Efficacy and Safety of Atomoxetine in Children With Recen... | NCT00191945

ID	Type	Description	Link
B4Z-XM-LYDM	Other Identifier	Eli Lilly and Company

Efficacy and Safety of Atomoxetine in Children With Recen... | NCT00191945 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Atomoxetine	Experimental	atomoxetine: 0.5 mg/kg/day every day (QD),by mouth (PO) for 2 weeks, 1.2 - 1.4 mg/kg/day QD, PO for 10 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1 year	Drug: Atomoxetine Hydrochloride
Placebo	Placebo Comparator	placebo every day (QD), by mouth (PO) for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1 year (open-label extension)	Drug: Atomoxetine Hydrochloride Drug: placebo

Name	Type	Description	Arm Group Labels	Other Names
Atomoxetine Hydrochloride	Drug		Atomoxetine Placebo	LY139603 Strattera

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 12 Week Endpoint	Measures the 18 symptoms contained in the DSM-IV 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.	Week 12

Secondary Outcomes

Measure	Description	Time Frame
Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 9 Weeks	Measures the 18 symptoms contained in the DSM-IV 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.	Week 9

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.		Badajoz		06080

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25019647	Derived	Bangs ME, Wietecha LA, Wang S, Buchanan AS, Kelsey DK. Meta-analysis of suicide-related behavior or ideation in child, adolescent, and adult patients treated with atomoxetine. J Child Adolesc Psychopharmacol. 2014 Oct;24(8):426-34. doi: 10.1089/cap.2014.0005. Epub 2014 Jul 14.
19785510	Derived	Montoya A, Hervas A, Cardo E, Artigas J, Mardomingo MJ, Alda JA, Gastaminza X, Garcia-Polavieja MJ, Gilaberte I, Escobar R. Evaluation of atomoxetine for first-line treatment of newly diagnosed, treatment-naive children and adolescents with attention deficit/hyperactivity disorder. Curr Med Res Opin. 2009 Nov;25(11):2745-54. doi: 10.1185/03007990903316152.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Atomoxetine	Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
FG001	Placebo

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Comment	Reasons
Parent's Decision		FG0003 subjects FG0010 subjects
Lost to Follow-up		FG0000 subjects FG0011 subjects
Non Protocol Compliance		FG0003 subjects FG0010 subjects
Physician Decision		FG0000 subjects FG0012 subjects

Arm/Group Information

ID	Title	Description
BG000	Atomoxetine	Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
BG001	Placebo	Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00010.3± 2.48 BG00110.3± 2.43 BG00210.3± 2.46

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00021 BG00110 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Spain

Title	Measurements
	BG000100 BG00151 BG002

Attention-Deficit/Hyperactivity Disorder Subtype

Number

participants

Title

Denominators

Categories

Inattentive

Title	Measurements
	BG00030 BG00119 BG002

Race/Ethnicity

Number

participants

Title

Denominators

Categories

Caucasian

Title	Measurements
	BG00098 BG00147 BG002

Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered

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.

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG00039.1± 9.0 BG001

Blood Pressure

Mean

Standard Deviation

mmHg

Title

Denominators

Categories

Systolic Blood Pressure

Title	Measurements
	BG000101.2± 10.01 BG001100.5± 10.01 BG002

Body Weight

Mean

Standard Deviation

kilograms

Title

Denominators

Categories

Title	Measurements
	BG00037.9± 11.86 BG00137.4± 12.18 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 12 Week Endpoint

Measures the 18 symptoms contained in the DSM-IV 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.

Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores.

Posted

Mean

Standard Deviation

units on a scale

Week 12

ID	Title	Description
OG000	Atomoxetine	Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
OG001	Placebo	Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year

Units	Counts
Participants	OG00099 OG00150

Title

Denominators

Categories

Title	Measurements
	OG00026.3± 12.7 OG00134.8± 12.3

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Mixed Models Analysis	Mixed Model Repeated Measures analysis method: treatment, study site, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction.	<0.001		Mean Difference (Net)	-7.9	Standard Error of the Mean	1.6		95	-11.0	-4.8			Least Squares Mean difference at week 12 (Atomoxetine minus Placebo)	No	Superiority or Other

Secondary

Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 9 Weeks

Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores.

Posted

Mean

Standard Deviation

units on a scale

Week 9

ID	Title	Description
OG000	Atomoxetine	Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
OG001	Placebo	Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year

Units	Counts
Participants

Secondary

Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 6 Weeks

Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores.

Posted

Mean

Standard Deviation

units on a scale

Week 6

ID	Title	Description
OG000	Atomoxetine	Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
OG001	Placebo	Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year

Units	Counts
Participants

Secondary

Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 4 Weeks

Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores.

Posted

Mean

Standard Deviation

units on a scale

Week 4

ID	Title	Description
OG000	Atomoxetine	Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
OG001	Placebo	Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year

Units	Counts
Participants

Secondary

Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score Change From Week 6 to Week 12

Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores.

Posted

Mean

Standard Deviation

units on a scale

week 6 and week 12

ID	Title	Description
OG000	Atomoxetine	Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
OG001	Placebo	Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year

Units	Counts

Secondary

Clinical Global Impressions- Attention-Deficit/Hyperactivity Disorder-Severity Changes From Baseline to Visit 7 (12 Weeks)

Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).

Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores.

Posted

Mean

Standard Deviation

units on a scale

Baseline and 12 weeks

ID	Title	Description
OG000	Atomoxetine	Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
OG001	Placebo	Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year

Units	Counts
Participants

Secondary

Clinical Global Impressions- Attention-Deficit/Hyperactivity Disorder-Severity Change From Baseline to Endpoint (Visit 18) of the Open-Label Extension (107 Weeks)

Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).

Intention to Treat analysis. Last observation carried forward.

Posted

Mean

Standard Deviation

units on a scale

Baseline and Open-Label Endpoint (107 weeks)

ID	Title	Description
OG000	Atomoxetine	0.5 mg/kg/day QD, PO for 2 weeks, 1.2 - 1.4 mg/kg/day QD, PO for 10 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1 year

Units	Counts
Participants	OG000

Secondary

Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S) Total Score Changes From Baseline to Endpoint (Week 12)

The CPRS-R:S has 27 items to be completed by the parent to assess behavioral problems related to ADHD. Individual item scores range from 0 (not at all true/never/seldom: lowest impairment) to 3 (very much true/very often/very frequent: highest impairment). The total score is calculated as the sum of all items. Total scores range from 0 to 81.

Intention to Treat analysis. Last observation carried forward.

Posted

Mean

Standard Deviation

units on a scale

Baseline and Week 12

ID	Title	Description
OG000	Atomoxetine	Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
OG001	Placebo	Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year

Units	Counts
Participants

Secondary

Child Health and Illness Profile (CHIP) Change From Baseline to Endpoint (12 Weeks)

Parent-rated assessment of a child's health status and level of functioning. It consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format (for example, 'how good is your child at making friends?' 1=never, 5=always). Standard scores (t-value) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Standard scores are expressed in standard deviation units. T-score=[(Score-4.2382)*10/0.32835]+50. Higher scores mean improvement.

Intention to Treat analysis. Last observation carried forward.

Posted

Mean

Standard Deviation

standard deviation units

Baseline to 12 weeks

ID	Title	Description
OG000	Atomoxetine	Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
OG001	Placebo	Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year

Secondary

Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version (K-SADS-PL)

The K-SADS-PL is a semi-structured interview schedule for assessing psychiatric disorders in children and adolescents. It is used to assess the status of 32 DSM-IV child and adolescent psychiatric diagnosis.

Intention to Treat analysis. All randomized participants who took at least one dose of study drug.

Posted

Number

participants

Baseline

ID	Title	Description
OG000	Atomoxetine	Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
OG001	Placebo	Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year

Units	Counts
Participants

Secondary

Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) at 107 Weeks (Open-Label Extension)

Intention to Treat analysis. Last observation carried forward.

Posted

Mean

Standard Deviation

units on a scale

Week 107

ID	Title	Description
OG000	Atomoxetine	0.5 mg/kg/day QD, PO for 2 weeks, 1.2 - 1.4 mg/kg/day QD, PO for 10 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1 year

Units	Counts
Participants	OG000

Secondary

Vital Signs - Systolic Blood Pressure

All randomized participants.

Posted

Mean

Standard Deviation

mmHg

Baseline and 12 weeks

ID	Title	Description
OG000	Atomoxetine	Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
OG001	Placebo	Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year

Units	Counts
Participants	OG000

Secondary

Vital Signs - Diastolic Blood Pressure

All randomized participants.

Posted

Mean

Standard Deviation

mmHg

Baseline and 12 weeks

ID	Title	Description
OG000	Atomoxetine	Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
OG001	Placebo	Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year

Units	Counts
Participants	OG000

Secondary

Vital Signs - Pulse

All randomized participants.

Posted

Mean

Standard Deviation

beats per minute

Baseline and 12 weeks

ID	Title	Description
OG000	Atomoxetine	Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
OG001	Placebo	Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year

Units	Counts
Participants	OG000

Secondary

Vital Signs - Weight

All randomized participants.

Posted

Mean

Standard Deviation

kilograms

Baseline and 12 weeks

ID	Title	Description
OG000	Atomoxetine	Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
OG001	Placebo	Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Atomoxetine	Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year			0	100	80	100
EG001	Placebo	Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year			1	51	38	51

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Vomiting	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment		EG0000 events0 affected100 at risk EG0011 events1 affected51 at risk
Dizziness	Nervous system disorders	MedDRA 9.0	Systematic Assessment		EG0000 events0 affected100 at risk EG0011 events1 affected51 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Tachycardia	Cardiac disorders	MedDRA 9.0	Systematic Assessment	EG0004 events4 affected100 at risk EG0013 events3 affected51 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG00020 events17 affected100 at risk EG0014 events4 affected51 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0007 events6 affected100 at risk EG0012 events2 affected51 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0004 events4 affected100 at risk EG0013 events3 affected51 at risk
Nausea	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0007 events5 affected100 at risk EG0012 events2 affected51 at risk
Vomiting	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG00022 events14 affected100 at risk EG0017 events7 affected51 at risk
Fatigue	General disorders	MedDRA 9.0	Systematic Assessment	EG00011 events10 affected100 at risk EG0011 events1 affected51 at risk
Pyrexia	General disorders	MedDRA 9.0	Systematic Assessment	EG0008 events7 affected100 at risk EG0013 events3 affected51 at risk
Ear infection	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0000 events0 affected100 at risk EG0013 events3 affected51 at risk
Nasopharyngitis	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0008 events7 affected100 at risk EG0017 events5 affected51 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 9.0	Systematic Assessment	EG00031 events31 affected100 at risk EG0014 events4 affected51 at risk
Dizziness	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG0008 events7 affected100 at risk EG0012 events2 affected51 at risk
Headache	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG00029 events24 affected100 at risk EG0018 events7 affected51 at risk
Somnolence	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG00024 events23 affected100 at risk EG0012 events2 affected51 at risk
Irritability	Psychiatric disorders	MedDRA 9.0	Systematic Assessment	EG00016 events14 affected100 at risk EG0016 events5 affected51 at risk
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Systematic Assessment	EG0002 events2 affected100 at risk EG0014 events4 affected51 at risk

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	A gatekeeper strategy was employed for sequentially testing the secondary hypotheses using a REML-based Mixed-Model Repeated Measures (MMRM) technique as defined for the primary efficacy analyses. If primary hypothesis is significant at 0.05 (2-sided), first secondary hypothesis will be tested at Visit 6 from MMRM. If comparison is significant, subsequent secondary hypotheses will be tested in sequence until first null hypothesis fails to be rejected.	Mixed Models Analysis	Mixed Model Repeated Measures analysis method: treatment, study site, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction.	<0.001		Mean Difference (Net)	-6.5	Standard Error of the Mean	1.5		95	-9.5	-3.6			Least Squares Mean difference at Week 9 (Atomoxetine - Placebo)	No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	A gatekeeper strategy was employed for sequentially testing the secondary hypotheses using a REML-based Mixed-Model Repeated Measures (MMRM) technique as defined for the primary efficacy analyses. If primary hypothesis is significant at 0.05 (2-sided), first secondary hypothesis will be tested at Visit 6 from MMRM. If comparison is significant, subsequent secondary hypotheses will be tested in sequence until first null hypothesis fails to be rejected.	Mixed Models Analysis	Mixed Model Repeated Measures analysis method: treatment, study site, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction.	0.0009		Mean Difference (Net)	-5.2	Standard Error of the Mean	1.5		95	-8.2	-2.2			Least Squares Mean difference at 6 weeks (Atomoxetine - Placebo)	No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	A gatekeeper strategy was employed for sequentially testing the secondary hypotheses using a REML-based Mixed-Model Repeated Measures (MMRM) technique as defined for the primary efficacy analyses. If primary hypothesis is significant at 0.05 (2-sided), first secondary hypothesis will be tested at Visit 6 from MMRM. If comparison is significant, subsequent secondary hypotheses will be tested in sequence until first null hypothesis fails to be rejected.	Mixed Models Analysis	Mixed Model Repeated Measures analysis method: treatment, study site, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction.	0.0033		Mean Difference (Net)	-3.8	Standard Error of the Mean	1.3		95	-6.4	-1.3			Least Squares Mean difference at 4 weeks (Atomoxetine - Placebo)	No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	A gatekeeper strategy was employed for sequentially testing the secondary hypotheses using a REML-based Mixed-Model Repeated Measures (MMRM) technique as defined for the primary efficacy analyses. If primary hypothesis is significant at 0.05 (2-sided), first secondary hypothesis will be tested at Visit 6 from MMRM. If comparison is significant, subsequent secondary hypotheses will be tested in sequence until first null hypothesis fails to be rejected.	Mixed Models Analysis	Mixed Model Repeated Measures analysis method: treatment, study site, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction.	0.013	P-value is for the difference between groups in the change from 12 weeks minus 6 weeks.	Mean Difference (Net)	-2.7	Standard Error of the Mean	1.1		95	-4.9	-0.6			Least Squares Mean difference between groups (Atomoxetine - Placebo) in change from 6 weeks to 12 weeks	No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Mixed Models Analysis	mixed model repeated measures analyis: treatment, visit, patient, and CPRS-R: S Total score at baseline as covariate, with treatment*visit interaction	<0.001	P-value is for the difference between groups in the change from 12 weeks minus baseline.	Mean Difference (Net)	-10.7	Standard Error of the Mean	2.3		95	-15.1	-6.2			Least Squares Mean difference between groups (Atomoxetine - Placebo) in change from baseline to 12 weeks.	No	Superiority or Other

Title

Denominators

Categories

Parent: Satisfaction Baseline

Title	Measurements
	OG00038.0± 14.9 OG00139.0± 14.7

Parent: Comfort Baseline

Title	Measurements
	OG00042.8± 12.5 OG00144.4± 11.7

Parent: Resilience Baseline

Title	Measurements
	OG00042.1± 11.2 OG00141.8± 11.6

Parent: Risk Avoidance Baseline

Title	Measurements
	OG00031.7± 15.8 OG00134.1± 15.9

Parent: Achievement Baseline

Title	Measurements
	OG00033.2± 9.5 OG00133.1± 10.8

Parent: Satisfaction 12 Weeks

Title	Measurements
	OG00040.4± 12.5 OG00140.0± 13.8

Parent: Comfort 12 Weeks

Title	Measurements
	OG00044.6± 11.4 OG00144.1± 11.5

Parent: Resilience 12 Weeks

Title	Measurements
	OG00045.3± 11.0 OG00142.2± 10.8

Parent: Risk Avoidance 12 Weeks

Title	Measurements
	OG00040.5± 14.8 OG00135.9± 13.9

Parent: Achievement 12 Weeks

Title	Measurements
	OG00038.0± 10.0 OG00134.4± 10.3

Child/Adolescent: Satisfaction Baseline

Title	Measurements
	OG00049.2± 9.2 OG00150.0± 12.6

Child/Adolescent: Comfort Baseline

Title	Measurements
	OG00049.9± 9.6 OG00150.6± 7.9

Child/Adolescent: Resilience Baseline

Title	Measurements
	OG00052.0± 10.8 OG00152.0± 11.6

Child/Adolescent: Risk Avoidance Baseline

Title	Measurements
	OG00047.6± 10.4 OG00149.1± 11.3

Child/Adolescent: Achievement Baseline

Title	Measurements
	OG00042.1± 10.3 OG00144.6± 10.8

Child/Adolescent: Satisfaction 12 Weeks

Title	Measurements
	OG00050.6± 9.2 OG00152.3± 11.1

Child/Adolescent: Comfort 12 Weeks

Title	Measurements
	OG00052.7± 8.2 OG00151.9± 7.7

Child/Adolescent: Resilience 12 Weeks

Title	Measurements
	OG00052.4± 9.5 OG00152.2± 9.4

Child/Adolescent: Risk Avoidance 12 Weeks

Title	Measurements
	OG00051.9± 8.7 OG00149.7± 11.7

Child/Adolescent: Achievement 12 Weeks

Title	Measurements
	OG00045.5± 10.2 OG00145.7± 11.5

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.	ANCOVA	0.810	P-value for Parent: Satisfaction difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.	Mean Difference (Net)	0.47	95	-3.39	4.33	No	Superiority or Other
OG000 OG001	ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.	ANCOVA	0.243	P-value for Parent: Comfort difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.	Mean Difference (Net)	1.96	95	-1.35	5.29	No	Superiority or Other
OG000 OG001	ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.	ANCOVA	0.419	P-value for Parent: Resilience difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.	Mean Difference (Net)	1.56	95	-2.26	5.39	No	Superiority or Other
OG000 OG001	ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.	ANCOVA	<0.001	P-value for Parent:Risk Avoidance difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.	Mean Difference (Net)	8.41	95	4.27	12.55	No	Superiority or Other
OG000 OG001	ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.	ANCOVA	0.042	P-value for Parent:Achievement difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.	Mean Difference (Net)	3.39	95	0.13	6.65	No	Superiority or Other
OG000 OG001	ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.	ANCOVA	0.323	P-value for Child/Adolescent:Satisfaction difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.	Mean Difference (Net)	-1.36	95	-4.06	1.35	No	Superiority or Other
OG000 OG001	ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.	ANCOVA	0.452	P-value for Child/Adolescent:Comfort difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.	Mean Difference (Net)	0.92	95	-1.49	3.34	No	Superiority or Other
OG000 OG001	ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.	ANCOVA	0.910	P-value for Child/Adolescent:Resilience difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.	Mean Difference (Net)	0.16	95	-2.59	2.90	No	Superiority or Other
OG000 OG001	ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.	ANCOVA	0.006	P-value for Child/Adolescent:Risk Avoidance difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.	Mean Difference (Net)	3.56	95	1.04	6.08	No	Superiority or Other
OG000 OG001	ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.	ANCOVA	0.541	P-value for Child/Adolescent:Achievement difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.	Mean Difference (Net)	0.99	95	-2.21	4.19	No	Superiority or Other

Title

Denominators

Categories

Participants with any Comorbidity

Title	Measurements
	OG00046 OG00122

Participants with Oppositional Defiant Disorder

Title	Measurements
	OG00028 OG00110

Participants with Tic Disorder

Title	Measurements
	OG00016 OG0019

Participants with Affective Disorders

Title	Measurements
	OG0003 OG0012

Participants with Anxiety Disorders

Title	Measurements
	OG00013 OG0016

Participants with Conduct Disorder

Title	Measurements
	OG0000 OG0010

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

ID	Term
D011437	Propylamines
D000588	Amines
D009930	Organic Chemicals