21 Months and up to 24 Months | Temperature of participants in degree Celsius was reported. |
| Temperature During >24 to <=30 Months of Participant's Age | Any visit during participants' age above 24 Months and up to 30 Months | Temperature of participants in degree Celsius was reported. |
| Respiratory Rate During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age | Any visit during participants' age from 0 to 2 Months | Respiratory rate of participants in breaths per minute was reported. |
| Respiratory Rate at 8 Months of Participant's Age | At 8 Months of participants' age | Respiratory rate of participants in breaths per minute was reported. |
| Respiratory Rate at 15 Months of Participant's Age | At 15 Months participants' age | Respiratory rate of participants in breaths per minute was reported. |
| Respiratory Rate During 0 to <=3 Months of Participant's Age | Any visit during participants' age from 0 to 3 Months | Respiratory rate of participants in breaths per minute was reported. |
| Respiratory Rate During >3 to <=6 Months of Participant's Age | Any visit during participants' age above 3 Months and up to 6 Months | Respiratory rate of participants in breaths per minute was reported. |
| Respiratory Rate During >6 to <=9 Months of Participant's Age | Any visit during participants' age above 6 Months and up to 9 Months | Respiratory rate of participants in breaths per minute was reported. |
| Respiratory Rate During >15 to <=18 Months of Participant's Age | Any visit during participants' age above 15 Months and up to 18 Months | Respiratory rate of participants in breaths per minute was reported. |
| Respiratory Rate During >21 to <=24 Months of Participant's Age | Any visit during participants' age above 21 Months and up to 24 Months | Respiratory rate of participants in breaths per minute was reported. |
| Respiratory Rate During >24 to <=30 Months of Participant's Age | Any visit during participants' age above 24 Months and up to 30 Months | Respiratory rate of participants in breaths per minute was reported. |
| Number of Participants With Abnormal Neurological Examination Findings During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age | Any visit during participants' age from 0 to 2 Months | 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. |
| Number of Participants With Abnormal Neurological Examination Findings at 8 Months of Participant's Age | At 8 Months of participants' age | 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. |
| Number of Participants With Abnormal Neurological Examination Findings at 15 Months of Participant's Age | At 15 Months of participants' age | 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. |
| Number of Participants With Abnormal Neurological Examination Findings at Follow-up Visit 1 (Month 20 of Participant's Age) | Follow-up Visit 1 (At the age of Month 20) | 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. |
| Number of Participants With Abnormal Neurological Examination Findings at Follow-up Visit 2 (Month 26 of Participant's Age) | Follow-up Visit 2 (At the age of 26 Months) | 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. |
| Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Month 8 of Participant's Age | At 8 Months of participants' age | 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. |
| Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Month 15 of Participant's Age | At 15 Months of participants' age | 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. |
| Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Follow-up Visit 1 (Month 20 of Participant's Age) | Follow-up Visit 1 (At the age of Month 20) | 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. |
| Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Follow-up Visit 2 (Month 26 of Participant's Age) | Follow-up Visit 2 (At the age of Month 26) | 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. |
| Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Month 8 of Participant's Age | At 8 Months of participants' age | 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. |
| Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Month 15 of Participant's Age | At 15 Months of participants' age | 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. |
| 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) | Follow-up Visit 1 (At the age of Month 20) | 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. |
| 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) | Follow-up Visit 2 (At the age of Month 26) | 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. |
Countries
United States
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.
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.
Participants by arm
| Arm | Count |
|---|---|
| Maternal Exposure to Tanezumab Infants in this reporting arm were those who had potential maternal exposure to tanezumab. | 2 |
| Maternal Exposure to Tramadol Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol. | 2 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Maternal Exposure to Tanezumab | Maternal Exposure to Tramadol |
|---|---|---|---|
| Age, Customized Infants and toddlers (28 days-23 months) | 4 Participants | 2 Participants | 2 Participants |
| Age, Customized Newborns (0-27 days) | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Pre-term newborn - gestational age < 37 week | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Other | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Race White | 2 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 3 Participants | 2 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 2 | 0 / 2 |
| other Total, other adverse events | 1 / 2 | 0 / 2 |
| serious Total, serious adverse events | 1 / 2 | 0 / 2 |
Outcome results
Primary
Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Follow-up Visit 1 (Month 20 of Participant's Age)
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.
Time frame: Follow-up Visit 1 (At the age of Month 20)
Population: Safety population analyzed. Overall Number of Participants Analyzed = 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 Maternal Exposure to Tanezumab to have follow up visit for BINS assessment. No participant of reporting arm Maternal Exposure to Tramadol was suggested for follow up visit, thus no data reported for this arm.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Maternal Exposure to Tanezumab | Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Follow-up Visit 1 (Month 20 of Participant's Age) | 7 units on a scale |
Primary
Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Follow-up Visit 2 (Month 26 of Participant's Age)
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.
Time frame: Follow-up Visit 2 (At the age of Month 26)
Population: Safety population analyzed. Overall Number of Participants Analyzed = 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 Maternal Exposure to Tanezumab to have follow up visit for BINS assessment. No participant of reporting arm Maternal Exposure to Tramadol was suggested for follow up visit, thus no data reported for this arm.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Maternal Exposure to Tanezumab | Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Follow-up Visit 2 (Month 26 of Participant's Age) | 6 units on a scale |
Primary
Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Month 15 of Participant's Age
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.
Time frame: At 15 Months of participants' age
Population: Safety population included all participants who were enrolled into the study.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Maternal Exposure to Tanezumab | Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Month 15 of Participant's Age | NA units on a scale |
| Maternal Exposure to Tramadol | Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Month 15 of Participant's Age | NA units on a scale |
Primary
Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Month 8 of Participant's Age
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.
Time frame: At 8 Months of participants' age
Population: Safety population included all participants who were enrolled into the study.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Maternal Exposure to Tanezumab | Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Month 8 of Participant's Age | NA units on a scale |
| Maternal Exposure to Tramadol | Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Month 8 of Participant's Age | NA units on a scale |
Primary
Body Length at 15 Months of Participant's Age
Body length of participants in cm was reported.
Time frame: At 15 Months of participant's age
Population: Safety population included all participants who were enrolled into the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maternal Exposure to Tanezumab | Body Length at 15 Months of Participant's Age | 82.3 cm | Standard Deviation 3.95 |
| Maternal Exposure to Tramadol | Body Length at 15 Months of Participant's Age | 81.3 cm | Standard Deviation 0 |
Primary
Body Length at 8 Months of Participant's Age
Body length of participants in cm was reported.
Time frame: At 8 Months of participant's age
Population: Safety population included all participants who were enrolled into the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maternal Exposure to Tanezumab | Body Length at 8 Months of Participant's Age | 73.6 cm | Standard Deviation 3.45 |
| Maternal Exposure to Tramadol | Body Length at 8 Months of Participant's Age | 73.7 cm | Standard Deviation 1.8 |
Primary
Body Length During 0 to <=3 Months of Participant's Age
Body length of participants in cm was reported.
Time frame: Any visit during participants' age from 0 to 3 Months
Population: Safety population included all participants who were enrolled into the study. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maternal Exposure to Tanezumab | Body Length During 0 to <=3 Months of Participant's Age | 54.6 cm | — |
| Maternal Exposure to Tramadol | Body Length During 0 to <=3 Months of Participant's Age | 56.5 cm | Standard Deviation 1.41 |
Primary
Body Length During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Body length of participants in cm was reported.
Time frame: Any visit during participants' age from 0 to 2 Months
Population: Safety population included all participants who were enrolled into the study. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maternal Exposure to Tanezumab | Body Length During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age | 54.6 cm | — |
| Maternal Exposure to Tramadol | Body Length During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age | 56.5 cm | Standard Deviation 1.41 |
Primary
Body Length During >15 to <=18 Months of Participant's Age
Body length of participants in cm was reported.
Time frame: Any visit during participants' age above 15 Months and up to 18 Months
Population: Safety population included all participants who were enrolled into the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maternal Exposure to Tanezumab | Body Length During >15 to <=18 Months of Participant's Age | 82.3 cm | Standard Deviation 3.95 |
| Maternal Exposure to Tramadol | Body Length During >15 to <=18 Months of Participant's Age | 81.3 cm | Standard Deviation 0 |
Primary
Body Length During >21 to <=24 Months of Participant's Age
Body length of participants in cm was reported.
Time frame: Any visit during participants' age above 21 Months and up to 24 Months
Population: Safety population included all participants who were enrolled into the study. Here, Overall Number of Participants Analyzed 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 \>21 to \<=24 months for reporting arm Maternal Exposure to Tramadol. Hence, for this reporting group no data was collected and reported.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Maternal Exposure to Tanezumab | Body Length During >21 to <=24 Months of Participant's Age | 92.5 cm |
Primary
Body Length During >24 to <=30 Months of Participant's Age
Body length of participants in cm was reported.
Time frame: Any visit during participants' age above 24 Months and up to 30 Months
Population: Safety population included all participants who were enrolled into the study. Here, Overall Number of Participants Analyzed 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 \>24 to \<=30 months for reporting arm Maternal Exposure to Tramadol. Hence, for this reporting group no data was collected and reported.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Maternal Exposure to Tanezumab | Body Length During >24 to <=30 Months of Participant's Age | 97.8 cm |
Primary
Body Length During >3 to <=6 Months of Participant's Age
Body length of participants in cm was reported.
Time frame: Any visit during participants' age above 3 Months and up to 6 Months
Population: Safety population analyzed. Overall Number of Participants Analyzed = 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 Maternal Exposure to Tramadol had a visit within this window period, hence, for this reporting group no data was collected and reported.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Maternal Exposure to Tanezumab | Body Length During >3 to <=6 Months of Participant's Age | 72.4 cm |
Primary
Body Length During >6 to <=9 Months of Participant's Age
Body length of participants in cm was reported.
Time frame: Any visit during participants' age above 6 Months and up to 9 Months
Population: Safety population included all participants who were enrolled into the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maternal Exposure to Tanezumab | Body Length During >6 to <=9 Months of Participant's Age | 73.6 cm | Standard Deviation 3.45 |
| Maternal Exposure to Tramadol | Body Length During >6 to <=9 Months of Participant's Age | 73.7 cm | Standard Deviation 1.8 |
Primary
Body Weight at 15 Months of Participant's Age
Body weight of participants in kilogram (kg) was reported.
Time frame: At 15 Months of participants' age
Population: Safety population included all participants who were enrolled into the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maternal Exposure to Tanezumab | Body Weight at 15 Months of Participant's Age | 13.6 kg | Standard Deviation 2.53 |
| Maternal Exposure to Tramadol | Body Weight at 15 Months of Participant's Age | 13.1 kg | Standard Deviation 1.09 |
Primary
Body Weight at 8 Months of Participant's Age
Body weight of participants in kilogram (kg) was reported.
Time frame: At 8 Months of participants' age
Population: Safety population included all participants who were enrolled into the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maternal Exposure to Tanezumab | Body Weight at 8 Months of Participant's Age | 11.3 kg | Standard Deviation 2.5 |
| Maternal Exposure to Tramadol | Body Weight at 8 Months of Participant's Age | 11.6 kg | Standard Deviation 0.39 |
Primary
Body Weight During 0 to <=3 Months of Participant's Age
Body weight of participants in kilogram (kg) was reported.
Time frame: Any visit during participants' age from 0 to 3 Months
Population: Safety population included all participants who were enrolled into the study. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maternal Exposure to Tanezumab | Body Weight During 0 to <=3 Months of Participant's Age | 3.4 kg | — |
| Maternal Exposure to Tramadol | Body Weight During 0 to <=3 Months of Participant's Age | 5.8 kg | Standard Deviation 1.03 |
Primary
Body Weight During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Body weight of participants in kilogram (kg) was reported.
Time frame: Any visit during participants' age from 0 to 2 Months
Population: Safety population included all participants who were enrolled into the study. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maternal Exposure to Tanezumab | Body Weight During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age | 3.4 kg | — |
| Maternal Exposure to Tramadol | Body Weight During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age | 5.8 kg | Standard Deviation 1.03 |
Primary
Body Weight During >15 to <=18 Months of Participant's Age
Body weight of participants in kg was reported.
Time frame: Any visit during participants' age above 15 Months and up to 18 Months
Population: Safety population included all participants who were enrolled into the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maternal Exposure to Tanezumab | Body Weight During >15 to <=18 Months of Participant's Age | 13.6 kg | Standard Deviation 2.53 |
| Maternal Exposure to Tramadol | Body Weight During >15 to <=18 Months of Participant's Age | 13.1 kg | Standard Deviation 1.09 |
Primary
Body Weight During >21 to <=24 Months of Participant's Age
Body weight of participants in kg was reported.
Time frame: Any visit during participants' age above 21 Months and up to 24 Months
Population: Safety population included all participants who were enrolled into the study. Here, Overall Number of Participants Analyzed 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 \>21 to \<=24 months for reporting arm Maternal Exposure to Tramadol. Hence, for this reporting group no data was collected and reported.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Maternal Exposure to Tanezumab | Body Weight During >21 to <=24 Months of Participant's Age | 16.0 kg |
Primary
Body Weight During >24 to <=30 Months of Participant's Age
Body weight of participants in kg was reported.
Time frame: Any visit during participants' age above 24 Months up to 30 Months
Population: Safety population included all participants who were enrolled into the study. Here, Overall Number of Participants Analyzed 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 \>24 to \<=30 months for reporting arm Maternal Exposure to Tramadol. Hence, for this reporting group no data was collected and reported.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Maternal Exposure to Tanezumab | Body Weight During >24 to <=30 Months of Participant's Age | 18.4 kg |
Primary
Body Weight During >3 to <=6 Months of Participant's Age
Body weight of participants in kg was reported.
Time frame: Any visit during participants' age above 3 Months and up to 6 Months
Population: Safety population analyzed. Overall Number of Participants Analyzed = 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 Maternal Exposure to Tramadol had a visit within this window period, hence, for this reporting group no data was collected and reported.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Maternal Exposure to Tanezumab | Body Weight During >3 to <=6 Months of Participant's Age | 11.3 kg |
Primary
Body Weight During >6 to <=9 Months of Participant's Age
Body weight of participants in kg was reported.
Time frame: Any visit during participants' age above 6 Months and up to 9 Months
Population: Safety population included all participants who were enrolled into the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maternal Exposure to Tanezumab | Body Weight During >6 to <=9 Months of Participant's Age | 11.3 kg | Standard Deviation 2.5 |
| Maternal Exposure to Tramadol | Body Weight During >6 to <=9 Months of Participant's Age | 11.6 kg | Standard Deviation 0.39 |
Primary
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)
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.
Time frame: Follow-up Visit 1 (At the age of Month 20)
Population: Safety population analyzed. Overall Number of Participants Analyzed = 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 Maternal Exposure to Tanezumab to have follow up visit for REEL-3 assessment. No participant of reporting arm Maternal Exposure to Tramadol was suggested for follow up visit, thus no data reported for this arm
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Maternal Exposure to Tanezumab | 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) | 88 units on a scale |
Primary
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)
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.
Time frame: Follow-up Visit 2 (At the age of Month 26)
Population: Safety population analyzed. Overall Number of Participants Analyzed = 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 Maternal Exposure to Tanezumab to have follow up visit for REEL-3 assessment. No participant of reporting arm Maternal Exposure to Tramadol was suggested for follow up visit, thus no data reported for this arm
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Maternal Exposure to Tanezumab | 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) | 92 units on a scale |
Primary
Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Month 15 of Participant's Age
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.
Time frame: At 15 Months of participants' age
Population: Safety population included all participants who were enrolled into the study.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Maternal Exposure to Tanezumab | Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Month 15 of Participant's Age | NA units on a scale |
| Maternal Exposure to Tramadol | Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Month 15 of Participant's Age | NA units on a scale |
Primary
Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Month 8 of Participant's Age
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.
Time frame: At 8 Months of participants' age
Population: Safety population included all participants who were enrolled into the study.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Maternal Exposure to Tanezumab | Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Month 8 of Participant's Age | NA units on a scale |
| Maternal Exposure to Tramadol | Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Month 8 of Participant's Age | NA units on a scale |
Primary
Number of Participants With Abnormal Neurological Examination Findings at 15 Months of Participant's Age
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.
Time frame: At 15 Months of participants' age
Population: Safety population included all participants who were enrolled into the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Maternal Exposure to Tanezumab | Number of Participants With Abnormal Neurological Examination Findings at 15 Months of Participant's Age | 1 Participants |
| Maternal Exposure to Tramadol | Number of Participants With Abnormal Neurological Examination Findings at 15 Months of Participant's Age | 0 Participants |
Primary
Number of Participants With Abnormal Neurological Examination Findings at 8 Months of Participant's Age
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.
Time frame: At 8 Months of participants' age
Population: Safety population included all participants who were enrolled into the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Maternal Exposure to Tanezumab | Number of Participants With Abnormal Neurological Examination Findings at 8 Months of Participant's Age | 0 Participants |
| Maternal Exposure to Tramadol | Number of Participants With Abnormal Neurological Examination Findings at 8 Months of Participant's Age | 0 Participants |
Primary
Number of Participants With Abnormal Neurological Examination Findings at Follow-up Visit 1 (Month 20 of Participant's Age)
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.
Time frame: Follow-up Visit 1 (At the age of Month 20)
Population: Safety population analyzed. Overall Number of Participants Analyzed = 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 Maternal Exposure to Tanezumab to have follow up visit for neurological examination. No participant of reporting arm Maternal Exposure to Tramadol was suggested for follow up visit, thus no data reported for this arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Maternal Exposure to Tanezumab | Number of Participants With Abnormal Neurological Examination Findings at Follow-up Visit 1 (Month 20 of Participant's Age) | 1 Participants |
| Maternal Exposure to Tramadol | Number of Participants With Abnormal Neurological Examination Findings at Follow-up Visit 1 (Month 20 of Participant's Age) | 0 Participants |
Primary
Number of Participants With Abnormal Neurological Examination Findings at Follow-up Visit 2 (Month 26 of Participant's Age)
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.
Time frame: Follow-up Visit 2 (At the age of 26 Months)
Population: Safety population analyzed. Overall Number of Participants Analyzed = 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 Maternal Exposure to Tanezumab to have follow up visit for neurological examination. No participant of reporting arm Maternal Exposure to Tramadol was suggested for follow up visit, thus no data reported for this arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Maternal Exposure to Tanezumab | Number of Participants With Abnormal Neurological Examination Findings at Follow-up Visit 2 (Month 26 of Participant's Age) | 1 Participants |
| Maternal Exposure to Tramadol | Number of Participants With Abnormal Neurological Examination Findings at Follow-up Visit 2 (Month 26 of Participant's Age) | 0 Participants |
Primary
Number of Participants With Abnormal Neurological Examination Findings During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
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.
Time frame: Any visit during participants' age from 0 to 2 Months
Population: Safety population included all participants who were enrolled into the study. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Maternal Exposure to Tanezumab | Number of Participants With Abnormal Neurological Examination Findings During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age | 0 Participants |
| Maternal Exposure to Tramadol | Number of Participants With Abnormal Neurological Examination Findings During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age | 0 Participants |
Primary
Occipital-frontal Head Circumference at 15 Months of Participant's Age
Occipital-frontal head circumference of participants in centimeter (cm) was reported.
Time frame: At 15 Months of participants' age
Population: Safety population included all participants who were enrolled into the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maternal Exposure to Tanezumab | Occipital-frontal Head Circumference at 15 Months of Participant's Age | 49.2 cm | Standard Deviation 2.33 |
| Maternal Exposure to Tramadol | Occipital-frontal Head Circumference at 15 Months of Participant's Age | 48.9 cm | Standard Deviation 2.69 |
Primary
Occipital-frontal Head Circumference at 8 Months of Participant's Age
Occipital-frontal head circumference of participants in centimeter (cm) was reported.
Time frame: At 8 Months of participants' age
Population: Safety population included all participants who were enrolled into the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maternal Exposure to Tanezumab | Occipital-frontal Head Circumference at 8 Months of Participant's Age | 47.0 cm | Standard Deviation 1.41 |
| Maternal Exposure to Tramadol | Occipital-frontal Head Circumference at 8 Months of Participant's Age | 47.2 cm | Standard Deviation 1.44 |
Primary
Occipital-frontal Head Circumference During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Occipital-frontal head circumference of participants in centimeter (cm) was reported.
Time frame: Any visit during participants' age from 0 to 2 Months
Population: Safety population included all participants who were enrolled into the study. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maternal Exposure to Tanezumab | Occipital-frontal Head Circumference During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age | 38.7 cm | — |
| Maternal Exposure to Tramadol | Occipital-frontal Head Circumference During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age | 38.7 cm | Standard Deviation 1.63 |
Primary
Occipital-frontal Head Circumference During 0 to Less Than or Equal to (<=) 3 Months of Participant's Age
Occipital-frontal head circumference of participants in centimeter (cm) was reported.
Time frame: Any visit during participants' age from 0 to 3 Months
Population: Safety population included all participants who were enrolled into the study. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maternal Exposure to Tanezumab | Occipital-frontal Head Circumference During 0 to Less Than or Equal to (<=) 3 Months of Participant's Age | 38.7 cm | — |
| Maternal Exposure to Tramadol | Occipital-frontal Head Circumference During 0 to Less Than or Equal to (<=) 3 Months of Participant's Age | 38.7 cm | Standard Deviation 1.63 |
Primary
Occipital-frontal Head Circumference During >15 to <=18 Months of Participant's Age
Occipital-frontal head circumference of participants in cm was reported.
Time frame: Any visit during participants' age above 15 Months and up to 18 Months
Population: Safety population included all participants who were enrolled into the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maternal Exposure to Tanezumab | Occipital-frontal Head Circumference During >15 to <=18 Months of Participant's Age | 49.2 cm | Standard Deviation 2.33 |
| Maternal Exposure to Tramadol | Occipital-frontal Head Circumference During >15 to <=18 Months of Participant's Age | 48.9 cm | Standard Deviation 2.69 |
Primary
Occipital-frontal Head Circumference During >21 to <=24 Months of Participant's Age
Occipital-frontal head circumference of participants in cm was reported.
Time frame: Any visit during participants' age above 21 Months and up to 24 Months
Population: Safety population included all participants who were enrolled into the study. Here, Overall Number of Participants Analyzed 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 \>21 to \<=24 months for reporting arm Maternal Exposure to Tramadol. Hence, for this reporting group no data was collected and reported.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Maternal Exposure to Tanezumab | Occipital-frontal Head Circumference During >21 to <=24 Months of Participant's Age | 49.0 cm |
Primary
Occipital-frontal Head Circumference During >24 to <=30 Months of Participant's Age
Occipital-frontal head circumference of participants in cm was reported.
Time frame: Any visit during participants' age above 24 Months and up to 30 Months
Population: Safety population included all participants who were enrolled into the study. Here, Overall Number of Participants Analyzed 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 \>24 to \<=30 months for reporting arm Maternal Exposure to Tramadol. Hence, for this reporting group no data was collected and reported.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Maternal Exposure to Tanezumab | Occipital-frontal Head Circumference During >24 to <=30 Months of Participant's Age | 50.5 cm |
Primary
Occipital-frontal Head Circumference During >6 to <=9 Months of Participant's Age
Occipital-frontal head circumference of participants in cm was reported.
Time frame: Any visit during participants' age above 6 Months and up to 9 Months
Population: Safety population included all participants who were enrolled into the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maternal Exposure to Tanezumab | Occipital-frontal Head Circumference During >6 to <=9 Months of Participant's Age | 47.0 cm | Standard Deviation 1.41 |
| Maternal Exposure to Tramadol | Occipital-frontal Head Circumference During >6 to <=9 Months of Participant's Age | 47.2 cm | Standard Deviation 1.44 |
Primary
Occipital-frontal Head Circumference During Greater Than (>) 3 to <=6 Months of Participant's Age
Occipital-frontal head circumference of participants in cm was reported.
Time frame: Any visit during participants' age above 3 Months and up to 6 Months
Population: Safety population analyzed. Overall Number of Participants Analyzed = 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 Maternal Exposure to Tramadol had a visit within this window period, hence, for this reporting group no data was collected and reported.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Maternal Exposure to Tanezumab | Occipital-frontal Head Circumference During Greater Than (>) 3 to <=6 Months of Participant's Age | 44.0 cm |
Primary
Pulse Rate at 15 Months of Participant's Age
Pulse rate of participants in beats per minute was reported.
Time frame: At 15 Months of participants' age
Population: Safety population included all participants who were enrolled into the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maternal Exposure to Tanezumab | Pulse Rate at 15 Months of Participant's Age | 108.5 beats per minute | Standard Deviation 20.51 |
| Maternal Exposure to Tramadol | Pulse Rate at 15 Months of Participant's Age | 116.0 beats per minute | Standard Deviation 5.66 |
Primary
Pulse Rate at 8 Months of Participant's Age
Pulse rate of participants in beats per minute was reported.
Time frame: At 8 Months of participants' age
Population: Safety population included all participants who were enrolled into the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maternal Exposure to Tanezumab | Pulse Rate at 8 Months of Participant's Age | 117.0 beats per minute | Standard Deviation 15.56 |
| Maternal Exposure to Tramadol | Pulse Rate at 8 Months of Participant's Age | 121.0 beats per minute | Standard Deviation 4.24 |
Primary
Pulse Rate During 0 to <=3 Months of Participant's Age
Pulse rate of participants in beats per minute was reported.
Time frame: Any visit during participants' age from 0 to 3 Months
Population: Safety population included all participants who were enrolled into the study. Here, Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maternal Exposure to Tanezumab | Pulse Rate During 0 to <=3 Months of Participant's Age | 124.0 beats per minute | — |
| Maternal Exposure to Tramadol | Pulse Rate During 0 to <=3 Months of Participant's Age | 144.0 beats per minute | Standard Deviation 15.56 |
Primary
Pulse Rate During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Pulse rate of participants in beats per minute was reported.
Time frame: Any visit during participants' age from 0 to 2 Months
Population: Safety population included all participants who were enrolled into the study. Here, Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maternal Exposure to Tanezumab | Pulse Rate During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age | 124.0 beats per minute | — |
| Maternal Exposure to Tramadol | Pulse Rate During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age | 144.0 beats per minute | Standard Deviation 15.56 |
Primary
Pulse Rate During >15 to <=18 Months of Participant's Age
Pulse rate of participants in beats per minute was reported.
Time frame: Any visit during participants' age above 15 Months and up to 18 Months
Population: Safety population included all participants who were enrolled into the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maternal Exposure to Tanezumab | Pulse Rate During >15 to <=18 Months of Participant's Age | 108.5 beats per minute | Standard Deviation 20.51 |
| Maternal Exposure to Tramadol | Pulse Rate During >15 to <=18 Months of Participant's Age | 116.0 beats per minute | Standard Deviation 5.66 |
Primary
Pulse Rate During >21 to <=24 Months of Participant's Age
Pulse rate of participants in beats per minute was reported.
Time frame: Any visit during participants' age above 21 Months and up to 24 Months
Population: Safety population included all participants who were enrolled into the study. Here, Overall Number of Participants Analyzed 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 \>21 to \<=24 months for reporting arm Maternal Exposure to Tramadol. Hence, for this reporting group no data was collected and reported.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Maternal Exposure to Tanezumab | Pulse Rate During >21 to <=24 Months of Participant's Age | 118.0 beats per minute |
Primary
Pulse Rate During >24 to <=30 Months of Participant's Age
Pulse rate of participants in beats per minute was reported.
Time frame: Any visit during participants' age above 24 Months and up to 30 Months
Population: Safety population included all participants who were enrolled into the study. Here, Overall Number of Participants Analyzed 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 \>24 to \<=30 months for reporting arm Maternal Exposure to Tramadol. Hence, for this reporting group no data was collected and reported.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Maternal Exposure to Tanezumab | Pulse Rate During >24 to <=30 Months of Participant's Age | 118.0 beats per minute |
Primary
Pulse Rate During >3 to <=6 Months of Participant's Age
Pulse rate of participants in beats per minute was reported.
Time frame: Any visit during participants' age above 3 Months and up to 6 Months
Population: Safety population analyzed. Overall Number of Participants Analyzed = 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 Maternal Exposure to Tramadol had a visit within this window period, hence, for this reporting group no data was collected and reported.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Maternal Exposure to Tanezumab | Pulse Rate During >3 to <=6 Months of Participant's Age | 128.0 beats per minute |
Primary
Pulse Rate During >6 to <=9 Months of Participant's Age
Pulse rate of participants in beats per minute was reported.
Time frame: Any visit during participants' age above 6 Months and up to 9 Months
Population: Safety population included all participants who were enrolled into the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maternal Exposure to Tanezumab | Pulse Rate During >6 to <=9 Months of Participant's Age | 117.0 beats per minute | Standard Deviation 15.56 |
| Maternal Exposure to Tramadol | Pulse Rate During >6 to <=9 Months of Participant's Age | 121.0 beats per minute | Standard Deviation 4.24 |
Primary
Respiratory Rate at 15 Months of Participant's Age
Respiratory rate of participants in breaths per minute was reported.
Time frame: At 15 Months participants' age
Population: Safety population included all participants who were enrolled into the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maternal Exposure to Tanezumab | Respiratory Rate at 15 Months of Participant's Age | 34.0 breaths per minute | Standard Deviation 14.14 |
| Maternal Exposure to Tramadol | Respiratory Rate at 15 Months of Participant's Age | 27.0 breaths per minute | Standard Deviation 1.41 |
Primary
Respiratory Rate at 8 Months of Participant's Age
Respiratory rate of participants in breaths per minute was reported.
Time frame: At 8 Months of participants' age
Population: Safety population included all participants who were enrolled into the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maternal Exposure to Tanezumab | Respiratory Rate at 8 Months of Participant's Age | 33.0 breaths per minute | Standard Deviation 1.41 |
| Maternal Exposure to Tramadol | Respiratory Rate at 8 Months of Participant's Age | 34.0 breaths per minute | Standard Deviation 2.83 |
Primary
Respiratory Rate During 0 to <=3 Months of Participant's Age
Respiratory rate of participants in breaths per minute was reported.
Time frame: Any visit during participants' age from 0 to 3 Months
Population: Safety population included all participants who were enrolled into the study. Here Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maternal Exposure to Tanezumab | Respiratory Rate During 0 to <=3 Months of Participant's Age | 30.0 breaths per minute | — |
| Maternal Exposure to Tramadol | Respiratory Rate During 0 to <=3 Months of Participant's Age | 57.0 breaths per minute | Standard Deviation 9.9 |
Primary
Respiratory Rate During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Respiratory rate of participants in breaths per minute was reported.
Time frame: Any visit during participants' age from 0 to 2 Months
Population: Safety population included all participants who were enrolled into the study. Here Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maternal Exposure to Tanezumab | Respiratory Rate During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age | 30.0 breaths per minute | — |
| Maternal Exposure to Tramadol | Respiratory Rate During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age | 57.0 breaths per minute | Standard Deviation 9.9 |
Primary
Respiratory Rate During >15 to <=18 Months of Participant's Age
Respiratory rate of participants in breaths per minute was reported.
Time frame: Any visit during participants' age above 15 Months and up to 18 Months
Population: Safety population included all participants who were enrolled into the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maternal Exposure to Tanezumab | Respiratory Rate During >15 to <=18 Months of Participant's Age | 34.0 breaths per minute | Standard Deviation 14.14 |
| Maternal Exposure to Tramadol | Respiratory Rate During >15 to <=18 Months of Participant's Age | 27.0 breaths per minute | Standard Deviation 1.41 |
Primary
Respiratory Rate During >21 to <=24 Months of Participant's Age
Respiratory rate of participants in breaths per minute was reported.
Time frame: Any visit during participants' age above 21 Months and up to 24 Months
Population: Safety population included all participants who were enrolled into the study. Here, Overall Number of Participants Analyzed 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 \>21 to \<=24 months for reporting arm Maternal Exposure to Tramadol. Hence, for this reporting group no data was collected and reported.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Maternal Exposure to Tanezumab | Respiratory Rate During >21 to <=24 Months of Participant's Age | 44.0 breaths per minute |
Primary
Respiratory Rate During >24 to <=30 Months of Participant's Age
Respiratory rate of participants in breaths per minute was reported.
Time frame: Any visit during participants' age above 24 Months and up to 30 Months
Population: Safety population included all participants who were enrolled into the study. Here, Overall Number of Participants Analyzed 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 \>24 to \<=30 months for reporting arm Maternal Exposure to Tramadol. Hence, for this reporting group no data was collected and reported.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Maternal Exposure to Tanezumab | Respiratory Rate During >24 to <=30 Months of Participant's Age | 44.0 breaths per minute |
Primary
Respiratory Rate During >3 to <=6 Months of Participant's Age
Respiratory rate of participants in breaths per minute was reported.
Time frame: Any visit during participants' age above 3 Months and up to 6 Months
Population: Safety population analyzed. Overall Number of Participants Analyzed = 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 Maternal Exposure to Tramadol had a visit within this window period, hence, for this reporting group no data was collected and reported.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Maternal Exposure to Tanezumab | Respiratory Rate During >3 to <=6 Months of Participant's Age | 44.0 breaths per minute |
Primary
Respiratory Rate During >6 to <=9 Months of Participant's Age
Respiratory rate of participants in breaths per minute was reported.
Time frame: Any visit during participants' age above 6 Months and up to 9 Months
Population: Safety population included all participants who were enrolled into the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maternal Exposure to Tanezumab | Respiratory Rate During >6 to <=9 Months of Participant's Age | 33.0 breaths per minute | Standard Deviation 1.41 |
| Maternal Exposure to Tramadol | Respiratory Rate During >6 to <=9 Months of Participant's Age | 34.0 breaths per minute | Standard Deviation 2.83 |
Primary
Systolic and Diastolic Blood Pressure at 15 Months of Participant's Age
Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.
Time frame: At 15 Months participants' age
Population: Safety population included all participants who were enrolled into the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Maternal Exposure to Tanezumab | Systolic and Diastolic Blood Pressure at 15 Months of Participant's Age | Systolic Blood Pressure | 94.5 mmHg | Standard Deviation 7.78 |
| Maternal Exposure to Tanezumab | Systolic and Diastolic Blood Pressure at 15 Months of Participant's Age | Diastolic Blood Pressure | 58.5 mmHg | Standard Deviation 2.12 |
| Maternal Exposure to Tramadol | Systolic and Diastolic Blood Pressure at 15 Months of Participant's Age | Systolic Blood Pressure | 80.0 mmHg | Standard Deviation 2.83 |
| Maternal Exposure to Tramadol | Systolic and Diastolic Blood Pressure at 15 Months of Participant's Age | Diastolic Blood Pressure | 43.0 mmHg | Standard Deviation 4.24 |
Primary
Systolic and Diastolic Blood Pressure at 8 Months of Participant's Age
Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.
Time frame: At 8 Months of participants' age
Population: Safety population included all participants who were enrolled into the study. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Maternal Exposure to Tanezumab | Systolic and Diastolic Blood Pressure at 8 Months of Participant's Age | Systolic Blood Pressure | 95.5 mmHg | Standard Deviation 19.09 |
| Maternal Exposure to Tanezumab | Systolic and Diastolic Blood Pressure at 8 Months of Participant's Age | Diastolic Blood Pressure | 66.0 mmHg | Standard Deviation 8.49 |
| Maternal Exposure to Tramadol | Systolic and Diastolic Blood Pressure at 8 Months of Participant's Age | Systolic Blood Pressure | 82.0 mmHg | — |
| Maternal Exposure to Tramadol | Systolic and Diastolic Blood Pressure at 8 Months of Participant's Age | Diastolic Blood Pressure | 40.0 mmHg | — |
Primary
Systolic and Diastolic Blood Pressure During 0 to <=3 Months of Participant's Age
Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.
Time frame: Any visit during participants' age from 0 to 3 Months
Population: Safety population included all participants who were enrolled into the study. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Maternal Exposure to Tanezumab | Systolic and Diastolic Blood Pressure During 0 to <=3 Months of Participant's Age | Systolic Blood Pressure | 90.0 mmHg |
| Maternal Exposure to Tanezumab | Systolic and Diastolic Blood Pressure During 0 to <=3 Months of Participant's Age | Diastolic Blood Pressure | 60.0 mmHg |
| Maternal Exposure to Tramadol | Systolic and Diastolic Blood Pressure During 0 to <=3 Months of Participant's Age | Systolic Blood Pressure | NA mmHg |
| Maternal Exposure to Tramadol | Systolic and Diastolic Blood Pressure During 0 to <=3 Months of Participant's Age | Diastolic Blood Pressure | NA mmHg |
Primary
Systolic and Diastolic Blood Pressure During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.
Time frame: Any visit during participants' age from 0 to 2 Months
Population: Safety population included all participants who were enrolled into the study. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Maternal Exposure to Tanezumab | Systolic and Diastolic Blood Pressure During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age | Systolic Blood Pressure | 90.0 mmHg |
| Maternal Exposure to Tanezumab | Systolic and Diastolic Blood Pressure During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age | Diastolic Blood Pressure | 60.0 mmHg |
| Maternal Exposure to Tramadol | Systolic and Diastolic Blood Pressure During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age | Systolic Blood Pressure | NA mmHg |
| Maternal Exposure to Tramadol | Systolic and Diastolic Blood Pressure During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age | Diastolic Blood Pressure | NA mmHg |
Primary
Systolic and Diastolic Blood Pressure During >15 to <=18 Months of Participant's Age
Systolic and diastolic blood pressure of participants in mmHg was reported.
Time frame: Any visit during participants' age above 15 Months and up to 18 Months
Population: Safety population included all participants who were enrolled into the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Maternal Exposure to Tanezumab | Systolic and Diastolic Blood Pressure During >15 to <=18 Months of Participant's Age | Systolic Blood Pressure | 94.5 mmHg | Standard Deviation 7.78 |
| Maternal Exposure to Tanezumab | Systolic and Diastolic Blood Pressure During >15 to <=18 Months of Participant's Age | Diastolic Blood Pressure | 58.5 mmHg | Standard Deviation 2.12 |
| Maternal Exposure to Tramadol | Systolic and Diastolic Blood Pressure During >15 to <=18 Months of Participant's Age | Systolic Blood Pressure | 80.0 mmHg | Standard Deviation 2.83 |
| Maternal Exposure to Tramadol | Systolic and Diastolic Blood Pressure During >15 to <=18 Months of Participant's Age | Diastolic Blood Pressure | 43.0 mmHg | Standard Deviation 4.24 |
Primary
Systolic and Diastolic Blood Pressure During >21 to <=24 Months of Participant's Age
Systolic and diastolic blood pressure of participants in mmHg was reported.
Time frame: Any visit during participants' age above 21 Months and up to 24 Months
Population: Safety population included all participants who were enrolled into the study. Here, Overall Number of Participants Analyzed 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 \>21 to \<=24 months for reporting arm Maternal Exposure to Tramadol. Hence, for this reporting group no data was collected and reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Maternal Exposure to Tanezumab | Systolic and Diastolic Blood Pressure During >21 to <=24 Months of Participant's Age | Systolic Blood Pressure | 123.0 mmHg |
| Maternal Exposure to Tanezumab | Systolic and Diastolic Blood Pressure During >21 to <=24 Months of Participant's Age | Diastolic Blood Pressure | 78.0 mmHg |
Primary
Systolic and Diastolic Blood Pressure During >24 to <=30 Months of Participant's Age
Systolic and diastolic blood pressure of participants in mmHg was reported.
Time frame: Any visit during participants' age above 24 Months and up to 30 Months
Population: Safety population included all participants who were enrolled into the study. Here, Overall Number of Participants Analyzed 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 \>24 to \<=30 months for reporting arm Maternal Exposure to Tramadol. Hence, for this reporting group no data was collected and reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Maternal Exposure to Tanezumab | Systolic and Diastolic Blood Pressure During >24 to <=30 Months of Participant's Age | Systolic Blood Pressure | 101.0 mmHg |
| Maternal Exposure to Tanezumab | Systolic and Diastolic Blood Pressure During >24 to <=30 Months of Participant's Age | Diastolic Blood Pressure | 55.0 mmHg |
Primary
Systolic and Diastolic Blood Pressure During >3 to <=6 Months of Participant's Age
Systolic and diastolic blood pressure of participants in mmHg was reported.
Time frame: Any visit during participants' age above 3 Months and up to 6 Months
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 Maternal Exposure to Tramadol had a visit within this window period; for Maternal Exposure to Tanezumab site missed to take participants' measurement. Thus, no data was collected and reported for both reporting arms.
Primary
Systolic and Diastolic Blood Pressure During >6 to <=9 Months of Participant's Age
Systolic and diastolic blood pressure of participants in mmHg was reported.
Time frame: Any visit during participants' age above 6 Months and up to 9 Months
Population: Safety population included all participants who were enrolled into the study. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Maternal Exposure to Tanezumab | Systolic and Diastolic Blood Pressure During >6 to <=9 Months of Participant's Age | Systolic Blood Pressure | 95.5 mmHg | Standard Deviation 19.09 |
| Maternal Exposure to Tanezumab | Systolic and Diastolic Blood Pressure During >6 to <=9 Months of Participant's Age | Diastolic Blood Pressure | 66.0 mmHg | Standard Deviation 8.49 |
| Maternal Exposure to Tramadol | Systolic and Diastolic Blood Pressure During >6 to <=9 Months of Participant's Age | Systolic Blood Pressure | 82.0 mmHg | — |
| Maternal Exposure to Tramadol | Systolic and Diastolic Blood Pressure During >6 to <=9 Months of Participant's Age | Diastolic Blood Pressure | 40.0 mmHg | — |
Primary
Temperature at 15 Months of Participant's Age
Temperature of participants in degree Celsius was reported.
Time frame: At 15 Months of participants' age
Population: Safety population included all participants who were enrolled into the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maternal Exposure to Tanezumab | Temperature at 15 Months of Participant's Age | 36.1 degree Celsius | Standard Deviation 0.47 |
| Maternal Exposure to Tramadol | Temperature at 15 Months of Participant's Age | 36.5 degree Celsius | Standard Deviation 0.04 |
Primary
Temperature at 8 Months of Participant's Age
Temperature of participants in degree Celsius was reported.
Time frame: At 8 Months of participants' age
Population: Safety population included all participants who were enrolled into the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maternal Exposure to Tanezumab | Temperature at 8 Months of Participant's Age | 36.3 degree Celsius | Standard Deviation 0.27 |
| Maternal Exposure to Tramadol | Temperature at 8 Months of Participant's Age | 36.7 degree Celsius | Standard Deviation 0.08 |
Primary
Temperature During 0 to <=3 Months of Participant's Age
Temperature of participants in degree Celsius was reported.
Time frame: Any visit during participants' age from 0 to 3 Months
Population: Safety population included all participants who were enrolled into the study. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maternal Exposure to Tanezumab | Temperature During 0 to <=3 Months of Participant's Age | 36.2 degree Celsius | — |
| Maternal Exposure to Tramadol | Temperature During 0 to <=3 Months of Participant's Age | 36.6 degree Celsius | Standard Deviation 0.08 |
Primary
Temperature During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Temperature of participants in degree Celsius was reported.
Time frame: Any visit during participants' age from 0 to 2 Months
Population: Safety population included all participants who were enrolled into the study. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maternal Exposure to Tanezumab | Temperature During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age | 36.2 degree Celsius | — |
| Maternal Exposure to Tramadol | Temperature During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age | 36.6 degree Celsius | Standard Deviation 0.08 |
Primary
Temperature During >15 to <=18 Months of Participant's Age
Temperature of participants in degree Celsius was reported.
Time frame: Any visit during participants' age above 15 Months and up to 18 Months
Population: Safety population included all participants who were enrolled into the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maternal Exposure to Tanezumab | Temperature During >15 to <=18 Months of Participant's Age | 36.1 degree Celsius | Standard Deviation 0.47 |
| Maternal Exposure to Tramadol | Temperature During >15 to <=18 Months of Participant's Age | 36.5 degree Celsius | Standard Deviation 0.04 |
Primary
Temperature During >21 to <=24 Months of Participant's Age
Temperature of participants in degree Celsius was reported.
Time frame: Any visit during participants' age above 21 Months and up to 24 Months
Population: Safety population included all participants who were enrolled into the study. Here, Overall Number of Participants Analyzed 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 \>21 to \<=24 months for reporting arm Maternal Exposure to Tramadol. Hence, for this reporting group no data was collected and reported.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Maternal Exposure to Tanezumab | Temperature During >21 to <=24 Months of Participant's Age | 36.4 degree Celsius |
Primary
Temperature During >24 to <=30 Months of Participant's Age
Temperature of participants in degree Celsius was reported.
Time frame: Any visit during participants' age above 24 Months and up to 30 Months
Population: Safety population included all participants who were enrolled into the study. Here, Overall Number of Participants Analyzed 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 \>24 to \<=30 months for reporting arm Maternal Exposure to Tramadol. Hence, for this reporting group no data was collected and reported.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Maternal Exposure to Tanezumab | Temperature During >24 to <=30 Months of Participant's Age | 36.3 degree Celsius |
Primary
Temperature During >3 to <=6 Months of Participant's Age
Temperature of participants in degree Celsius was reported.
Time frame: Any visit during participants' age above 3 Months and up to 6 Months
Population: Safety population analyzed. Overall Number of Participants Analyzed = 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 Maternal Exposure to Tramadol had a visit within this window period, hence, for this reporting group no data was collected and reported.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Maternal Exposure to Tanezumab | Temperature During >3 to <=6 Months of Participant's Age | 36.4 degree Celsius |
Primary
Temperature During >6 to <=9 Months of Participant's Age
Temperature of participants in degree Celsius was reported.
Time frame: Any visit during participants' age above 6 Months and up to 9 Months
Population: Safety population included all participants who were enrolled into the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maternal Exposure to Tanezumab | Temperature During >6 to <=9 Months of Participant's Age | 36.3 degree Celsius | Standard Deviation 0.27 |
| Maternal Exposure to Tramadol | Temperature During >6 to <=9 Months of Participant's Age | 36.7 degree Celsius | Standard Deviation 0.08 |