Fever, Pain
Conditions
Brief summary
Intravenous acetaminophen (IVAPAP) is safe in repeated dose, multi-day clinical use when administered at a daily dose of 40 to 75 mg/kg body weight
Detailed description
To assess the safety of intravenous acetaminophen (IV APAP) when used over one or more days for the treatment of acute pain or fever in pediatric (neonates, infants, children and adolescents) inpatients who are unable to take anything by mouth (NPO), require or would benefit from IV treatment, or are willing and able to stay on IVAPAP therapy for 1 to 7 days.
Interventions
DRUGIV Acetaminophen
Target is 1 to 7 days of therapy with intravenous (IV) Acetaminophen (IV APAP) at a dose of 40 to 75 mg/kg body weight/day administered as an IV infusion (or by syringe pump) over 15 minutes and given every 4 to 6 hours as a scheduled dose
Sponsors
Mallinckrodt
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
37 Weeks to 16 Years
Healthy volunteers
No
Inclusion criteria
* The Subject's Parent or Guardian must provide written informed consent, with Subject assent where appropriate, prior to the Subject's participation in the Study. * Be less than 17 years of age and older than 37 weeks post conception * Anticipated by the Investigator to require multi-day (minimum of one day) use of intravenous (IV) treatment either because of a having a status of nothing by mouth (NPO) or a medical condition that makes oral intake difficult or be willing to undergo at least 5 days of treatment with IV acetaminophen for the treatment of pain or fever * Have the ability to read and understand the Study procedures and have the ability to communicate meaningfully with the Study Investigator and staff (if the Subject is of preverbal age or cannot read or communicate meaningfully, then the Subject's Parent or Guardian must meet this criterion) * If a female of child bearing potential, have a negative pregnancy test
Exclusion criteria
* Has significant medical disease(s), laboratory abnormalities or condition(s) that in the Investigator's judgment could compromise the Subject's welfare, ability to communicate with the Study staff, complete Study activities, or would otherwise contraindicate Study participation * Has known hypersensitivity or contraindication to receiving IV acetaminophen or the inactive ingredients (excipients) of IV acetaminophen * Has impaired liver function, e.g. Alanine aminotransferase (ALT) greater than or equal to 3 times the upper limit of normal (ULN), bilirubin greater than or equal to 3 times ULN, known active hepatic disease (e.g., hepatitis), evidence of clinically significant chronic liver disease or other condition affecting the liver (e.g., alcoholism as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), cirrhosis, or chronic hepatitis) that may suggest the potential for an increased susceptibility to hepatic toxicity with IV acetaminophen exposure * Has participated in an interventional clinical Study (investigational or marketed product) within 30 days of Study entry
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting at Least One Treatment Emergent Adverse Event (TEAE) | First dose to end of treatment period | A TEAE is defined as an adverse event that starts on or after the start of study medication. |
| Number of Subjects Reporting at Least One Serious Treatment Emergent Adverse Event | First dose to 30 days after last dose | A Serious Treatment Emergent Adverse Event is defined as any untoward medical occurrence at any dose of IV APAP 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Day 0 to Day 5, Day 7 or Early Termination from study | Subject's (parent/guardian) was asked to evaluate the overall study treatment using a 4-point categorical evaluation scale (0= poor, 1= fair, 2=good, 3= excellent). |
| Physician's Global Assessment of Study Treatment | End of study or Early Termination | Physicians were asked to evaluate the overall study treatment using a 4-point categorical evaluation scale (0= poor, 1= fair,2=good, 3= excellent). |
Countries
United States
Participant flow
Recruitment details
Multi-center study conducted in the United States from 19 Mar 2008 - 24Dec 2008
Pre-assignment details
No subjects were entered into the Infants (29 days to 1 year old): IV APAP 6.7 - 12.5 mg/kg q4h group
Participants by arm
| Arm | Count |
|---|---|
| Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours | 1 |
| Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours | 3 |
| Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h Children 2 to \< 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours | 7 |
| Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h Children 2 to \< 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours | 33 |
| Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h Adolescents 12 to \<= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours | 9 |
| Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h Adolescents 12 to \<= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours | 42 |
| Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h Infants 12 to \< 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours | 1 |
| Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h Infants 12 to \< 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours | 4 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Dose limiting toxicity | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 0 |
| Overall Study | Early discharge from hospital | 0 | 0 | 2 | 5 | 0 | 10 | 1 | 0 |
| Overall Study | Other | 0 | 2 | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h | Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h | Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h | Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h | Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h | Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h | Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h | Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 3 Participants | 7 Participants | 33 Participants | 9 Participants | 42 Participants | 1 Participants | 4 Participants | 100 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 | 0 Participants | 2 Participants | 5 Participants | 17 Participants | 6 Participants | 29 Participants | 0 Participants | 3 Participants | 62 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants | 16 Participants | 3 Participants | 13 Participants | 1 Participants | 1 Participants | 38 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 | 1 / 1 | 1 / 3 | 5 / 7 | 24 / 33 | 9 / 9 | 33 / 42 | 0 / 1 | 2 / 4 |
| serious Total, serious adverse events | 1 / 1 | 1 / 3 | 0 / 7 | 13 / 33 | 2 / 9 | 3 / 42 | 0 / 1 | 1 / 4 |
Outcome results
Primary
Number of Subjects Reporting at Least One Serious Treatment Emergent Adverse Event
A Serious Treatment Emergent Adverse Event is defined as any untoward medical occurrence at any dose of IV APAP 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 after last dose
Population: All analysis will be carried out using the safety population, defined as all subjects who received at least one dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h | Number of Subjects Reporting at Least One Serious Treatment Emergent Adverse Event | 1 Subjects |
| Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h | Number of Subjects Reporting at Least One Serious Treatment Emergent Adverse Event | 1 Subjects |
| Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h | Number of Subjects Reporting at Least One Serious Treatment Emergent Adverse Event | 0 Subjects |
| Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h | Number of Subjects Reporting at Least One Serious Treatment Emergent Adverse Event | 13 Subjects |
| Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h | Number of Subjects Reporting at Least One Serious Treatment Emergent Adverse Event | 2 Subjects |
| Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h | Number of Subjects Reporting at Least One Serious Treatment Emergent Adverse Event | 3 Subjects |
| Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h | Number of Subjects Reporting at Least One Serious Treatment Emergent Adverse Event | 0 Subjects |
| Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h | Number of Subjects Reporting at Least One Serious Treatment Emergent Adverse Event | 1 Subjects |
Primary
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 to end of treatment period
Population: All analysis will be carried out using the safety population, defined as all subjects who received at least one dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h | Number of Subjects Reporting at Least One Treatment Emergent Adverse Event (TEAE) | 1 Subjects |
| Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h | Number of Subjects Reporting at Least One Treatment Emergent Adverse Event (TEAE) | 1 Subjects |
| Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h | Number of Subjects Reporting at Least One Treatment Emergent Adverse Event (TEAE) | 5 Subjects |
| Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h | Number of Subjects Reporting at Least One Treatment Emergent Adverse Event (TEAE) | 25 Subjects |
| Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h | Number of Subjects Reporting at Least One Treatment Emergent Adverse Event (TEAE) | 9 Subjects |
| Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h | Number of Subjects Reporting at Least One Treatment Emergent Adverse Event (TEAE) | 35 Subjects |
| Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h | Number of Subjects Reporting at Least One Treatment Emergent Adverse Event (TEAE) | 0 Subjects |
| Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h | Number of Subjects Reporting at Least One Treatment Emergent Adverse Event (TEAE) | 2 Subjects |
Secondary
Physician's Global Assessment of Study Treatment
Physicians were asked to evaluate the overall study treatment using a 4-point categorical evaluation scale (0= poor, 1= fair,2=good, 3= excellent).
Time frame: End of study or Early Termination
Population: All analysis will be carried out using the safety population, defined as all subjects who received at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h | Physician's Global Assessment of Study Treatment | Fair | 0 participants |
| Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h | Physician's Global Assessment of Study Treatment | Excellent | 1 participants |
| Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h | Physician's Global Assessment of Study Treatment | Poor | 0 participants |
| Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h | Physician's Global Assessment of Study Treatment | Good | 0 participants |
| Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h | Physician's Global Assessment of Study Treatment | Missing | 0 participants |
| Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h | Physician's Global Assessment of Study Treatment | Excellent | 1 participants |
| Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h | Physician's Global Assessment of Study Treatment | Good | 2 participants |
| Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h | Physician's Global Assessment of Study Treatment | Poor | 0 participants |
| Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h | Physician's Global Assessment of Study Treatment | Missing | 0 participants |
| Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h | Physician's Global Assessment of Study Treatment | Fair | 0 participants |
| Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h | Physician's Global Assessment of Study Treatment | Excellent | 6 participants |
| Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h | Physician's Global Assessment of Study Treatment | Poor | 0 participants |
| Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h | Physician's Global Assessment of Study Treatment | Missing | 0 participants |
| Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h | Physician's Global Assessment of Study Treatment | Fair | 0 participants |
| Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h | Physician's Global Assessment of Study Treatment | Good | 1 participants |
| Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h | Physician's Global Assessment of Study Treatment | Good | 15 participants |
| Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h | Physician's Global Assessment of Study Treatment | Poor | 0 participants |
| Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h | Physician's Global Assessment of Study Treatment | Fair | 0 participants |
| Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h | Physician's Global Assessment of Study Treatment | Excellent | 13 participants |
| Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h | Physician's Global Assessment of Study Treatment | Missing | 5 participants |
| Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h | Physician's Global Assessment of Study Treatment | Good | 4 participants |
| Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h | Physician's Global Assessment of Study Treatment | Missing | 0 participants |
| Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h | Physician's Global Assessment of Study Treatment | Poor | 0 participants |
| Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h | Physician's Global Assessment of Study Treatment | Fair | 0 participants |
| Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h | Physician's Global Assessment of Study Treatment | Excellent | 5 participants |
| Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h | Physician's Global Assessment of Study Treatment | Excellent | 25 participants |
| Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h | Physician's Global Assessment of Study Treatment | Missing | 0 participants |
| Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h | Physician's Global Assessment of Study Treatment | Fair | 1 participants |
| Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h | Physician's Global Assessment of Study Treatment | Poor | 0 participants |
| Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h | Physician's Global Assessment of Study Treatment | Good | 16 participants |
| Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h | Physician's Global Assessment of Study Treatment | Fair | 0 participants |
| Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h | Physician's Global Assessment of Study Treatment | Good | 0 participants |
| Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h | Physician's Global Assessment of Study Treatment | Missing | 0 participants |
| Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h | Physician's Global Assessment of Study Treatment | Excellent | 1 participants |
| Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h | Physician's Global Assessment of Study Treatment | Poor | 0 participants |
| Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h | Physician's Global Assessment of Study Treatment | Missing | 1 participants |
| Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h | Physician's Global Assessment of Study Treatment | Excellent | 2 participants |
| Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h | Physician's Global Assessment of Study Treatment | Poor | 0 participants |
| Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h | Physician's Global Assessment of Study Treatment | Fair | 0 participants |
| Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h | Physician's Global Assessment of Study Treatment | Good | 1 participants |
Secondary
Subject's (Parent/Guardian) Global Evaluation of Study Treatment
Subject's (parent/guardian) was asked to evaluate the overall study treatment using a 4-point categorical evaluation scale (0= poor, 1= fair, 2=good, 3= excellent).
Time frame: Day 0 to Day 5, Day 7 or Early Termination from study
Population: All analysis will be carried out using the safety population, defined as all subjects who received at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h | Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Poor | 0 participants |
| Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h | Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Missing | 0 participants |
| Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h | Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Excellent | 1 participants |
| Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h | Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Good | 0 participants |
| Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h | Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Fair | 0 participants |
| Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h | Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Fair | 0 participants |
| Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h | Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Excellent | 0 participants |
| Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h | Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Missing | 0 participants |
| Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h | Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Good | 3 participants |
| Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h | Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Poor | 0 participants |
| Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h | Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Fair | 0 participants |
| Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h | Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Missing | 0 participants |
| Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h | Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Poor | 0 participants |
| Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h | Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Excellent | 6 participants |
| Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h | Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Good | 1 participants |
| Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h | Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Good | 11 participants |
| Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h | Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Missing | 5 participants |
| Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h | Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Poor | 0 participants |
| Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h | Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Fair | 0 participants |
| Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h | Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Excellent | 17 participants |
| Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h | Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Good | 3 participants |
| Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h | Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Poor | 0 participants |
| Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h | Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Fair | 1 participants |
| Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h | Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Excellent | 5 participants |
| Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h | Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Missing | 0 participants |
| Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h | Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Good | 17 participants |
| Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h | Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Excellent | 23 participants |
| Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h | Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Fair | 2 participants |
| Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h | Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Poor | 0 participants |
| Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h | Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Missing | 0 participants |
| Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h | Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Good | 0 participants |
| Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h | Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Poor | 0 participants |
| Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h | Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Fair | 0 participants |
| Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h | Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Missing | 0 participants |
| Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h | Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Excellent | 1 participants |
| Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h | Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Missing | 1 participants |
| Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h | Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Excellent | 2 participants |
| Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h | Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Poor | 0 participants |
| Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h | Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Good | 1 participants |
| Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h | Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Fair | 0 participants |