Comparison of Atomoxetine and Placebo in Children With At... | NCT00191906

ID	Type	Description	Link
B4Z-MC-LYCK	Other Identifier	Eli Lilly and Company

Label	Type	Description	Intervention Names
Atomoxetine first, then Placebo	Experimental	Atomoxetine, 1.2 mg/kg/day, by mouth (PO) for 4 weeks, 2 week washout period and cross-over to placebo, every day (QD), PO for 4 weeks	Drug: Atomoxetine Hydrochloride Drug: placebo
Placebo first, then Atomoxetine	Experimental	Placebo, every day (QD), by mouth (PO) for 4 weeks, 2 week washout period and cross-over to atomoxetine 1.2 mg/kg/day, PO for 4 weeks	Drug: Atomoxetine Hydrochloride Drug: placebo
Normal Control	No Intervention	Normal controls were children selected from the general population. The normal control was matched (have same proportion) by sex (male/female) and by age (have same age range) as the study population.
Reading Disordered Control	No Intervention	The reading disordered control group is comprised of children with reading disorder who receive standard remedial teaching therapy.

Name	Type	Description	Arm Group Labels	Other Names
Atomoxetine Hydrochloride	Drug	Atomoxetine, 1.2 mg/kg/day, by mouth (PO)	Atomoxetine first, then Placebo Placebo first, then Atomoxetine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Stop Signal Reaction Time (SSRT) as Derived From the Stop Signal Reaction Time Paradigm	SSRT measures response execution (go trials) and response inhibition (stop trials). Go trials consist of stimulus (airplane). Child to press response button corresponding to direction airplane is pointing. Stop trials consist of go trial and audible stop signal. Initial delay between go trial and stop signal = 250 msec. If child succeeded in inhibiting response, delay on next stop trial increased by 50 msec, otherwise, delay decreased by 50 msec. SSRT = subtract mean delay from mean go signal reaction time. Lower scores mean better ability to suppress response when presented with stop signal.	Baseline and Week 4 of initial therapy and Week 4 of crossover therapy

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Mean Stop Signal Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset	SSRT measures response execution (go trials) and response inhibition (stop trials). Go trials consist of stimulus (airplane). Child to press response button corresponding to direction airplane is pointing. Stop trials consist of go trial and audible stop signal. Initial delay between go trial and stop signal = 250 msec. If child succeeded in inhibiting response, delay on next stop trial increased by 50 msec, otherwise, delay decreased by 50 msec. SSRT = subtract mean delay from mean go signal reaction time. Lower scores mean better ability to suppress response when presented with stop signal.

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

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.		Ghent		9000

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.
20035588	Derived	de Jong CG, Van De Voorde S, Roeyers H, Raymaekers R, Allen AJ, Knijff S, Verhelst H, Temmink AH, Smit LM, Rodriques-Pereira R, Vandenberghe D, van Welsen I, ter Schuren L, Al-Hakim M, Amin A, Vlasveld L, Oosterlaan J, Sergeant JA. Differential effects of atomoxetine on executive functioning and lexical decision in attention-deficit/hyperactivity disorder and reading disorder. J Child Adolesc Psychopharmacol. 2009 Dec;19(6):699-707. doi: 10.1089/cap.2009.0029.

ID	Title	Description
FG000	Atomoxetine First, Then Placebo	Atomoxetine 1.2 mg/kg/day, by mouth for 4 weeks, 2 week washout period and then cross-over to placebo, every day, by mouth for 4 weeks.
FG001	Placebo First, Then Atomoxetine

ID	Title	Description
BG000	Atomoxetine First, Then Placebo	Atomoxetine 1.2 mg/kg/day for 4 weeks, 2 week washout, and then placebo for 4 weeks
BG001	Placebo First, Then Atomoxetine	Placebo for 4 weeks, 2 week washout, and then atomoxetine 1.2 mg/kg/day for 4 weeks.
BG002	Normal Control	Untreated normal controls were children selected from the general population. The normal control was matched (have same proportion) by sex (male/female) and by age (have same age range) as the study population.
BG003	Reading Disordered Control	Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG00039 BG00137 BG00227 BG00318 BG004121

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

Stop Signal Reaction Time (SSRT) as Derived From the Stop Signal Reaction Time Paradigm

SSRT measures response execution (go trials) and response inhibition (stop trials). Go trials consist of stimulus (airplane). Child to press response button corresponding to direction airplane is pointing. Stop trials consist of go trial and audible stop signal. Initial delay between go trial and stop signal = 250 msec. If child succeeded in inhibiting response, delay on next stop trial increased by 50 msec, otherwise, delay decreased by 50 msec. SSRT = subtract mean delay from mean go signal reaction time. Lower scores mean better ability to suppress response when presented with stop signal.

All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.

Posted

Least Squares Mean

Standard Error

milliseconds (msec)

Baseline and Week 4 of initial therapy and Week 4 of crossover therapy

ID	Title	Description
OG000	Atomoxetine	Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.
OG001	Placebo	Placebo, daily, by mouth for 4 weeks.

Units	Counts
Participants	OG00071 OG00176

Title

Denominators

Categories

ADHD-Combined Type

Title	Measurements
	OG000299.90± 13.29 OG001308.82± 14.53

Reading Disorder

Title	Measurements
	OG000

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	Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.	Repeated Measures	Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.	0.504	P-value for Overall. No adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.						95						No	Superiority or Other

Secondary

Change From Baseline in Mean Stop Signal Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset

Posted

Mean

Standard Deviation

milliseconds

Baseline and 4 weeks of therapy

ID	Title	Description
OG000	ADHD-C	atomoxetine-treated Attention-Deficit/Hyperactivity Disorder-Combined Type
OG001	Normal Control	Untreated normal controls were children selected from the general population. The normal control was matched (have same proportion) by sex (male/female) and by age (have same age range) as the study population.

Secondary

Change From Baseline in Mean Stop Signal Reaction Time Comparison of ADHD-C+RD and RD to Reading Disordered Control Group in >=10 Year Old Subset

Posted

Mean

Standard Deviation

milliseconds

Baseline and 4 weeks of therapy

ID	Title	Description
OG000	ADHD-C+RD	atomoxetine-treated Comorbid Attention-Deficit/Hyperactivity Disorder-Combined Type + Reading Disorder
OG001	Reading Disorder	atomoxetine-treated Reading Disorder
OG002	Reading Disordered Control

Secondary

Lexical Decision Task Mean Reaction Time: Correct Words

Measure of reaction time to identify whether a word displayed on a computer is a real or correct word versus a pseudo word. During the performance of the lexical decision task that was presented on a computer, the reaction times and accuracy of responses were measured. Data presented are the mean reaction times over the 4 weeks of each therapy for identifying correct words correctly.

Posted

Least Squares Mean

Standard Error

milliseconds

Baseline and Week 4 of initial therapy and Week 4 of crossover therapy

ID	Title	Description
OG000	Atomoxetine	Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.
OG001	Placebo	Placebo, daily, by mouth for 4 weeks.

Units	Counts
Participants

Secondary

Lexical Decision Task Mean Reaction Time: Pseudo Words

Measure of reaction time to identify whether a word displayed on a computer is a pseudo word versus a real or correct word. During the performance of the lexical decision task that was presented on a computer, the reaction times and accuracy of responses were measured. Data presented are the mean reaction times over the 4 weeks of each therapy for identifying pseudo words correctly.

Posted

Least Squares Mean

Standard Error

milliseconds

Baseline and Week 4 of initial therapy and Week 4 of crossover therapy

ID	Title	Description
OG000	Atomoxetine	Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.
OG001	Placebo	Placebo, daily, by mouth for 4 weeks.

Units	Counts
Participants

Secondary

Working Memory by Corsi Block Tapping Test (CBTT)

Measures the visuo-spatial working memory span, and corresponds to the longest sequence of blocks that has been reproduced correctly at least once. Scores can range from 3 to 8, with the higher score indicating better function.

Posted

Least Squares Mean

Standard Error

blocks correctly sequenced

Baseline and Week 4 of initial therapy and Week 4 of crossover therapy

ID	Title	Description
OG000	Atomoxetine	Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.
OG001	Placebo	Placebo, daily, by mouth for 4 weeks.

Units	Counts
Participants	OG000

Secondary

Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Total Score

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline and Week 4 of initial therapy and Week 4 of crossover therapy

ID	Title	Description
OG000	Atomoxetine
OG001	Placebo

Units	Counts
Participants	OG000

Secondary

Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Inattention Subscale

Measures the degree of inattention symptoms based on answers to 9 items. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often), for a total Inattention Subscale score range of 0 to 27.

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline and Week 4 of initial therapy and Week 4 of crossover therapy

ID	Title	Description
OG000	Atomoxetine	Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.
OG001	Placebo	Placebo, daily, by mouth for 4 weeks.

Units	Counts
Participants	OG000

Secondary

Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Hyperactivity-Impulsivity Subscale

Measures the degree of hyperactivity-impulsivity symptoms, based on answers to 9 items. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often) for a total Hyperactivity-Impulsivity Subscale score of 0 to 27.

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline and Week 4 of initial therapy and Week 4 of crossover therapy

ID	Title	Description
OG000	Atomoxetine	Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.
OG001	Placebo	Placebo, daily, by mouth for 4 weeks.

Units	Counts
Participants	OG000

Secondary

Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Total T-Score

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 score is computed as the sum of the scores on each of the 18 items. Total score is the sum of the scores on the 18 items and range from 0 to 54. Total T-score = (Total Score - 50)/10. Total T-score ranges from -5 (low severity) to 0.4 (high severity).

Posted

Least Squares Mean

Standard Error

T-Score of units on a scale

Baseline and Week 4 of initial therapy and Week 4 of crossover therapy

ID	Title	Description
OG000	Atomoxetine	Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.
OG001	Placebo	Placebo, daily, by mouth for 4 weeks.

Units	Counts
Participants

Secondary

Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale

Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment (1=very much improved, 7=very much worsened).

Posted

Least Squares Mean

Standard Error

units on a scale

4 week therapy endpoint

ID	Title	Description
OG000	Atomoxetine	Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.
OG001	Placebo	Placebo, daily, by mouth for 4 weeks.

Units	Counts
Participants	OG000

Secondary

Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale

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

Posted

Least Squares Mean

Standard Error

units on a scale

4 week therapy endpoint

ID	Title	Description
OG000	Atomoxetine	Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.
OG001	Placebo	Placebo, daily, by mouth for 4 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset: Pseudohomophones

Measure of reaction time in determining whether the stimulus sounds like a real word ('yes' response) or not ('no' response) using pseudohomophones and pseudo words. Data presented here are for reaction time to identifying psuedohomophones correctly.

Posted

Mean

Standard Deviation

milliseconds

Baseline and 4 weeks of therapy

ID	Title	Description
OG000	ADHD-C	atomoxetine-treated Attention-Deficit/Hyperactivity Disorder-Combined Type
OG001	Normal Control	Untreated normal controls were children selected from the general population. The normal control was matched (have same proportion) by sex (male/female) and by age (have same age range) as the study population.

Units	Counts
Participants

Secondary

Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset: Pseudo Words

Measure of reaction time in determining whether the stimulus sounds like a real word ('yes' response) or not ('no' response) using pseudo homophones and pseudo words. Data presented here are for reaction time to identifying pseudo words correctly.

Posted

Mean

Standard Deviation

milliseconds

Baseline and 4 weeks of therapy

ID	Title	Description
OG000	ADHD-C	atomoxetine-treated Attention-Deficit/Hyperactivity Disorder-Combined Type
OG001	Normal Control	Untreated normal controls were children selected from the general population. The normal control was matched (have same proportion) by sex (male/female) and by age (have same age range) as the study population.

Units	Counts
Participants

Secondary

Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C+RD and RD to Reading Disordered Control Group in >=10 Year Old Subset: Pseudohomophones

Measure of reaction time in determining whether the stimulus sounds like a real word ('yes' response) or not ('no' response) using pseudo homophones and pseudo words. Data presented here are for reaction time to identifying psuedohomophones correctly.

Posted

Mean

Standard Deviation

milliseconds

Baseline and 4 weeks of therapy

ID	Title	Description
OG000	ADHD-C+ RD	atomoxetine-treated Comorbid Attention-Deficit/Hyperactivity Disorder-Combined Type + Reading Disorder
OG001	Reading Disorder	atomoxetine-treated Reading Disorder
OG002	Reading Disordered Control	Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.

Secondary

Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C+RD and RD to Reading Disordered Control Group in >=10 Year Old Subset: Pseudo Words

Measure of reaction time in determining whether the stimulus sounds like a real word ('yes' response) or not ('no' response) using pseudo homophones and pseudo words. Data presented here are for reaction time to indentifying pseudo words correctly.

Posted

Mean

Standard Deviation

milliseconds

Baseline and 4 weeks of therapy

ID	Title	Description
OG000	ADHD-C+RD	atomoxetine-treated Attention-Deficit/Hyperactivity Disorder-Combined Type + Reading Disorder
OG001	Reading Disorder	atomoxetine-treated Reading Disorder
OG002	Reading Disordered Control	Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Ear pain	Ear and labyrinth disorders	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected76 at risk EG0011 events1 affected74 at risk EG0020 events0 affected25 at risk
Eyelid oedema	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected76 at risk EG0011 events1 affected74 at risk EG0020 events0 affected25 at risk
Mydriasis	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected76 at risk EG0011 events1 affected74 at risk EG0020 events0 affected25 at risk
Visual disturbance	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected76 at risk EG0011 events1 affected74 at risk EG0020 events0 affected25 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected76 at risk EG0017 events6 affected74 at risk EG0027 events6 affected25 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0004 events3 affected76 at risk EG0014 events4 affected74 at risk EG0021 events1 affected25 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected76 at risk EG0014 events4 affected74 at risk EG0022 events2 affected25 at risk
Nausea	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected76 at risk EG0017 events7 affected74 at risk EG0024 events3 affected25 at risk
Tooth disorder	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected76 at risk EG0010 events0 affected74 at risk EG0020 events0 affected25 at risk
Vomiting	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected76 at risk EG0015 events5 affected74 at risk EG0023 events2 affected25 at risk
Fatigue	General disorders	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected76 at risk EG00111 events9 affected74 at risk EG0024 events4 affected25 at risk
Feeling abnormal	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected76 at risk EG0012 events2 affected74 at risk EG0020 events0 affected25 at risk
Malaise	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected76 at risk EG0012 events2 affected74 at risk EG0020 events0 affected25 at risk
Peripheral coldness	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected76 at risk EG0011 events1 affected74 at risk EG0020 events0 affected25 at risk
Gastroenteritis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected76 at risk EG0013 events3 affected74 at risk EG0020 events0 affected25 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected76 at risk EG0011 events1 affected74 at risk EG0020 events0 affected25 at risk
Tonsillitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected76 at risk EG0011 events1 affected74 at risk EG0020 events0 affected25 at risk
Joint sprain	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected76 at risk EG0010 events0 affected74 at risk EG0020 events0 affected25 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected76 at risk EG0011 events1 affected74 at risk EG0020 events0 affected25 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected76 at risk EG0011 events1 affected74 at risk EG0020 events0 affected25 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0004 events4 affected76 at risk EG0016 events6 affected74 at risk EG0027 events7 affected25 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected76 at risk EG0010 events0 affected74 at risk EG0020 events0 affected25 at risk
Disturbance in attention	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected76 at risk EG0011 events1 affected74 at risk EG0020 events0 affected25 at risk
Dizziness	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected76 at risk EG0012 events2 affected74 at risk EG0020 events0 affected25 at risk
Headache	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG00011 events10 affected76 at risk EG00110 events10 affected74 at risk EG0029 events8 affected25 at risk
Poor quality sleep	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected76 at risk EG0011 events1 affected74 at risk EG0020 events0 affected25 at risk
Syncope	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected76 at risk EG0011 events1 affected74 at risk EG0020 events0 affected25 at risk
Apathy	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected76 at risk EG0012 events2 affected74 at risk EG0020 events0 affected25 at risk
Eating disorder	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected76 at risk EG0011 events1 affected74 at risk EG0020 events0 affected25 at risk
Emotional disorder	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected76 at risk EG0011 events1 affected74 at risk EG0020 events0 affected25 at risk
Fear	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected76 at risk EG0011 events1 affected74 at risk EG0020 events0 affected25 at risk
Initial insomnia	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected76 at risk EG0010 events0 affected74 at risk EG0020 events0 affected25 at risk
Negativism	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected76 at risk EG0011 events1 affected74 at risk EG0020 events0 affected25 at risk
Nightmare	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected76 at risk EG0011 events1 affected74 at risk EG0020 events0 affected25 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected76 at risk EG0010 events0 affected74 at risk EG0020 events0 affected25 at risk
Rhinalgia	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected76 at risk EG0010 events0 affected74 at risk EG0020 events0 affected25 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected76 at risk EG0011 events1 affected74 at risk EG0020 events0 affected25 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected76 at risk EG0011 events1 affected74 at risk EG0020 events0 affected25 at risk
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected76 at risk EG0011 events1 affected74 at risk EG0020 events0 affected25 at risk
Swelling face	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected76 at risk EG0010 events0 affected74 at risk EG0020 events0 affected25 at risk
Job dissatisfaction	Social circumstances	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected76 at risk EG0011 events1 affected74 at risk EG0020 events0 affected25 at risk
Pallor	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected76 at risk EG0013 events2 affected74 at risk EG0020 events0 affected25 at risk
Raynaud's phenomenon	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected76 at risk EG0011 events1 affected74 at risk EG0020 events0 affected25 at risk

ID	Term
D001289	Attention Deficit Disorder with Hyperactivity
D004410	Dyslexia

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders
D007806	Language Disorders
D003147	Communication Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D000067559	Specific Learning Disorder
D007859	Learning Disabilities
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D011437	Propylamines
D000588	Amines
D009930	Organic Chemicals

ID	Title	Description	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	As Randomized Placebo (Crossover)	Patients in either Crossover Period receiving Placebo	76	28	76
EG001	As Randomized Atomoxetine (Crossover)	Patients in either Crossover Period receiving Atomoxetine	74	35	74
EG002	Open Label Atomoxetine	Patients in the Open Label extension receiving Atomoxetine	25	24	25