Trial Outcomes & Findings for A Pharmacokinetics Study of MK-7655A in Pediatric Participants With Gram-negative Infections (MK-7655A-020) (NCT NCT03230916)
NCT ID: NCT03230916
Last Updated: 2024-02-06
Results Overview
Area under the concentration time curve from time 0 to infinity (AUC0-∞) of plasma imipenem (IMI) was calculated. AUC0-∞ is the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
47 participants
Primary outcome timeframe
30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5
Results posted on
2024-02-06
Participant Flow
Note: Participant information is shown by age cohort and drug dosage to provide clinically-similar groups for analysis of participant baseline characteristics and safety data. Participant information in pharmacokinetic (PK) outcome measures is shown by age cohort, drug dose received and infusion time in order to provide appropriate and clinically discrete groups for PK analysis and modeling.
Participant milestones
| Measure |
Cohort 1: IMI/REL 15/7.5 mg/kg
Adolescents (age 12 to \<18 years) administered with a single intravenous (IV) 30-minute infusion dose of imipenem/cilastatin/relebactam (IMI/REL) at 15/7.5 mg/kg, up to maximum dose of 500/250 mg
|
Cohort 2: IMI/REL 15/7.5 mg/kg
Older children (6 to \<12 years) administered with a single IV 30-minute or 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg, up to a maximum dose of 500/250 mg
|
Cohort 3: IMI/REL 15/7.5 mg/kg
Younger children (2 to \<6 years) administered with a single IV 30-minute or 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 4: IMI/REL 10/5 mg/kg
Infants (3 months to \<1 year) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
|
Cohort 4: IMI/REL 15/7.5 mg/kg
Toddlers (1 to \<2 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 5: Subcohort 1: IMI/REL 10/5 mg/kg
Young infants (4 weeks to \<3 months of age) administered with a single IV 60-minute dose of IMI/REL at 10/5 mg/kg
|
Cohort 5: Subcohort 2: IMI/REL 10/5 mg/kg
Older neonates (1 to \<4 weeks of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
|
Cohort 5: Subcohort 3: IMI/REL 10/5 mg/kg
Younger neonates (\<1 week of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
|
Cohort 5: Subcohort 1: IMI/REL 15/7.5 mg/kg
Young infants (4 weeks to \<3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 5: Subcohort 2: IMI/REL 15/7.5 mg/kg
Older neonates (1 to \<4 weeks of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 5: Subcohort 3: IMI/REL 15/7.5 mg/kg
Younger neonates (\<1 week of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
6
|
4
|
4
|
6
|
3
|
2
|
2
|
3
|
4
|
|
Overall Study
Treated
|
7
|
6
|
6
|
4
|
4
|
5
|
3
|
2
|
2
|
3
|
4
|
|
Overall Study
COMPLETED
|
7
|
6
|
6
|
4
|
4
|
5
|
3
|
2
|
2
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1: IMI/REL 15/7.5 mg/kg
Adolescents (age 12 to \<18 years) administered with a single intravenous (IV) 30-minute infusion dose of imipenem/cilastatin/relebactam (IMI/REL) at 15/7.5 mg/kg, up to maximum dose of 500/250 mg
|
Cohort 2: IMI/REL 15/7.5 mg/kg
Older children (6 to \<12 years) administered with a single IV 30-minute or 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg, up to a maximum dose of 500/250 mg
|
Cohort 3: IMI/REL 15/7.5 mg/kg
Younger children (2 to \<6 years) administered with a single IV 30-minute or 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 4: IMI/REL 10/5 mg/kg
Infants (3 months to \<1 year) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
|
Cohort 4: IMI/REL 15/7.5 mg/kg
Toddlers (1 to \<2 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 5: Subcohort 1: IMI/REL 10/5 mg/kg
Young infants (4 weeks to \<3 months of age) administered with a single IV 60-minute dose of IMI/REL at 10/5 mg/kg
|
Cohort 5: Subcohort 2: IMI/REL 10/5 mg/kg
Older neonates (1 to \<4 weeks of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
|
Cohort 5: Subcohort 3: IMI/REL 10/5 mg/kg
Younger neonates (\<1 week of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
|
Cohort 5: Subcohort 1: IMI/REL 15/7.5 mg/kg
Young infants (4 weeks to \<3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 5: Subcohort 2: IMI/REL 15/7.5 mg/kg
Older neonates (1 to \<4 weeks of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 5: Subcohort 3: IMI/REL 15/7.5 mg/kg
Younger neonates (\<1 week of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Pharmacokinetics Study of MK-7655A in Pediatric Participants With Gram-negative Infections (MK-7655A-020)
Baseline characteristics by cohort
| Measure |
Cohort 1: IMI/REL 15/7.5 mg/kg
n=7 Participants
Adolescents (age 12 to \<18 years) administered with a single intravenous (IV) 30-minute infusion dose of imipenem/cilastatin/relebactam (IMI/REL) at 15/7.5 mg/kg, up to maximum dose of 500/250 mg
|
Cohort 2: IMI/REL 15/7.5 mg/kg
n=6 Participants
Older children (6 to \<12 years) administered with a single IV 30-minute or 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg, up to a maximum dose of 500/250 mg
|
Cohort 3: IMI/REL 15/7.5 mg/kg
n=6 Participants
Younger children (2 to \<6 years) administered with a single IV 30-minute or 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 4: IMI/REL 10/5 mg/kg
n=4 Participants
Infants (3 months to \<1 year) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
|
Cohort 4: IMI/REL 15/7.5 mg/kg
n=4 Participants
Toddlers (1 to \<2 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 5: Subcohort 1: IMI/REL 10/5 mg/kg
n=6 Participants
Young infants (4 weeks to \<3 months of age) administered with a single IV 60-minute dose of IMI/REL at 10/5 mg/kg
|
Cohort 5: Subcohort 2: IMI/REL 10/5 mg/kg
n=3 Participants
Older neonates (1 to \<4 weeks of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
|
Cohort 5: Subcohort 3: IMI/REL 10/5 mg/kg
n=2 Participants
Younger neonates (\<1 week of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
|
Cohort 5: Subcohort 1: IMI/REL 15/7.5 mg/kg
n=2 Participants
Young infants (4 weeks to \<3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 5: Subcohort 2: IMI/REL 15/7.5 mg/kg
n=3 Participants
Older neonates (1 to \<4 weeks of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 5: Subcohort 3: IMI/REL 15/7.5 mg/kg
n=4 Participants
Younger neonates (\<1 week of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
39 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Age, Customized
In utero
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Age, Customized
Preterm newborn infants (gestational age < 37 wks)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Age, Customized
Newborns (0-27 days)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
|
Age, Customized
Infants and toddlers (28 days-23 months)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
16 Participants
n=42 Participants
|
|
Age, Customized
Children (2-11 years)
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
|
Age, Customized
Adolescents (12-17 years)
|
7 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
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
|
Age, Customized
Adults (18-64 years)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Age, Customized
From 65-84 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Age, Customized
85 years and over
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
28 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
19 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
37 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5Population: All allocated participants who were compliant with the protocol and had at least 1 post-dose pharmacokinetic (PK) data point available for IMI AUC0-∞
Area under the concentration time curve from time 0 to infinity (AUC0-∞) of plasma imipenem (IMI) was calculated. AUC0-∞ is the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time.
Outcome measures
| Measure |
Cohort 5: IMI/REL 10/5 mg/kg 60-minute Infusion
n=6 Participants
Neonates to infants (birth to \<3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
|
Cohort 5: IMI/REL 15/7.5 mg/kg 60-minute Infusion
n=9 Participants
Neonates to infants (birth to \<3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 1: IMI/REL 500/250 mg 30-minute Infusion
n=6 Participants
Adolescents (age 12 to \<18 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg
|
Cohort 2: IMI/REL 15/7.5 mg/kg 30-minute Infusion
n=1 Participants
Older children (6 to \<12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 2: IMI/REL 15/7.5 mg/kg mg 60-minute Infusion
n=2 Participants
Older children (6 to \<12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 2: IMI/REL 500/250 mg 30-minute Infusion
n=2 Participants
Older children (6 to \<12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg
|
Cohort 2: IMI/REL 500/250 mg 60-minute Infusion
n=1 Participants
Older children (6 to \<12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 500/250 mg
|
Cohort 3: IMI/REL 15/7.5 mg/kg 30-minute Infusion
n=3 Participants
Younger children (2 to \<6 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 3: IMI/REL 15/7.5 mg/kg 60-minute Infusion
n=3 Participants
Younger children (2 to \<6 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 4: IMI/REL 10/5 mg/kg 60-minute Infusion
n=4 Participants
Infants (3 months to \<1 year) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
|
Cohort 4: IMI/REL 15/7.5 mg/kg 60-minute Infusion
n=4 Participants
Toddlers (1 to 2 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Imipenem (IMI) Area Under the Concentration Time Curve From Time 0 to Infinity (AUC0-∞)
|
152.5 μM*hr
Geometric Coefficient of Variation 14.1
|
271.3 μM*hr
Geometric Coefficient of Variation 15.4
|
134.7 μM*hr
Geometric Coefficient of Variation 19.8
|
153.2 μM*hr
Geometric Coefficient of Variation NA
NA=not calculated
|
219.4 μM*hr
Geometric Coefficient of Variation 39.2
|
139.4 μM*hr
Geometric Coefficient of Variation 26.6
|
140 μM*hr
Geometric Coefficient of Variation NA
NA=not calculated
|
156 μM*hr
Geometric Coefficient of Variation 18.9
|
163 μM*hr
Geometric Coefficient of Variation 31.2
|
95.4 μM*hr
Geometric Coefficient of Variation 39.3
|
219.2 μM*hr
Geometric Coefficient of Variation 39.6
|
PRIMARY outcome
Timeframe: 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5Population: All allocated participants who were compliant with the protocol and had at least 1 post-dose pharmacokinetic (PK) data point available for IMI Cmax
Maximum plasma concentration (Cmax) of IMI was calculated. Cmax is the peak plasma concentration of study drug after administration.
Outcome measures
| Measure |
Cohort 5: IMI/REL 10/5 mg/kg 60-minute Infusion
n=6 Participants
Neonates to infants (birth to \<3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
|
Cohort 5: IMI/REL 15/7.5 mg/kg 60-minute Infusion
n=9 Participants
Neonates to infants (birth to \<3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 1: IMI/REL 500/250 mg 30-minute Infusion
n=6 Participants
Adolescents (age 12 to \<18 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg
|
Cohort 2: IMI/REL 15/7.5 mg/kg 30-minute Infusion
n=1 Participants
Older children (6 to \<12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 2: IMI/REL 15/7.5 mg/kg mg 60-minute Infusion
n=2 Participants
Older children (6 to \<12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 2: IMI/REL 500/250 mg 30-minute Infusion
n=2 Participants
Older children (6 to \<12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg
|
Cohort 2: IMI/REL 500/250 mg 60-minute Infusion
n=1 Participants
Older children (6 to \<12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 500/250 mg
|
Cohort 3: IMI/REL 15/7.5 mg/kg 30-minute Infusion
n=3 Participants
Younger children (2 to \<6 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 3: IMI/REL 15/7.5 mg/kg 60-minute Infusion
n=3 Participants
Younger children (2 to \<6 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 4: IMI/REL 10/5 mg/kg 60-minute Infusion
n=4 Participants
Infants (3 months to \<1 year) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
|
Cohort 4: IMI/REL 15/7.5 mg/kg 60-minute Infusion
n=4 Participants
Toddlers (1 to 2 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
IMI Maximum Concentration (Cmax)
|
79.4 μM
Geometric Coefficient of Variation 26.4
|
119.8 μM
Geometric Coefficient of Variation 16.8
|
107.6 μM
Geometric Coefficient of Variation 16.4
|
126.0 μM
Geometric Coefficient of Variation NA
NA=not calculated
|
123.0 μM
Geometric Coefficient of Variation 20.6
|
114.2 μM
Geometric Coefficient of Variation 9.2
|
110.6 μM
Geometric Coefficient of Variation NA
NA=not calculated
|
150.3 μM
Geometric Coefficient of Variation 6.7
|
125.1 μM
Geometric Coefficient of Variation 25.2
|
64.9 μM
Geometric Coefficient of Variation 29.6
|
127.7 μM
Geometric Coefficient of Variation 36.0
|
PRIMARY outcome
Timeframe: 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5Population: All allocated participants who were compliant with the protocol and had at least 1 post-dose PK data point available for IMI Vc
Central volume of distribution (Vc) of plasma IMI was calculated.
Outcome measures
| Measure |
Cohort 5: IMI/REL 10/5 mg/kg 60-minute Infusion
n=6 Participants
Neonates to infants (birth to \<3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
|
Cohort 5: IMI/REL 15/7.5 mg/kg 60-minute Infusion
n=9 Participants
Neonates to infants (birth to \<3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 1: IMI/REL 500/250 mg 30-minute Infusion
n=6 Participants
Adolescents (age 12 to \<18 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg
|
Cohort 2: IMI/REL 15/7.5 mg/kg 30-minute Infusion
n=1 Participants
Older children (6 to \<12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 2: IMI/REL 15/7.5 mg/kg mg 60-minute Infusion
n=2 Participants
Older children (6 to \<12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 2: IMI/REL 500/250 mg 30-minute Infusion
n=2 Participants
Older children (6 to \<12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg
|
Cohort 2: IMI/REL 500/250 mg 60-minute Infusion
n=1 Participants
Older children (6 to \<12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 500/250 mg
|
Cohort 3: IMI/REL 15/7.5 mg/kg 30-minute Infusion
n=3 Participants
Younger children (2 to \<6 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 3: IMI/REL 15/7.5 mg/kg 60-minute Infusion
n=3 Participants
Younger children (2 to \<6 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 4: IMI/REL 10/5 mg/kg 60-minute Infusion
n=4 Participants
Infants (3 months to \<1 year) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
|
Cohort 4: IMI/REL 15/7.5 mg/kg 60-minute Infusion
n=4 Participants
Toddlers (1 to 2 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
IMI Central Volume of Distribution (Vc)
|
1.06 Liters
Geometric Coefficient of Variation 29.6
|
0.95 Liters
Geometric Coefficient of Variation 34.2
|
10.27 Liters
Geometric Coefficient of Variation 16.2
|
8.00 Liters
Geometric Coefficient of Variation NA
NA=not calculated
|
4.33 Liters
Geometric Coefficient of Variation 5.2
|
9.60 Liters
Geometric Coefficient of Variation 2.4
|
8.70 Liters
Geometric Coefficient of Variation NA
NA=not calculated
|
3.49 Liters
Geometric Coefficient of Variation 19.6
|
2.49 Liters
Geometric Coefficient of Variation 34.6
|
2.39 Liters
Geometric Coefficient of Variation 53.2
|
1.52 Liters
Geometric Coefficient of Variation 35.0
|
PRIMARY outcome
Timeframe: 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5Population: All allocated participants who were compliant with the protocol and had at least 1 post-dose PK data point available for IMI CL
Systemic clearance (CL) of plasma IMI was calculated.
Outcome measures
| Measure |
Cohort 5: IMI/REL 10/5 mg/kg 60-minute Infusion
n=6 Participants
Neonates to infants (birth to \<3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
|
Cohort 5: IMI/REL 15/7.5 mg/kg 60-minute Infusion
n=9 Participants
Neonates to infants (birth to \<3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 1: IMI/REL 500/250 mg 30-minute Infusion
n=6 Participants
Adolescents (age 12 to \<18 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg
|
Cohort 2: IMI/REL 15/7.5 mg/kg 30-minute Infusion
n=1 Participants
Older children (6 to \<12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 2: IMI/REL 15/7.5 mg/kg mg 60-minute Infusion
n=2 Participants
Older children (6 to \<12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 2: IMI/REL 500/250 mg 30-minute Infusion
n=2 Participants
Older children (6 to \<12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg
|
Cohort 2: IMI/REL 500/250 mg 60-minute Infusion
n=1 Participants
Older children (6 to \<12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 500/250 mg
|
Cohort 3: IMI/REL 15/7.5 mg/kg 30-minute Infusion
n=3 Participants
Younger children (2 to \<6 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 3: IMI/REL 15/7.5 mg/kg 60-minute Infusion
n=3 Participants
Younger children (2 to \<6 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 4: IMI/REL 10/5 mg/kg 60-minute Infusion
n=4 Participants
Infants (3 months to \<1 year) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
|
Cohort 4: IMI/REL 15/7.5 mg/kg 60-minute Infusion
n=4 Participants
Toddlers (1 to 2 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
IMI Clearance (CL)
|
1.10 L/hr
Geometric Coefficient of Variation 26.2
|
0.66 L/hr
Geometric Coefficient of Variation 20.4
|
12.58 L/hr
Geometric Coefficient of Variation 18.4
|
9.60 L/hr
Geometric Coefficient of Variation NA
NA=not calculated
|
5.25 L/hr
Geometric Coefficient of Variation 9.2
|
11.67 L/hr
Geometric Coefficient of Variation 27.6
|
11.74 L/hr
Geometric Coefficient of Variation NA
NA=not calculated
|
5.31 L/hr
Geometric Coefficient of Variation 29.7
|
4.43 L/hr
Geometric Coefficient of Variation 45.2
|
3.31 L/hr
Geometric Coefficient of Variation 60.1
|
1.70 L/hr
Geometric Coefficient of Variation 48.1
|
PRIMARY outcome
Timeframe: 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5Population: All allocated participants who were compliant with the protocol and had at least 1 post-dose PK data point available for IMI %TMIC
Percentage of time spent above the minimum inhibitory concentration (%TMIC) of plasma IMI was calculated. %TMIC is defined as the percentage of time (in hours) in which the lowest concentration of a study drug, completely inhibits growth of the specific organism being tested.
Outcome measures
| Measure |
Cohort 5: IMI/REL 10/5 mg/kg 60-minute Infusion
n=6 Participants
Neonates to infants (birth to \<3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
|
Cohort 5: IMI/REL 15/7.5 mg/kg 60-minute Infusion
n=9 Participants
Neonates to infants (birth to \<3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 1: IMI/REL 500/250 mg 30-minute Infusion
n=6 Participants
Adolescents (age 12 to \<18 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg
|
Cohort 2: IMI/REL 15/7.5 mg/kg 30-minute Infusion
n=1 Participants
Older children (6 to \<12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 2: IMI/REL 15/7.5 mg/kg mg 60-minute Infusion
n=2 Participants
Older children (6 to \<12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 2: IMI/REL 500/250 mg 30-minute Infusion
n=2 Participants
Older children (6 to \<12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg
|
Cohort 2: IMI/REL 500/250 mg 60-minute Infusion
n=1 Participants
Older children (6 to \<12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 500/250 mg
|
Cohort 3: IMI/REL 15/7.5 mg/kg 30-minute Infusion
n=3 Participants
Younger children (2 to \<6 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 3: IMI/REL 15/7.5 mg/kg 60-minute Infusion
n=3 Participants
Younger children (2 to \<6 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 4: IMI/REL 10/5 mg/kg 60-minute Infusion
n=4 Participants
Infants (3 months to \<1 year) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
|
Cohort 4: IMI/REL 15/7.5 mg/kg 60-minute Infusion
n=4 Participants
Toddlers (1 to 2 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
IMI Percentage of Time Above the Minimum Concentration (%TMIC)
|
70.2 Percentage of time
Geometric Coefficient of Variation 10.6
|
93.7 Percentage of time
Geometric Coefficient of Variation 9.3
|
56.5 Percentage of time
Geometric Coefficient of Variation 17.1
|
58.3 Percentage of time
Geometric Coefficient of Variation NA
NA=not calculated
|
80.3 Percentage of time
Geometric Coefficient of Variation 26.7
|
61.6 Percentage of time
Geometric Coefficient of Variation 25.1
|
56.7 Percentage of time
Geometric Coefficient of Variation NA
NA=not calculated
|
50.1 Percentage of time
Geometric Coefficient of Variation 15.7
|
57.7 Percentage of time
Geometric Coefficient of Variation 18.8
|
50.4 Percentage of time
Geometric Coefficient of Variation 30.5
|
73.9 Percentage of time
Geometric Coefficient of Variation 19.7
|
PRIMARY outcome
Timeframe: 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5Population: All allocated participants who were compliant with the protocol and had at least 1 post-dose PK data point available for REL AUC0-∞
Area under the concentration time curve from time 0 to infinity (AUC0-∞) of plasma relebactam (REL) was calculated. AUC0-∞ is the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time.
Outcome measures
| Measure |
Cohort 5: IMI/REL 10/5 mg/kg 60-minute Infusion
n=6 Participants
Neonates to infants (birth to \<3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
|
Cohort 5: IMI/REL 15/7.5 mg/kg 60-minute Infusion
n=9 Participants
Neonates to infants (birth to \<3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 1: IMI/REL 500/250 mg 30-minute Infusion
n=6 Participants
Adolescents (age 12 to \<18 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg
|
Cohort 2: IMI/REL 15/7.5 mg/kg 30-minute Infusion
n=1 Participants
Older children (6 to \<12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 2: IMI/REL 15/7.5 mg/kg mg 60-minute Infusion
n=2 Participants
Older children (6 to \<12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 2: IMI/REL 500/250 mg 30-minute Infusion
n=2 Participants
Older children (6 to \<12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg
|
Cohort 2: IMI/REL 500/250 mg 60-minute Infusion
n=1 Participants
Older children (6 to \<12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 500/250 mg
|
Cohort 3: IMI/REL 15/7.5 mg/kg 30-minute Infusion
n=3 Participants
Younger children (2 to \<6 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 3: IMI/REL 15/7.5 mg/kg 60-minute Infusion
n=3 Participants
Younger children (2 to \<6 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 4: IMI/REL 10/5 mg/kg 60-minute Infusion
n=4 Participants
Infants (3 months to \<1 year) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
|
Cohort 4: IMI/REL 15/7.5 mg/kg 60-minute Infusion
n=4 Participants
Toddlers (1 to 2 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Relebactam (REL) AUC0-∞
|
91.8 μM*hr
Geometric Coefficient of Variation 18.3
|
220.7 μM*hr
Geometric Coefficient of Variation 34.1
|
80.1 μM*hr
Geometric Coefficient of Variation 20.0
|
105.6 μM*hr
Geometric Coefficient of Variation NA
NA=not calculated
|
123.8 μM*hr
Geometric Coefficient of Variation 59.5
|
90.3 μM*hr
Geometric Coefficient of Variation 35.1
|
80.2 μM*hr
Geometric Coefficient of Variation NA
NA=not calculated
|
85.7 μM*hr
Geometric Coefficient of Variation 32.4
|
81.7 μM*hr
Geometric Coefficient of Variation 42.0
|
52.8 μM*hr
Geometric Coefficient of Variation 33.6
|
126.6 μM*hr
Geometric Coefficient of Variation 53.7
|
PRIMARY outcome
Timeframe: 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5Population: All allocated participants who were compliant with the protocol and had at least 1 post-dose PK data point available for REL Cmax
Maximum plasma concentration (Cmax) of REL was calculated. Cmax is the peak plasma concentration of study drug after administration.
Outcome measures
| Measure |
Cohort 5: IMI/REL 10/5 mg/kg 60-minute Infusion
n=6 Participants
Neonates to infants (birth to \<3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
|
Cohort 5: IMI/REL 15/7.5 mg/kg 60-minute Infusion
n=9 Participants
Neonates to infants (birth to \<3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 1: IMI/REL 500/250 mg 30-minute Infusion
n=6 Participants
Adolescents (age 12 to \<18 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg
|
Cohort 2: IMI/REL 15/7.5 mg/kg 30-minute Infusion
n=1 Participants
Older children (6 to \<12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 2: IMI/REL 15/7.5 mg/kg mg 60-minute Infusion
n=2 Participants
Older children (6 to \<12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 2: IMI/REL 500/250 mg 30-minute Infusion
n=2 Participants
Older children (6 to \<12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg
|
Cohort 2: IMI/REL 500/250 mg 60-minute Infusion
n=1 Participants
Older children (6 to \<12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 500/250 mg
|
Cohort 3: IMI/REL 15/7.5 mg/kg 30-minute Infusion
n=3 Participants
Younger children (2 to \<6 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 3: IMI/REL 15/7.5 mg/kg 60-minute Infusion
n=3 Participants
Younger children (2 to \<6 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 4: IMI/REL 10/5 mg/kg 60-minute Infusion
n=4 Participants
Infants (3 months to \<1 year) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
|
Cohort 4: IMI/REL 15/7.5 mg/kg 60-minute Infusion
n=4 Participants
Toddlers (1 to 2 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
REL Maximum Concentration (Cmax)
|
34.22 μM
Geometric Coefficient of Variation 17.3
|
61.04 μM
Geometric Coefficient of Variation 21.9
|
49.33 μM
Geometric Coefficient of Variation 23.0
|
86.52 μM
Geometric Coefficient of Variation NA
NA=not calculated
|
60.32 μM
Geometric Coefficient of Variation 30.7
|
57.44 μM
Geometric Coefficient of Variation 26.1
|
48.73 μM
Geometric Coefficient of Variation NA
NA=not calculated
|
59.05 μM
Geometric Coefficient of Variation 9.08
|
48.59 μM
Geometric Coefficient of Variation 22.9
|
32.74 μM
Geometric Coefficient of Variation 15.0
|
59.55 μM
Geometric Coefficient of Variation 17.1
|
PRIMARY outcome
Timeframe: 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5Population: All allocated participants who were compliant with the protocol and had at least 1 post-dose PK data point available for REL CL
Systemic clearance (CL) of plasma REL was calculated.
Outcome measures
| Measure |
Cohort 5: IMI/REL 10/5 mg/kg 60-minute Infusion
n=6 Participants
Neonates to infants (birth to \<3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
|
Cohort 5: IMI/REL 15/7.5 mg/kg 60-minute Infusion
n=9 Participants
Neonates to infants (birth to \<3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 1: IMI/REL 500/250 mg 30-minute Infusion
n=6 Participants
Adolescents (age 12 to \<18 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg
|
Cohort 2: IMI/REL 15/7.5 mg/kg 30-minute Infusion
n=1 Participants
Older children (6 to \<12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 2: IMI/REL 15/7.5 mg/kg mg 60-minute Infusion
n=2 Participants
Older children (6 to \<12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 2: IMI/REL 500/250 mg 30-minute Infusion
n=2 Participants
Older children (6 to \<12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg
|
Cohort 2: IMI/REL 500/250 mg 60-minute Infusion
n=1 Participants
Older children (6 to \<12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 500/250 mg
|
Cohort 3: IMI/REL 15/7.5 mg/kg 30-minute Infusion
n=3 Participants
Younger children (2 to \<6 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 3: IMI/REL 15/7.5 mg/kg 60-minute Infusion
n=3 Participants
Younger children (2 to \<6 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 4: IMI/REL 10/5 mg/kg 60-minute Infusion
n=4 Participants
Infants (3 months to \<1 year) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
|
Cohort 4: IMI/REL 15/7.5 mg/kg 60-minute Infusion
n=4 Participants
Toddlers (1 to 2 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
REL Clearance (CL)
|
0.74 L/hr
Geometric Coefficient of Variation 27.0
|
0.35 L/hr
Geometric Coefficient of Variation 30.7
|
8.98 L/hr
Geometric Coefficient of Variation 20.7
|
6.10 L/hr
Geometric Coefficient of Variation NA
NA=not calculated
|
3.96 L/hr
Geometric Coefficient of Variation 28.9
|
8.03 L/hr
Geometric Coefficient of Variation 35.7
|
8.65 L/hr
Geometric Coefficient of Variation NA
NA=not calculated
|
4.20 L/hr
Geometric Coefficient of Variation 40.8
|
3.65 L/hr
Geometric Coefficient of Variation 54.1
|
2.56 L/hr
Geometric Coefficient of Variation 54.5
|
1.27 L/hr
Geometric Coefficient of Variation 62.9
|
PRIMARY outcome
Timeframe: 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5Population: All allocated participants who were compliant with the protocol and had at least 1 post-dose PK data point available for REL Vc
Central volume of distribution (Vc) of plasma REL was calculated.
Outcome measures
| Measure |
Cohort 5: IMI/REL 10/5 mg/kg 60-minute Infusion
n=6 Participants
Neonates to infants (birth to \<3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
|
Cohort 5: IMI/REL 15/7.5 mg/kg 60-minute Infusion
n=9 Participants
Neonates to infants (birth to \<3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 1: IMI/REL 500/250 mg 30-minute Infusion
n=6 Participants
Adolescents (age 12 to \<18 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg
|
Cohort 2: IMI/REL 15/7.5 mg/kg 30-minute Infusion
n=1 Participants
Older children (6 to \<12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 2: IMI/REL 15/7.5 mg/kg mg 60-minute Infusion
n=2 Participants
Older children (6 to \<12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 2: IMI/REL 500/250 mg 30-minute Infusion
n=2 Participants
Older children (6 to \<12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg
|
Cohort 2: IMI/REL 500/250 mg 60-minute Infusion
n=1 Participants
Older children (6 to \<12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 500/250 mg
|
Cohort 3: IMI/REL 15/7.5 mg/kg 30-minute Infusion
n=3 Participants
Younger children (2 to \<6 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 3: IMI/REL 15/7.5 mg/kg 60-minute Infusion
n=3 Participants
Younger children (2 to \<6 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 4: IMI/REL 10/5 mg/kg 60-minute Infusion
n=4 Participants
Infants (3 months to \<1 year) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
|
Cohort 4: IMI/REL 15/7.5 mg/kg 60-minute Infusion
n=4 Participants
Toddlers (1 to 2 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
REL Central Volume of Distribution (Vc)
|
1.21 Liters
Geometric Coefficient of Variation 24.6
|
0.90 Liters
Geometric Coefficient of Variation 36.7
|
10.58 Liters
Geometric Coefficient of Variation 17.2
|
6.76 Liters
Geometric Coefficient of Variation NA
NA=not calculated
|
4.95 Liters
Geometric Coefficient of Variation 1.6
|
9.81 Liters
Geometric Coefficient of Variation 6.1
|
9.38 Liters
Geometric Coefficient of Variation NA
NA=not calculated
|
3.83 Liters
Geometric Coefficient of Variation 13.8
|
2.88 Liters
Geometric Coefficient of Variation 27.4
|
2.43 Liters
Geometric Coefficient of Variation 38.8
|
1.70 Liters
Geometric Coefficient of Variation 21.1
|
PRIMARY outcome
Timeframe: 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5Population: Due to sparse PK sampling schedule, per participant data could not be calculated.
Area under the concentration time curve from time 0 to infinity (AUC0-∞) of plasma cilastatin (CIL) was not calculated. AUC0-∞ is the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5Population: All allocated participants who were compliant with the protocol and had at least 1 post-dose PK data point available for CIL Tmax
Time to maximum plasma concentration (Tmax) of CIL was determined. Tmax is defined as the time after drug administration at which peak drug concentration in plasma occurs.
Outcome measures
| Measure |
Cohort 5: IMI/REL 10/5 mg/kg 60-minute Infusion
n=7 Participants
Neonates to infants (birth to \<3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
|
Cohort 5: IMI/REL 15/7.5 mg/kg 60-minute Infusion
n=9 Participants
Neonates to infants (birth to \<3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 1: IMI/REL 500/250 mg 30-minute Infusion
n=6 Participants
Adolescents (age 12 to \<18 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg
|
Cohort 2: IMI/REL 15/7.5 mg/kg 30-minute Infusion
n=1 Participants
Older children (6 to \<12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 2: IMI/REL 15/7.5 mg/kg mg 60-minute Infusion
n=2 Participants
Older children (6 to \<12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 2: IMI/REL 500/250 mg 30-minute Infusion
n=2 Participants
Older children (6 to \<12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg
|
Cohort 2: IMI/REL 500/250 mg 60-minute Infusion
n=1 Participants
Older children (6 to \<12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 500/250 mg
|
Cohort 3: IMI/REL 15/7.5 mg/kg 30-minute Infusion
n=3 Participants
Younger children (2 to \<6 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 3: IMI/REL 15/7.5 mg/kg 60-minute Infusion
n=3 Participants
Younger children (2 to \<6 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 4: IMI/REL 10/5 mg/kg 60-minute Infusion
n=4 Participants
Infants (3 months to \<1 year) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
|
Cohort 4: IMI/REL 15/7.5 mg/kg 60-minute Infusion
n=4 Participants
Toddlers (1 to 2 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
CIL Time to Maximum Concentration (Tmax)
|
1.1 Hours
Interval 1.1 to 1.2
|
1.2 Hours
Interval 1.1 to 1.3
|
0.58 Hours
Interval 0.52 to 0.58
|
0.53 Hours
Interval 0.53 to 0.53
|
1.1 Hours
Interval 1.1 to 1.1
|
0.58 Hours
Interval 0.57 to 0.58
|
1.1 Hours
Interval 1.1 to 1.1
|
0.58 Hours
Interval 0.57 to 0.58
|
1.1 Hours
Interval 1.1 to 1.1
|
1.1 Hours
Interval 1.1 to 1.7
|
1.2 Hours
Interval 1.1 to 1.2
|
PRIMARY outcome
Timeframe: 30 min after the start of infusion for Cohort 1; 60 min after the start of infusion for Cohorts 2-5Population: All allocated participants who were compliant with the protocol and had at least 1 post-dose PK data point available for CIL Ceoi
Concentration at end of infusion (Ceoi) of plasma CIL was determined.
Outcome measures
| Measure |
Cohort 5: IMI/REL 10/5 mg/kg 60-minute Infusion
n=7 Participants
Neonates to infants (birth to \<3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
|
Cohort 5: IMI/REL 15/7.5 mg/kg 60-minute Infusion
n=9 Participants
Neonates to infants (birth to \<3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 1: IMI/REL 500/250 mg 30-minute Infusion
n=6 Participants
Adolescents (age 12 to \<18 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg
|
Cohort 2: IMI/REL 15/7.5 mg/kg 30-minute Infusion
n=1 Participants
Older children (6 to \<12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 2: IMI/REL 15/7.5 mg/kg mg 60-minute Infusion
n=2 Participants
Older children (6 to \<12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 2: IMI/REL 500/250 mg 30-minute Infusion
n=2 Participants
Older children (6 to \<12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg
|
Cohort 2: IMI/REL 500/250 mg 60-minute Infusion
n=1 Participants
Older children (6 to \<12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 500/250 mg
|
Cohort 3: IMI/REL 15/7.5 mg/kg 30-minute Infusion
n=3 Participants
Younger children (2 to \<6 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 3: IMI/REL 15/7.5 mg/kg 60-minute Infusion
n=3 Participants
Younger children (2 to \<6 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 4: IMI/REL 10/5 mg/kg 60-minute Infusion
n=3 Participants
Infants (3 months to \<1 year) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
|
Cohort 4: IMI/REL 15/7.5 mg/kg 60-minute Infusion
n=4 Participants
Toddlers (1 to 2 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
CIL Concentration at End of Infusion (Ceoi)
|
63.6 μM
Geometric Coefficient of Variation 28.0
|
107.0 μM
Geometric Coefficient of Variation 20.0
|
86.9 μM
Geometric Coefficient of Variation 41.0
|
122 μM
Geometric Coefficient of Variation NA
Geometric coefficient of variation cannot be calculated for a sample size of 1.
|
111 μM
Geometric Coefficient of Variation 51
|
80.5 μM
Geometric Coefficient of Variation 22
|
74.8 μM
Geometric Coefficient of Variation NA
Geometric coefficient of variation cannot be calculated for a sample size of 1.
|
102 μM
Geometric Coefficient of Variation 32
|
80.9 μM
Geometric Coefficient of Variation 62
|
37.0 μM
Geometric Coefficient of Variation 64.0
|
94.5 μM
Geometric Coefficient of Variation 42.0
|
PRIMARY outcome
Timeframe: 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5Population: Due to sparse PK sampling schedule, per participant data could not be calculated.
Terminal half-life (t1/2) of plasma CIL was not calculated.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5Population: Due to sparse PK sampling schedule, per participant data could not be calculated.
Systemic clearance (CL) of plasma CIL was not calculated.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to12 hrs after start of DI for Cohort 5Population: Due to sparse PK sampling schedule, per participant data could not be calculated.
Volume of distribution (Vss) of plasma CIL was not calculated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 17 daysPopulation: All allocated participants who received infusion (including partial doses) of study drug
Number of participants with one or more AEs was calculated. An AE is defined as any untoward medical occurrence in a participant administered study drug and which may or may not have a causal relationship to the study drug.
Outcome measures
| Measure |
Cohort 5: IMI/REL 10/5 mg/kg 60-minute Infusion
n=3 Participants
Neonates to infants (birth to \<3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
|
Cohort 5: IMI/REL 15/7.5 mg/kg 60-minute Infusion
n=4 Participants
Neonates to infants (birth to \<3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 1: IMI/REL 500/250 mg 30-minute Infusion
n=7 Participants
Adolescents (age 12 to \<18 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg
|
Cohort 2: IMI/REL 15/7.5 mg/kg 30-minute Infusion
n=6 Participants
Older children (6 to \<12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 2: IMI/REL 15/7.5 mg/kg mg 60-minute Infusion
n=6 Participants
Older children (6 to \<12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 2: IMI/REL 500/250 mg 30-minute Infusion
n=4 Participants
Older children (6 to \<12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg
|
Cohort 2: IMI/REL 500/250 mg 60-minute Infusion
n=4 Participants
Older children (6 to \<12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 500/250 mg
|
Cohort 3: IMI/REL 15/7.5 mg/kg 30-minute Infusion
n=5 Participants
Younger children (2 to \<6 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 3: IMI/REL 15/7.5 mg/kg 60-minute Infusion
n=3 Participants
Younger children (2 to \<6 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 4: IMI/REL 10/5 mg/kg 60-minute Infusion
n=2 Participants
Infants (3 months to \<1 year) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
|
Cohort 4: IMI/REL 15/7.5 mg/kg 60-minute Infusion
n=2 Participants
Toddlers (1 to 2 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced an Adverse Event (AE)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: All allocated participants who received infusion (including partial doses) of study drug
Number of participants who discontinued study drug due to an AE was calculated. An AE is defined as any untoward medical occurrence in a participant administered study drug and which may or may not have a causal relationship to the study drug.
Outcome measures
| Measure |
Cohort 5: IMI/REL 10/5 mg/kg 60-minute Infusion
n=3 Participants
Neonates to infants (birth to \<3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
|
Cohort 5: IMI/REL 15/7.5 mg/kg 60-minute Infusion
n=4 Participants
Neonates to infants (birth to \<3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 1: IMI/REL 500/250 mg 30-minute Infusion
n=7 Participants
Adolescents (age 12 to \<18 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg
|
Cohort 2: IMI/REL 15/7.5 mg/kg 30-minute Infusion
n=6 Participants
Older children (6 to \<12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 2: IMI/REL 15/7.5 mg/kg mg 60-minute Infusion
n=6 Participants
Older children (6 to \<12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 2: IMI/REL 500/250 mg 30-minute Infusion
n=4 Participants
Older children (6 to \<12 years) administered with a single IV 30-minute infusion dose of IMI/REL at 500/250 mg
|
Cohort 2: IMI/REL 500/250 mg 60-minute Infusion
n=4 Participants
Older children (6 to \<12 years) administered with a single IV 60-minute infusion dose of IMI/REL at 500/250 mg
|
Cohort 3: IMI/REL 15/7.5 mg/kg 30-minute Infusion
n=5 Participants
Younger children (2 to \<6 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 3: IMI/REL 15/7.5 mg/kg 60-minute Infusion
n=3 Participants
Younger children (2 to \<6 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 4: IMI/REL 10/5 mg/kg 60-minute Infusion
n=2 Participants
Infants (3 months to \<1 year) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
|
Cohort 4: IMI/REL 15/7.5 mg/kg 60-minute Infusion
n=2 Participants
Toddlers (1 to 2 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Discontinued Study Drug Due to an AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Cohort 1: IMI/REL 15/7.5 mg/kg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 2: IMI/REL 15/7.5 mg/kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 3: IMI/REL 15/7.5 mg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 4: IMI/REL 10/5 mg/kg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 4: IMI/REL 15/7.5 mg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 5: Subcohort 1: IMI/REL 10/5 mg/kg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 5: Subcohort 2: IMI/REL 10/5 mg/kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 5: Subcohort 3: IMI/REL 10/5 mg/kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 5: Subcohort 1: IMI/REL 15/7.5 mg/kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 5: Subcohort 2: IMI/REL 15/7.5 mg/kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 5: Subcohort 3: IMI/REL 15/7.5 mg/kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1: IMI/REL 15/7.5 mg/kg
n=7 participants at risk
Adolescents (age 12 to \<18 years) administered with a single IV 30-minute infusion dose of IMI/REL at 15/7.5 mg/kg, up to maximum dose of 500/250 mg
|
Cohort 2: IMI/REL 15/7.5 mg/kg
n=6 participants at risk
Older children (6 to \<12 years) administered with a single IV 30-minute or 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg, up to a maximum dose of 500/250 mg
|
Cohort 3: IMI/REL 15/7.5 mg/kg
n=6 participants at risk
Younger children (2 to \<6 years) administered with a single IV 30-minute or 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 4: IMI/REL 10/5 mg/kg
n=4 participants at risk
Infants (3 months to \<1 year) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
|
Cohort 4: IMI/REL 15/7.5 mg/kg
n=4 participants at risk
Toddlers (1 to \<2 years) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 5: Subcohort 1: IMI/REL 10/5 mg/kg
n=5 participants at risk
Young infants (4 weeks to \<3 months of age) administered with a single IV 60-minute dose of IMI/REL at 10/5 mg/kg
|
Cohort 5: Subcohort 2: IMI/REL 10/5 mg/kg
n=3 participants at risk
Older neonates (1 to \<4 weeks of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
|
Cohort 5: Subcohort 3: IMI/REL 10/5 mg/kg
n=2 participants at risk
Younger neonates (\<1 week of age) administered with a single IV 60-minute infusion dose of IMI/REL at 10/5 mg/kg
|
Cohort 5: Subcohort 1: IMI/REL 15/7.5 mg/kg
n=2 participants at risk
Young infants (4 weeks to \<3 months of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 5: Subcohort 2: IMI/REL 15/7.5 mg/kg
n=3 participants at risk
Older neonates (1 to \<4 weeks of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
Cohort 5: Subcohort 3: IMI/REL 15/7.5 mg/kg
n=4 participants at risk
Younger neonates (\<1 week of age) administered with a single IV 60-minute infusion dose of IMI/REL at 15/7.5 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
14.3%
1/7 • Number of events 1 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/6 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
33.3%
2/6 • Number of events 2 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/4 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/4 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/5 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/3 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/2 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/2 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/3 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/4 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
|
Blood and lymphatic system disorders
Thrombocytoses
|
0.00%
0/7 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/6 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
16.7%
1/6 • Number of events 1 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/4 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/4 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/5 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/3 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/2 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/2 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/3 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/4 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/7 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/6 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
16.7%
1/6 • Number of events 1 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
25.0%
1/4 • Number of events 1 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/4 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
20.0%
1/5 • Number of events 1 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/3 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/2 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/2 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/3 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/4 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/7 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/6 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/6 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/4 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/4 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
20.0%
1/5 • Number of events 1 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/3 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/2 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/2 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/3 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/4 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
|
Investigations
Aspartate aminotransferase increased
|
14.3%
1/7 • Number of events 1 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/6 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/6 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/4 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/4 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/5 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/3 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/2 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/2 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/3 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/4 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
1/7 • Number of events 1 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/6 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/6 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/4 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/4 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/5 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/3 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/2 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/2 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/3 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/4 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/7 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/6 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/6 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/4 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
25.0%
1/4 • Number of events 1 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/5 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/3 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/2 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/2 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/3 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/4 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/7 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/6 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/6 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/4 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
25.0%
1/4 • Number of events 1 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/5 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/3 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/2 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/2 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/3 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
0.00%
0/4 • Up to 17 days (AE reporting), up to 19 days (all-cause mortality)
The analysis population included all allocated participants who received infusion (including partial doses) of study drug. Note: Participant information is shown by age cohort and drug dosage, to provide clinically-similar groups for analysis of safety data.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
- Publication restrictions are in place
Restriction type: OTHER