Trial Outcomes & Findings for Safety and Efficacy of Dexmedetomidine (DEX) for Sedation of Subjects ≥1 Month to <17 Years Undergoing MRI Scans (NCT NCT04237792)
NCT ID: NCT04237792
Last Updated: 2022-11-16
Results Overview
Percentage of participants who did not require PRO to complete MRI scan in the combined age cohorts are reported in this outcome measure.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
128 participants
Primary outcome timeframe
Up to maximum of 3 hours during MRI scan on Day 1
Results posted on
2022-11-16
Participant Flow
Total 141 participants were screened. Out of 141 participants, only 128 participants who met eligibility criteria signed the informed consent document, were enrolled and randomized. Out of 128 randomized participants, 6 participants were not treated.
Pediatric participants were administered with dexmedetomidine (DEX), and with propofol (PRO) as needed, for procedural sedation for magnetic resonance imaging (MRI) scans.
Participant milestones
| Measure |
Low Dose: Age >=1 Month to <2 Years
Day 1: Participants aged \>=1 month to \<2 years, were randomized to receive a loading dose of DEX 0.5 microgram per kilogram (mcg/kg) over 10 minutes as intravenous (IV) infusion followed by continuous maintenance dose of DEX 0.5 mcg/kg/hour IV. If an adequate level of sedation was not achieved, participants were co-administered with PRO IV per physical investigator (PI) clinical judgment. MRI scan started on achieving an adequate sedation level. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours. Treatment PRO first bolus strength would be 500 mcg/kg and then maintenance infusion at 50 mcg/kg/min. Participants were monitored for a minimum of 1 hour after completion of MRI scan. Day 2: Participants were followed up after 24 hours (+/- 2 hours) post discontinuation of DEX. Participants had a long-term follow-up contact via phone call at 28 to 31 days post last administration of study drug.
|
Middle Dose: Age >=1 Month to <2 Years
Day 1: Participants aged \>=1 month to \<2 years, were randomized to receive a loading dose of DEX 1 mcg/kg over 10 minutes as IV infusion followed by continuous maintenance dose of DEX 1 mcg/kg/hour IV. If an adequate level of sedation was not achieved, participants were co-administered with PRO IV per PI clinical judgment. MRI scan started on achieving an adequate sedation level. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours. Treatment PRO first bolus strength would be 500 mcg/kg and then maintenance infusion at 50 mcg/kg/min. Participants were monitored for a minimum of 1 hour after completion of MRI scan. Day 2: Participants were followed up after 24 hours (+/- 2 hours) post discontinuation of DEX. Participants had a long-term follow-up contact via phone call at 28 to 31 days post last administration of study drug.
|
High Dose: Age >=1 Month to <2 Years
Day 1: Participants aged \>=1 month to \<2 years, were randomized to receive a loading dose of DEX 1.5 mcg/kg over 10 minutes as IV infusion followed by continuous maintenance dose of DEX 1.5 mcg/kg/hour IV. If an adequate level of sedation was not achieved, participants were co-administered with PRO IV per PI clinical judgment. MRI scan started on achieving an adequate sedation level. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours. Treatment PRO first bolus strength would be 500 mcg/kg and then maintenance infusion at 50 mcg/kg/min. Participants were monitored for a minimum of 1 hour after completion of MRI scan. Day 2: Participants were followed up after 24 hours (+/- 2 hours) post discontinuation of DEX. Participants had a long-term follow-up contact via phone call at 28 to 31 days post last administration of study drug.
|
Low Dose: Age >=2 Years to <17 Years
Day 1: Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes as IV infusion followed by continuous maintenance dose of DEX 0.5 mcg/kg/hour IV. If an adequate level of sedation was not achieved, participants were co-administered with PRO IV per PI clinical judgment. MRI scan started on achieving an adequate sedation level. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours. Treatment PRO first bolus strength would be 500 mcg/kg and then maintenance infusion at 50 mcg/kg/min. Participants were monitored for a minimum of 1 hour after completion of MRI scan. Day 2: Participants were followed up after 24 hours (+/- 2 hours) post discontinuation of DEX. Participants had a long-term follow-up contact via phone call at 28 to 31 days post last administration of study drug.
|
Middle Dose: Age >=2 Years to <17 Years
Day 1: Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 1.2 mcg/kg over 10 minutes as IV infusion followed by continuous maintenance dose of DEX 1 mcg/kg/hour IV. If an adequate level of sedation was not achieved, participants were co-administered with PRO IV per PI clinical judgment. MRI scan started on achieving an adequate sedation level. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours. Treatment PRO first bolus strength would be 500 mcg/kg and then maintenance infusion at 50 mcg/kg/min. Participants were monitored for a minimum of 1 hour after completion of MRI scan. Day 2: Participants were followed up after 24 hours (+/- 2 hours) post discontinuation of DEX. Participants had a long-term follow-up contact via phone call at 28 to 31 days post last administration of study drug.
|
High Dose: Age >=2 Years to <17 Years
Day 1: Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 2 mcg/kg over 10 minutes as IV infusion followed by continuous maintenance dose of DEX 1.5 mcg/kg/hour IV. If an adequate level of sedation was not achieved, participants were co-administered with PRO IV per PI clinical judgment. MRI scan started on achieving an adequate sedation level. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours. Treatment PRO first bolus strength would be 500 mcg/kg and then maintenance infusion at 50 mcg/kg/min. Participants were monitored for a minimum of 1 hour after completion of MRI scan. Day 2: Participants were followed up after 24 hours (+/- 2 hours) post discontinuation of DEX. Participants had a long-term follow-up contact via phone call at 28 to 31 days post last administration of study drug.
|
|---|---|---|---|---|---|---|
|
Treatment (Day 1)
STARTED
|
21
|
22
|
20
|
23
|
21
|
21
|
|
Treatment (Day 1)
Treated With DEX
|
20
|
21
|
18
|
22
|
21
|
20
|
|
Treatment (Day 1)
COMPLETED
|
19
|
21
|
17
|
22
|
20
|
18
|
|
Treatment (Day 1)
NOT COMPLETED
|
2
|
1
|
3
|
1
|
1
|
3
|
|
MRI Scan (Day 1)
STARTED
|
20
|
21
|
18
|
22
|
21
|
20
|
|
MRI Scan (Day 1)
COMPLETED
|
20
|
21
|
18
|
22
|
21
|
20
|
|
MRI Scan (Day 1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Post MRI Scan Recovery (Day 1)
STARTED
|
20
|
21
|
18
|
22
|
21
|
20
|
|
Post MRI Scan Recovery (Day 1)
COMPLETED
|
20
|
21
|
18
|
22
|
21
|
20
|
|
Post MRI Scan Recovery (Day 1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Follow-up (FU) (Day 2)
STARTED
|
20
|
21
|
18
|
22
|
21
|
20
|
|
Follow-up (FU) (Day 2)
COMPLETED
|
20
|
21
|
18
|
22
|
21
|
20
|
|
Follow-up (FU) (Day 2)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Long Term FU (Any Day From Day 29 to 32)
STARTED
|
20
|
21
|
18
|
22
|
21
|
20
|
|
Long Term FU (Any Day From Day 29 to 32)
COMPLETED
|
20
|
21
|
18
|
22
|
21
|
20
|
|
Long Term FU (Any Day From Day 29 to 32)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Low Dose: Age >=1 Month to <2 Years
Day 1: Participants aged \>=1 month to \<2 years, were randomized to receive a loading dose of DEX 0.5 microgram per kilogram (mcg/kg) over 10 minutes as intravenous (IV) infusion followed by continuous maintenance dose of DEX 0.5 mcg/kg/hour IV. If an adequate level of sedation was not achieved, participants were co-administered with PRO IV per physical investigator (PI) clinical judgment. MRI scan started on achieving an adequate sedation level. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours. Treatment PRO first bolus strength would be 500 mcg/kg and then maintenance infusion at 50 mcg/kg/min. Participants were monitored for a minimum of 1 hour after completion of MRI scan. Day 2: Participants were followed up after 24 hours (+/- 2 hours) post discontinuation of DEX. Participants had a long-term follow-up contact via phone call at 28 to 31 days post last administration of study drug.
|
Middle Dose: Age >=1 Month to <2 Years
Day 1: Participants aged \>=1 month to \<2 years, were randomized to receive a loading dose of DEX 1 mcg/kg over 10 minutes as IV infusion followed by continuous maintenance dose of DEX 1 mcg/kg/hour IV. If an adequate level of sedation was not achieved, participants were co-administered with PRO IV per PI clinical judgment. MRI scan started on achieving an adequate sedation level. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours. Treatment PRO first bolus strength would be 500 mcg/kg and then maintenance infusion at 50 mcg/kg/min. Participants were monitored for a minimum of 1 hour after completion of MRI scan. Day 2: Participants were followed up after 24 hours (+/- 2 hours) post discontinuation of DEX. Participants had a long-term follow-up contact via phone call at 28 to 31 days post last administration of study drug.
|
High Dose: Age >=1 Month to <2 Years
Day 1: Participants aged \>=1 month to \<2 years, were randomized to receive a loading dose of DEX 1.5 mcg/kg over 10 minutes as IV infusion followed by continuous maintenance dose of DEX 1.5 mcg/kg/hour IV. If an adequate level of sedation was not achieved, participants were co-administered with PRO IV per PI clinical judgment. MRI scan started on achieving an adequate sedation level. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours. Treatment PRO first bolus strength would be 500 mcg/kg and then maintenance infusion at 50 mcg/kg/min. Participants were monitored for a minimum of 1 hour after completion of MRI scan. Day 2: Participants were followed up after 24 hours (+/- 2 hours) post discontinuation of DEX. Participants had a long-term follow-up contact via phone call at 28 to 31 days post last administration of study drug.
|
Low Dose: Age >=2 Years to <17 Years
Day 1: Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes as IV infusion followed by continuous maintenance dose of DEX 0.5 mcg/kg/hour IV. If an adequate level of sedation was not achieved, participants were co-administered with PRO IV per PI clinical judgment. MRI scan started on achieving an adequate sedation level. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours. Treatment PRO first bolus strength would be 500 mcg/kg and then maintenance infusion at 50 mcg/kg/min. Participants were monitored for a minimum of 1 hour after completion of MRI scan. Day 2: Participants were followed up after 24 hours (+/- 2 hours) post discontinuation of DEX. Participants had a long-term follow-up contact via phone call at 28 to 31 days post last administration of study drug.
|
Middle Dose: Age >=2 Years to <17 Years
Day 1: Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 1.2 mcg/kg over 10 minutes as IV infusion followed by continuous maintenance dose of DEX 1 mcg/kg/hour IV. If an adequate level of sedation was not achieved, participants were co-administered with PRO IV per PI clinical judgment. MRI scan started on achieving an adequate sedation level. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours. Treatment PRO first bolus strength would be 500 mcg/kg and then maintenance infusion at 50 mcg/kg/min. Participants were monitored for a minimum of 1 hour after completion of MRI scan. Day 2: Participants were followed up after 24 hours (+/- 2 hours) post discontinuation of DEX. Participants had a long-term follow-up contact via phone call at 28 to 31 days post last administration of study drug.
|
High Dose: Age >=2 Years to <17 Years
Day 1: Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 2 mcg/kg over 10 minutes as IV infusion followed by continuous maintenance dose of DEX 1.5 mcg/kg/hour IV. If an adequate level of sedation was not achieved, participants were co-administered with PRO IV per PI clinical judgment. MRI scan started on achieving an adequate sedation level. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours. Treatment PRO first bolus strength would be 500 mcg/kg and then maintenance infusion at 50 mcg/kg/min. Participants were monitored for a minimum of 1 hour after completion of MRI scan. Day 2: Participants were followed up after 24 hours (+/- 2 hours) post discontinuation of DEX. Participants had a long-term follow-up contact via phone call at 28 to 31 days post last administration of study drug.
|
|---|---|---|---|---|---|---|
|
Treatment (Day 1)
Adverse Event
|
1
|
0
|
0
|
0
|
1
|
1
|
|
Treatment (Day 1)
Other
|
0
|
0
|
1
|
0
|
0
|
1
|
|
Treatment (Day 1)
Not treated
|
1
|
1
|
2
|
1
|
0
|
1
|
Baseline Characteristics
Safety and Efficacy of Dexmedetomidine (DEX) for Sedation of Subjects ≥1 Month to <17 Years Undergoing MRI Scans
Baseline characteristics by cohort
| Measure |
Low Dose: Age >=1 Month to <2 Years
n=20 Participants
Day 1: Participants aged \>=1 month to \<2 years, were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes as IV infusion followed by continuous maintenance dose of DEX 0.5 mcg/kg/hour IV. If an adequate level of sedation was not achieved, participants were co-administered with PRO IV per PI clinical judgment. MRI scan started on achieving an adequate sedation level. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours. Treatment PRO first bolus strength would be 500 mcg/kg and then maintenance infusion at 50 mcg/kg/min. Participants were monitored for a minimum of 1 hour after completion of MRI scan. Day 2: Participants were followed up after 24 hours (+/- 2 hours) post discontinuation of DEX. Participants had a long-term follow-up contact via phone call at 28 to 31 days post last administration of study drug.
|
Middle Dose: Age >=1 Month to <2 Years
n=21 Participants
Day 1: Participants aged \>=1 month to \<2 years, were randomized to receive a loading dose of DEX 1 mcg/kg over 10 minutes as IV infusion followed by continuous maintenance dose of DEX 1 mcg/kg/hour IV. If an adequate level of sedation was not achieved, participants were co-administered with PRO IV per PI clinical judgment. MRI scan started on achieving an adequate sedation level. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours. Treatment PRO first bolus strength would be 500 mcg/kg and then maintenance infusion at 50 mcg/kg/min. Participants were monitored for a minimum of 1 hour after completion of MRI scan. Day 2: Participants were followed up after 24 hours (+/- 2 hours) post discontinuation of DEX. Participants had a long-term follow-up contact via phone call at 28 to 31 days post last administration of study drug.
|
High Dose: Age >=1 Month to <2 Years
n=18 Participants
Day 1: Participants aged \>=1 month to \<2 years, were randomized to receive a loading dose of DEX 1.5 mcg/kg over 10 minutes as IV infusion followed by continuous maintenance dose of DEX 1.5 mcg/kg/hour IV. If an adequate level of sedation was not achieved, participants were co-administered with PRO IV per PI clinical judgment. MRI scan started on achieving an adequate sedation level. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours. Treatment PRO first bolus strength would be 500 mcg/kg and then maintenance infusion at 50 mcg/kg/min. Participants were monitored for a minimum of 1 hour after completion of MRI scan. Day 2: Participants were followed up after 24 hours (+/- 2 hours) post discontinuation of DEX. Participants had a long-term follow-up contact via phone call at 28 to 31 days post last administration of study drug.
|
Low Dose: Age >=2 Years to <17 Years
n=22 Participants
Day 1: Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes as IV infusion followed by continuous maintenance dose of DEX 0.5 mcg/kg/hour IV. If an adequate level of sedation was not achieved, participants were co-administered with PRO IV per PI clinical judgment. MRI scan started on achieving an adequate sedation level. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours. Treatment PRO first bolus strength would be 500 mcg/kg and then maintenance infusion at 50 mcg/kg/min. Participants were monitored for a minimum of 1 hour after completion of MRI scan. Day 2: Participants were followed up after 24 hours (+/- 2 hours) post discontinuation of DEX. Participants had a long-term follow-up contact via phone call at 28 to 31 days post last administration of study drug.
|
Middle Dose: Age >=2 Years to <17 Years
n=21 Participants
Day 1: Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 1.2 mcg/kg over 10 minutes as IV infusion followed by continuous maintenance dose of DEX 1 mcg/kg/hour IV. If an adequate level of sedation was not achieved, participants were co-administered with PRO IV per PI clinical judgment. MRI scan started on achieving an adequate sedation level. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours. Treatment PRO first bolus strength would be 500 mcg/kg and then maintenance infusion at 50 mcg/kg/min. Participants were monitored for a minimum of 1 hour after completion of MRI scan. Day 2: Participants were followed up after 24 hours (+/- 2 hours) post discontinuation of DEX. Participants had a long-term follow-up contact via phone call at 28 to 31 days post last administration of study drug.
|
High Dose: Age >=2 Years to <17 Years
n=20 Participants
Day 1: Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 2 mcg/kg over 10 minutes as IV infusion followed by continuous maintenance dose of DEX 1.5 mcg/kg/hour IV. If an adequate level of sedation was not achieved, participants were co-administered with PRO IV per PI clinical judgment. MRI scan started on achieving an adequate sedation level. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours. Treatment PRO first bolus strength would be 500 mcg/kg and then maintenance infusion at 50 mcg/kg/min. Participants were monitored for a minimum of 1 hour after completion of MRI scan. Day 2: Participants were followed up after 24 hours (+/- 2 hours) post discontinuation of DEX. Participants had a long-term follow-up contact via phone call at 28 to 31 days post last administration of study drug.
|
Total
n=122 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
0.99 Years
STANDARD_DEVIATION 0.612 • n=5 Participants
|
0.90 Years
STANDARD_DEVIATION 0.488 • n=7 Participants
|
0.96 Years
STANDARD_DEVIATION 0.384 • n=5 Participants
|
6.68 Years
STANDARD_DEVIATION 2.922 • n=4 Participants
|
7.40 Years
STANDARD_DEVIATION 3.230 • n=21 Participants
|
6.63 Years
STANDARD_DEVIATION 3.277 • n=8 Participants
|
4.02 Years
STANDARD_DEVIATION 3.743 • n=8 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
59 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
63 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
19 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
100 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
41 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
57 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Up to maximum of 3 hours during MRI scan on Day 1Population: FAS included all randomized participants who received any amount of DEX.
Percentage of participants who did not require PRO to complete MRI scan in the combined age cohorts are reported in this outcome measure.
Outcome measures
| Measure |
High Dose: Combined Age
n=38 Participants
Participants aged \>=1 month to \<2 years and \>=2 years to \<17 years were randomized to receive a loading dose of DEX 1.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour and a loading dose of DEX 2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Low Dose: Combined Age
n=42 Participants
Participants aged \>=1 month to \<2 years and \>=2 years to \<17 years were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
High Dose: Age >=2 Years to <17 Years
Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Low Dose: Age >=2 Years to <17 Years
Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Middle Dose: Age >=2 Years to <17 Years
Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 1.2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Low Dose: Age >=2 Years to <17 Years
Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
High Dose: Combined Age
Participants aged \>=1 month to \<2 years and \>=2 years to \<17 years were randomized to receive a loading dose of DEX 1.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour and a loading dose of DEX 2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Middle Dose: Combined Age
Participants aged \>=1 month to \<2 years and \>=2 years to \<17 years were randomized to receive a loading dose of DEX 1 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour and a loading dose of DEX 1.2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Low Dose: Combined Age
Participants aged \>=1 month to \<2 years and \>=2 years to \<17 years were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants at the DEX High Dose Versus Low Dose in the Combined Age Cohorts Who Did Not Require Concomitant PRO to Complete MRI
|
63.2 Percentage of participants
Interval 46.0 to 78.0
|
14.3 Percentage of participants
Interval 5.0 to 29.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to maximum of 3 hours during MRI scan on Day 1Population: FAS included all randomized participants who received any amount of DEX.
Percentage of participants who did not require PRO to complete MRI scan in each age cohort are reported in this outcome measure.
Outcome measures
| Measure |
High Dose: Combined Age
n=18 Participants
Participants aged \>=1 month to \<2 years and \>=2 years to \<17 years were randomized to receive a loading dose of DEX 1.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour and a loading dose of DEX 2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Low Dose: Combined Age
n=20 Participants
Participants aged \>=1 month to \<2 years and \>=2 years to \<17 years were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
High Dose: Age >=2 Years to <17 Years
n=20 Participants
Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Low Dose: Age >=2 Years to <17 Years
n=22 Participants
Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Middle Dose: Age >=2 Years to <17 Years
Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 1.2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Low Dose: Age >=2 Years to <17 Years
Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
High Dose: Combined Age
Participants aged \>=1 month to \<2 years and \>=2 years to \<17 years were randomized to receive a loading dose of DEX 1.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour and a loading dose of DEX 2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Middle Dose: Combined Age
Participants aged \>=1 month to \<2 years and \>=2 years to \<17 years were randomized to receive a loading dose of DEX 1 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour and a loading dose of DEX 1.2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Low Dose: Combined Age
Participants aged \>=1 month to \<2 years and \>=2 years to \<17 years were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants at the DEX High Dose Versus Low Dose in Each Age Cohort Who Did Not Require Concomitant PRO to Complete MRI
|
50.0 Percentage of participants
Interval 26.0 to 74.0
|
15.0 Percentage of participants
Interval 3.0 to 38.0
|
75.0 Percentage of participants
Interval 51.0 to 91.0
|
13.6 Percentage of participants
Interval 3.0 to 35.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to maximum of 3 hours during MRI scan on Day 1Population: FAS included all randomized participants who received any amount of DEX.
Percentage of participants who did not require PRO to complete MRI scan in each age cohort and combined age cohorts are reported in this outcome measure.
Outcome measures
| Measure |
High Dose: Combined Age
n=18 Participants
Participants aged \>=1 month to \<2 years and \>=2 years to \<17 years were randomized to receive a loading dose of DEX 1.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour and a loading dose of DEX 2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Low Dose: Combined Age
n=21 Participants
Participants aged \>=1 month to \<2 years and \>=2 years to \<17 years were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
High Dose: Age >=2 Years to <17 Years
n=20 Participants
Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Low Dose: Age >=2 Years to <17 Years
n=20 Participants
Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Middle Dose: Age >=2 Years to <17 Years
n=21 Participants
Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 1.2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Low Dose: Age >=2 Years to <17 Years
n=22 Participants
Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
High Dose: Combined Age
n=38 Participants
Participants aged \>=1 month to \<2 years and \>=2 years to \<17 years were randomized to receive a loading dose of DEX 1.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour and a loading dose of DEX 2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Middle Dose: Combined Age
n=42 Participants
Participants aged \>=1 month to \<2 years and \>=2 years to \<17 years were randomized to receive a loading dose of DEX 1 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour and a loading dose of DEX 1.2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Low Dose: Combined Age
n=42 Participants
Participants aged \>=1 month to \<2 years and \>=2 years to \<17 years were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants at the DEX Middle Dose vs Low Dose and High Dose vs Middle Dose in Each Age Cohort and Combined Age Cohorts Who Did Not Require Concomitant PRO to Complete MRI
|
50.0 Percentage of participants
|
9.5 Percentage of participants
|
15.0 Percentage of participants
|
75.0 Percentage of participants
|
61.9 Percentage of participants
|
13.6 Percentage of participants
|
63.2 Percentage of participants
|
35.7 Percentage of participants
|
14.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to maximum of 3 hours during MRI scan on Day 1Population: FAS included all randomized participants who received any amount of DEX. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
In this outcome measure percentage of time for which participant had maintained PSSS score of 2 was reported. PSSS score ranges from 0 to 5, where 0= sedation with abnormal physiologic parameters requiring acute intervention, 1= sedation with normal vital signs, but requiring airway intervention, 2= no movement during procedure, no frown, no verbalization of complaint indicating no pain and anxiety, 3= no movement during procedure but expression of pain and anxiety on face, verbalization of complaint, requiring help positioning, 4= movement during procedure requiring gentle immobilization for positioning, verbalization of some discomfort or stress, but no crying or shouting that expresses stress or objection, 5= movement impeding proceduralist and requiring forceful immobilization, crying or shouting during procedure, but vocalization not required. Higher score indicated less sedation.
Outcome measures
| Measure |
High Dose: Combined Age
n=20 Participants
Participants aged \>=1 month to \<2 years and \>=2 years to \<17 years were randomized to receive a loading dose of DEX 1.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour and a loading dose of DEX 2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Low Dose: Combined Age
n=21 Participants
Participants aged \>=1 month to \<2 years and \>=2 years to \<17 years were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
High Dose: Age >=2 Years to <17 Years
n=18 Participants
Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Low Dose: Age >=2 Years to <17 Years
n=22 Participants
Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Middle Dose: Age >=2 Years to <17 Years
n=20 Participants
Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 1.2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Low Dose: Age >=2 Years to <17 Years
n=20 Participants
Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
High Dose: Combined Age
n=42 Participants
Participants aged \>=1 month to \<2 years and \>=2 years to \<17 years were randomized to receive a loading dose of DEX 1.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour and a loading dose of DEX 2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Middle Dose: Combined Age
n=41 Participants
Participants aged \>=1 month to \<2 years and \>=2 years to \<17 years were randomized to receive a loading dose of DEX 1 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour and a loading dose of DEX 1.2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Low Dose: Combined Age
n=38 Participants
Participants aged \>=1 month to \<2 years and \>=2 years to \<17 years were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Time at Target Pediatric Sedation State Scale (PSSS) Score of 2 After the Administration of the DEX Loading Dose and During the DEX Maintenance Infusion - By Age Cohort and Combined Age
|
77.5 Percentage of time
Standard Deviation 15.94
|
82.5 Percentage of time
Standard Deviation 12.04
|
87.8 Percentage of time
Standard Deviation 23.93
|
76.8 Percentage of time
Standard Deviation 18.36
|
92.2 Percentage of time
Standard Deviation 9.72
|
94.1 Percentage of time
Standard Deviation 12.22
|
77.2 Percentage of time
Standard Deviation 17.04
|
87.2 Percentage of time
Standard Deviation 11.88
|
91.1 Percentage of time
Standard Deviation 18.71
|
SECONDARY outcome
Timeframe: Up to maximum of 3 hours during MRI scan on Day 1Population: FAS included all randomized participants who received any amount of DEX.
Participants who did not have PRO administered were censored.
Outcome measures
| Measure |
High Dose: Combined Age
n=20 Participants
Participants aged \>=1 month to \<2 years and \>=2 years to \<17 years were randomized to receive a loading dose of DEX 1.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour and a loading dose of DEX 2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Low Dose: Combined Age
n=21 Participants
Participants aged \>=1 month to \<2 years and \>=2 years to \<17 years were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
High Dose: Age >=2 Years to <17 Years
n=18 Participants
Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Low Dose: Age >=2 Years to <17 Years
n=22 Participants
Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Middle Dose: Age >=2 Years to <17 Years
n=21 Participants
Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 1.2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Low Dose: Age >=2 Years to <17 Years
n=20 Participants
Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
High Dose: Combined Age
n=42 Participants
Participants aged \>=1 month to \<2 years and \>=2 years to \<17 years were randomized to receive a loading dose of DEX 1.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour and a loading dose of DEX 2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Middle Dose: Combined Age
n=42 Participants
Participants aged \>=1 month to \<2 years and \>=2 years to \<17 years were randomized to receive a loading dose of DEX 1 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour and a loading dose of DEX 1.2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Low Dose: Combined Age
n=38 Participants
Participants aged \>=1 month to \<2 years and \>=2 years to \<17 years were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
|---|---|---|---|---|---|---|---|---|---|
|
Time From the Start of DEX Loading Dose Infusion to the Time of First PRO Bolus Infusion - By Age Cohort and Combined Age
|
16.0 Minutes
Interval 15.0 to 21.0
|
17.0 Minutes
Interval 16.0 to 25.0
|
62.0 Minutes
Interval 19.0 to
Upper value of 95 % confidence interval (CI) could not be estimated due to less number of participants with event.
|
16.5 Minutes
Interval 15.0 to 25.0
|
NA Minutes
Interval 31.0 to
Median and upper value of 95 % CI could not be estimated due to less number of participants with event.
|
NA Minutes
Interval 72.0 to
Median and upper value of 95 % CI could not be estimated due to less number of participants with event.
|
16.0 Minutes
Interval 15.0 to 20.0
|
31.5 Minutes
Interval 17.0 to 64.0
|
NA Minutes
Interval 45.0 to
Median and upper value of 95 % CI could not be estimated due to less number of participants with event.
|
SECONDARY outcome
Timeframe: Post MRI scan on Day 1 up to 24 hoursPopulation: FAS included all randomized participants who received any amount of DEX.
Emergence time: time from the end of the MRI scan to when the participant met a Modified Aldrete score \>=9. Participants who were withdrawn or discharged without reaching a Modified Aldrete score \>=9, were censored, time computed from end of MRI scan to time of the last clinical assessment (vital signs). Zero minute was used as the censored time if no vital signs were taken during the post-MRI recovery period. Modified Aldrete score: validated observational medical scoring system that allowed verbal prompts for the measurement of recovery after anesthesia (post anesthesia) which included items: activity, respiration, circulation, consciousness, and oxygenation. Each item was scored from 0 to 2, higher scores signified better recovery. The scores of each item were summed to obtain a total score of 0 to 10, where higher scores indicated well recovered participant post anesthesia.
Outcome measures
| Measure |
High Dose: Combined Age
n=20 Participants
Participants aged \>=1 month to \<2 years and \>=2 years to \<17 years were randomized to receive a loading dose of DEX 1.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour and a loading dose of DEX 2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Low Dose: Combined Age
n=21 Participants
Participants aged \>=1 month to \<2 years and \>=2 years to \<17 years were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
High Dose: Age >=2 Years to <17 Years
n=18 Participants
Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Low Dose: Age >=2 Years to <17 Years
n=22 Participants
Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Middle Dose: Age >=2 Years to <17 Years
n=21 Participants
Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 1.2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Low Dose: Age >=2 Years to <17 Years
n=20 Participants
Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
High Dose: Combined Age
n=42 Participants
Participants aged \>=1 month to \<2 years and \>=2 years to \<17 years were randomized to receive a loading dose of DEX 1.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour and a loading dose of DEX 2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Middle Dose: Combined Age
n=42 Participants
Participants aged \>=1 month to \<2 years and \>=2 years to \<17 years were randomized to receive a loading dose of DEX 1 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour and a loading dose of DEX 1.2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Low Dose: Combined Age
n=38 Participants
Participants aged \>=1 month to \<2 years and \>=2 years to \<17 years were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
|---|---|---|---|---|---|---|---|---|---|
|
Emergence Time - By Age Cohort and Combined Age
|
30.0 Minutes
Interval 6.0 to 59.0
|
41.0 Minutes
Interval 34.0 to 54.0
|
38.0 Minutes
Interval 12.0 to 51.0
|
35.0 Minutes
Interval 21.0 to 49.0
|
46.0 Minutes
Interval 25.0 to 64.0
|
50.0 Minutes
Interval 35.0 to 62.0
|
35.0 Minutes
Interval 21.0 to 41.0
|
42.5 Minutes
Interval 35.0 to 52.0
|
45.5 Minutes
Interval 35.0 to 54.0
|
SECONDARY outcome
Timeframe: Up to maximum of 3 hours during MRI scan on Day 1Population: FAS included all randomized participants who received any amount of DEX.
Outcome measures
| Measure |
High Dose: Combined Age
n=20 Participants
Participants aged \>=1 month to \<2 years and \>=2 years to \<17 years were randomized to receive a loading dose of DEX 1.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour and a loading dose of DEX 2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Low Dose: Combined Age
n=21 Participants
Participants aged \>=1 month to \<2 years and \>=2 years to \<17 years were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
High Dose: Age >=2 Years to <17 Years
n=18 Participants
Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Low Dose: Age >=2 Years to <17 Years
n=22 Participants
Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Middle Dose: Age >=2 Years to <17 Years
n=21 Participants
Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 1.2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Low Dose: Age >=2 Years to <17 Years
n=20 Participants
Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
High Dose: Combined Age
n=42 Participants
Participants aged \>=1 month to \<2 years and \>=2 years to \<17 years were randomized to receive a loading dose of DEX 1.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour and a loading dose of DEX 2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Middle Dose: Combined Age
n=42 Participants
Participants aged \>=1 month to \<2 years and \>=2 years to \<17 years were randomized to receive a loading dose of DEX 1 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour and a loading dose of DEX 1.2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Low Dose: Combined Age
n=38 Participants
Participants aged \>=1 month to \<2 years and \>=2 years to \<17 years were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Received PRO - By Age Cohort and Combined Age
|
17 Participants
|
19 Participants
|
9 Participants
|
19 Participants
|
8 Participants
|
5 Participants
|
36 Participants
|
27 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Up to maximum of 3 hours during MRI scan on Day 1Population: FAS included all randomized participants who received any amount of DEX. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Outcome measures
| Measure |
High Dose: Combined Age
n=17 Participants
Participants aged \>=1 month to \<2 years and \>=2 years to \<17 years were randomized to receive a loading dose of DEX 1.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour and a loading dose of DEX 2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Low Dose: Combined Age
n=19 Participants
Participants aged \>=1 month to \<2 years and \>=2 years to \<17 years were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
High Dose: Age >=2 Years to <17 Years
n=9 Participants
Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Low Dose: Age >=2 Years to <17 Years
n=19 Participants
Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Middle Dose: Age >=2 Years to <17 Years
n=8 Participants
Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 1.2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Low Dose: Age >=2 Years to <17 Years
n=5 Participants
Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
High Dose: Combined Age
n=36 Participants
Participants aged \>=1 month to \<2 years and \>=2 years to \<17 years were randomized to receive a loading dose of DEX 1.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour and a loading dose of DEX 2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Middle Dose: Combined Age
n=27 Participants
Participants aged \>=1 month to \<2 years and \>=2 years to \<17 years were randomized to receive a loading dose of DEX 1 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour and a loading dose of DEX 1.2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Low Dose: Combined Age
n=14 Participants
Participants aged \>=1 month to \<2 years and \>=2 years to \<17 years were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
|---|---|---|---|---|---|---|---|---|---|
|
Total Amount (mcg Per kg) of Concomitant PRO Required to Successfully Complete MRI - By Age Cohort and Combined Age
|
4012.1 mcg per kg
Standard Deviation 2334.66
|
4730.3 mcg per kg
Standard Deviation 3398.21
|
2822.8 mcg per kg
Standard Deviation 1593.84
|
5559.2 mcg per kg
Standard Deviation 4038.95
|
5001.9 mcg per kg
Standard Deviation 4093.70
|
4513.0 mcg per kg
Standard Deviation 4620.56
|
4828.6 mcg per kg
Standard Deviation 3390.42
|
4810.7 mcg per kg
Standard Deviation 3538.71
|
3426.4 mcg per kg
Standard Deviation 2973.00
|
SECONDARY outcome
Timeframe: Up to maximum of 3 hours during MRI scan on Day 1Population: FAS included all randomized participants who received any amount of DEX. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Outcome measures
| Measure |
High Dose: Combined Age
n=17 Participants
Participants aged \>=1 month to \<2 years and \>=2 years to \<17 years were randomized to receive a loading dose of DEX 1.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour and a loading dose of DEX 2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Low Dose: Combined Age
n=19 Participants
Participants aged \>=1 month to \<2 years and \>=2 years to \<17 years were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
High Dose: Age >=2 Years to <17 Years
n=9 Participants
Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Low Dose: Age >=2 Years to <17 Years
n=19 Participants
Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Middle Dose: Age >=2 Years to <17 Years
n=7 Participants
Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 1.2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Low Dose: Age >=2 Years to <17 Years
n=4 Participants
Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
High Dose: Combined Age
n=36 Participants
Participants aged \>=1 month to \<2 years and \>=2 years to \<17 years were randomized to receive a loading dose of DEX 1.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour and a loading dose of DEX 2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Middle Dose: Combined Age
n=26 Participants
Participants aged \>=1 month to \<2 years and \>=2 years to \<17 years were randomized to receive a loading dose of DEX 1 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour and a loading dose of DEX 1.2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Low Dose: Combined Age
n=13 Participants
Participants aged \>=1 month to \<2 years and \>=2 years to \<17 years were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour respectively. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
|---|---|---|---|---|---|---|---|---|---|
|
Body Weight/Time Adjusted Total Amount (Per kg Per Minute) of Concomitant PRO Required to Successfully Complete MRI - By Age Cohort and Combined Age
|
59.43 mcg per kg per minute
Standard Deviation 18.625
|
71.38 mcg per kg per minute
Standard Deviation 32.895
|
47.41 mcg per kg per minute
Standard Deviation 14.454
|
81.28 mcg per kg per minute
Standard Deviation 38.406
|
74.70 mcg per kg per minute
Standard Deviation 24.487
|
76.36 mcg per kg per minute
Standard Deviation 47.656
|
70.96 mcg per kg per minute
Standard Deviation 32.243
|
72.28 mcg per kg per minute
Standard Deviation 30.418
|
56.31 mcg per kg per minute
Standard Deviation 30.007
|
Adverse Events
Low Dose: Age >=1 Month to <2 Years
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Middle Dose: Age >=1 Month to <2 Years
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
High Dose: Age >=1 Month to <2 Years
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Combined Dose: Age >=1 Month to <2 Years
Serious events: 0 serious events
Other events: 56 other events
Deaths: 0 deaths
Low Dose: Age >=2 Years to <17 Years
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Middle Dose: Age >=2 Years to <17 Years
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
High Dose: Age >=2 Years to <17 Years
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Combined Dose: Age >=2 Years to <17 Years
Serious events: 1 serious events
Other events: 57 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Low Dose: Age >=1 Month to <2 Years
n=20 participants at risk
Participants aged \>=1 month to \< 2 years, were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Middle Dose: Age >=1 Month to <2 Years
n=21 participants at risk
Participants aged \>=1 month to \< 2 years, were randomized to receive a loading dose of DEX 1 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
High Dose: Age >=1 Month to <2 Years
n=18 participants at risk
Participants aged \>=1 month to \< 2 years, were randomized to receive a loading dose of DEX 1.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Combined Dose: Age >=1 Month to <2 Years
n=59 participants at risk
Participants were randomized to receive a loading dose of DEX 0.5 mcg/kg (low dose), 1 mcg/kg (middle dose), and 1.5 mcg/kg (high dose) over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour (low dose), 1 mcg/kg/hour (middle dose), and 1.5 mcg/kg/hour (high dose).
|
Low Dose: Age >=2 Years to <17 Years
n=22 participants at risk
Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Middle Dose: Age >=2 Years to <17 Years
n=21 participants at risk
Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 1.2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
High Dose: Age >=2 Years to <17 Years
n=20 participants at risk
Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Combined Dose: Age >=2 Years to <17 Years
n=63 participants at risk
Participants were randomized to receive a loading dose of DEX 0.5 mcg/kg (low dose), 1.2 mcg/kg (middle dose), and 2 mcg/kg (high dose) over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour (low dose), 1 mcg/kg/hour (middle dose), and 1.5 mcg/kg/hour (high dose).
|
|---|---|---|---|---|---|---|---|---|
|
Vascular disorders
Hypertension
|
0.00%
0/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/18 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/59 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/22 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
5.0%
1/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
1.6%
1/63 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
Other adverse events
| Measure |
Low Dose: Age >=1 Month to <2 Years
n=20 participants at risk
Participants aged \>=1 month to \< 2 years, were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Middle Dose: Age >=1 Month to <2 Years
n=21 participants at risk
Participants aged \>=1 month to \< 2 years, were randomized to receive a loading dose of DEX 1 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
High Dose: Age >=1 Month to <2 Years
n=18 participants at risk
Participants aged \>=1 month to \< 2 years, were randomized to receive a loading dose of DEX 1.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Combined Dose: Age >=1 Month to <2 Years
n=59 participants at risk
Participants were randomized to receive a loading dose of DEX 0.5 mcg/kg (low dose), 1 mcg/kg (middle dose), and 1.5 mcg/kg (high dose) over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour (low dose), 1 mcg/kg/hour (middle dose), and 1.5 mcg/kg/hour (high dose).
|
Low Dose: Age >=2 Years to <17 Years
n=22 participants at risk
Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 0.5 mcg/kg over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Middle Dose: Age >=2 Years to <17 Years
n=21 participants at risk
Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 1.2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
High Dose: Age >=2 Years to <17 Years
n=20 participants at risk
Participants aged \>=2 years to \<17 years, were randomized to receive a loading dose of DEX 2 mcg/kg over 10 minutes followed by maintenance dose of DEX 1.5 mcg/kg/hour. If adequate sedation was not achieved PRO was co-administered. DEX and PRO (if needed) continued till completion of MRI scan. MRI scan was expected to complete in not more than 3 hours.
|
Combined Dose: Age >=2 Years to <17 Years
n=63 participants at risk
Participants were randomized to receive a loading dose of DEX 0.5 mcg/kg (low dose), 1.2 mcg/kg (middle dose), and 2 mcg/kg (high dose) over 10 minutes followed by maintenance dose of DEX 0.5 mcg/kg/hour (low dose), 1 mcg/kg/hour (middle dose), and 1.5 mcg/kg/hour (high dose).
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Bradycardia
|
45.0%
9/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
57.1%
12/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
72.2%
13/18 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
57.6%
34/59 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
68.2%
15/22 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
57.1%
12/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
70.0%
14/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
65.1%
41/63 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
|
Cardiac disorders
Rebound tachycardia
|
0.00%
0/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/18 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/59 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/22 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
5.0%
1/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
1.6%
1/63 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
|
Cardiac disorders
Sinus arrhythmia
|
0.00%
0/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
5.6%
1/18 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
1.7%
1/59 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/22 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/63 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
|
Cardiac disorders
Tachycardia
|
10.0%
2/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
4.8%
1/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/18 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
5.1%
3/59 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
4.5%
1/22 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
5.0%
1/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
3.2%
2/63 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
|
Congenital, familial and genetic disorders
Arnold-Chiari malformation
|
0.00%
0/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/18 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/59 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/22 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
5.0%
1/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
1.6%
1/63 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
|
Congenital, familial and genetic disorders
Syringomyelia
|
0.00%
0/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/18 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/59 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/22 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
5.0%
1/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
1.6%
1/63 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/18 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/59 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/22 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
4.8%
1/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
1.6%
1/63 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/18 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/59 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/22 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
4.8%
1/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
5.0%
1/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
3.2%
2/63 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
1/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/18 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
1.7%
1/59 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/22 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
4.8%
1/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
1.6%
1/63 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
1/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/18 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
1.7%
1/59 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
4.5%
1/22 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
1.6%
1/63 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
|
Injury, poisoning and procedural complications
Anaesthetic complication neurological
|
0.00%
0/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
5.6%
1/18 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
1.7%
1/59 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/22 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
4.8%
1/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
1.6%
1/63 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
5.6%
1/18 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
1.7%
1/59 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/22 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/63 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
|
Investigations
Blood pressure increased
|
0.00%
0/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/18 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/59 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
4.5%
1/22 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
1.6%
1/63 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
|
Nervous system disorders
Seizure
|
0.00%
0/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/18 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/59 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
4.5%
1/22 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
1.6%
1/63 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/18 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/59 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/22 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
5.0%
1/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
1.6%
1/63 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Bradypnoea
|
95.0%
19/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
76.2%
16/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
66.7%
12/18 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
79.7%
47/59 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
63.6%
14/22 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
52.4%
11/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
50.0%
10/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
55.6%
35/63 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
15.0%
3/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
14.3%
3/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/18 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
10.2%
6/59 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
13.6%
3/22 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
5.0%
1/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
6.3%
4/63 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
5.0%
1/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/18 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
1.7%
1/59 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/22 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/63 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/18 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/59 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
4.5%
1/22 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
1.6%
1/63 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
|
Vascular disorders
Diastolic hypertension
|
5.0%
1/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
14.3%
3/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
16.7%
3/18 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
11.9%
7/59 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
9.1%
2/22 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
5.0%
1/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
4.8%
3/63 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
|
Vascular disorders
Diastolic hypotension
|
5.0%
1/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/18 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
1.7%
1/59 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/22 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
4.8%
1/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
1.6%
1/63 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
|
Vascular disorders
Hypertension
|
45.0%
9/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
57.1%
12/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
50.0%
9/18 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
50.8%
30/59 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
9.1%
2/22 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
23.8%
5/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
40.0%
8/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
23.8%
15/63 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
|
Vascular disorders
Hypotension
|
45.0%
9/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
28.6%
6/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
16.7%
3/18 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
30.5%
18/59 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
18.2%
4/22 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
23.8%
5/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
15.0%
3/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
19.0%
12/63 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
|
Vascular disorders
Systolic hypertension
|
0.00%
0/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
14.3%
3/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
5.6%
1/18 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
6.8%
4/59 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
4.5%
1/22 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
9.5%
2/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
10.0%
2/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
7.9%
5/63 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
|
Vascular disorders
Withdrawal hypertension
|
0.00%
0/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/18 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/59 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/22 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
0.00%
0/21 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
5.0%
1/20 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
1.6%
1/63 • Day 1 up to maximum of 31 days after last dose of study drug (up to maximum of 32 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set consisted of all randomized participants who received any amount of DEX. Safety data was presented by dose level, overall (combined two age cohorts) and within each age cohort.
|
Additional Information
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