Trial Outcomes & Findings for Protocol to Monitor the Neurological Development of Infants With Exposure in Utero From Birth to 15 Months in Tanezumab Clinical Studies (NCT NCT03031938)

Results Overview

Occipital-frontal head circumference of participants in centimeter (cm) was reported.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

4 participants

Primary outcome timeframe

Any visit during participants' age from 0 to 2 Months

Results posted on

2021-06-25

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Maternal Exposure to Tanezumab Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Overall Study STARTED	2	2
Overall Study COMPLETED	1	2
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Maternal Exposure to Tanezumab Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Overall Study Death	1	0

Baseline Characteristics

Protocol to Monitor the Neurological Development of Infants With Exposure in Utero From Birth to 15 Months in Tanezumab Clinical Studies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Maternal Exposure to Tanezumab n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.	Total n=4 Participants Total of all reporting groups
Age, Customized Pre-term newborn - gestational age < 37 week	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized Newborns (0-27 days)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized Infants and toddlers (28 days-23 months)	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Occipital-frontal head circumference of participants in centimeter (cm) was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=1 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Occipital-frontal Head Circumference During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age	38.7 cm	38.7 cm Standard Deviation 1.63

PRIMARY outcome

Timeframe: At 8 Months of participants' age

Population: Safety population included all participants who were enrolled into the study.

Occipital-frontal head circumference of participants in centimeter (cm) was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Occipital-frontal Head Circumference at 8 Months of Participant's Age	47.0 cm Standard Deviation 1.41	47.2 cm Standard Deviation 1.44

PRIMARY outcome

Timeframe: At 15 Months of participants' age

Population: Safety population included all participants who were enrolled into the study.

Occipital-frontal head circumference of participants in centimeter (cm) was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Occipital-frontal Head Circumference at 15 Months of Participant's Age	49.2 cm Standard Deviation 2.33	48.9 cm Standard Deviation 2.69

PRIMARY outcome

Timeframe: 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.

Occipital-frontal head circumference of participants in centimeter (cm) was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=1 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Occipital-frontal Head Circumference During 0 to Less Than or Equal to (<=) 3 Months of Participant's Age	38.7 cm	38.7 cm Standard Deviation 1.63

PRIMARY outcome

Timeframe: 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.

Occipital-frontal head circumference of participants in cm was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=1 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Occipital-frontal Head Circumference During Greater Than (>) 3 to <=6 Months of Participant's Age	44.0 cm	—

PRIMARY outcome

Timeframe: 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.

Occipital-frontal head circumference of participants in cm was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Occipital-frontal Head Circumference During >6 to <=9 Months of Participant's Age	47.0 cm Standard Deviation 1.41	47.2 cm Standard Deviation 1.44

PRIMARY outcome

Timeframe: 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.

Occipital-frontal head circumference of participants in cm was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Occipital-frontal Head Circumference During >15 to <=18 Months of Participant's Age	49.2 cm Standard Deviation 2.33	48.9 cm Standard Deviation 2.69

PRIMARY outcome

Timeframe: 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.

Occipital-frontal head circumference of participants in cm was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=1 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Occipital-frontal Head Circumference During >21 to <=24 Months of Participant's Age	49.0 cm	—

PRIMARY outcome

Timeframe: 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.

Occipital-frontal head circumference of participants in cm was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=1 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Occipital-frontal Head Circumference During >24 to <=30 Months of Participant's Age	50.5 cm	—

PRIMARY outcome

Timeframe: 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.

Body length of participants in cm was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=1 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Body Length During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age	54.6 cm	56.5 cm Standard Deviation 1.41

PRIMARY outcome

Timeframe: At 8 Months of participant's age

Population: Safety population included all participants who were enrolled into the study.

Body length of participants in cm was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Body Length at 8 Months of Participant's Age	73.6 cm Standard Deviation 3.45	73.7 cm Standard Deviation 1.80

PRIMARY outcome

Timeframe: At 15 Months of participant's age

Population: Safety population included all participants who were enrolled into the study.

Body length of participants in cm was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Body Length at 15 Months of Participant's Age	82.3 cm Standard Deviation 3.95	81.3 cm Standard Deviation 0.00

PRIMARY outcome

Timeframe: 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.

Body length of participants in cm was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=1 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Body Length During 0 to <=3 Months of Participant's Age	54.6 cm	56.5 cm Standard Deviation 1.41

PRIMARY outcome

Timeframe: 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.

Body length of participants in cm was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=1 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Body Length During >3 to <=6 Months of Participant's Age	72.4 cm	—

PRIMARY outcome

Timeframe: 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.

Body length of participants in cm was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Body Length During >6 to <=9 Months of Participant's Age	73.6 cm Standard Deviation 3.45	73.7 cm Standard Deviation 1.80

PRIMARY outcome

Timeframe: 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.

Body length of participants in cm was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Body Length During >15 to <=18 Months of Participant's Age	82.3 cm Standard Deviation 3.95	81.3 cm Standard Deviation 0.00

PRIMARY outcome

Timeframe: 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.

Body length of participants in cm was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=1 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Body Length During >21 to <=24 Months of Participant's Age	92.5 cm	—

PRIMARY outcome

Timeframe: 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.

Body length of participants in cm was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=1 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Body Length During >24 to <=30 Months of Participant's Age	97.8 cm	—

PRIMARY outcome

Timeframe: 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.

Body weight of participants in kilogram (kg) was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=1 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Body Weight During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age	3.4 kg	5.8 kg Standard Deviation 1.03

PRIMARY outcome

Timeframe: At 8 Months of participants' age

Population: Safety population included all participants who were enrolled into the study.

Body weight of participants in kilogram (kg) was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Body Weight at 8 Months of Participant's Age	11.3 kg Standard Deviation 2.50	11.6 kg Standard Deviation 0.39

PRIMARY outcome

Timeframe: At 15 Months of participants' age

Population: Safety population included all participants who were enrolled into the study.

Body weight of participants in kilogram (kg) was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Body Weight at 15 Months of Participant's Age	13.6 kg Standard Deviation 2.53	13.1 kg Standard Deviation 1.09

PRIMARY outcome

Timeframe: 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.

Body weight of participants in kilogram (kg) was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=1 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Body Weight During 0 to <=3 Months of Participant's Age	3.4 kg	5.8 kg Standard Deviation 1.03

PRIMARY outcome

Timeframe: 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.

Body weight of participants in kg was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=1 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Body Weight During >3 to <=6 Months of Participant's Age	11.3 kg	—

PRIMARY outcome

Timeframe: 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.

Body weight of participants in kg was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Body Weight During >6 to <=9 Months of Participant's Age	11.3 kg Standard Deviation 2.50	11.6 kg Standard Deviation 0.39

PRIMARY outcome

Timeframe: 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.

Body weight of participants in kg was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Body Weight During >15 to <=18 Months of Participant's Age	13.6 kg Standard Deviation 2.53	13.1 kg Standard Deviation 1.09

PRIMARY outcome

Timeframe: 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.

Body weight of participants in kg was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=1 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Body Weight During >21 to <=24 Months of Participant's Age	16.0 kg	—

PRIMARY outcome

Timeframe: 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.

Body weight of participants in kg was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=1 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Body Weight During >24 to <=30 Months of Participant's Age	18.4 kg	—

PRIMARY outcome

Timeframe: 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.

Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=1 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
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	NA mmHg Standard Deviation NA Investigator tried to measure infants blood pressure but could not obtain measurements, hence no data available to report.
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	NA mmHg Standard Deviation NA Investigator tried to measure infants blood pressure but could not obtain measurements, hence no data available to report.

PRIMARY outcome

Timeframe: 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.

Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=1 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Systolic and Diastolic Blood Pressure at 8 Months of Participant's Age Systolic Blood Pressure	95.5 mmHg Standard Deviation 19.09	82.0 mmHg
Systolic and Diastolic Blood Pressure at 8 Months of Participant's Age Diastolic Blood Pressure	66.0 mmHg Standard Deviation 8.49	40.0 mmHg

PRIMARY outcome

Timeframe: At 15 Months participants' age

Population: Safety population included all participants who were enrolled into the study.

Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Systolic and Diastolic Blood Pressure at 15 Months of Participant's Age Systolic Blood Pressure	94.5 mmHg Standard Deviation 7.78	80.0 mmHg Standard Deviation 2.83
Systolic and Diastolic Blood Pressure at 15 Months of Participant's Age Diastolic Blood Pressure	58.5 mmHg Standard Deviation 2.12	43.0 mmHg Standard Deviation 4.24

PRIMARY outcome

Timeframe: 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.

Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=1 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Systolic and Diastolic Blood Pressure During 0 to <=3 Months of Participant's Age Systolic Blood Pressure	90.0 mmHg	NA mmHg Standard Deviation NA Investigator tried to measure infants blood pressure but could not obtain measurements, hence no data available to report.
Systolic and Diastolic Blood Pressure During 0 to <=3 Months of Participant's Age Diastolic Blood Pressure	60.0 mmHg	NA mmHg Standard Deviation NA Investigator tried to measure infants blood pressure but could not obtain measurements, hence no data available to report.

PRIMARY outcome

Timeframe: 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.

Systolic and diastolic blood pressure of participants in mmHg was reported.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

Systolic and diastolic blood pressure of participants in mmHg was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=1 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Systolic and Diastolic Blood Pressure During >6 to <=9 Months of Participant's Age Systolic Blood Pressure	95.5 mmHg Standard Deviation 19.09	82.0 mmHg
Systolic and Diastolic Blood Pressure During >6 to <=9 Months of Participant's Age Diastolic Blood Pressure	66.0 mmHg Standard Deviation 8.49	40.0 mmHg

PRIMARY outcome

Timeframe: 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.

Systolic and diastolic blood pressure of participants in mmHg was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Systolic and Diastolic Blood Pressure During >15 to <=18 Months of Participant's Age Systolic Blood Pressure	94.5 mmHg Standard Deviation 7.78	80.0 mmHg Standard Deviation 2.83
Systolic and Diastolic Blood Pressure During >15 to <=18 Months of Participant's Age Diastolic Blood Pressure	58.5 mmHg Standard Deviation 2.12	43.0 mmHg Standard Deviation 4.24

PRIMARY outcome

Timeframe: 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.

Systolic and diastolic blood pressure of participants in mmHg was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=1 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Systolic and Diastolic Blood Pressure During >21 to <=24 Months of Participant's Age Systolic Blood Pressure	123.0 mmHg	—
Systolic and Diastolic Blood Pressure During >21 to <=24 Months of Participant's Age Diastolic Blood Pressure	78.0 mmHg	—

PRIMARY outcome

Timeframe: 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.

Systolic and diastolic blood pressure of participants in mmHg was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=1 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Systolic and Diastolic Blood Pressure During >24 to <=30 Months of Participant's Age Systolic Blood Pressure	101.0 mmHg	—
Systolic and Diastolic Blood Pressure During >24 to <=30 Months of Participant's Age Diastolic Blood Pressure	55.0 mmHg	—

PRIMARY outcome

Timeframe: 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.

Pulse rate of participants in beats per minute was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=1 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Pulse Rate During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age	124.0 beats per minute	144.0 beats per minute Standard Deviation 15.56

PRIMARY outcome

Timeframe: At 8 Months of participants' age

Population: Safety population included all participants who were enrolled into the study.

Pulse rate of participants in beats per minute was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Pulse Rate at 8 Months of Participant's Age	117.0 beats per minute Standard Deviation 15.56	121.0 beats per minute Standard Deviation 4.24

PRIMARY outcome

Timeframe: At 15 Months of participants' age

Population: Safety population included all participants who were enrolled into the study.

Pulse rate of participants in beats per minute was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Pulse Rate at 15 Months of Participant's Age	108.5 beats per minute Standard Deviation 20.51	116.0 beats per minute Standard Deviation 5.66

PRIMARY outcome

Timeframe: 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.

Pulse rate of participants in beats per minute was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=1 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Pulse Rate During 0 to <=3 Months of Participant's Age	124.0 beats per minute	144.0 beats per minute Standard Deviation 15.56

PRIMARY outcome

Timeframe: 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.

Pulse rate of participants in beats per minute was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=1 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Pulse Rate During >3 to <=6 Months of Participant's Age	128.0 beats per minute	—

PRIMARY outcome

Timeframe: 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.

Pulse rate of participants in beats per minute was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Pulse Rate During >6 to <=9 Months of Participant's Age	117.0 beats per minute Standard Deviation 15.56	121.0 beats per minute Standard Deviation 4.24

PRIMARY outcome

Timeframe: 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.

Pulse rate of participants in beats per minute was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Pulse Rate During >15 to <=18 Months of Participant's Age	108.5 beats per minute Standard Deviation 20.51	116.0 beats per minute Standard Deviation 5.66

PRIMARY outcome

Timeframe: 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.

Pulse rate of participants in beats per minute was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=1 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Pulse Rate During >21 to <=24 Months of Participant's Age	118.0 beats per minute	—

PRIMARY outcome

Timeframe: 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.

Pulse rate of participants in beats per minute was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=1 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Pulse Rate During >24 to <=30 Months of Participant's Age	118.0 beats per minute	—

PRIMARY outcome

Timeframe: 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.

Temperature of participants in degree Celsius was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=1 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Temperature During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age	36.2 degree Celsius	36.6 degree Celsius Standard Deviation 0.08

PRIMARY outcome

Timeframe: At 8 Months of participants' age

Population: Safety population included all participants who were enrolled into the study.

Temperature of participants in degree Celsius was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Temperature at 8 Months of Participant's Age	36.3 degree Celsius Standard Deviation 0.27	36.7 degree Celsius Standard Deviation 0.08

PRIMARY outcome

Timeframe: At 15 Months of participants' age

Population: Safety population included all participants who were enrolled into the study.

Temperature of participants in degree Celsius was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Temperature at 15 Months of Participant's Age	36.1 degree Celsius Standard Deviation 0.47	36.5 degree Celsius Standard Deviation 0.04

PRIMARY outcome

Timeframe: 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.

Temperature of participants in degree Celsius was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=1 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Temperature During 0 to <=3 Months of Participant's Age	36.2 degree Celsius	36.6 degree Celsius Standard Deviation 0.08

PRIMARY outcome

Timeframe: 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.

Temperature of participants in degree Celsius was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=1 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Temperature During >3 to <=6 Months of Participant's Age	36.4 degree Celsius	—

PRIMARY outcome

Timeframe: 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.

Temperature of participants in degree Celsius was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Temperature During >6 to <=9 Months of Participant's Age	36.3 degree Celsius Standard Deviation 0.27	36.7 degree Celsius Standard Deviation 0.08

PRIMARY outcome

Timeframe: 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.

Temperature of participants in degree Celsius was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Temperature During >15 to <=18 Months of Participant's Age	36.1 degree Celsius Standard Deviation 0.47	36.5 degree Celsius Standard Deviation 0.04

PRIMARY outcome

Timeframe: 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.

Temperature of participants in degree Celsius was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=1 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Temperature During >21 to <=24 Months of Participant's Age	36.4 degree Celsius	—

PRIMARY outcome

Timeframe: 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.

Temperature of participants in degree Celsius was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=1 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Temperature During >24 to <=30 Months of Participant's Age	36.3 degree Celsius	—

PRIMARY outcome

Timeframe: 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.

Respiratory rate of participants in breaths per minute was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=1 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Respiratory Rate During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age	30.0 breaths per minute	57.0 breaths per minute Standard Deviation 9.90

PRIMARY outcome

Timeframe: At 8 Months of participants' age

Population: Safety population included all participants who were enrolled into the study.

Respiratory rate of participants in breaths per minute was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Respiratory Rate at 8 Months of Participant's Age	33.0 breaths per minute Standard Deviation 1.41	34.0 breaths per minute Standard Deviation 2.83

PRIMARY outcome

Timeframe: At 15 Months participants' age

Population: Safety population included all participants who were enrolled into the study.

Respiratory rate of participants in breaths per minute was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Respiratory Rate at 15 Months of Participant's Age	34.0 breaths per minute Standard Deviation 14.14	27.0 breaths per minute Standard Deviation 1.41

PRIMARY outcome

Timeframe: 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.

Respiratory rate of participants in breaths per minute was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=1 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Respiratory Rate During 0 to <=3 Months of Participant's Age	30.0 breaths per minute	57.0 breaths per minute Standard Deviation 9.90

PRIMARY outcome

Timeframe: 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.

Respiratory rate of participants in breaths per minute was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=1 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Respiratory Rate During >3 to <=6 Months of Participant's Age	44.0 breaths per minute	—

PRIMARY outcome

Timeframe: 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.

Respiratory rate of participants in breaths per minute was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Respiratory Rate During >6 to <=9 Months of Participant's Age	33.0 breaths per minute Standard Deviation 1.41	34.0 breaths per minute Standard Deviation 2.83

PRIMARY outcome

Timeframe: 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.

Respiratory rate of participants in breaths per minute was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Respiratory Rate During >15 to <=18 Months of Participant's Age	34.0 breaths per minute Standard Deviation 14.14	27.0 breaths per minute Standard Deviation 1.41

PRIMARY outcome

Timeframe: 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.

Respiratory rate of participants in breaths per minute was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=1 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Respiratory Rate During >21 to <=24 Months of Participant's Age	44.0 breaths per minute	—

PRIMARY outcome

Timeframe: 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.

Respiratory rate of participants in breaths per minute was reported.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=1 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Respiratory Rate During >24 to <=30 Months of Participant's Age	44.0 breaths per minute	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=1 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator 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	0 Participants

PRIMARY outcome

Timeframe: At 8 Months of participants' age

Population: Safety population included all participants who were enrolled into the study.

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.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Number of Participants With Abnormal Neurological Examination Findings at 8 Months of Participant's Age	0 Participants	0 Participants

PRIMARY outcome

Timeframe: At 15 Months of participants' age

Population: Safety population included all participants who were enrolled into the study.

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.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Number of Participants With Abnormal Neurological Examination Findings at 15 Months of Participant's Age	1 Participants	0 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=1 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Number of Participants With Abnormal Neurological Examination Findings at Follow-up Visit 1 (Month 20 of Participant's Age)	1 Participants	0 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=1 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Number of Participants With Abnormal Neurological Examination Findings at Follow-up Visit 2 (Month 26 of Participant's Age)	1 Participants	0 Participants

PRIMARY outcome

Timeframe: At 8 Months of participants' age

Population: Safety population included all participants who were enrolled into the study.

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.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Month 8 of Participant's Age	NA units on a scale Standard Deviation NA Summarized data was not available, individual BINS total score for 2 participants were 13 and 11 respectively.	NA units on a scale Standard Deviation NA Summarized data was not available, individual BINS total score for 2 participants were 11 and 9 respectively.

PRIMARY outcome

Timeframe: At 15 Months of participants' age

Population: Safety population included all participants who were enrolled into the study.

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.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Month 15 of Participant's Age	NA units on a scale Standard Deviation NA Summarized data was not available, individual BINS total score for 2 participants were 11 and 7 respectively.	NA units on a scale Standard Deviation NA Summarized data was not available, individual BINS total score for 2 participants were 11 and 10 respectively.

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=1 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Follow-up Visit 1 (Month 20 of Participant's Age)	7 units on a scale	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=1 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Follow-up Visit 2 (Month 26 of Participant's Age)	6 units on a scale	—

PRIMARY outcome

Timeframe: At 8 Months of participants' age

Population: Safety population included all participants who were enrolled into the study.

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.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator 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 Standard Deviation NA Summarized data was not available, individual REEL-3 language ability total score for 2 participants were 95 and 91 respectively.	NA units on a scale Standard Deviation NA Summarized data was not available, individual REEL-3 language ability total score for 2 participants were 97 and 93 respectively.

PRIMARY outcome

Timeframe: At 15 Months of participants' age

Population: Safety population included all participants who were enrolled into the study.

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.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 Participants Infants in this reporting arm were those who had potential maternal exposure to comparator 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 Standard Deviation NA Summarized data was not available, individual REEL-3 language ability total score for 2 participants were 86 and 89 respectively.	NA units on a scale Standard Deviation NA Summarized data was not available, individual REEL-3 language ability total score for 2 participants were 99 and 97 respectively.

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=1 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
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 outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Maternal Exposure to Tanezumab n=1 Participants Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
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	—

Adverse Events

Maternal Exposure to Tanezumab

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Maternal Exposure to Tramadol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Maternal Exposure to Tanezumab n=2 participants at risk Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 participants at risk Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
General disorders Drowning	50.0% 1/2 • Number of events 1 • From the participants' age of 0 month to maximum of 36 months Same event may appear as both adverse event (AE) and serious adverse event (SAE). An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE.	0.00% 0/2 • From the participants' age of 0 month to maximum of 36 months Same event may appear as both adverse event (AE) and serious adverse event (SAE). An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE.

Other adverse events

Other adverse events
Measure	Maternal Exposure to Tanezumab n=2 participants at risk Infants in this reporting arm were those who had potential maternal exposure to tanezumab.	Maternal Exposure to Tramadol n=2 participants at risk Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.
Nervous system disorders Speech disorder/ Language development delay	50.0% 1/2 • Number of events 1 • From the participants' age of 0 month to maximum of 36 months Same event may appear as both adverse event (AE) and serious adverse event (SAE). An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE.	0.00% 0/2 • From the participants' age of 0 month to maximum of 36 months Same event may appear as both adverse event (AE) and serious adverse event (SAE). An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE.
Nervous system disorders Speech disorder developmental / Speech developmental delay	50.0% 1/2 • Number of events 1 • From the participants' age of 0 month to maximum of 36 months Same event may appear as both adverse event (AE) and serious adverse event (SAE). An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE.	0.00% 0/2 • From the participants' age of 0 month to maximum of 36 months Same event may appear as both adverse event (AE) and serious adverse event (SAE). An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE.

Additional Information

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Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER