Trial Outcomes & Findings for Comparison of Atomoxetine Versus Placebo in Children With Attention-Deficit/Hyperactivity Disorder (ADHD) (NCT NCT00546910)
NCT ID: NCT00546910
Last Updated: 2010-08-10
Results Overview
Infra-red camera tracks movement of head reflector on patient performing computer test. Hyperactivity test variables: TA=percent time patient moved\>1 centimeter (cm)/second; DIS=path of movement (m); AR=total area (cm2) of movements; ME=number of position changes\>1 mm; MS=degree (percent) of directional changes. Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and standard deviation (SD)=1 in general population, expressing the probability determined by the Gamma function in terms of SD of Gaussian density). Higher scores reflect more severe symptoms.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
125 participants
Primary outcome timeframe
Baseline, 8 weeks (W8)
Results posted on
2010-08-10
Participant Flow
Participant milestones
| Measure |
Atomoxetine
0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
|
Placebo
Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
|
|---|---|---|
|
Overall Study
STARTED
|
63
|
62
|
|
Overall Study
COMPLETED
|
54
|
51
|
|
Overall Study
NOT COMPLETED
|
9
|
11
|
Reasons for withdrawal
| Measure |
Atomoxetine
0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
|
Placebo
Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
3
|
|
Overall Study
Lack of Efficacy
|
5
|
7
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Comparison of Atomoxetine Versus Placebo in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
Baseline characteristics by cohort
| Measure |
Atomoxetine
n=63 Participants
0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
|
Placebo
n=62 Participants
Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
|
Total
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
9.1 years
STANDARD_DEVIATION 1.93 • n=5 Participants
|
8.9 years
STANDARD_DEVIATION 1.64 • n=7 Participants
|
9.0 years
STANDARD_DEVIATION 1.79 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
62 participants
n=5 Participants
|
62 participants
n=7 Participants
|
124 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
63 participants
n=5 Participants
|
62 participants
n=7 Participants
|
125 participants
n=5 Participants
|
|
Diagnosis
ADHD-Combined Type
|
40 participants
n=5 Participants
|
48 participants
n=7 Participants
|
88 participants
n=5 Participants
|
|
Diagnosis
ADHD-Predominantly Inattentive Type
|
17 participants
n=5 Participants
|
11 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Diagnosis
ADHD- Predominantly Hyperactive-Impulsive Type
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Number of Participants with Family History of ADHD
At least one known relative with ADHD
|
36 participants
n=5 Participants
|
35 participants
n=7 Participants
|
71 participants
n=5 Participants
|
|
Number of Participants with Family History of ADHD
None or missing
|
27 participants
n=5 Participants
|
27 participants
n=7 Participants
|
54 participants
n=5 Participants
|
|
Number of Participants with Prior Therapy For Attention-Deficit/Hyperactive Disorder (ADHD)
Previous treatment for ADHD
|
26 participants
n=5 Participants
|
27 participants
n=7 Participants
|
53 participants
n=5 Participants
|
|
Number of Participants with Prior Therapy For Attention-Deficit/Hyperactive Disorder (ADHD)
None or missing
|
37 participants
n=5 Participants
|
35 participants
n=7 Participants
|
72 participants
n=5 Participants
|
|
Number of Participants with Psychiatric Comorbidities
At least one psychiatric comorbidity
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Number of Participants with Psychiatric Comorbidities
None or missing
|
38 participants
n=5 Participants
|
37 participants
n=7 Participants
|
75 participants
n=5 Participants
|
|
Summary Of Participants' Living Arrangements
Nuclear Family (Biological Mother and Father)
|
38 participants
n=5 Participants
|
36 participants
n=7 Participants
|
74 participants
n=5 Participants
|
|
Summary Of Participants' Living Arrangements
Single Mother
|
15 participants
n=5 Participants
|
17 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Summary Of Participants' Living Arrangements
Step Parent (One Biologic and one step parent)
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
ADHD Rating Scale-IV Parent Version: Investigator Administered & Scored, Total Score
|
37.30 units on a scale
STANDARD_DEVIATION 10.62 • n=5 Participants
|
36.68 units on a scale
STANDARD_DEVIATION 12.53 • n=7 Participants
|
36.99 units on a scale
STANDARD_DEVIATION 11.56 • n=5 Participants
|
|
Clinical Global Impressions - Severity Of Attention Deficit Hyperactive Disorder Score
|
5.11 units on a scale
STANDARD_DEVIATION 1.02 • n=5 Participants
|
5.05 units on a scale
STANDARD_DEVIATION 1.11 • n=7 Participants
|
5.08 units on a scale
STANDARD_DEVIATION 1.06 • n=5 Participants
|
|
Time Since Initial Diagnosis Of ADHD
|
1.8 years
STANDARD_DEVIATION 2.23 • n=5 Participants
|
1.6 years
STANDARD_DEVIATION 1.89 • n=7 Participants
|
1.7 years
STANDARD_DEVIATION 2.06 • n=5 Participants
|
|
Time Since Onset Of ADHD Symptoms
|
4.9 years
STANDARD_DEVIATION 2.12 • n=5 Participants
|
5.2 years
STANDARD_DEVIATION 1.95 • n=7 Participants
|
5.0 years
STANDARD_DEVIATION 2.04 • n=5 Participants
|
|
Weekly Rating Of Evening & Morning Behavior-Revised-Investigator Rated, Total & Subscores
Total Score
|
21.70 units on a scale
STANDARD_DEVIATION 7.64 • n=5 Participants
|
21.58 units on a scale
STANDARD_DEVIATION 7.91 • n=7 Participants
|
21.64 units on a scale
STANDARD_DEVIATION 7.75 • n=5 Participants
|
|
Weekly Rating Of Evening & Morning Behavior-Revised-Investigator Rated, Total & Subscores
Morning Subscore
|
5.56 units on a scale
STANDARD_DEVIATION 2.66 • n=5 Participants
|
4.63 units on a scale
STANDARD_DEVIATION 2.92 • n=7 Participants
|
5.10 units on a scale
STANDARD_DEVIATION 2.82 • n=5 Participants
|
|
Weekly Rating Of Evening & Morning Behavior-Revised-Investigator Rated, Total & Subscores
Evening Subscore
|
14.54 units on a scale
STANDARD_DEVIATION 4.76 • n=5 Participants
|
15.39 units on a scale
STANDARD_DEVIATION 4.74 • n=7 Participants
|
14.96 units on a scale
STANDARD_DEVIATION 4.75 • n=5 Participants
|
|
Weekly Rating Of Evening & Morning Behavior-Revised-Investigator Rated, Total & Subscores
Item 11 Subscore
|
1.60 units on a scale
STANDARD_DEVIATION 1.23 • n=5 Participants
|
1.56 units on a scale
STANDARD_DEVIATION 1.26 • n=7 Participants
|
1.58 units on a scale
STANDARD_DEVIATION 1.24 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 8 weeks (W8)Population: Full analysis population (N=125) including all randomized participants taking at least one dose of study medication.
Infra-red camera tracks movement of head reflector on patient performing computer test. Hyperactivity test variables: TA=percent time patient moved\>1 centimeter (cm)/second; DIS=path of movement (m); AR=total area (cm2) of movements; ME=number of position changes\>1 mm; MS=degree (percent) of directional changes. Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and standard deviation (SD)=1 in general population, expressing the probability determined by the Gamma function in terms of SD of Gaussian density). Higher scores reflect more severe symptoms.
Outcome measures
| Measure |
Atomoxetine
n=63 Participants
0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
|
Placebo
n=62 Participants
Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
|
|---|---|---|
|
Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8
Baseline: TA- Evening
|
0.66 Q-scores
Standard Deviation 1.26
|
0.85 Q-scores
Standard Deviation 0.83
|
|
Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8
W8 Change: TA- Evening
|
-0.55 Q-scores
Standard Deviation 1.08
|
0.03 Q-scores
Standard Deviation 0.76
|
|
Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8
Baseline: DIS- Noon
|
1.55 Q-scores
Standard Deviation 1.86
|
1.62 Q-scores
Standard Deviation 1.74
|
|
Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8
W8 Change: DIS- Morning
|
-0.51 Q-scores
Standard Deviation 1.80
|
0.38 Q-scores
Standard Deviation 1.75
|
|
Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8
W8 Change: DIS- Noon
|
-1.06 Q-scores
Standard Deviation 1.94
|
0.49 Q-scores
Standard Deviation 1.52
|
|
Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8
Baseline: ME- Morning
|
0.97 Q-scores
Standard Deviation 1.32
|
1.15 Q-scores
Standard Deviation 1.11
|
|
Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8
Baseline: AR- Morning
|
1.14 Q-scores
Standard Deviation 1.65
|
1.40 Q-scores
Standard Deviation 1.56
|
|
Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8
Baseline: AR- Noon
|
1.25 Q-scores
Standard Deviation 1.66
|
1.45 Q-scores
Standard Deviation 1.59
|
|
Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8
Baseline: AR- Evening
|
1.19 Q-scores
Standard Deviation 1.81
|
1.58 Q-scores
Standard Deviation 1.67
|
|
Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8
W8 Change: AR- Morning
|
-0.38 Q-scores
Standard Deviation 1.58
|
0.39 Q-scores
Standard Deviation 1.60
|
|
Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8
W8 Change: AR- Noon
|
-0.87 Q-scores
Standard Deviation 1.70
|
0.40 Q-scores
Standard Deviation 1.18
|
|
Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8
W8 Change: AR- Evening
|
-0.71 Q-scores
Standard Deviation 1.53
|
-0.00 Q-scores
Standard Deviation 1.45
|
|
Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8
Baseline: ME- Noon
|
0.98 Q-scores
Standard Deviation 1.29
|
1.09 Q-scores
Standard Deviation 1.19
|
|
Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8
Baseline: ME- Evening
|
0.94 Q-scores
Standard Deviation 1.45
|
1.18 Q-scores
Standard Deviation 1.18
|
|
Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8
W8 Change: ME- Morning
|
-0.47 Q-scores
Standard Deviation 1.42
|
0.20 Q-scores
Standard Deviation 1.19
|
|
Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8
W8 Change: ME- Noon
|
-0.82 Q-scores
Standard Deviation 1.48
|
0.28 Q-scores
Standard Deviation 1.01
|
|
Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8
W8 Change: ME- Evening
|
-0.72 Q-scores
Standard Deviation 1.41
|
0.06 Q-scores
Standard Deviation 1.06
|
|
Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8
Baseline: MS- Morning
|
0.21 Q-scores
Standard Deviation 1.08
|
0.38 Q-scores
Standard Deviation 1.01
|
|
Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8
Baseline: MS- Noon
|
0.25 Q-scores
Standard Deviation 1.12
|
0.32 Q-scores
Standard Deviation 0.95
|
|
Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8
Baseline: MS- Evening
|
0.22 Q-scores
Standard Deviation 1.21
|
0.35 Q-scores
Standard Deviation 1.05
|
|
Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8
W8 Change: MS- Morning
|
-0.22 Q-scores
Standard Deviation 1.29
|
-0.04 Q-scores
Standard Deviation 1.07
|
|
Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8
W8 Change: MS- Noon
|
-0.39 Q-scores
Standard Deviation 1.37
|
-0.12 Q-scores
Standard Deviation 0.94
|
|
Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8
W8 Change: MS- Evening
|
-0.38 Q-scores
Standard Deviation 1.31
|
-0.19 Q-scores
Standard Deviation 1.09
|
|
Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8
Baseline: TA-Morning
|
0.62 Q-scores
Standard Deviation 1.27
|
0.84 Q-scores
Standard Deviation 0.84
|
|
Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8
Baseline: TA- Noon
|
0.65 Q-scores
Standard Deviation 1.13
|
0.76 Q-scores
Standard Deviation 0.79
|
|
Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8
W8 Change: TA- Morning
|
-0.32 Q-scores
Standard Deviation 1.00
|
0.06 Q-scores
Standard Deviation 0.84
|
|
Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8
W8 Change: TA- Noon
|
-0.60 Q-scores
Standard Deviation 1.13
|
0.15 Q-scores
Standard Deviation 0.74
|
|
Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8
Baseline: DIS- Morning
|
1.41 Q-scores
Standard Deviation 1.69
|
1.62 Q-scores
Standard Deviation 1.68
|
|
Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8
Baseline: DIS- Evening
|
1.47 Q-scores
Standard Deviation 1.86
|
1.75 Q-scores
Standard Deviation 1.73
|
|
Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8
W8 Change: DIS- Evening
|
-0.87 Q-scores
Standard Deviation 1.71
|
0.07 Q-scores
Standard Deviation 1.54
|
PRIMARY outcome
Timeframe: Baseline, 8 weeksPopulation: Full analysis population (N=125) including all randomized participants taking at least one dose of study medication.
Computer test. Patient is to press button if target appears, but not at non-target. Inattention test variables: mRT=average time (ms) from target presentation to response; RTV=standard deviation of mRT; nVRT=RTV expressed in terms of RT (variation as a percent of mean value); OE= percent of omitted targets. Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and SD=1 in the general population, expressing the probability determined by the Gamma function in terms of SD of Gaussian density). Higher scores reflect more severe symptoms.
Outcome measures
| Measure |
Atomoxetine
n=63 Participants
0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
|
Placebo
n=62 Participants
Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
|
|---|---|---|
|
Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8
Baseline: RTV-Morning
|
2.93 Q-scores
Standard Deviation 2.41
|
2.49 Q-scores
Standard Deviation 1.62
|
|
Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8
W8: mRT- Noon
|
-0.35 Q-scores
Standard Deviation 1.53
|
0.12 Q-scores
Standard Deviation 1.42
|
|
Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8
W8: mRT- Evening
|
-0.13 Q-scores
Standard Deviation 1.40
|
0.48 Q-scores
Standard Deviation 1.37
|
|
Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8
Baseline: RTV-Noon
|
2.95 Q-scores
Standard Deviation 2.11
|
2.48 Q-scores
Standard Deviation 1.92
|
|
Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8
Baseline: RTV-Evening
|
2.63 Q-scores
Standard Deviation 2.49
|
2.19 Q-scores
Standard Deviation 2.00
|
|
Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8
W8: RTV-Morning
|
-0.89 Q-scores
Standard Deviation 2.29
|
-0.09 Q-scores
Standard Deviation 1.78
|
|
Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8
W8: RTV-Noon
|
-1.07 Q-scores
Standard Deviation 1.92
|
0.00 Q-scores
Standard Deviation 1.70
|
|
Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8
W8: RTV-Evening
|
-0.90 Q-scores
Standard Deviation 1.98
|
-0.00 Q-scores
Standard Deviation 1.88
|
|
Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8
Baseline: OR- Morning
|
1.12 Q-scores
Standard Deviation 1.24
|
1.13 Q-scores
Standard Deviation 1.19
|
|
Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8
Baseline: OR- Noon
|
1.31 Q-scores
Standard Deviation 1.32
|
1.30 Q-scores
Standard Deviation 1.32
|
|
Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8
Baseline: OR- Evening
|
1.22 Q-scores
Standard Deviation 1.43
|
1.28 Q-scores
Standard Deviation 1.34
|
|
Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8
W8: OR- Morning
|
0.01 Q-scores
Standard Deviation 1.83
|
0.54 Q-scores
Standard Deviation 1.14
|
|
Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8
W8: OR- Noon
|
0.03 Q-scores
Standard Deviation 1.45
|
0.53 Q-scores
Standard Deviation 1.17
|
|
Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8
W8: OR- Evening
|
-0.04 Q-scores
Standard Deviation 1.50
|
0.52 Q-scores
Standard Deviation 1.20
|
|
Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8
Baseline: mRT- Morning
|
2.42 Q-scores
Standard Deviation 2.03
|
1.92 Q-scores
Standard Deviation 1.53
|
|
Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8
Baseline: mRT- Noon
|
2.40 Q-scores
Standard Deviation 1.78
|
2.02 Q-scores
Standard Deviation 1.49
|
|
Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8
Baseline: mRT- Evening
|
2.23 Q-scores
Standard Deviation 1.77
|
1.86 Q-scores
Standard Deviation 1.49
|
|
Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8
W8: mRT- Morning
|
-0.18 Q-scores
Standard Deviation 1.84
|
0.35 Q-scores
Standard Deviation 1.28
|
|
Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8
Baseline: nVRT-Morning
|
1.00 Q-scores
Standard Deviation 1.60
|
0.93 Q-scores
Standard Deviation 1.28
|
|
Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8
Baseline: nVRT-Noon
|
1.06 Q-scores
Standard Deviation 1.48
|
0.82 Q-scores
Standard Deviation 1.26
|
|
Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8
Baseline: nVRT-Evening
|
0.92 Q-scores
Standard Deviation 1.81
|
0.68 Q-scores
Standard Deviation 1.31
|
|
Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8
W8: nVRT-Morning
|
-0.59 Q-scores
Standard Deviation 1.58
|
-0.36 Q-scores
Standard Deviation 1.15
|
|
Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8
W8: nVRT-Noon
|
-0.65 Q-scores
Standard Deviation 1.48
|
-0.09 Q-scores
Standard Deviation 0.97
|
|
Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8
W8: nVRT-Evening
|
-0.65 Q-scores
Standard Deviation 1.75
|
-0.33 Q-scores
Standard Deviation 1.19
|
PRIMARY outcome
Timeframe: Baseline, 8 weeksPopulation: Full analysis population (N=125) including all randomized participants taking at least one dose of study medication.
Computer test. Patient is to press button if target appears, but not at non-target. Impulsivity variables during test: CE=percent of response to non-target; ANT=percent of responses prior to target presentation. Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and standard deviation=1 in the general population, expressing the probability determined by the Gamma function in terms of standard deviation of Gaussian density). Higher scores reflect more severe symptoms.
Outcome measures
| Measure |
Atomoxetine
n=63 Participants
0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
|
Placebo
n=62 Participants
Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
|
|---|---|---|
|
Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8
Baseline: CE- Morning
|
-0.68 Q-scores
Standard Deviation 1.34
|
-0.89 Q-scores
Standard Deviation 1.03
|
|
Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8
Baseline: CE- Noon
|
-0.65 Q-scores
Standard Deviation 1.29
|
-0.85 Q-scores
Standard Deviation 0.94
|
|
Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8
Baseline: CE- Evening
|
-0.80 Q-scores
Standard Deviation 1.23
|
-0.87 Q-scores
Standard Deviation 1.06
|
|
Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8
W8: CE- Morning
|
-0.88 Q-scores
Standard Deviation 1.33
|
-0.32 Q-scores
Standard Deviation 0.90
|
|
Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8
W8: CE- Noon
|
-0.94 Q-scores
Standard Deviation 1.33
|
-0.44 Q-scores
Standard Deviation 0.82
|
|
Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8
W8: CE- Evening
|
-0.76 Q-scores
Standard Deviation 1.31
|
-0.49 Q-scores
Standard Deviation 0.92
|
|
Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8
Baseline: AR- Morning
|
0.41 Q-scores
Standard Deviation 1.15
|
0.15 Q-scores
Standard Deviation 0.88
|
|
Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8
Baseline: AR- Noon
|
0.28 Q-scores
Standard Deviation 1.06
|
0.12 Q-scores
Standard Deviation 0.85
|
|
Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8
Baseline: AR- Evening
|
0.32 Q-scores
Standard Deviation 1.16
|
0.08 Q-scores
Standard Deviation 0.85
|
|
Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8
W8: AR- Morning
|
-0.50 Q-scores
Standard Deviation 0.98
|
-0.34 Q-scores
Standard Deviation 0.84
|
|
Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8
W8: AR-Noon
|
-0.54 Q-scores
Standard Deviation 0.87
|
-0.31 Q-scores
Standard Deviation 0.84
|
|
Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8
W8: AR- Evening
|
-0.52 Q-scores
Standard Deviation 0.83
|
-0.28 Q-scores
Standard Deviation 0.78
|
PRIMARY outcome
Timeframe: Baseline, 8 weeksPopulation: Full analysis population (N=125) including all randomized participants taking at least one dose of study medication.
Computer test. Patient is to press button if target appears, but not at non-target. Other variables during test: ER=percent of overall incorrect responses (CE and OE); MR=percent of multiple responses per presentation of target (patient responds more than once to target). Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and standard deviation=1 in the general population, expressing the probability determined by the Gamma function in terms of standard deviation of Gaussian density). Higher scores reflect more severe symptoms.
Outcome measures
| Measure |
Atomoxetine
n=63 Participants
0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
|
Placebo
n=62 Participants
Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
|
|---|---|---|
|
Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8
Baseline: ER- Morning
|
0.37 Q-scores
Standard Deviation 1.56
|
0.30 Q-scores
Standard Deviation 1.15
|
|
Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8
Baseline: ER- Noon
|
0.52 Q-scores
Standard Deviation 1.46
|
0.41 Q-scores
Standard Deviation 1.24
|
|
Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8
Baseline: ER- Evening
|
0.37 Q-scores
Standard Deviation 1.58
|
0.41 Q-scores
Standard Deviation 1.24
|
|
Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8
W8: ER- Morning
|
-0.41 Q-scores
Standard Deviation 2.06
|
0.35 Q-scores
Standard Deviation 1.10
|
|
Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8
W8: ER- Noon
|
-0.44 Q-scores
Standard Deviation 1.70
|
0.32 Q-scores
Standard Deviation 1.06
|
|
Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8
W8: ER- Evening
|
-0.43 Q-scores
Standard Deviation 1.80
|
0.28 Q-scores
Standard Deviation 1.10
|
|
Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8
Baseline: MR- Morning
|
-0.04 Q-scores
Standard Deviation 1.25
|
-0.26 Q-scores
Standard Deviation 0.84
|
|
Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8
Baseline: MR- Noon
|
0.01 Q-scores
Standard Deviation 1.15
|
-0.30 Q-scores
Standard Deviation 0.95
|
|
Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8
Baseline: MR- Evening
|
0.03 Q-scores
Standard Deviation 1.25
|
-0.34 Q-scores
Standard Deviation 0.89
|
|
Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8
W8: MR- Morning
|
-0.23 Q-scores
Standard Deviation 1.15
|
-0.24 Q-scores
Standard Deviation 0.78
|
|
Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8
W8: MR- Noon
|
-0.45 Q-scores
Standard Deviation 0.97
|
-0.16 Q-scores
Standard Deviation 0.83
|
|
Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8
W8: MR- Evening
|
-0.35 Q-scores
Standard Deviation 1.30
|
-0.16 Q-scores
Standard Deviation 0.77
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: Full analysis population (N=125) including all randomized participants taking at least one dose of study medication.
Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.
Outcome measures
| Measure |
Atomoxetine
n=63 Participants
0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
|
Placebo
n=62 Participants
Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
|
|---|---|---|
|
Change From Baseline Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered And Scored (ADHDRS-IV-Parent:Inv) Total Score At Week 8
Baseline to Visit 7 (Week 8)
|
-17.19 units on a scale
Standard Deviation 15.63
|
-4.76 units on a scale
Standard Deviation 11.51
|
|
Change From Baseline Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered And Scored (ADHDRS-IV-Parent:Inv) Total Score At Week 8
Baseline to LOCF
|
-15.78 units on a scale
Standard Deviation 15.19
|
-4.21 units on a scale
Standard Deviation 10.89
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: Full analysis population (N=125) including all randomized participants taking at least one dose of study medication.
CGI-S-ADHD measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).
Outcome measures
| Measure |
Atomoxetine
n=63 Participants
0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
|
Placebo
n=62 Participants
Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
|
|---|---|---|
|
Change From Baseline Clinical Global Impressions-Severity of ADHD (CGI-S-ADHD) Score at Week 8
Baseline to Visit 7 (Week 8)
|
-1.78 units on a scale
Standard Deviation 1.61
|
-0.63 units on a scale
Standard Deviation 1.11
|
|
Change From Baseline Clinical Global Impressions-Severity of ADHD (CGI-S-ADHD) Score at Week 8
Baseline to LOCF
|
-1.52 units on a scale
Standard Deviation 1.63
|
-0.40 units on a scale
Standard Deviation 1.17
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: Full analysis population (N=125) including all randomized participants taking at least one dose of study medication.
Weekly Rating Of Evening \& Morning Behavior-Revised-Investigator Rated (WREMB-R-Inv) measures the level of difficulty of 11 common morning or evening behaviors (e.g. getting out of bed, doing homework, sitting through dinner). Possible scores for each item range from 0 (no difficulty) to 3 (a lot of difficulty) with a Total score (maximum score=33), Morning subscore (maximum score=9), Evening subscore (maximum score=24), and Item 11 score which pertains to degree of difficulty falling asleep (maximum score=3).
Outcome measures
| Measure |
Atomoxetine
n=63 Participants
0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
|
Placebo
n=62 Participants
Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
|
|---|---|---|
|
Change From Baseline Weekly Rating Of Evening and Morning Behavior-Revised-Investigator Rated, Total and Subscores at Week 8
Total Score: Baseline to Visit 7 (Week 8)
|
-10.72 units on a scale
Standard Deviation 10.21
|
-5.10 units on a scale
Standard Deviation 6.83
|
|
Change From Baseline Weekly Rating Of Evening and Morning Behavior-Revised-Investigator Rated, Total and Subscores at Week 8
Total Score: Baseline to LOCF
|
-9.59 units on a scale
Standard Deviation 9.98
|
-3.90 units on a scale
Standard Deviation 7.83
|
|
Change From Baseline Weekly Rating Of Evening and Morning Behavior-Revised-Investigator Rated, Total and Subscores at Week 8
Evening Subscore: Baseline to Visit 7 (Week 8)
|
-6.91 units on a scale
Standard Deviation 6.38
|
-3.57 units on a scale
Standard Deviation 4.36
|
|
Change From Baseline Weekly Rating Of Evening and Morning Behavior-Revised-Investigator Rated, Total and Subscores at Week 8
Evening Subscore: Baseline to LOCF
|
-6.30 units on a scale
Standard Deviation 6.21
|
-3.03 units on a scale
Standard Deviation 5.18
|
|
Change From Baseline Weekly Rating Of Evening and Morning Behavior-Revised-Investigator Rated, Total and Subscores at Week 8
Morning Subscore: Baseline to Visit 7 (Week 8)
|
-2.81 units on a scale
Standard Deviation 3.04
|
-1.16 units on a scale
Standard Deviation 2.74
|
|
Change From Baseline Weekly Rating Of Evening and Morning Behavior-Revised-Investigator Rated, Total and Subscores at Week 8
Morning Subscore: Baseline to LOCF
|
-2.46 units on a scale
Standard Deviation 3.00
|
-0.65 units on a scale
Standard Deviation 2.94
|
|
Change From Baseline Weekly Rating Of Evening and Morning Behavior-Revised-Investigator Rated, Total and Subscores at Week 8
Item 11 Subscore: Baseline to Visit 7 (Week 8)
|
-1.00 units on a scale
Standard Deviation 1.60
|
-0.37 units on a scale
Standard Deviation 1.00
|
|
Change From Baseline Weekly Rating Of Evening and Morning Behavior-Revised-Investigator Rated, Total and Subscores at Week 8
Item 11 Subscore: Baseline to LOCF
|
-0.83 units on a scale
Standard Deviation 1.60
|
-0.23 units on a scale
Standard Deviation 1.05
|
Adverse Events
Atomoxetine
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Atomoxetine
n=63 participants at risk
0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
|
Placebo
n=62 participants at risk
Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
7/63 • Number of events 8
|
3.2%
2/62 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.2%
2/63 • Number of events 2
|
4.8%
3/62 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
9.5%
6/63 • Number of events 7
|
3.2%
2/62 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
4.8%
3/63 • Number of events 3
|
3.2%
2/62 • Number of events 2
|
|
General disorders
Fatigue
|
6.3%
4/63 • Number of events 4
|
1.6%
1/62 • Number of events 2
|
|
General disorders
Pyrexia
|
4.8%
3/63 • Number of events 3
|
0.00%
0/62
|
|
Infections and infestations
Influenza
|
0.00%
0/63
|
4.8%
3/62 • Number of events 4
|
|
Infections and infestations
Nasopharyngitis
|
4.8%
3/63 • Number of events 3
|
3.2%
2/62 • Number of events 2
|
|
Infections and infestations
Respiratory tract infection
|
1.6%
1/63 • Number of events 1
|
4.8%
3/62 • Number of events 3
|
|
Infections and infestations
Upper respiratory tract infection
|
6.3%
4/63 • Number of events 4
|
0.00%
0/62
|
|
Metabolism and nutrition disorders
Anorexia
|
4.8%
3/63 • Number of events 3
|
0.00%
0/62
|
|
Nervous system disorders
Headache
|
4.8%
3/63 • Number of events 3
|
8.1%
5/62 • Number of events 5
|
|
Psychiatric disorders
Aggression
|
0.00%
0/63
|
6.5%
4/62 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
6.3%
4/63 • Number of events 4
|
0.00%
0/62
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60