Trial Outcomes & Findings for Safety and Pharmacokinetic (PK) Study of Intravenous (IV) Acetaminophen Administration in Pediatric Inpatients (NCT NCT00493246)
NCT ID: NCT00493246
Last Updated: 2016-10-21
Results Overview
Cmax: Maximum Plasma Concentration
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
75 participants
Primary outcome timeframe
Time Zero (just prior to first dose) to 24 hours post first dose
Results posted on
2016-10-21
Participant Flow
The study was conducted at 5 sites in the US from 27 June 2007 to 01Sep 2008.
Participant milestones
| Measure |
Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen
Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
|
Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen
Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
|
Infants: 12.5 mg/kg q4h IV Acetaminophen
Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen
Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen
Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen
Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen
Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen
Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
12
|
13
|
9
|
16
|
12
|
10
|
|
Overall Study
COMPLETED
|
2
|
1
|
12
|
13
|
8
|
15
|
11
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen
Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
|
Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen
Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
|
Infants: 12.5 mg/kg q4h IV Acetaminophen
Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen
Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen
Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen
Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen
Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen
Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
No access to draw blood
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Safety and Pharmacokinetic (PK) Study of Intravenous (IV) Acetaminophen Administration in Pediatric Inpatients
Baseline characteristics by cohort
| Measure |
Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen
n=2 Participants
Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
|
Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen
n=1 Participants
Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
|
Infants: 12.5 mg/kg q4h IV Acetaminophen
n=12 Participants
Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen
n=13 Participants
Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen
n=9 Participants
Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen
n=16 Participants
Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen
n=12 Participants
Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen
n=10 Participants
Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
16 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
10 Participants
n=6 Participants
|
75 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Age, Categorical
>=65 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
6 Participants
n=6 Participants
|
31 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
44 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Time Zero (just prior to first dose) to 24 hours post first dosePopulation: Subjects who received at least one dose of IV acetaminophen and had at least 3 PK sampling assessments were included in the PK analysis.This outcome measure represents PK parameters for the first dose of IV acetaminophen.
Cmax: Maximum Plasma Concentration
Outcome measures
| Measure |
Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen
n=2 Participants
Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
|
Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen
n=1 Participants
Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
|
Infants: 12.5 mg/kg q4h IV Acetaminophen
n=12 Participants
Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen
n=13 Participants
Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen
n=9 Participants
Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen
n=16 Participants
Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen
n=12 Participants
Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen
n=10 Participants
Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
|---|---|---|---|---|---|---|---|---|
|
Single-dose Maximum Plasma Concentration (Cmax) , Micrograms Per Milliliter (µg/mL) Pharmacokinetics of IV Acetaminophen
|
40.1 micrograms per milliliter (µg/mL)
Interval 15.9 to 64.4
|
20.1 micrograms per milliliter (µg/mL)
Interval 20.1 to 20.1
|
16.7 micrograms per milliliter (µg/mL)
Interval 12.1 to 23.0
|
19.3 micrograms per milliliter (µg/mL)
Interval 16.2 to 25.4
|
18.2 micrograms per milliliter (µg/mL)
Interval 13.5 to 27.1
|
21.6 micrograms per milliliter (µg/mL)
Interval 14.4 to 60.8
|
15.9 micrograms per milliliter (µg/mL)
Interval 10.6 to 28.8
|
25.5 micrograms per milliliter (µg/mL)
Interval 9.91 to 49.8
|
PRIMARY outcome
Timeframe: Time Zero (just prior to first dose) to 24 hours post first dosePopulation: Subjects who received at least one dose of IV acetaminophen and had at least 3 PK sampling assessments were included in the PK analysis.This outcome measure represents PK parameters for the first dose of IV acetaminophen.
Tmax: Time to reach maximum plasma concentration (Cmax)
Outcome measures
| Measure |
Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen
n=2 Participants
Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
|
Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen
n=1 Participants
Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
|
Infants: 12.5 mg/kg q4h IV Acetaminophen
n=12 Participants
Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen
n=13 Participants
Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen
n=9 Participants
Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen
n=16 Participants
Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen
n=12 Participants
Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen
n=10 Participants
Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
|---|---|---|---|---|---|---|---|---|
|
Single-dose Time to Reach Maximum Plasma Concentration [Tmax(h)] Pharmacokinetics of IV Acetaminophen
|
0.450 Hour
Interval 0.4 to 0.5
|
0.333 Hour
Interval 0.333 to 0.333
|
0.267 Hour
Interval 0.0 to 0.383
|
0.267 Hour
Interval 0.25 to 0.933
|
0.250 Hour
Interval 0.0833 to 0.3
|
0.250 Hour
Interval 0.0833 to 0.417
|
0.250 Hour
Interval 0.0833 to 0.283
|
0.267 Hour
Interval 0.0 to 0.333
|
PRIMARY outcome
Timeframe: Time Zero (just prior to first dose) to 48 hours post first doseAUC 0-t (µg\*h/ml): Area under the plasma concentration versus time curve from time 0 (predose) to the time of the dosing interval at steady-state.
Outcome measures
| Measure |
Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen
n=2 Participants
Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
|
Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen
n=1 Participants
Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
|
Infants: 12.5 mg/kg q4h IV Acetaminophen
n=12 Participants
Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen
n=13 Participants
Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen
n=9 Participants
Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen
n=16 Participants
Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen
n=12 Participants
Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen
n=10 Participants
Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
|---|---|---|---|---|---|---|---|---|
|
Multiple-dose Area Und the Curve (AUC) From Time 0 (Predose) to the Time of the Dosing Interval at Steady-state (0-t (µg*h/ml) Pharmacokinetics of IV Acetaminophen
|
65.6 µg*h/ml
Interval 55.8 to 75.4
|
105 µg*h/ml
Interval 105.0 to 105.0
|
43.3 µg*h/ml
Interval 9.15 to 79.2
|
51.9 µg*h/ml
Interval 36.0 to 200.0
|
37.8 µg*h/ml
Interval 11.3 to 52.3
|
48.0 µg*h/ml
Interval 32.2 to 131.0
|
47.7 µg*h/ml
Interval 22.4 to 132.0
|
64.0 µg*h/ml
Interval 33.2 to 84.1
|
PRIMARY outcome
Timeframe: 48hrsPopulation: Subjects who received at least one dose of IV acetaminophen and had at least 3 PK sampling assessments were included in the PK analysis.This outcome measure represents PK parameters for the last dose of IV acetaminophen. Due to only one subject in the Neonate 15mg/kg group, t1/2 (h) was not calculated.
t1/2: Terminal elimination half-life
Outcome measures
| Measure |
Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen
n=2 Participants
Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
|
Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen
Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
|
Infants: 12.5 mg/kg q4h IV Acetaminophen
n=12 Participants
Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen
n=13 Participants
Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen
n=9 Participants
Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen
n=16 Participants
Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen
n=12 Participants
Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen
n=10 Participants
Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
|---|---|---|---|---|---|---|---|---|
|
Multiple-dose Terminal Elimination Half-life [t1/2(h)] Pharmacokinetics of IV Acetaminophen
|
3.88 Hours
Interval 3.88 to 3.88
|
—
|
2.37 Hours
Interval 1.15 to 2.81
|
2.79 Hours
Interval 2.1 to 5.43
|
2.64 Hours
Interval 2.24 to 4.46
|
2.77 Hours
Interval 2.15 to 4.85
|
3.37 Hours
Interval 2.69 to 4.16
|
4.10 Hours
Interval 2.48 to 4.36
|
SECONDARY outcome
Timeframe: First dose of study medication to 30 days after the last dose of study medicationA TEAE is defined as an adverse event that starts on or after the start of study medication
Outcome measures
| Measure |
Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen
n=2 Participants
Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
|
Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen
n=1 Participants
Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
|
Infants: 12.5 mg/kg q4h IV Acetaminophen
n=12 Participants
Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen
n=13 Participants
Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen
n=9 Participants
Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen
n=16 Participants
Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen
n=12 Participants
Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen
n=10 Participants
Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE)
|
2 Participants
|
1 Participants
|
10 Participants
|
9 Participants
|
2 Participants
|
11 Participants
|
10 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: First dose to 30 days following last dose of study medicationPopulation: All analyses of safety were conducted on the Safety population, which included those subjects who received any portion of a dose of IV acetaminophen.
A Serious Treatment Emergent Adverse Event is defined as any untoward medical occurrence at any dose of IV acetaminophen that; Results in Death, Is life-threatening, Requires inpatient hospitalization or causes prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, Is an important medical event
Outcome measures
| Measure |
Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen
n=2 Participants
Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
|
Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen
n=1 Participants
Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
|
Infants: 12.5 mg/kg q4h IV Acetaminophen
n=12 Participants
Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen
n=13 Participants
Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen
n=9 Participants
Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen
n=16 Participants
Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen
n=12 Participants
Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen
n=10 Participants
Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
|---|---|---|---|---|---|---|---|---|
|
Subjects Who Experience at Least One Serious Treatment-Emergent Adverse Event (TEAE)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
Adverse Events
Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Infants: 12.5 mg/kg q4h IV Acetaminophen
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen
n=2 participants at risk
Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
|
Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen
n=1 participants at risk
Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
|
Infants: 12.5 mg/kg q4h IV Acetaminophen
n=12 participants at risk
Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen
n=13 participants at risk
Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen
n=9 participants at risk
Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen
n=16 participants at risk
Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen
n=12 participants at risk
Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen
n=10 participants at risk
Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/13 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/16 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
10.0%
1/10 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
7.7%
1/13 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/16 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/10 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal disorders chylothorax
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/13 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
6.2%
1/16 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/10 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
|
Surgical and medical procedures
Post procedural drainage
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/13 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/16 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
8.3%
1/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/10 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
|
Investigations
Thoracic cavity drainage test abnormal
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/13 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
11.1%
1/9 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/16 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/10 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
|
Infections and infestations
Wound infection
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/13 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
6.2%
1/16 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/10 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
Other adverse events
| Measure |
Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen
n=2 participants at risk
Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
|
Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen
n=1 participants at risk
Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
|
Infants: 12.5 mg/kg q4h IV Acetaminophen
n=12 participants at risk
Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen
n=13 participants at risk
Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen
n=9 participants at risk
Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen
n=16 participants at risk
Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen
n=12 participants at risk
Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen
n=10 participants at risk
Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
|
|---|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
8.3%
1/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/13 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/16 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/10 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
7.7%
1/13 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/16 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
8.3%
1/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
10.0%
1/10 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
|
Injury, poisoning and procedural complications
Allergic Transfusion Reaction
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/13 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/16 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
10.0%
1/10 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
8.3%
1/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
7.7%
1/13 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/16 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/10 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/13 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
6.2%
1/16 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
10.0%
1/10 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
50.0%
1/2 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
100.0%
1/1 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
8.3%
1/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
15.4%
2/13 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
18.8%
3/16 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
8.3%
1/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/10 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/13 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
6.2%
1/16 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/10 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
|
Infections and infestations
Central Line Infection
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
7.7%
1/13 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/16 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/10 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
|
Nervous system disorders
Cerebrovascular Spasm
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/13 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
11.1%
1/9 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/16 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/10 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
15.4%
2/13 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
6.2%
1/16 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
16.7%
2/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/10 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
|
General disorders
Face edema
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/13 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
11.1%
1/9 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
6.2%
1/16 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
8.3%
1/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/10 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
|
Investigations
Haemoglobin Decreased
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/13 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/16 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
10.0%
1/10 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
|
Vascular disorders
Hypertension
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
7.7%
1/13 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/16 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/10 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
16.7%
2/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
7.7%
1/13 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
11.1%
1/9 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
12.5%
2/16 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
10.0%
1/10 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
50.0%
1/2 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
25.0%
3/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
7.7%
1/13 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
6.2%
1/16 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
8.3%
1/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
10.0%
1/10 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/13 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
11.1%
1/9 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
6.2%
1/16 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/10 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/13 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/16 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
8.3%
1/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/10 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
|
Investigations
Liver Function Test Abnormal
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/13 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/16 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
10.0%
1/10 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
7.7%
1/13 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
25.0%
4/16 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
41.7%
5/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
20.0%
2/10 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
|
General disorders
Oedema
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
8.3%
1/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/13 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/16 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/10 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
8.3%
1/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/13 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/16 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/10 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/13 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
11.1%
1/9 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
6.2%
1/16 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
8.3%
1/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/10 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
50.0%
1/2 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
33.3%
4/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/13 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
18.8%
3/16 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
8.3%
1/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
10.0%
1/10 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
7.7%
1/13 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/16 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/10 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
|
Injury, poisoning and procedural complications
Procedural Hypertension
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/13 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/16 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
8.3%
1/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/10 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
8.3%
1/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
7.7%
1/13 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
31.2%
5/16 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
8.3%
1/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
20.0%
2/10 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
100.0%
1/1 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
16.7%
2/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
7.7%
1/13 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
11.1%
1/9 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/16 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/10 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
7.7%
1/13 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/16 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/10 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
|
General disorders
Pyrexia
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/13 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
6.2%
1/16 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
8.3%
1/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
10.0%
1/10 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
7.7%
1/13 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/16 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/10 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
16.7%
2/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
7.7%
1/13 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/16 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/10 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
|
Nervous system disorders
Vocal Cord Paralysis
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
7.7%
1/13 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/16 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/10 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/2 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/1 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
16.7%
2/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
15.4%
2/13 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/9 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/16 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/12 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
0.00%
0/10 • Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Investigator may publish 18 months after Cadence's final evaluation of all study data from all sites, whichever occurs first.Manuscripts/abstracts will be provided to Cadence for review and comment at least 30 days prior to submission.Cadence shall have 30 days to respond with comments.
- Publication restrictions are in place
Restriction type: OTHER