Trial Outcomes & Findings for Study of DA-9501 In Pediatric Subjects In The Intensive Care Unit (NCT NCT02757625)

NCT ID: NCT02757625

Last Updated: 2018-12-17

Results Overview

Percentage of participants who did not require rescue medication for Sedation (Midazolam) based on the data of investigator's judgement and State Behavioral Scale (SBS) (which was a sedation assessment instrument for intubated participants and its score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= unresponsive. During intubation \[placement of a flexible plastic tube into the trachea to maintain an open airway or to serve as a conduit through which to administer certain drugs\], the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation \[removal of endotracheal tube\], the target sedation depth was -1 to 0, where higher score indicated more responsive) were reported.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 63 participants
• Primary outcome timeframe: From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days)
• Results posted on: 2018-12-17

Participant Flow

Participant milestones

Measure	Dexmedetomidine: >=45 Weeks CGA to <12 Months Participants with age between \>=45 weeks corrected gestation age (CGA) to \<12 months received 0.2 microgram per kilogram per hour (mcg/kg/h) of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=12 Months to <24 Months Participants with age between \>=12 months to \<24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=2 Years to <6 Years Participants with age between \>=2 years to \<6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=6 Years to <17 Years Participants with age between \>=6 years to \<17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Overall Study STARTED	14	18	19	12
Overall Study COMPLETED	14	18	17	12
Overall Study NOT COMPLETED	0	0	2	0

Reasons for withdrawal

Measure	Dexmedetomidine: >=45 Weeks CGA to <12 Months Participants with age between \>=45 weeks corrected gestation age (CGA) to \<12 months received 0.2 microgram per kilogram per hour (mcg/kg/h) of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=12 Months to <24 Months Participants with age between \>=12 months to \<24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=2 Years to <6 Years Participants with age between \>=2 years to \<6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=6 Years to <17 Years Participants with age between \>=6 years to \<17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Overall Study Investigator's discretion	0	0	1	0
Overall Study Adverse Event	0	0	1	0

Baseline Characteristics

Study of DA-9501 In Pediatric Subjects In The Intensive Care Unit

Baseline characteristics by cohort

Measure	Dexmedetomidine: >=45 Weeks CGA to <12 Months n=14 Participants Participants with age between \>=45 weeks CGA to \<12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=12 Months to <24 Months n=18 Participants Participants with age between \>=12 months to \<24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=2 Years to <6 Years n=19 Participants Participants with age between \>=2 years to \<6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=6 Years to <17 Years n=12 Participants Participants with age between \>=6 years to \<17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Total n=63 Participants Total of all reporting groups
Age, Continuous	6.1 months STANDARD_DEVIATION 2.1 • n=5 Participants	16.9 months STANDARD_DEVIATION 3.6 • n=7 Participants	45.7 months STANDARD_DEVIATION 14.6 • n=5 Participants	112.1 months STANDARD_DEVIATION 37.9 • n=4 Participants	41.3 months STANDARD_DEVIATION 41.8 • n=21 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	5 Participants n=4 Participants	27 Participants n=21 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	11 Participants n=7 Participants	12 Participants n=5 Participants	7 Participants n=4 Participants	36 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	14 Participants n=5 Participants	18 Participants n=7 Participants	19 Participants n=5 Participants	12 Participants n=4 Participants	63 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants

PRIMARY outcome

Timeframe: From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days)

Population: FAS included all participants who received at least one dose of the study drug.

Percentage of participants who did not require rescue medication for Sedation (Midazolam) based on the data of investigator's judgement and State Behavioral Scale (SBS) (which was a sedation assessment instrument for intubated participants and its score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= unresponsive. During intubation [placement of a flexible plastic tube into the trachea to maintain an open airway or to serve as a conduit through which to administer certain drugs], the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation [removal of endotracheal tube], the target sedation depth was -1 to 0, where higher score indicated more responsive) were reported.

Outcome measures

Measure	Dexmedetomidine: >=45 Weeks CGA to <12 Months n=14 Participants Participants with age between \>=45 weeks CGA to \<12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=12 Months to <24 Months n=18 Participants Participants with age between \>=12 months to \<24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=2 Years to <6 Years n=19 Participants Participants with age between \>=2 years to \<6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=6 Years to <17 Years n=12 Participants Participants with age between \>=6 years to \<17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: All Participants n=63 Participants Participants with age between \>=45 weeks CGA to \<17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Percentage of Participants Who Did Not Require a Rescue Sedative Within 24 Hours of Dosing of Study Drug	78.6 percentage of participants Interval 51.7 to 93.2	66.7 percentage of participants Interval 43.6 to 83.9	78.9 percentage of participants Interval 56.1 to 92.0	91.7 percentage of participants Interval 62.5 to 100.0	77.8 percentage of participants Interval 66.0 to 86.4

SECONDARY outcome

Timeframe: From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days)

Population: FAS included all participants who received at least one dose of the study drug.

Percentage of participants who did not require administration of a rescue analgesic (Fentanyl) in addition to administration of the study drug based on investigator's judgement were reported.

Outcome measures

Measure	Dexmedetomidine: >=45 Weeks CGA to <12 Months n=14 Participants Participants with age between \>=45 weeks CGA to \<12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=12 Months to <24 Months n=18 Participants Participants with age between \>=12 months to \<24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=2 Years to <6 Years n=19 Participants Participants with age between \>=2 years to \<6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=6 Years to <17 Years n=12 Participants Participants with age between \>=6 years to \<17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: All Participants n=63 Participants Participants with age between \>=45 weeks CGA to \<17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Percentage of Participants Who Did Not Require Administration of a Rescue Analgesic Within 24 Hours of Dosing of Study Drug	85.7 percentage of participants Interval 58.8 to 97.2	100.0 percentage of participants Interval 79.3 to 100.0	94.7 percentage of participants Interval 73.5 to 100.0	66.7 percentage of participants Interval 38.8 to 86.4	88.9 percentage of participants Interval 78.5 to 94.8

SECONDARY outcome

Timeframe: From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days)

Population: Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue medication in the specified evaluation period).

Total amount of rescue sedative (midazolam) administered Within 24 Hours of dosing of study drug.

Outcome measures

Measure	Dexmedetomidine: >=45 Weeks CGA to <12 Months n=3 Participants Participants with age between \>=45 weeks CGA to \<12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=12 Months to <24 Months n=6 Participants Participants with age between \>=12 months to \<24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=2 Years to <6 Years n=4 Participants Participants with age between \>=2 years to \<6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=6 Years to <17 Years n=1 Participants Participants with age between \>=6 years to \<17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: All Participants n=14 Participants Participants with age between \>=45 weeks CGA to \<17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Total Amount of Rescue Sedative Administered Within 24 Hours of Dosing of Study Drug	0.882 milligrams (mg) Standard Deviation 0.8282	3.188 milligrams (mg) Standard Deviation 1.6935	2.469 milligrams (mg) Standard Deviation 1.3975	1.960 milligrams (mg)	2.401 milligrams (mg) Standard Deviation 1.5793

SECONDARY outcome

Timeframe: From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days)

Population: Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue medication in the specified evaluation period).

Total amount of rescue sedative (midazolam) required within 24 hours of dosing of study drug. Dose was adjusted for body weight (mg divided by kg).

Outcome measures

Measure	Dexmedetomidine: >=45 Weeks CGA to <12 Months n=3 Participants Participants with age between \>=45 weeks CGA to \<12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=12 Months to <24 Months n=6 Participants Participants with age between \>=12 months to \<24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=2 Years to <6 Years n=4 Participants Participants with age between \>=2 years to \<6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=6 Years to <17 Years n=1 Participants Participants with age between \>=6 years to \<17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: All Participants n=14 Participants Participants with age between \>=45 weeks CGA to \<17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Body Weight Adjusted Total Amount (Per Kg) of Rescue Sedative Taken Within 24 Hours of Dosing of Study Drug	0.135 mg/kg Standard Deviation 0.1160	0.353 mg/kg Standard Deviation 0.2219	0.142 mg/kg Standard Deviation 0.0668	0.100 mg/kg Standard Deviation 0	0.228 mg/kg Standard Deviation 0.1866

SECONDARY outcome

Timeframe: From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days)

Population: Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue medication in the specified evaluation period). Here "N" signifies number of participants who were evaluable for this specified outcome measure.

Total amount of rescue sedative (fentanyl) required Within 24 Hours of dosing of study drug.

Outcome measures

Measure	Dexmedetomidine: >=45 Weeks CGA to <12 Months n=2 Participants Participants with age between \>=45 weeks CGA to \<12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=12 Months to <24 Months Participants with age between \>=12 months to \<24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=2 Years to <6 Years n=1 Participants Participants with age between \>=2 years to \<6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=6 Years to <17 Years n=4 Participants Participants with age between \>=6 years to \<17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: All Participants n=7 Participants Participants with age between \>=45 weeks CGA to \<17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Total Amount of Rescue Analgesic Taken Within 24 Hours of Dosing of Study Drug	91.70 micrograms Standard Deviation 78.772	—	97.50 micrograms Standard Deviation 0	81.74 micrograms Standard Deviation 15.754	86.84 micrograms Standard Deviation 34.676

SECONDARY outcome

Timeframe: From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days)

Population: Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue medication in the specified evaluation period). Here "N" signifies number of participants who were evaluable for this specified outcome measure.

Total amount of rescue analgesic (fentanyl) within 24 Hours of dosing of study drug. Dose was adjusted for body weight (mcg divided by kg).

Outcome measures

Measure	Dexmedetomidine: >=45 Weeks CGA to <12 Months n=2 Participants Participants with age between \>=45 weeks CGA to \<12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=12 Months to <24 Months Participants with age between \>=12 months to \<24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=2 Years to <6 Years n=1 Participants Participants with age between \>=2 years to \<6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=6 Years to <17 Years n=4 Participants Participants with age between \>=6 years to \<17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: All Participants n=7 Participants Participants with age between \>=45 weeks CGA to \<17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Body Weight Adjusted Total Amount of Rescue Analgesic Taken Within 24 Hours of Dosing of Study Drug	15.00 mcg/kg Standard Deviation 9.899	—	5.00 mcg/kg Standard Deviation 0	3.78 mcg/kg Standard Deviation 1.311	7.16 mcg/kg Standard Deviation 6.789

SECONDARY outcome

Timeframe: From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days)

Population: FAS included all participants who received at least one dose of the study drug. Here "N" signifies number of participants who were evaluable for this specified outcome measure.

Time duration for which the target sedation level was maintained during the specified evaluation period within participants was reported. Target sedation level was analyzed by target sedation scores by using the SBS. SBS was a sedation assessment instrument for intubated participants and its score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= unresponsive. During intubation (placement of a flexible plastic tube into the trachea to maintain an open airway or to serve as a conduit through which to administer certain drugs), the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation (removal of endotracheal tube), the target sedation depth was -1 to 0, where higher score indicated more responsive.

Outcome measures

Measure	Dexmedetomidine: >=45 Weeks CGA to <12 Months n=13 Participants Participants with age between \>=45 weeks CGA to \<12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=12 Months to <24 Months n=17 Participants Participants with age between \>=12 months to \<24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=2 Years to <6 Years n=19 Participants Participants with age between \>=2 years to \<6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=6 Years to <17 Years n=11 Participants Participants with age between \>=6 years to \<17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: All Participants n=60 Participants Participants with age between \>=45 weeks CGA to \<17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Duration of Maintenance of Target Sedation Level Within 24 Hours of Dosing of Study Drug	7.95 hours Standard Deviation 7.191	3.89 hours Standard Deviation 2.859	3.52 hours Standard Deviation 5.495	2.96 hours Standard Deviation 2.017	4.50 hours Standard Deviation 5.112

SECONDARY outcome

Timeframe: From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days)

Population: FAS included all participants who received at least one dose of the study drug. Here "N" signifies number of participants who were evaluable for this specified outcome measure.

Percentage of time duration for which the target sedation level was maintained during the specified evaluation period within participants was reported. Target sedation level was analyzed by target sedation scores by using the state behavioral scale (SBS). SBS is a sedation assessment instrument and it's score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= non-responsive. During intubation the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation, the target sedation depth was -1 to 0, where higher score indicated more responsive.

Outcome measures

Measure	Dexmedetomidine: >=45 Weeks CGA to <12 Months n=13 Participants Participants with age between \>=45 weeks CGA to \<12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=12 Months to <24 Months n=17 Participants Participants with age between \>=12 months to \<24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=2 Years to <6 Years n=19 Participants Participants with age between \>=2 years to \<6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=6 Years to <17 Years n=11 Participants Participants with age between \>=6 years to \<17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: All Participants n=60 Participants Participants with age between \>=45 weeks CGA to \<17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Percentage of Maintenance Duration of Target Sedation Level Within 24 Hours of Dosing of Study Drug	54.08 percentage of time Standard Deviation 31.825	60.97 percentage of time Standard Deviation 28.104	50.54 percentage of time Standard Deviation 27.898	62.25 percentage of time Standard Deviation 34.836	56.54 percentage of time Standard Deviation 29.911

SECONDARY outcome

Timeframe: After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days)

Population: Participants from FAS population whose period of dosing of investigational product exceeded 24 hours.

Percentage of participants whose period of dosing of the investigational product exceeded 24 hours and who did not received rescue medication for Sedation (Midazolam) based on the data of investigator's judgement and SBS (which was a sedation assessment instrument for intubated participants and its score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= unresponsive. During intubation [placement of a flexible plastic tube into the trachea to maintain an open airway or to serve as a conduit through which to administer certain drugs], the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation [removal of endotracheal tube], the target sedation depth was -1 to 0, where higher score indicated more responsive) were reported.

Outcome measures

Measure	Dexmedetomidine: >=45 Weeks CGA to <12 Months n=2 Participants Participants with age between \>=45 weeks CGA to \<12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=12 Months to <24 Months Participants with age between \>=12 months to \<24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=2 Years to <6 Years n=1 Participants Participants with age between \>=2 years to \<6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=6 Years to <17 Years Participants with age between \>=6 years to \<17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: All Participants n=3 Participants Participants with age between \>=45 weeks CGA to \<17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Percentage of Participants Who Did Not Use a Rescue Sedative After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation	100.0 percentage of participants Interval 29.0 to 100.0	—	100.0 percentage of participants Interval 16.7 to 100.0	—	100.0 percentage of participants Interval 38.3 to 100.0

SECONDARY outcome

Timeframe: After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days)

Population: Participants from FAS population whose period of dosing of investigational product exceeded 24 hours.

Percentage of participants whose period of dosing of the investigational product exceeded 24 hours and who did not received rescue analgesic (Fentanyl) based on the investigator's judgement were reported.

Outcome measures

Measure	Dexmedetomidine: >=45 Weeks CGA to <12 Months n=2 Participants Participants with age between \>=45 weeks CGA to \<12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=12 Months to <24 Months Participants with age between \>=12 months to \<24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=2 Years to <6 Years n=1 Participants Participants with age between \>=2 years to \<6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=6 Years to <17 Years Participants with age between \>=6 years to \<17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: All Participants n=3 Participants Participants with age between \>=45 weeks CGA to \<17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Percentage of Participants Who Did Not Require Dosing of a Rescue Analgesic After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation	100.0 percentage of participants Interval 29.0 to 100.0	—	100.0 percentage of participants Interval 16.7 to 100.0	—	100.0 percentage of participants Interval 38.3 to 100.0

SECONDARY outcome

Timeframe: After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days)

Population: Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue medication in the specified evaluation period).

Total amount of rescue sedative (midazolam) administered after 24 hours of dosing of study drug.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days)

Population: Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue sedative in the specified evaluation period).

Total amount of rescue sedative (midazolam) required after 24 hours of dosing of study drug. Dose was adjusted for body weight (mg divided by kg).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days)

Population: Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue medication in the specified evaluation period).

Total amount of rescue analgesic (Fentanyl) administered by the participants after 24 hours of dosing of study drug.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days)

Population: Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue medication in the specified evaluation period).

Total amount of rescue analgesic (fentanyl) after 24 hours of dosing of study drug. Dose was adjusted for body weight (mcg divided by kg).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days)

Population: Participants from FAS population whose period of dosing of investigational product exceeded 24 hours.

Time duration for which the target sedation level was maintained during the specified evaluation period within participants was reported. Target sedation level was analyzed by target sedation scores by using the state behavioral scale (SBS). SBS is a sedation assessment instrument for intubated participants and its score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= unresponsive. During intubation (placement of a flexible plastic tube into the trachea to maintain an open airway or to serve as a conduit through which to administer certain drugs), the target sedation depth by SBS was -2 to 0, where higher score indicated more stability and after extubation (removal of endotracheal tube), the target sedation depth was -1 to 0, where higher score indicated more stability.

Outcome measures

Measure	Dexmedetomidine: >=45 Weeks CGA to <12 Months n=2 Participants Participants with age between \>=45 weeks CGA to \<12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=12 Months to <24 Months Participants with age between \>=12 months to \<24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=2 Years to <6 Years n=1 Participants Participants with age between \>=2 years to \<6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=6 Years to <17 Years Participants with age between \>=6 years to \<17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: All Participants n=3 Participants Participants with age between \>=45 weeks CGA to \<17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Duration of Maintenance of Target Sedation Level After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation	0.81 hours Standard Deviation 0.672	—	0.92 hours Standard Deviation 0	—	0.84 hours Standard Deviation 0.479

SECONDARY outcome

Timeframe: After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days)

Population: Participants from FAS population whose period of dosing of investigational product exceeded 24 hours.

Percentage of time duration for which the target sedation level was maintained during the specified evaluation period within participants was reported. Target sedation level was analyzed by target sedation scores by using the state behavioral scale (SBS). SBS is a sedation assessment instrument and it's score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= non-responsive. During intubation the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation, the target sedation depth was -1 to 0, where higher score indicated more responsive.

Outcome measures

Measure	Dexmedetomidine: >=45 Weeks CGA to <12 Months n=2 Participants Participants with age between \>=45 weeks CGA to \<12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=12 Months to <24 Months Participants with age between \>=12 months to \<24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=2 Years to <6 Years n=1 Participants Participants with age between \>=2 years to \<6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=6 Years to <17 Years Participants with age between \>=6 years to \<17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: All Participants n=3 Participants Participants with age between \>=45 weeks CGA to \<17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Percentage of Maintenance Duration of Target Sedation Level After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation	75.00 percentage of time Standard Deviation 35.355	—	100.00 percentage of time Standard Deviation 0	—	83.33 percentage of time Standard Deviation 28.868

SECONDARY outcome

Timeframe: From extubation till end of treatment (6 hours after start of study drug dosing up to 28 days)

Population: FAS included all participants who received at least one dose of the study drug. Here "N" signifies number of participants who were evaluable for this specified outcome measure.

Time duration for which the target sedation level was maintained during the specified evaluation period within participants was reported. Target sedation level was analyzed by target sedation scores by using the state behavioral scale (SBS). SBS is a sedation assessment instrument for intubated participants and its score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= unresponsive. During intubation (placement of a flexible plastic tube into the trachea to maintain an open airway or to serve as a conduit through which to administer certain drugs), the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation (removal of endotracheal tube), the target sedation depth was -1 to 0, where higher score indicated more responsive.

Outcome measures

Measure	Dexmedetomidine: >=45 Weeks CGA to <12 Months n=14 Participants Participants with age between \>=45 weeks CGA to \<12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=12 Months to <24 Months n=18 Participants Participants with age between \>=12 months to \<24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=2 Years to <6 Years n=16 Participants Participants with age between \>=2 years to \<6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=6 Years to <17 Years n=10 Participants Participants with age between \>=6 years to \<17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: All Participants n=58 Participants Participants with age between \>=45 weeks CGA to \<17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Duration of Maintenance of Target Sedation Level After Extubation	11.68 hours Standard Deviation 11.589	7.73 hours Standard Deviation 7.543	7.60 hours Standard Deviation 4.355	6.73 hours Standard Deviation 5.036	8.42 hours Standard Deviation 7.679

SECONDARY outcome

Timeframe: From extubation till end of treatment (6 hours after start of study drug dosing up to 28 days)

Population: FAS included all participants who received at least one dose of the study drug. Here "N" signifies number of participants who were evaluable for this specified outcome measure.

Percentage of time duration for which the target sedation level was maintained during the specified evaluation period within participants was reported. Target sedation level was analyzed by target sedation scores by using the state behavioral scale (SBS). SBS is a sedation assessment instrument and it's score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= non-responsive. During intubation the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation, the target sedation depth was -1 to 0, where higher score indicated more responsive.

Outcome measures

Measure	Dexmedetomidine: >=45 Weeks CGA to <12 Months n=14 Participants Participants with age between \>=45 weeks CGA to \<12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=12 Months to <24 Months n=18 Participants Participants with age between \>=12 months to \<24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=2 Years to <6 Years n=16 Participants Participants with age between \>=2 years to \<6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=6 Years to <17 Years n=10 Participants Participants with age between \>=6 years to \<17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: All Participants n=58 Participants Participants with age between \>=45 weeks CGA to \<17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Percentage of Maintenance Duration of Target Sedation Level After Extubation	69.99 Percentage of time Standard Deviation 28.260	53.93 Percentage of time Standard Deviation 28.613	54.45 Percentage of time Standard Deviation 30.805	55.82 Percentage of time Standard Deviation 41.195	58.19 Percentage of time Standard Deviation 31.829

SECONDARY outcome

Timeframe: From extubation till end of treatment (6 hours after start of study drug dosing up to 28 days)

Population: Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue sedative in the specified evaluation period). Here "N" signifies number of participants who were evaluable for this specified outcome measure.

Total amount of rescue sedative (Midazolam) administered by the participants after extubation.

Outcome measures

Measure	Dexmedetomidine: >=45 Weeks CGA to <12 Months n=2 Participants Participants with age between \>=45 weeks CGA to \<12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=12 Months to <24 Months n=2 Participants Participants with age between \>=12 months to \<24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=2 Years to <6 Years n=1 Participants Participants with age between \>=2 years to \<6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=6 Years to <17 Years Participants with age between \>=6 years to \<17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: All Participants n=5 Participants Participants with age between \>=45 weeks CGA to \<17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Total Amount of Rescue Sedative Taken After Extubation	0.537 mg Standard Deviation 0.3741	0.719 mg Standard Deviation 0.3379	5.994 mg	—	1.701 mg Standard Deviation 2.4148

SECONDARY outcome

Timeframe: From extubation till end of treatment (6 hours after start of study drug dosing up to 28 days)

Population: Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue sedative in the specified evaluation period). Here "N" signifies number of participants who were evaluable for this specified outcome measure.

Total amount of rescue sedative (midazolam) administered by the participants after extubation. Dose was adjusted for body weight (mg divided by kg).

Outcome measures

Measure	Dexmedetomidine: >=45 Weeks CGA to <12 Months n=2 Participants Participants with age between \>=45 weeks CGA to \<12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=12 Months to <24 Months n=2 Participants Participants with age between \>=12 months to \<24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=2 Years to <6 Years n=1 Participants Participants with age between \>=2 years to \<6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=6 Years to <17 Years Participants with age between \>=6 years to \<17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: All Participants n=5 Participants Participants with age between \>=45 weeks CGA to \<17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Body Weight Adjusted Total Amount of Rescue Sedative Taken After Extubation	0.109 mg/kg Standard Deviation 0.0976	0.072 mg/kg Standard Deviation 0.0304	0.370 mg/kg	—	0.146 mg/kg Standard Deviation 0.1364

SECONDARY outcome

Timeframe: From extubation till end of treatment (6 hours after start of study drug dosing up to 28 days)

Population: Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue sedative in the specified evaluation period). Here "N" signifies number of participants who were evaluable for this specified outcome measure.

Total amount of rescue analgesic (fentanyl) administered by the participants after extubation.

Outcome measures

Measure	Dexmedetomidine: >=45 Weeks CGA to <12 Months Participants with age between \>=45 weeks CGA to \<12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=12 Months to <24 Months Participants with age between \>=12 months to \<24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=2 Years to <6 Years n=1 Participants Participants with age between \>=2 years to \<6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=6 Years to <17 Years Participants with age between \>=6 years to \<17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: All Participants n=1 Participants Participants with age between \>=45 weeks CGA to \<17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Total Amount of Rescue Analgesic Taken After Extubation	—	—	42.90 mcg	—	42.90 mcg

SECONDARY outcome

Timeframe: From extubation till end of treatment (6 hours after start of study drug dosing up to 28 days)

Population: Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue sedative in the specified evaluation period). Here "N" signifies number of participants who were evaluable for this specified outcome measure.

Total amount of rescue analgesic (fentanyl) administered by the participants after extubation. Dose was adjusted for body weight (mcg divided by kg).

Outcome measures

Measure	Dexmedetomidine: >=45 Weeks CGA to <12 Months Participants with age between \>=45 weeks CGA to \<12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=12 Months to <24 Months Participants with age between \>=12 months to \<24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=2 Years to <6 Years n=1 Participants Participants with age between \>=2 years to \<6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=6 Years to <17 Years Participants with age between \>=6 years to \<17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: All Participants n=1 Participants Participants with age between \>=45 weeks CGA to \<17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Body Weight Adjusted Total Amount of Rescue Analgesic Taken After Extubation	—	—	3.00 mcg/kg	—	3.00 mcg/kg

SECONDARY outcome

Timeframe: Baseline (start of study drug dosing) until end of mechanical ventilation (up to 28 days)

Population: FAS: all participants who received at least one dose of the investigational product.

Time to conclusion of mechanical ventilation was defined as time duration from start of study drug administration until the end of mechanical ventilation.

Outcome measures

Measure	Dexmedetomidine: >=45 Weeks CGA to <12 Months n=14 Participants Participants with age between \>=45 weeks CGA to \<12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=12 Months to <24 Months n=18 Participants Participants with age between \>=12 months to \<24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=2 Years to <6 Years n=19 Participants Participants with age between \>=2 years to \<6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=6 Years to <17 Years n=12 Participants Participants with age between \>=6 years to \<17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: All Participants n=63 Participants Participants with age between \>=45 weeks CGA to \<17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Median Time to Conclusion of Mechanical Ventilation	9.5 hours Interval 6.3 to 17.5	6.0 hours Interval 4.6 to 6.3	4.1 hours Interval 3.0 to 6.0	4.5 hours Interval 3.8 to 6.0	6.0 hours Interval 4.8 to 6.2

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 28 days after end of study drug dosing (up to 56 days)

Population: Safety analysis set included all participants who received at least one dose of the investigational product.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to up to 28 days after end of study drug dosing (up to 56 days) that were absent before treatment or that worsened relative to pretreatment state. AEs included both non-serious adverse events (AEs) and SAEs.

Outcome measures

Measure	Dexmedetomidine: >=45 Weeks CGA to <12 Months n=14 Participants Participants with age between \>=45 weeks CGA to \<12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=12 Months to <24 Months n=18 Participants Participants with age between \>=12 months to \<24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=2 Years to <6 Years n=19 Participants Participants with age between \>=2 years to \<6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=6 Years to <17 Years n=12 Participants Participants with age between \>=6 years to \<17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: All Participants n=63 Participants Participants with age between \>=45 weeks CGA to \<17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Number of Participants With Treatment- Emergent Adverse Events (AE) and Serious Adverse Events (SAE) SAEs	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Treatment- Emergent Adverse Events (AE) and Serious Adverse Events (SAE) AEs	11 Participants	16 Participants	16 Participants	12 Participants	55 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 28 days after end of study drug dosing (Day 56)

Population: Safety analysis set included all participants who received at least one dose of the investigational product.

Vital signs included: systolic and diastolic blood pressure, heart rate, respiratory rate, percutaneous oxygen saturation, end-tidal carbon dioxide, core body temperature and body weight. Criteria for clinically significant vital signs abnormalities was based on Investigators decision.

Outcome measures

Measure	Dexmedetomidine: >=45 Weeks CGA to <12 Months n=14 Participants Participants with age between \>=45 weeks CGA to \<12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=12 Months to <24 Months n=18 Participants Participants with age between \>=12 months to \<24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=2 Years to <6 Years n=19 Participants Participants with age between \>=2 years to \<6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=6 Years to <17 Years n=12 Participants Participants with age between \>=6 years to \<17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: All Participants n=63 Participants Participants with age between \>=45 weeks CGA to \<17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Number of Participants With Clinically Significant Change From Baseline in Vital Signs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 28 days after end of study drug dosing (Day 56)

Population: Safety analysis set included all participants who received at least one dose of the investigational product. Here "N" signifies number of participants who were evaluable for this specified outcome measure.

Criteria for abnormality: hemoglobin, hematocrit and red blood cell count <0.8*lower limit of normal(LLN); platelet <0.5*LLN; >1.75*upper limit of normal(ULN); white blood cell count <0.6*LLN; >1.5*ULN; lymphocytes, neutrophils and stab cells <0.8*LLN; >1.2*ULN; eosinophils, basophils and monocytes >1.2*ULN; total bilirubin >1.5*ULN; aspartate aminotransferase, alanine aminotransferase and gamma guanosine triphosphate and alkaline phosphatase >3*ULN; total protein and albumin <0.8*LLN; >1.2*ULN; glucose <0.6*LLN; >1.5*ULN; blood urea nitrogen and creatinine >1.3*ULN; uric acid >1.2*ULN; sodium <0.95*LLN; >1.05*ULN, potassium, calcium and magnesium <0.9*LLN; >1.1*ULN; phosphate <0.8*LLN; >1.2*ULN.

Outcome measures

Measure	Dexmedetomidine: >=45 Weeks CGA to <12 Months n=14 Participants Participants with age between \>=45 weeks CGA to \<12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=12 Months to <24 Months n=18 Participants Participants with age between \>=12 months to \<24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=2 Years to <6 Years n=18 Participants Participants with age between \>=2 years to \<6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=6 Years to <17 Years n=12 Participants Participants with age between \>=6 years to \<17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: All Participants n=62 Participants Participants with age between \>=45 weeks CGA to \<17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Number of Participants With Laboratory Test Abnormalities	13 Participants	18 Participants	15 Participants	11 Participants	57 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 28 days after end of study drug dosing (Day 56)

Population: Safety analysis set included all participants who received at least one dose of the investigational product. Here "N" signifies number of participants who were evaluable for this specified outcome measure.

Total input fluid volume was defined as the quantity of total fluids administered and total output fluid volume was defined as the quantity of total fluids excreted or lost during the specified evaluation period.

Outcome measures

Measure	Dexmedetomidine: >=45 Weeks CGA to <12 Months n=14 Participants Participants with age between \>=45 weeks CGA to \<12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=12 Months to <24 Months n=18 Participants Participants with age between \>=12 months to \<24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=2 Years to <6 Years n=18 Participants Participants with age between \>=2 years to \<6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=6 Years to <17 Years n=12 Participants Participants with age between \>=6 years to \<17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: All Participants n=63 Participants Participants with age between \>=45 weeks CGA to \<17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Total Input/Output Fluid Volume Output Volume	975.06 milliliters (mL) Standard Deviation 436.904	801.53 milliliters (mL) Standard Deviation 353.379	1041.80 milliliters (mL) Standard Deviation 356.375	1313.58 milliliters (mL) Standard Deviation 625.474	1009.58 milliliters (mL) Standard Deviation 461.471
Total Input/Output Fluid Volume Input Volume	779.39 milliliters (mL) Standard Deviation 342.617	799.18 milliliters (mL) Standard Deviation 356.254	1023.60 milliliters (mL) Standard Deviation 337.825	1415.96 milliliters (mL) Standard Deviation 822.212	979.24 milliliters (mL) Standard Deviation 520.514

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 28 days after end of study drug dosing (Day 56)

Population: Safety analysis set included all participants who received at least one dose of the investigational product.

The potential withdrawal symptoms were defined as AEs that occurred or worsened after end of administration of dexmedetomidine. It included bradycardia, abdominal discomfort, abdominal pain, dry mouth, nausea, vomiting, injection site pain, pyrexia, body temperature increased, electrocardiogram QT prolonged, neuralgia, agitation, atelectasis, oropharyngeal pain and hypotension. Incidence of potential withdrawal symptoms was reported in terms of number of participants who had any of the mentioned withdrawal symptoms.

Outcome measures

Measure	Dexmedetomidine: >=45 Weeks CGA to <12 Months n=14 Participants Participants with age between \>=45 weeks CGA to \<12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=12 Months to <24 Months n=18 Participants Participants with age between \>=12 months to \<24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=2 Years to <6 Years n=19 Participants Participants with age between \>=2 years to \<6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=6 Years to <17 Years n=12 Participants Participants with age between \>=6 years to \<17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: All Participants n=63 Participants Participants with age between \>=45 weeks CGA to \<17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Incidence of Potential Withdrawal Symptoms Vomiting	1 Participants	1 Participants	1 Participants	4 Participants	7 Participants
Incidence of Potential Withdrawal Symptoms Injection site pain	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Incidence of Potential Withdrawal Symptoms Pyrexia	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Incidence of Potential Withdrawal Symptoms Agitation	1 Participants	1 Participants	1 Participants	0 Participants	3 Participants
Incidence of Potential Withdrawal Symptoms Atelectasis	1 Participants	1 Participants	0 Participants	0 Participants	2 Participants
Incidence of Potential Withdrawal Symptoms Oropharyngeal pain	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Incidence of Potential Withdrawal Symptoms Hypotension	0 Participants	1 Participants	1 Participants	1 Participants	3 Participants
Incidence of Potential Withdrawal Symptoms Bradycardia	0 Participants	4 Participants	0 Participants	0 Participants	4 Participants
Incidence of Potential Withdrawal Symptoms Abdominal discomfort	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Incidence of Potential Withdrawal Symptoms Abdominal pain	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Incidence of Potential Withdrawal Symptoms Dry mouth	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Incidence of Potential Withdrawal Symptoms Nausea	0 Participants	0 Participants	2 Participants	3 Participants	5 Participants
Incidence of Potential Withdrawal Symptoms Body temperature increased	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Incidence of Potential Withdrawal Symptoms Electrocardiogram QT prolonged	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Incidence of Potential Withdrawal Symptoms Neuralgia	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 28 days after end of study drug dosing (Day 56)

Population: Safety analysis set included all participants who received at least one dose of the investigational product. Here "N" signifies number of participants who were evaluable for this specified outcome measure.

Criteria for clinically significant electrocardiogram abnormalities was based on Investigators decision.

Outcome measures

Measure	Dexmedetomidine: >=45 Weeks CGA to <12 Months n=14 Participants Participants with age between \>=45 weeks CGA to \<12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=12 Months to <24 Months n=18 Participants Participants with age between \>=12 months to \<24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=2 Years to <6 Years n=19 Participants Participants with age between \>=2 years to \<6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=6 Years to <17 Years n=12 Participants Participants with age between \>=6 years to \<17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: All Participants n=63 Participants Participants with age between \>=45 weeks CGA to \<17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

Dexmedetomidine: >=45 Weeks CGA to <12 Months

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Dexmedetomidine: >=12 Months to <24 Months

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Dexmedetomidine: >=2 Years to <6 Years

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Dexmedetomidine: >=6 Years to <17 Years

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Dexmedetomidine: All Participants

Serious events: 1 serious events

Other events: 55 other events

Deaths: 0 deaths

Serious adverse events

Measure	Dexmedetomidine: >=45 Weeks CGA to <12 Months n=14 participants at risk Participants with age between \>=45 weeks CGA to \<12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=12 Months to <24 Months n=18 participants at risk Participants with age between \>=12 months to \<24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=2 Years to <6 Years n=19 participants at risk Participants with age between \>=2 years to \<6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=6 Years to <17 Years n=12 participants at risk Participants with age between \>=6 years to \<17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: All Participants n=63 participants at risk Participants with age between \>=45 weeks CGA to \<17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Cardiac disorders Cardiac tamponade	0.00% 0/14 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/18 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	5.3% 1/19 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/12 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	1.6% 1/63 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.

Other adverse events

Measure	Dexmedetomidine: >=45 Weeks CGA to <12 Months n=14 participants at risk Participants with age between \>=45 weeks CGA to \<12 months received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=12 Months to <24 Months n=18 participants at risk Participants with age between \>=12 months to \<24 months received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=2 Years to <6 Years n=19 participants at risk Participants with age between \>=2 years to \<6 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: >=6 Years to <17 Years n=12 participants at risk Participants with age between \>=6 years to \<17 years received 0.2 mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.	Dexmedetomidine: All Participants n=63 participants at risk Participants with age between \>=45 weeks CGA to \<17 years received 0.2 microgram per mcg/kg/h of dexmedetomidine infusion for up to 28 days. The infusion rate was adjusted from 0.2 to 1.4 mcg/kg/h as per pediatric participant's sedative state.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.00% 0/14 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/18 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/19 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	8.3% 1/12 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	1.6% 1/63 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/14 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	5.6% 1/18 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	5.3% 1/19 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/12 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	3.2% 2/63 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
Cardiac disorders Bradycardia	42.9% 6/14 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	38.9% 7/18 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	26.3% 5/19 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	16.7% 2/12 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	31.7% 20/63 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/14 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/18 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	5.3% 1/19 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/12 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	1.6% 1/63 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
Gastrointestinal disorders Abdominal pain	0.00% 0/14 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/18 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/19 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	8.3% 1/12 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	1.6% 1/63 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
Gastrointestinal disorders Dry mouth	0.00% 0/14 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/18 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	5.3% 1/19 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/12 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	1.6% 1/63 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
Gastrointestinal disorders Gastric mucosal lesion	0.00% 0/14 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/18 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	5.3% 1/19 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/12 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	1.6% 1/63 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
Gastrointestinal disorders Mouth ulceration	0.00% 0/14 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	5.6% 1/18 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/19 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/12 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	1.6% 1/63 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
Gastrointestinal disorders Vomiting	7.1% 1/14 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	5.6% 1/18 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	10.5% 2/19 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	41.7% 5/12 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	14.3% 9/63 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
General disorders Injection site pain	0.00% 0/14 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/18 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/19 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	8.3% 1/12 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	1.6% 1/63 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
General disorders Pyrexia	7.1% 1/14 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	11.1% 2/18 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	5.3% 1/19 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	16.7% 2/12 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	9.5% 6/63 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
Infections and infestations Pneumonia	0.00% 0/14 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/18 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	5.3% 1/19 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/12 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	1.6% 1/63 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
Gastrointestinal disorders Nausea	0.00% 0/14 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/18 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	10.5% 2/19 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	41.7% 5/12 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	11.1% 7/63 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
Injury, poisoning and procedural complications Postoperative fever	0.00% 0/14 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/18 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	5.3% 1/19 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/12 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	1.6% 1/63 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
Investigations Body temperature increased	7.1% 1/14 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	11.1% 2/18 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/19 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/12 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	4.8% 3/63 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
Investigations Electrocardiogram QT prolonged	0.00% 0/14 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/18 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	5.3% 1/19 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/12 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	1.6% 1/63 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
Metabolism and nutrition disorders Acidosis	0.00% 0/14 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/18 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	5.3% 1/19 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/12 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	1.6% 1/63 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
Nervous system disorders Headache	0.00% 0/14 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/18 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/19 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	8.3% 1/12 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	1.6% 1/63 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
Nervous system disorders Neuralgia	0.00% 0/14 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/18 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/19 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	8.3% 1/12 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	1.6% 1/63 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
Psychiatric disorders Agitation	28.6% 4/14 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	11.1% 2/18 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	5.3% 1/19 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/12 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	11.1% 7/63 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
Renal and urinary disorders Acute kidney injury	0.00% 0/14 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/18 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	5.3% 1/19 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/12 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	1.6% 1/63 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
Respiratory, thoracic and mediastinal disorders Atelectasis	7.1% 1/14 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	5.6% 1/18 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/19 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/12 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	3.2% 2/63 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
Respiratory, thoracic and mediastinal disorders Hypoxia	7.1% 1/14 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/18 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/19 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/12 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	1.6% 1/63 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
Respiratory, thoracic and mediastinal disorders Laryngeal oedema	0.00% 0/14 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	5.6% 1/18 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/19 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/12 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	1.6% 1/63 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/14 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/18 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/19 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	8.3% 1/12 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	1.6% 1/63 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/14 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	5.6% 1/18 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/19 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/12 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	1.6% 1/63 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
Respiratory, thoracic and mediastinal disorders Respiratory depression	14.3% 2/14 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	38.9% 7/18 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	15.8% 3/19 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	41.7% 5/12 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	27.0% 17/63 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
Respiratory, thoracic and mediastinal disorders Respiratory tract oedema	7.1% 1/14 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	5.6% 1/18 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	5.3% 1/19 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/12 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	4.8% 3/63 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/14 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	5.6% 1/18 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/19 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/12 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	1.6% 1/63 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
Skin and subcutaneous tissue disorders Erythema	7.1% 1/14 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/18 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/19 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/12 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	1.6% 1/63 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
Vascular disorders Hypertension	0.00% 0/14 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/18 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	0.00% 0/19 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	8.3% 1/12 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	1.6% 1/63 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
Vascular disorders Hypotension	21.4% 3/14 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	44.4% 8/18 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	57.9% 11/19 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	75.0% 9/12 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.	49.2% 31/63 • Baseline up to 28 days after end of study drug dosing (Day 56) Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.

Additional Information

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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