Fever, Pain
Conditions
Brief summary
We are doing this study to find out what happens to acetaminophen in the body after it is given to children through the vein. Children's bodies may handle drugs differently than adults. Understanding how long the drug stays in the body and how the drug is changed or metabolized by the body (called pharmacokinetics) is an important step in learning what the best dose of acetaminophen for children should be. We are also interested in learning about the safety of this medication when given to children.
Detailed description
A Prospective, Multi-Center, Randomized, Open-Label, Single and Repeated Dose, 48 Hour Study, of Intravenous Acetaminophen in Pediatric Inpatients to Determine Pharmacokinetics (PK) and Safety in Acute Pain and Fever
Interventions
DRUGIV Acetaminophen
This study will investigate two doses (12.5 milligrams/kilogram (mg/kg) and 15 milligrams/kilogram) based on weight administered every four hours (q4h), every six hours (q6h), or every eight hours (q8h) (depending on age) Neonates: 12.5 mg/kg q6h IV acetaminophen Neonates: 15 mg/kg q8h IV acetaminophen Infants: 12.5 mg/kg q4h IV acetaminophen Infants: 15 mg/kg q6h IV acetaminophen Children: 12.5 mg/kg q4h IV acetaminophen Children: 15 mg/kg q6h IV acetaminophen Adolescents: 12.5 mg/kg q4h IV acetaminophen Adolescents: 15 mg/kg q6h IV acetaminophen
Sponsors
Mallinckrodt
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
29 Days to 16 Years
Healthy volunteers
No
Inclusion criteria
To be eligible for entry into the Study, Subjects must meet or Subjects' Parent or Guardian must meet, agree with or confirm all of the following criteria: 1. Provide written Informed Consent/Assent prior to participation in the Study 2. Age strata: * Full-term Neonates (≤ 28 days old and minimum post conception age of 37 weeks at birth) * Infants \[29 days to \<2 years (yrs) old\] * 29 days to \<6 months * 6 to \<12 months * 12 to \<24 months) * Children (2 yrs to \<12 yrs old) * Adolescents (12 yrs to ≤16 yrs old) 3. Inpatient status: are currently inpatients or have an admission scheduled and will soon become an inpatient (e.g., elective surgery) 4. Diagnosis: requires or will require analgesic treatment for acute pain or antipyretic treatment for fever 5. IV access: have a need for IV access for the duration of the Study either due to a nothing by mouth (NPO) status or due to the Investigator's assessment that oral treatment is not optimal (for example, severe nausea or vomiting) 6. The Subject's Parent/Guardian must have the ability to read and understand the Study procedures and have the ability to communicate meaningfully with the Study Investigator and staff 7. Be free of other physical, mental, or medical conditions which, in the opinion of the Investigator after completing the screening assessment, make Study participation inadvisable 8. If a female of child bearing potential, have a negative pregnancy test
Exclusion criteria
(Screening) A Subject is NOT eligible for entry if ANY of the following criteria are met: 1. Is not able to comply with the plasma sampling requirements of the Study 2. Has known or suspected hypersensitivity to acetaminophen or the inactive excipients of IV Acetaminophen. 3. Has been taking any acetaminophen-containing product in the 12 hours prior or any of the following in the 48 hours prior to randomization in the Study: probenecid, disulfiram, isoniazide, St. John's wort, skullcap, chaparral, comfrey, germander, jin bu huan, kava, pennyroyal, and valerian 4. Has any significant medical condition that in the opinion of the Investigator contraindicates participation in the Study 5. Has impaired liver function, with evidence of clinically significant liver disease, or other condition that may suggest the potential for an increased susceptibility to hepatic toxicity with IV APAP exposure. For this criterion, a total bilirubin greater than 1.5 times upper limit of normal (ULN) for age or an Alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) or Aspartate transaminase (AST) serum glutamic oxaloacetic transaminase (SGOT) greater than 2.5 times ULN for age will be deemed as evidence of clinically significant (Common Terminology Criteria for Adverse Events \[CTCAE\] Grade 2) liver dysfunction or disease. 6. Has significantly impaired renal function or known significant renal disease, as evidenced by an estimated glomerular filtration rate (using the Schwartz formula) calculated to be less than 1/3rd of normal for the applicable age strata 7. Has participated in another interventional clinical Study (investigational or marketed product) within 30 days of the planned Study randomization date
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Single-dose Maximum Plasma Concentration (Cmax) , Micrograms Per Milliliter (µg/mL) Pharmacokinetics of IV Acetaminophen | Time Zero (just prior to first dose) to 24 hours post first dose | Cmax: Maximum Plasma Concentration |
| Single-dose Time to Reach Maximum Plasma Concentration [Tmax(h)] Pharmacokinetics of IV Acetaminophen | Time Zero (just prior to first dose) to 24 hours post first dose | Tmax: Time to reach maximum plasma concentration (Cmax) |
| 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 | Time Zero (just prior to first dose) to 48 hours post first dose | AUC 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. |
| Multiple-dose Terminal Elimination Half-life [t1/2(h)] Pharmacokinetics of IV Acetaminophen | 48hrs | t1/2: Terminal elimination half-life |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE) | First dose of study medication to 30 days after the last dose of study medication | A TEAE is defined as an adverse event that starts on or after the start of study medication |
| Subjects Who Experience at Least One Serious Treatment-Emergent Adverse Event (TEAE) | First dose to 30 days following last dose of study medication | 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 |
Countries
United States
Participant flow
Recruitment details
The study was conducted at 5 sites in the US from 27 June 2007 to 01Sep 2008.
Participants by arm
| Arm | Count |
|---|---|
| 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) | 2 |
| 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) | 1 |
| 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. | 12 |
| 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. | 13 |
| 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. | 9 |
| 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. | 16 |
| 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. | 12 |
| 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. | 10 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | No access to draw blood | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen | Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen | Infants: 12.5 mg/kg q4h IV Acetaminophen | Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen | Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen | Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen | Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen | Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 2 Participants | 1 Participants | 12 Participants | 13 Participants | 9 Participants | 16 Participants | 12 Participants | 10 Participants | 75 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 4 Participants | 7 Participants | 4 Participants | 6 Participants | 2 Participants | 6 Participants | 31 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 8 Participants | 6 Participants | 5 Participants | 10 Participants | 10 Participants | 4 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 2 | 1 / 1 | 10 / 12 | 7 / 13 | 1 / 9 | 10 / 16 | 10 / 12 | 5 / 10 |
| serious Total, serious adverse events | 0 / 2 | 0 / 1 | 0 / 12 | 1 / 13 | 1 / 9 | 2 / 16 | 1 / 12 | 1 / 10 |
Outcome results
Primary
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
AUC 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.
Time frame: Time Zero (just prior to first dose) to 48 hours post first dose
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen | 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 |
| Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen | 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 | 105 µg*h/ml |
| Infants: 12.5 mg/kg q4h IV Acetaminophen | 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 | 43.3 µg*h/ml |
| Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen | 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 | 51.9 µg*h/ml |
| Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen | 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 | 37.8 µg*h/ml |
| Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen | 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 | 48.0 µg*h/ml |
| Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen | 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 | 47.7 µg*h/ml |
| Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen | 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 | 64.0 µg*h/ml |
Primary
Multiple-dose Terminal Elimination Half-life [t1/2(h)] Pharmacokinetics of IV Acetaminophen
t1/2: Terminal elimination half-life
Time frame: 48hrs
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen | Multiple-dose Terminal Elimination Half-life [t1/2(h)] Pharmacokinetics of IV Acetaminophen | 3.88 Hours |
| Infants: 12.5 mg/kg q4h IV Acetaminophen | Multiple-dose Terminal Elimination Half-life [t1/2(h)] Pharmacokinetics of IV Acetaminophen | 2.37 Hours |
| Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen | Multiple-dose Terminal Elimination Half-life [t1/2(h)] Pharmacokinetics of IV Acetaminophen | 2.79 Hours |
| Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen | Multiple-dose Terminal Elimination Half-life [t1/2(h)] Pharmacokinetics of IV Acetaminophen | 2.64 Hours |
| Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen | Multiple-dose Terminal Elimination Half-life [t1/2(h)] Pharmacokinetics of IV Acetaminophen | 2.77 Hours |
| Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen | Multiple-dose Terminal Elimination Half-life [t1/2(h)] Pharmacokinetics of IV Acetaminophen | 3.37 Hours |
| Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen | Multiple-dose Terminal Elimination Half-life [t1/2(h)] Pharmacokinetics of IV Acetaminophen | 4.10 Hours |
Primary
Single-dose Maximum Plasma Concentration (Cmax) , Micrograms Per Milliliter (µg/mL) Pharmacokinetics of IV Acetaminophen
Cmax: Maximum Plasma Concentration
Time frame: Time Zero (just prior to first dose) to 24 hours post first dose
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen | Single-dose Maximum Plasma Concentration (Cmax) , Micrograms Per Milliliter (µg/mL) Pharmacokinetics of IV Acetaminophen | 40.1 micrograms per milliliter (µg/mL) |
| Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen | Single-dose Maximum Plasma Concentration (Cmax) , Micrograms Per Milliliter (µg/mL) Pharmacokinetics of IV Acetaminophen | 20.1 micrograms per milliliter (µg/mL) |
| Infants: 12.5 mg/kg q4h IV Acetaminophen | Single-dose Maximum Plasma Concentration (Cmax) , Micrograms Per Milliliter (µg/mL) Pharmacokinetics of IV Acetaminophen | 16.7 micrograms per milliliter (µg/mL) |
| Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen | Single-dose Maximum Plasma Concentration (Cmax) , Micrograms Per Milliliter (µg/mL) Pharmacokinetics of IV Acetaminophen | 19.3 micrograms per milliliter (µg/mL) |
| Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen | Single-dose Maximum Plasma Concentration (Cmax) , Micrograms Per Milliliter (µg/mL) Pharmacokinetics of IV Acetaminophen | 18.2 micrograms per milliliter (µg/mL) |
| Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen | Single-dose Maximum Plasma Concentration (Cmax) , Micrograms Per Milliliter (µg/mL) Pharmacokinetics of IV Acetaminophen | 21.6 micrograms per milliliter (µg/mL) |
| Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen | Single-dose Maximum Plasma Concentration (Cmax) , Micrograms Per Milliliter (µg/mL) Pharmacokinetics of IV Acetaminophen | 15.9 micrograms per milliliter (µg/mL) |
| Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen | Single-dose Maximum Plasma Concentration (Cmax) , Micrograms Per Milliliter (µg/mL) Pharmacokinetics of IV Acetaminophen | 25.5 micrograms per milliliter (µg/mL) |
Primary
Single-dose Time to Reach Maximum Plasma Concentration [Tmax(h)] Pharmacokinetics of IV Acetaminophen
Tmax: Time to reach maximum plasma concentration (Cmax)
Time frame: Time Zero (just prior to first dose) to 24 hours post first dose
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen | Single-dose Time to Reach Maximum Plasma Concentration [Tmax(h)] Pharmacokinetics of IV Acetaminophen | 0.450 Hour |
| Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen | Single-dose Time to Reach Maximum Plasma Concentration [Tmax(h)] Pharmacokinetics of IV Acetaminophen | 0.333 Hour |
| Infants: 12.5 mg/kg q4h IV Acetaminophen | Single-dose Time to Reach Maximum Plasma Concentration [Tmax(h)] Pharmacokinetics of IV Acetaminophen | 0.267 Hour |
| Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen | Single-dose Time to Reach Maximum Plasma Concentration [Tmax(h)] Pharmacokinetics of IV Acetaminophen | 0.267 Hour |
| Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen | Single-dose Time to Reach Maximum Plasma Concentration [Tmax(h)] Pharmacokinetics of IV Acetaminophen | 0.250 Hour |
| Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen | Single-dose Time to Reach Maximum Plasma Concentration [Tmax(h)] Pharmacokinetics of IV Acetaminophen | 0.250 Hour |
| Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen | Single-dose Time to Reach Maximum Plasma Concentration [Tmax(h)] Pharmacokinetics of IV Acetaminophen | 0.250 Hour |
| Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen | Single-dose Time to Reach Maximum Plasma Concentration [Tmax(h)] Pharmacokinetics of IV Acetaminophen | 0.267 Hour |
Secondary
Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE)
A TEAE is defined as an adverse event that starts on or after the start of study medication
Time frame: First dose of study medication to 30 days after the last dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen | Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE) | 2 Participants |
| Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen | Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE) | 1 Participants |
| Infants: 12.5 mg/kg q4h IV Acetaminophen | Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE) | 10 Participants |
| Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen | Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE) | 9 Participants |
| Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen | Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE) | 2 Participants |
| Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen | Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE) | 11 Participants |
| Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen | Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE) | 10 Participants |
| Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen | Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE) | 6 Participants |
Secondary
Subjects Who Experience at Least One Serious Treatment-Emergent Adverse Event (TEAE)
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
Time frame: First dose to 30 days following last dose of study medication
Population: All analyses of safety were conducted on the Safety population, which included those subjects who received any portion of a dose of IV acetaminophen.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen | Subjects Who Experience at Least One Serious Treatment-Emergent Adverse Event (TEAE) | 0 Participants |
| Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen | Subjects Who Experience at Least One Serious Treatment-Emergent Adverse Event (TEAE) | 0 Participants |
| Infants: 12.5 mg/kg q4h IV Acetaminophen | Subjects Who Experience at Least One Serious Treatment-Emergent Adverse Event (TEAE) | 0 Participants |
| Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen | Subjects Who Experience at Least One Serious Treatment-Emergent Adverse Event (TEAE) | 1 Participants |
| Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen | Subjects Who Experience at Least One Serious Treatment-Emergent Adverse Event (TEAE) | 1 Participants |
| Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen | Subjects Who Experience at Least One Serious Treatment-Emergent Adverse Event (TEAE) | 2 Participants |
| Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen | Subjects Who Experience at Least One Serious Treatment-Emergent Adverse Event (TEAE) | 1 Participants |
| Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen | Subjects Who Experience at Least One Serious Treatment-Emergent Adverse Event (TEAE) | 1 Participants |