Trial Outcomes & Findings for Atomoxetine PBPK-PD Clinical Study (NCT NCT03154359)
NCT ID: NCT03154359
Last Updated: 2023-08-08
Results Overview
Classification of participants as "responders" versus "non-responders" is based on percent reduction in total National Initiative for Children's Healthcare Quality (NICHQ) Vanderbilt Assessment Scale (3rd edition) score from baseline. Participants with ≥40% reduction in total score from baseline are classified as responders. The scale assesses the presence and severity of 18 DSM-V criteria for attention deficit hyperactivity disorder (ADHD) symptoms. Symptoms are rated on a 4-point Likert-type scale: 0 ("Never") to 3 ("Very Often"). Maximum total symptom score is 54.The measure includes 8 questions assessing functional impairment ("Performance"). Impairment is rated on a 5-point Likert-type scale: 1 ("Excellent") to 5 ("Problematic").
COMPLETED
51 participants
6 weeks
2023-08-08
Participant Flow
Participants were recruited over 6 years from a patient population seeking care for Attention Deficit Hyperactivity Disorder (ADHD).
A total of 51 participants were enrolled in the study. All participants completed a screening visit, and 9 participants screenfailed/were determined to be ineligible.
Participant milestones
| Measure |
Atomoxetine HCl (Strattera)
Study participants will receive atomoxetine at a dose expected to result in steady-state maximum concentration (Cmax,ss) values of 400 ng/mL. Dose will be calculated using a model based on CYP2D6 predicted phenotype, height, weight, body habitus, and gender. Study clinicians may titrate up the dose to reach Cmax,ss values of 600 ng/mL or 800 ng/mL according to participant response.
|
|---|---|
|
Overall Study
STARTED
|
42
|
|
Overall Study
6 Weeks
|
29
|
|
Overall Study
18 Weeks
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
22
|
Reasons for withdrawal
| Measure |
Atomoxetine HCl (Strattera)
Study participants will receive atomoxetine at a dose expected to result in steady-state maximum concentration (Cmax,ss) values of 400 ng/mL. Dose will be calculated using a model based on CYP2D6 predicted phenotype, height, weight, body habitus, and gender. Study clinicians may titrate up the dose to reach Cmax,ss values of 600 ng/mL or 800 ng/mL according to participant response.
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|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Lack of Efficacy
|
2
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Physician Decision
|
3
|
|
Overall Study
Protocol Violation
|
4
|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Disruption of study due to COVID-19
|
4
|
Baseline Characteristics
Atomoxetine PBPK-PD Clinical Study
Baseline characteristics by cohort
| Measure |
Atomoxetine HCl (Strattera)
n=42 Participants
Study participants will receive atomoxetine at a dose expected to result in steady-state maximum concentration (Cmax,ss) values of 400 ng/mL. Individualized dose to achieve the desired Cmax,ss of 400 ng/ml (approximately 90 minutes after dose administration) is determined using a pharmacokinetic model that includes as input information each participant's CYP2D6 genotype-predicted phenotype, height, weight, body habitus, and gender. Study clinicians may titrate up the dose to reach predicted Cmax,ss values of 600 ng/mL or 800 ng/mL according to participant response.
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|---|---|
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Age, Continuous
|
10.62 years
STANDARD_DEVIATION 2.75 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Neuropsychiatric Comorbidities
Anxiety
|
3 Participants
n=5 Participants
|
|
Neuropsychiatric Comorbidities
Oppositional Defiant Disorder
|
4 Participants
n=5 Participants
|
|
Neuropsychiatric Comorbidities
Dyslexia
|
2 Participants
n=5 Participants
|
|
Neuropsychiatric Comorbidities
Learning Delay
|
2 Participants
n=5 Participants
|
|
Neuropsychiatric Comorbidities
Other
|
2 Participants
n=5 Participants
|
|
Neuropsychiatric Comorbidities
None
|
29 Participants
n=5 Participants
|
|
Weight
|
42.93 kilograms (kg)
STANDARD_DEVIATION 20.78 • n=5 Participants
|
|
ADHD Subtype (based on NICHQ Vanderbilt Assessment Scale score)
Inattentive Subtype
|
9 Participants
n=5 Participants
|
|
ADHD Subtype (based on NICHQ Vanderbilt Assessment Scale score)
Hyperactive/Impulsive Subtype
|
2 Participants
n=5 Participants
|
|
ADHD Subtype (based on NICHQ Vanderbilt Assessment Scale score)
Combined Subtype
|
27 Participants
n=5 Participants
|
|
ADHD Subtype (based on NICHQ Vanderbilt Assessment Scale score)
Below Threshold
|
4 Participants
n=5 Participants
|
|
ADHD Subtype (based on K-SADS-PL)
Inattentive Subtype
|
16 Participants
n=5 Participants
|
|
ADHD Subtype (based on K-SADS-PL)
Hyperactive/Impulsive Subtype
|
3 Participants
n=5 Participants
|
|
ADHD Subtype (based on K-SADS-PL)
Combine Subtype
|
21 Participants
n=5 Participants
|
|
ADHD Subtype (based on K-SADS-PL)
Below Threshold
|
2 Participants
n=5 Participants
|
|
CYP2D6 Activity Score
0
|
3 Participants
n=5 Participants
|
|
CYP2D6 Activity Score
0.25
|
3 Participants
n=5 Participants
|
|
CYP2D6 Activity Score
0.5
|
1 Participants
n=5 Participants
|
|
CYP2D6 Activity Score
0.75
|
1 Participants
n=5 Participants
|
|
CYP2D6 Activity Score
1
|
15 Participants
n=5 Participants
|
|
CYP2D6 Activity Score
1.25
|
6 Participants
n=5 Participants
|
|
CYP2D6 Activity Score
1.5
|
5 Participants
n=5 Participants
|
|
CYP2D6 Activity Score
2
|
7 Participants
n=5 Participants
|
|
CYP2D6 Activity Score
3
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Individuals who completed 6 week milestone
Classification of participants as "responders" versus "non-responders" is based on percent reduction in total National Initiative for Children's Healthcare Quality (NICHQ) Vanderbilt Assessment Scale (3rd edition) score from baseline. Participants with ≥40% reduction in total score from baseline are classified as responders. The scale assesses the presence and severity of 18 DSM-V criteria for attention deficit hyperactivity disorder (ADHD) symptoms. Symptoms are rated on a 4-point Likert-type scale: 0 ("Never") to 3 ("Very Often"). Maximum total symptom score is 54.The measure includes 8 questions assessing functional impairment ("Performance"). Impairment is rated on a 5-point Likert-type scale: 1 ("Excellent") to 5 ("Problematic").
Outcome measures
| Measure |
Atomoxetine HCl (Strattera)
n=29 Participants
Study participants will receive atomoxetine at a dose expected to result in Cmax,ss values of 400 ng/mL. Study clinicians may titrate up the dose to reach Cmax,ss values of 600 ng/mL or 800 ng/mL according to participant response.
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|---|---|
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Number of Participants Classified as Responders and Non-responders to Intervention
Responders
|
14 Participants
|
|
Number of Participants Classified as Responders and Non-responders to Intervention
Non-Responders
|
15 Participants
|
PRIMARY outcome
Timeframe: 18 weeksPopulation: Participants who completed 18 week milestone
Classification of participants as "responders" versus "non-responders" is based on percent reduction in total National Initiative for Children's Healthcare Quality (NICHQ) Vanderbilt Assessment Scale (3rd edition) score from baseline. Participants with ≥40% reduction in total score from baseline are classified as responders. The scale assesses the presence and severity of 18 DSM-V criteria for attention deficit hyperactivity disorder (ADHD) symptoms. Symptoms are rated on a 4-point Likert-type scale: 0 ("Never") to 3 ("Very Often"). Maximum total symptom score is 54.The measure includes 8 questions assessing functional impairment ("Performance"). Impairment is rated on a 5-point Likert-type scale: 1 ("Excellent") to 5 ("Problematic").
Outcome measures
| Measure |
Atomoxetine HCl (Strattera)
n=20 Participants
Study participants will receive atomoxetine at a dose expected to result in Cmax,ss values of 400 ng/mL. Study clinicians may titrate up the dose to reach Cmax,ss values of 600 ng/mL or 800 ng/mL according to participant response.
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|---|---|
|
Number of Participants Classified as Responders and Non-responders to Intervention
Responder
|
13 Participants
|
|
Number of Participants Classified as Responders and Non-responders to Intervention
Non-Responder
|
7 Participants
|
PRIMARY outcome
Timeframe: Baseline (first dose)Population: 6-week and 18-week responder classifications have different sample sizes, as there are 2 milestones within this study.
Cmax is the highest concentration of atomoxetine measured over a 12-hour period following administration of the drug on pharmacokinetic study days occurring at baseline (first dose). Cmax is an estimate of atomoxetine systemic exposure and is compared between responders and non-responders.
Outcome measures
| Measure |
Atomoxetine HCl (Strattera)
n=29 Participants
Study participants will receive atomoxetine at a dose expected to result in Cmax,ss values of 400 ng/mL. Study clinicians may titrate up the dose to reach Cmax,ss values of 600 ng/mL or 800 ng/mL according to participant response.
|
|---|---|
|
Maximum Plasma Concentration (Cmax) of Atomoxetine
Responder at 6 weeks
|
268.5 ng/mL
Standard Deviation 117.2
|
|
Maximum Plasma Concentration (Cmax) of Atomoxetine
Non-Responder at 6 weeks
|
220.4 ng/mL
Standard Deviation 76.0
|
|
Maximum Plasma Concentration (Cmax) of Atomoxetine
Responder at 18 weeks
|
247.8 ng/mL
Standard Deviation 128.7
|
|
Maximum Plasma Concentration (Cmax) of Atomoxetine
Non-Responder at 18 weeks
|
216.2 ng/mL
Standard Deviation 77.3
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Participants who completed 6 week milestone
Cmax is the highest concentration of atomoxetine measured following administration of the drug on pharmacokinetic study days occurring at 6 weeks. Cmax is an estimate of atomoxetine systemic exposure and is compared between responders and non-responders.
Outcome measures
| Measure |
Atomoxetine HCl (Strattera)
n=29 Participants
Study participants will receive atomoxetine at a dose expected to result in Cmax,ss values of 400 ng/mL. Study clinicians may titrate up the dose to reach Cmax,ss values of 600 ng/mL or 800 ng/mL according to participant response.
|
|---|---|
|
Maximum Plasma Concentration (Cmax) of Atomoxetine
Responders
|
554.2 ng/mL
Standard Error 63.5
|
|
Maximum Plasma Concentration (Cmax) of Atomoxetine
Non-Responders
|
501.7 ng/mL
Standard Error 61.4
|
PRIMARY outcome
Timeframe: 18 weeksPopulation: The overall participants were classified into 2 groups based on responder status.
Cmax is the highest concentration of atomoxetine measured following administration of the drug on pharmacokinetic study days occurring at 18 weeks. Cmax is an estimate of atomoxetine systemic exposure and is compared between responders and non-responders.
Outcome measures
| Measure |
Atomoxetine HCl (Strattera)
n=20 Participants
Study participants will receive atomoxetine at a dose expected to result in Cmax,ss values of 400 ng/mL. Study clinicians may titrate up the dose to reach Cmax,ss values of 600 ng/mL or 800 ng/mL according to participant response.
|
|---|---|
|
Maximum Plasma Concentration (Cmax) of Atomoxetine
Responders
|
601.3 ng/mL
Standard Error 88.2
|
|
Maximum Plasma Concentration (Cmax) of Atomoxetine
Non-Responders
|
375.5 ng/mL
Standard Error 120.2
|
PRIMARY outcome
Timeframe: Baseline (first dose)Population: 6-week and 18-week responder classifications have different sample sizes, as there are 2 milestones within this study.
AUC is the area under the plasma concentration-time curve following administration of atomoxetine. For the baseline pharmacokinetic study (first dose of atomoxetine) plasma concentrations were measured at 17 timepoints between 0 and 72 hours (0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 48, and 72 hours) post-dose for CYP2D6 poor and intermediate metabolizers, and 12 timepoints between 0 and 12 hours (0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours) after dose administration for all other participants. The AUC was generated using a mixed log-linear approach and extrapolated to infinity. AUC is compared between responders and non-responders.
Outcome measures
| Measure |
Atomoxetine HCl (Strattera)
n=29 Participants
Study participants will receive atomoxetine at a dose expected to result in Cmax,ss values of 400 ng/mL. Study clinicians may titrate up the dose to reach Cmax,ss values of 600 ng/mL or 800 ng/mL according to participant response.
|
|---|---|
|
Area Under the Plasma Concentration-time Curve (AUC) of Atomoxetine
Responder at 6 weeks
|
1515.3 (ng*hours)/mL
Standard Deviation 1169.2
|
|
Area Under the Plasma Concentration-time Curve (AUC) of Atomoxetine
Non-responder at 6 weeks
|
1246.9 (ng*hours)/mL
Standard Deviation 913.4
|
|
Area Under the Plasma Concentration-time Curve (AUC) of Atomoxetine
Responder at 18 weeks
|
1495.7 (ng*hours)/mL
Standard Deviation 1197.6
|
|
Area Under the Plasma Concentration-time Curve (AUC) of Atomoxetine
Non-responder at 18 weeks
|
1462.7 (ng*hours)/mL
Standard Deviation 1283.4
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: The overall participants were classified into 2 groups based on responder status.
For the steady-state pharmacokinetic studies at 6 weeks, plasma concentrations were measured at 15 timepoints between 0 and 24 hours (0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 hours) post-dose for CYP2D6 poor and intermediate metabolizers, and at 12 timepoints between 0 and 12 hours (0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours) and extrapolated to 24 hours for all other participants. AUC is compared between responders and non-responders.
Outcome measures
| Measure |
Atomoxetine HCl (Strattera)
n=29 Participants
Study participants will receive atomoxetine at a dose expected to result in Cmax,ss values of 400 ng/mL. Study clinicians may titrate up the dose to reach Cmax,ss values of 600 ng/mL or 800 ng/mL according to participant response.
|
|---|---|
|
Area Under the Plasma Concentration-time Curve (AUC) of Atomoxetine
Responders
|
2802.5 (ng*hours)/mL
Standard Error 423.4
|
|
Area Under the Plasma Concentration-time Curve (AUC) of Atomoxetine
Non-Responders
|
2809.4 (ng*hours)/mL
Standard Error 409.0
|
PRIMARY outcome
Timeframe: 18 weeksPopulation: The overall participants were classified into 2 groups based on responder status.
For the steady-state pharmacokinetic studies at 18 weeks, plasma concentrations were measured at 15 timepoints between 0 and 24 hours (0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 hours) post-dose for CYP2D6 poor and intermediate metabolizers, and at 12 timepoints between 0 and 12 hours (0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours) and extrapolated to 24 hours for all other participants. AUC is compared between responders and non-responders.
Outcome measures
| Measure |
Atomoxetine HCl (Strattera)
n=20 Participants
Study participants will receive atomoxetine at a dose expected to result in Cmax,ss values of 400 ng/mL. Study clinicians may titrate up the dose to reach Cmax,ss values of 600 ng/mL or 800 ng/mL according to participant response.
|
|---|---|
|
Area Under the Plasma Concentration-time Curve (AUC) of Atomoxetine
Responders
|
3149.2 (ng*hours)/mL
Standard Error 511.3
|
|
Area Under the Plasma Concentration-time Curve (AUC) of Atomoxetine
Non-Responders
|
2880.0 (ng*hours)/mL
Standard Error 696.7
|
PRIMARY outcome
Timeframe: BaselinePopulation: 6-week and 18-week responder classifications have different sample sizes, as there are 2 milestones within this study.
DHPG has been proposed as a biomarker of the activity of the norepinephrine reuptake transporter (NET; SLC6A2), the target of atomoxetine action. DHPG is a degradation product of norepinephrine after it has been taken up by pre-synaptic neurons, and higher concentrations in plasma are considered to reflect higher NET activity (higher reuptake of norepinephrine into pre-synaptic neurons). To assess the potential value of DHPG as a biomarker of atomoxetine response in ADHD, absolute baseline and pre-dose concentrations of DHPG will be compared between atomoxetine responders and non-responders.
Outcome measures
| Measure |
Atomoxetine HCl (Strattera)
n=29 Participants
Study participants will receive atomoxetine at a dose expected to result in Cmax,ss values of 400 ng/mL. Study clinicians may titrate up the dose to reach Cmax,ss values of 600 ng/mL or 800 ng/mL according to participant response.
|
|---|---|
|
Plasma Concentration of 3,4-dihydroxyphenylglycol (DHPG)
Responder at 6 weeks
|
0.363 ng/mL
Standard Deviation 0.164
|
|
Plasma Concentration of 3,4-dihydroxyphenylglycol (DHPG)
Non-responder at 6 weeks
|
0.412 ng/mL
Standard Deviation 0.178
|
|
Plasma Concentration of 3,4-dihydroxyphenylglycol (DHPG)
Responder at 18 weeks
|
0.382 ng/mL
Standard Deviation 0.177
|
|
Plasma Concentration of 3,4-dihydroxyphenylglycol (DHPG)
Non-responder at 18 weeks
|
0.363 ng/mL
Standard Deviation 0.184
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: The overall participants were classified into 2 groups based on responder status.
DHPG has been proposed as a biomarker of the activity of the norepinephrine reuptake transporter (NET; SLC6A2), the target of atomoxetine action. DHPG is a degradation product of norepinephrine after it has been taken up by pre-synaptic neurons, and higher concentrations in plasma are considered to reflect higher NET activity (higher reuptake of norepinephrine into pre-synaptic neurons). To assess the potential value of DHPG as a biomarker of atomoxetine response in ADHD, pre-dose concentration of DHPG at the 6-week pharmacokinetic study visit will be compared between atomoxetine responders and non-responders.
Outcome measures
| Measure |
Atomoxetine HCl (Strattera)
n=29 Participants
Study participants will receive atomoxetine at a dose expected to result in Cmax,ss values of 400 ng/mL. Study clinicians may titrate up the dose to reach Cmax,ss values of 600 ng/mL or 800 ng/mL according to participant response.
|
|---|---|
|
Plasma Concentration of 3,4-dihydroxyphenylglycol (DHPG)
Responders
|
0.395 ng/mL
Standard Deviation 0.150
|
|
Plasma Concentration of 3,4-dihydroxyphenylglycol (DHPG)
Non-Responders
|
0.345 ng/mL
Standard Deviation 0.125
|
PRIMARY outcome
Timeframe: 18 weeksPopulation: The overall participants were classified into 2 groups based on responder status.
DHPG has been proposed as a biomarker of the activity of the norepinephrine reuptake transporter (NET; SLC6A2), the target of atomoxetine action. DHPG is a degradation product of norepinephrine after it has been taken up by pre-synaptic neurons, and higher concentrations in plasma are considered to reflect higher NET activity (higher reuptake of norepinephrine into pre-synaptic neurons). To assess the potential value of DHPG as a biomarker of atomoxetine response in ADHD, pre-dose concentration of DHPG at the 18-week pharmacokinetic study visit will be compared between atomoxetine responders and non-responders.
Outcome measures
| Measure |
Atomoxetine HCl (Strattera)
n=20 Participants
Study participants will receive atomoxetine at a dose expected to result in Cmax,ss values of 400 ng/mL. Study clinicians may titrate up the dose to reach Cmax,ss values of 600 ng/mL or 800 ng/mL according to participant response.
|
|---|---|
|
Plasma Concentration of 3,4-dihydroxyphenylglycol (DHPG)
Responders
|
0.323 ng/mL
Standard Deviation 0.140
|
|
Plasma Concentration of 3,4-dihydroxyphenylglycol (DHPG)
Non-responders
|
0.283 ng/mL
Standard Deviation 0.139
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: The overall participants were classified into 2 groups based on responder status.
The change in DHPG will be compared between atomoxetine responders and non-responders.
Outcome measures
| Measure |
Atomoxetine HCl (Strattera)
n=29 Participants
Study participants will receive atomoxetine at a dose expected to result in Cmax,ss values of 400 ng/mL. Study clinicians may titrate up the dose to reach Cmax,ss values of 600 ng/mL or 800 ng/mL according to participant response.
|
|---|---|
|
Change in Plasma Concentration of DHPG From Baseline
Responders
|
0.031 ng/mL
Standard Deviation 0.180
|
|
Change in Plasma Concentration of DHPG From Baseline
Non-Responders
|
-0.066 ng/mL
Standard Deviation 0.157
|
PRIMARY outcome
Timeframe: 18 weeksPopulation: The overall participants were classified into 2 groups based on responder status.
The change in DHPG will be compared between atomoxetine responders and non-responders.
Outcome measures
| Measure |
Atomoxetine HCl (Strattera)
n=20 Participants
Study participants will receive atomoxetine at a dose expected to result in Cmax,ss values of 400 ng/mL. Study clinicians may titrate up the dose to reach Cmax,ss values of 600 ng/mL or 800 ng/mL according to participant response.
|
|---|---|
|
Change in Plasma Concentration of DHPG From Baseline
Responders
|
-0.059 ng/mL
Standard Deviation 0.074
|
|
Change in Plasma Concentration of DHPG From Baseline
Non-responders
|
-0.081 ng/mL
Standard Deviation 0.140
|
Adverse Events
Atomoxetine HCl (Strattera)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Atomoxetine HCl (Strattera)
n=42 participants at risk
Study participants will receive atomoxetine at a dose expected to result in steady-state maximum concentration (Cmax,ss) values of 400 ng/mL. Dose will be calculated using a model based on CYP2D6 predicted phenotype, height, weight, body habitus, and gender. Study clinicians may titrate up the dose to reach Cmax,ss values of 600 ng/mL or 800 ng/mL according to participant response.
|
|---|---|
|
Gastrointestinal disorders
Nausea/Vomiting/Upset Stomach
|
47.6%
20/42 • Adverse event data was collected over the full 18 weeks of participation in the study.
|
|
Gastrointestinal disorders
Decreased Appetite
|
9.5%
4/42 • Adverse event data was collected over the full 18 weeks of participation in the study.
|
|
Gastrointestinal disorders
Diarrhea
|
4.8%
2/42 • Adverse event data was collected over the full 18 weeks of participation in the study.
|
|
Infections and infestations
Cold/Flu
|
23.8%
10/42 • Adverse event data was collected over the full 18 weeks of participation in the study.
|
|
Infections and infestations
Fever
|
4.8%
2/42 • Adverse event data was collected over the full 18 weeks of participation in the study.
|
|
Infections and infestations
Ear Infection
|
4.8%
2/42 • Adverse event data was collected over the full 18 weeks of participation in the study.
|
|
Infections and infestations
Sore Throat
|
4.8%
2/42 • Adverse event data was collected over the full 18 weeks of participation in the study.
|
|
Nervous system disorders
Headache
|
21.4%
9/42 • Adverse event data was collected over the full 18 weeks of participation in the study.
|
|
Psychiatric disorders
Irritability
|
4.8%
2/42 • Adverse event data was collected over the full 18 weeks of participation in the study.
|
|
Psychiatric disorders
Mood Disturbance
|
4.8%
2/42 • Adverse event data was collected over the full 18 weeks of participation in the study.
|
|
Psychiatric disorders
Self-Injurious Behavior
|
4.8%
2/42 • Adverse event data was collected over the full 18 weeks of participation in the study.
|
|
General disorders
Fatigue
|
19.0%
8/42 • Adverse event data was collected over the full 18 weeks of participation in the study.
|
|
Musculoskeletal and connective tissue disorders
Foot injury
|
4.8%
2/42 • Adverse event data was collected over the full 18 weeks of participation in the study.
|
Additional Information
James Steven Leeder, PharmD, PhD
Children's Mercy Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place