Safety and Pharmacokinetic (PK) Study of Intravenous (IV)... | NCT00493246 | Trialant
NCT00493246
Sponsor
Mallinckrodt
Status
Completed
Last Update Posted
Oct 21, 2016Estimated
Enrollment
75Actual
Phase
Phase 1
Conditions
Pain
Fever
Interventions
IV Acetaminophen
IV Acetaminophen
Countries
United States
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT00493246
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CPI-APA-102
Secondary IDs
Not provided
Brief Title
Safety and Pharmacokinetic (PK) Study of Intravenous (IV) Acetaminophen Administration in Pediatric Inpatients
Official Title
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
Acronym
Not provided
Organization
MallinckrodtINDUSTRY
Status Module
Record Verification Date
Sep 2016
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 2007
Primary Completion Date
Nov 2008Actual
Completion Date
Nov 2008Actual
First Submitted Date
Jun 27, 2007
First Submission Date that Met QC Criteria
Jun 27, 2007
First Posted Date
Jun 28, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 25, 2009
Results First Submitted that Met QC Criteria
Nov 30, 2010
Results First Posted Date
Dec 29, 2010Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Sep 8, 2016
Last Update Posted Date
Oct 21, 2016Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
MallinckrodtINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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
Intravenous Acetaminophen administered 15 milligrams/kilogram (mg/kg) every 8 hours (q8h) or every 6 hours (q6h) based age of subject
Drug: IV Acetaminophen
Intravenous (IV) Acetaminophen 12.5 (mg/kg)
Experimental
Intravenous Acetaminophen administered 12.5 milligrams/kilogram (mg/kg) every 6 hours (q6h) or every 4 hours (q4h)
Drug: IV Acetaminophen
Interventions
Name
Type
Description
Arm Group Labels
Other Names
IV Acetaminophen
Drug
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
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Single-dose Maximum Plasma Concentration (Cmax) , Micrograms Per Milliliter (µg/mL) Pharmacokinetics of IV Acetaminophen
Cmax: Maximum Plasma Concentration
Time Zero (just prior to first dose) to 24 hours post first dose
Single-dose Time to Reach Maximum Plasma Concentration [Tmax(h)] Pharmacokinetics of IV Acetaminophen
Tmax: Time to reach maximum plasma concentration (Cmax)
Time Zero (just prior to first dose) to 24 hours post first dose
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 Zero (just prior to first dose) to 48 hours post first dose
Multiple-dose Terminal Elimination Half-life [t1/2(h)] Pharmacokinetics of IV Acetaminophen
t1/2: Terminal elimination half-life
48hrs
Secondary Outcomes
Measure
Description
Time Frame
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
First dose of study medication to 30 days after the last dose of study medication
Subjects Who Experience at Least One Serious Treatment-Emergent Adverse Event (TEAE)
Other Outcomes
Not provided
Eligibility Module
Eligibility 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:
Provide written Informed Consent/Assent prior to participation in the Study
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)
Inpatient status: are currently inpatients or have an admission scheduled and will soon become an inpatient (e.g., elective surgery)
Diagnosis: requires or will require analgesic treatment for acute pain or antipyretic treatment for fever
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)
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
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
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:
Is not able to comply with the plasma sampling requirements of the Study
Has known or suspected hypersensitivity to acetaminophen or the inactive excipients of IV Acetaminophen.
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
Has any significant medical condition that in the opinion of the Investigator contraindicates participation in the Study
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.
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
Has participated in another interventional clinical Study (investigational or marketed product) within 30 days of the planned Study randomization date
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
29 Days
Maximum Age
16 Years
Standard Ages
Child
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Lucile Packard Children's Hospital
Stanford
California
94305
United States
CS Mott Childrens Hospital
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Not provided
Recruitment Details
The study was conducted at 5 sites in the US from 27 June 2007 to 01Sep 2008.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
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)
FG001
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)
FG002
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.
FG003
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.
FG004
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.
FG005
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.
FG006
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.
FG007
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.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0011 subjects
FG00212 subjects
FG00313 subjects
FG0049 subjectsAll subjects who were randomized.Excludes 1 subject who was randomized in error.
FG00516 subjectsAll subjects who were randomized.
FG00612 subjectsAll subjects who were randomized.
FG00710 subjectsAll subjects who were randomized.
COMPLETED
FG0002 subjectsCompleted study 30 days after the last dose
FG0011 subjectsCompleted study 30 days after the last dose
FG00212 subjectsCompleted study 30 days after the last dose
FG003
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
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)
BG001
Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
The Safety Population (subjects who received any part of a dose of IV acetaminophen) are included in this baseline measure.
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Single-dose Maximum Plasma Concentration (Cmax) , Micrograms Per Milliliter (µg/mL) Pharmacokinetics of IV Acetaminophen
Cmax: Maximum Plasma Concentration
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.
Posted
Sep 2009
Median
Full Range
micrograms per milliliter (µg/mL)
Time Zero (just prior to first dose) to 24 hours post first dose
ID
Title
Description
OG000
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)
OG001
Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen
Adverse Events Module
Frequency Threshold
5
Time Frame
Adverse Events and Serious Adverse Events were reported from the start of study medication to 30 days following the last dose of study medication.
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
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)
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal Pain
Gastrointestinal disorders
MedDRA (10.0)
Non-systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acidosis
Metabolism and nutrition disorders
MedDRA (10.0)
Non-systematic Assessment
More Info Module
Limitations and Caveats
Median ranges were not calculated or not assessable for neonates at the following due to limited samples.:
12.5 mg/kg q6h- t1/2 (h)
15 mg/kg q8h -Cmax, Tmax, AUC0-t and t1/2.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Point of Contact
Title
Organization
Phone
Extension
Email
Lawrence Hill
Mallinckrodt Pharmaceuticals
908-238-6370
lawrence.hill@mallinckrodt.com
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D010146
Pain
D005334
Fever
Ancestor Terms
ID
Term
D009461
Neurologic Manifestations
D012816
Signs and Symptoms
D013568
Pathological Conditions, Signs and Symptoms
D001832
Body Temperature Changes
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
MeSH Terms
ID
Term
D000082
Acetaminophen
Ancestor Terms
ID
Term
D000083
Acetanilides
D000813
Anilides
D000577
Amides
D009930
Organic Chemicals
D000814
Browse Leaves
Not provided
Browse Branches
Not provided
Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Intravenous (IV) Acetaminophen 12.5 (mg/kg)
APAP
IV APAP
IV Acetaminophen
Drug
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
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
First dose to 30 days following last dose of study medication
Ann Arbor
Michigan
48109
United States
Duke University Health Systems
Durham
North Carolina
27710
United States
Children's Hospital Of Philadelphia
Philadelphia
Pennsylvania
19104
United States
Children's Hospital Of Pittsburgh
Pittsburgh
Pennsylvania
15213
United States
13 subjects
Completed study 30 days after the last dose
FG0048 subjectsCompleted study 30 days after the last dose
FG00515 subjectsCompleted study 30 days after the last dose
FG00611 subjectsCompleted study 30 days after the last dose
FG00710 subjectsCompleted study 30 days after the last dose
1 subjects
FG0051 subjects
FG0061 subjects
FG0070 subjects
0 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
No access to draw blood
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
BG002
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.
BG003
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.
BG004
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.
BG005
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.
BG006
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.
BG007
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.
BG008
Total
Total of all reporting groups
2
BG0011
BG00212
BG00313
BG0049
BG00516
BG00612
BG00710
BG00875
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0002
BG0011
BG00212
BG00313
BG0049
BG00516
BG00612
BG00710
BG00875
Between 18 and 65 years
BG0000
BG0010
BG0020
BG0030
BG004
>=65 years
BG0000
BG0010
BG0020
BG0030
BG004
Sex: Female, Male
The Safety Population (subjects who received any part of a dose of IV acetaminophen) are included in this baseline measure.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0011
BG0024
BG0037
BG0044
BG0056
BG0062
BG0076
BG00831
Male
BG0001
BG0010
BG0028
BG0036
BG004
Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
Units
Counts
Participants
OG0002
OG0011
OG00212
OG00313
OG0049
OG00516
OG00612
OG00710
Title
Denominators
Categories
Title
Measurements
OG00040.1(15.9 to 64.4)
OG00120.1(20.1 to 20.1)
OG00216.7(12.1 to 23.0)
OG00319.3(16.2 to 25.4)
OG00418.2(13.5 to 27.1)
OG00521.6(14.4 to 60.8)
OG00615.9(10.6 to 28.8)
OG00725.5(9.91 to 49.8)
Primary
Single-dose Time to Reach Maximum Plasma Concentration [Tmax(h)] Pharmacokinetics of IV Acetaminophen
Tmax: Time to reach maximum plasma concentration (Cmax)
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.
Posted
Median
Full Range
Hour
Time Zero (just prior to first dose) to 24 hours post first dose
ID
Title
Description
OG000
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)
OG001
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)
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
Units
Counts
Participants
OG0002
OG0011
OG00212
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.450(0.400 to 0.500)
OG0010.333(0.333 to 0.333)
OG0020.267(0.000 to 0.383)
OG003
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.
Posted
Sep 2009
Median
Full Range
µg*h/ml
Time Zero (just prior to first dose) to 48 hours post first dose
ID
Title
Description
OG000
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)
OG001
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)
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
Units
Counts
Participants
OG0002
OG0011
OG00212
OG003
Title
Denominators
Categories
Title
Measurements
OG00065.6(55.8 to 75.4)
OG001105(105 to 105)
OG00243.3(9.15 to 79.2)
OG003
Primary
Multiple-dose Terminal Elimination Half-life [t1/2(h)] Pharmacokinetics of IV Acetaminophen
t1/2: Terminal elimination half-life
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.
Posted
Sep 2009
Median
Full Range
Hours
48hrs
ID
Title
Description
OG000
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)
OG001
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)
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
Units
Counts
Participants
OG0002
OG0010
OG00212
OG003
Title
Denominators
Categories
Title
Measurements
OG0003.88(3.88 to 3.88)
OG0022.37(1.15 to 2.81)
OG0032.79(2.10 to 5.43)
OG004
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
Posted
Sep 2009
Number
Participants
First dose of study medication to 30 days after the last dose of study medication
ID
Title
Description
OG000
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)
OG001
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)
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
Units
Counts
Participants
OG0002
OG0011
OG00212
OG003
Title
Denominators
Categories
Title
Measurements
OG0002
OG0011
OG00210
OG003
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
All analyses of safety were conducted on the Safety population, which included those subjects who received any portion of a dose of IV acetaminophen.
Posted
Number
Participants
First dose to 30 days following last dose of study medication
ID
Title
Description
OG000
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)
OG001
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)
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
Units
Counts
Participants
OG0002
OG0011
OG00212
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
0
2
2
2
EG001
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)
0
1
1
1
EG002
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.
0
12
10
12
EG003
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.
1
13
7
13
EG004
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.
1
9
1
9
EG005
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.
2
16
10
16
EG006
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.
1
12
10
12
EG007
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.
1
10
5
10
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected12 at risk
EG0030 affected13 at risk
EG0040 affected9 at risk
EG0050 affected16 at risk
EG0060 affected12 at risk
EG0071 affected10 at risk
Convulsion
Nervous system disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected12 at risk
EG0031 affected13 at risk
EG0040 affected9 at risk
EG0050 affected16 at risk
EG0060 affected12 at risk
EG0070 affected10 at risk
Mediastinal disorders chylothorax
Respiratory, thoracic and mediastinal disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected12 at risk
EG0030 affected13 at risk
EG0040 affected9 at risk
EG0051 affected16 at risk
EG0060 affected12 at risk
EG0070 affected10 at risk
Post procedural drainage
Surgical and medical procedures
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected12 at risk
EG0030 affected13 at risk
EG0040 affected9 at risk
EG0050 affected16 at risk
EG0061 affected12 at risk
EG0070 affected10 at risk
Thoracic cavity drainage test abnormal
Investigations
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected12 at risk
EG0030 affected13 at risk
EG0041 affected9 at risk
EG0050 affected16 at risk
EG0060 affected12 at risk
EG0070 affected10 at risk
Wound infection
Infections and infestations
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected12 at risk
EG0030 affected13 at risk
EG0040 affected9 at risk
EG0051 affected16 at risk
EG0060 affected12 at risk
EG0070 affected10 at risk
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0021 affected12 at risk
EG0030 affected13 at risk
EG0040 affected9 at risk
EG0050 affected16 at risk
EG0060 affected12 at risk
EG0070 affected10 at risk
Agitation
Psychiatric disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected12 at risk
EG0031 affected13 at risk
EG0040 affected9 at risk
EG0050 affected16 at risk
EG0061 affected12 at risk
EG0071 affected10 at risk
Allergic Transfusion Reaction
Injury, poisoning and procedural complications
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected12 at risk
EG0030 affected13 at risk
EG0040 affected9 at risk
EG0050 affected16 at risk
EG0060 affected12 at risk
EG0071 affected10 at risk
Anemia
Blood and lymphatic system disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0021 affected12 at risk
EG0031 affected13 at risk
EG0040 affected9 at risk
EG0050 affected16 at risk
EG0060 affected12 at risk
EG0070 affected10 at risk
Anxiety
Psychiatric disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected12 at risk
EG0030 affected13 at risk
EG0040 affected9 at risk
EG0051 affected16 at risk
EG0060 affected12 at risk
EG0071 affected10 at risk
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA 10.0
Non-systematic Assessment
EG0001 affected2 at risk
EG0011 affected1 at risk
EG0021 affected12 at risk
EG0032 affected13 at risk
EG0040 affected9 at risk
EG0053 affected16 at risk
EG0061 affected12 at risk
EG0070 affected10 at risk
Blister
Skin and subcutaneous tissue disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected12 at risk
EG0030 affected13 at risk
EG0040 affected9 at risk
EG0051 affected16 at risk
EG0060 affected12 at risk
EG0070 affected10 at risk
Central Line Infection
Infections and infestations
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected12 at risk
EG0031 affected13 at risk
EG0040 affected9 at risk
EG0050 affected16 at risk
EG0060 affected12 at risk
EG0070 affected10 at risk
Cerebrovascular Spasm
Nervous system disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected12 at risk
EG0030 affected13 at risk
EG0041 affected9 at risk
EG0050 affected16 at risk
EG0060 affected12 at risk
EG0070 affected10 at risk
Constipation
Gastrointestinal disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected12 at risk
EG0032 affected13 at risk
EG0040 affected9 at risk
EG0051 affected16 at risk
EG0062 affected12 at risk
EG0070 affected10 at risk
Face edema
General disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected12 at risk
EG0030 affected13 at risk
EG0041 affected9 at risk
EG0051 affected16 at risk
EG0061 affected12 at risk
EG0070 affected10 at risk
Haemoglobin Decreased
Investigations
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected12 at risk
EG0030 affected13 at risk
EG0040 affected9 at risk
EG0050 affected16 at risk
EG0060 affected12 at risk
EG0071 affected10 at risk
Hypertension
Vascular disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected12 at risk
EG0031 affected13 at risk
EG0040 affected9 at risk
EG0050 affected16 at risk
EG0060 affected12 at risk
EG0070 affected10 at risk
Hypokalemia
Metabolism and nutrition disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0022 affected12 at risk
EG0031 affected13 at risk
EG0041 affected9 at risk
EG0052 affected16 at risk
EG0060 affected12 at risk
EG0071 affected10 at risk
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 10.0
Non-systematic Assessment
EG0001 affected2 at risk
EG0010 affected1 at risk
EG0023 affected12 at risk
EG0031 affected13 at risk
EG0040 affected9 at risk
EG0051 affected16 at risk
EG0061 affected12 at risk
EG0071 affected10 at risk
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected12 at risk
EG0030 affected13 at risk
EG0041 affected9 at risk
EG0051 affected16 at risk
EG0060 affected12 at risk
EG0070 affected10 at risk
Insomnia
Psychiatric disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected12 at risk
EG0030 affected13 at risk
EG0040 affected9 at risk
EG0050 affected16 at risk
EG0061 affected12 at risk
EG0070 affected10 at risk
Liver Function Test Abnormal
Investigations
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected12 at risk
EG0030 affected13 at risk
EG0040 affected9 at risk
EG0050 affected16 at risk
EG0060 affected12 at risk
EG0071 affected10 at risk
Nausea
Gastrointestinal disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected12 at risk
EG0031 affected13 at risk
EG0040 affected9 at risk
EG0054 affected16 at risk
EG0065 affected12 at risk
EG0072 affected10 at risk
Oedema
General disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0021 affected12 at risk
EG0030 affected13 at risk
EG0040 affected9 at risk
EG0050 affected16 at risk
EG0060 affected12 at risk
EG0070 affected10 at risk
Oliguria
Renal and urinary disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0021 affected12 at risk
EG0030 affected13 at risk
EG0040 affected9 at risk
EG0050 affected16 at risk
EG0060 affected12 at risk
EG0070 affected10 at risk
Periorbital edema
Skin and subcutaneous tissue disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected12 at risk
EG0030 affected13 at risk
EG0041 affected9 at risk
EG0051 affected16 at risk
EG0061 affected12 at risk
EG0070 affected10 at risk
Pleural Effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (10.0)
Non-systematic Assessment
EG0001 affected2 at risk
EG0010 affected1 at risk
EG0024 affected12 at risk
EG0030 affected13 at risk
EG0040 affected9 at risk
EG0053 affected16 at risk
EG0061 affected12 at risk
EG0071 affected10 at risk
Polyuria
Renal and urinary disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected12 at risk
EG0031 affected13 at risk
EG0040 affected9 at risk
EG0050 affected16 at risk
EG0060 affected12 at risk
EG0070 affected10 at risk
Procedural Hypertension
Injury, poisoning and procedural complications
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected12 at risk
EG0030 affected13 at risk
EG0040 affected9 at risk
EG0050 affected16 at risk
EG0061 affected12 at risk
EG0070 affected10 at risk
Pruritis
Skin and subcutaneous tissue disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0021 affected12 at risk
EG0031 affected13 at risk
EG0040 affected9 at risk
EG0055 affected16 at risk
EG0061 affected12 at risk
EG0072 affected10 at risk
Pulmonary Edema
Respiratory, thoracic and mediastinal disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected1 at risk
EG0022 affected12 at risk
EG0031 affected13 at risk
EG0041 affected9 at risk
EG0050 affected16 at risk
EG0060 affected12 at risk
EG0070 affected10 at risk
Pulmonary Hypertension
Respiratory, thoracic and mediastinal disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected12 at risk
EG0031 affected13 at risk
EG0040 affected9 at risk
EG0050 affected16 at risk
EG0060 affected12 at risk
EG0070 affected10 at risk
Pyrexia
General disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected12 at risk
EG0030 affected13 at risk
EG0040 affected9 at risk
EG0051 affected16 at risk
EG0061 affected12 at risk
EG0071 affected10 at risk
Rash
Skin and subcutaneous tissue disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected12 at risk
EG0031 affected13 at risk
EG0040 affected9 at risk
EG0050 affected16 at risk
EG0060 affected12 at risk
EG0070 affected10 at risk
Stridor
Respiratory, thoracic and mediastinal disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0022 affected12 at risk
EG0031 affected13 at risk
EG0040 affected9 at risk
EG0050 affected16 at risk
EG0060 affected12 at risk
EG0070 affected10 at risk
Vocal Cord Paralysis
Nervous system disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0020 affected12 at risk
EG0031 affected13 at risk
EG0040 affected9 at risk
EG0050 affected16 at risk
EG0060 affected12 at risk
EG0070 affected10 at risk
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA (10.0)
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected1 at risk
EG0022 affected12 at risk
EG0032 affected13 at risk
EG0040 affected9 at risk
EG0050 affected16 at risk
EG0060 affected12 at risk
EG0070 affected10 at risk
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.