Double-blind, Placebo-controlled, Randomised Withdrawal,... | NCT00784654

ID	Type	Description	Link
2008-000720-10	EudraCT Number

Status Module

Label	Type	Description	Intervention Names
Lisdexamfetamine dimesylate (LDX)	Experimental	Open-label 30, 50, or 70mg	Drug: Lisdexamfetamine dimesylate (LDX)
Placebo	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Lisdexamfetamine dimesylate (LDX)	Drug	LDX 30, 50, or 70mg capsule once per day (open-label and double-blind periods)	Lisdexamfetamine dimesylate (LDX)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent of Participants With Treatment Failures at End of The Randomized Withdrawal Period	Treatment failure defined as 50% increase (worsening) in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) total score and >= 2 point increase (worsening) in the Clinical Global Impression-Severity of Illness (CGI-S) score observed at any visit during the randomized withdrawal period compared to the respective scores at baseline of randomized withdrawal period. Subjects without an endpoint value were classed as treatment failures.	Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)

Secondary Outcomes

Measure	Description	Time Frame
Change From Open-Label Baseline in The Attention Deficit Hyperactivity Disorder Rating Scale-Fourth Edition (ADHD-RS-IV) Total Score at Endpoint (Week-26) of The Open-label Period	ADHD-RS-IV consists of 18 items scored on a 4-point scale from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. A decrease in score indicates an improvement in ADHD symptomology.	Open-label baseline and Endpoint (Week-26)

Other Outcomes

Measure	Description	Time Frame
Percent of Participants With CGI-S at Open-label Baseline	CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill).	Open-label baseline
Percent of Participants With CGI-S at Randomized Withdrawal Baseline

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject's parent or legally authorised representative(LAR) must provide signature of informed consent, and there must be documentation of assent (if applicable) by the subject indicating that the subject is aware of the investigational nature of the study and the required procedures and restrictions in accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6 and applicable regulations before completing any study-related procedures.
Subject and parent/LAR are willing and able to comply with all the testing and requirements defined in this protocol, including oversight of morning dosing. Specifically, the parent/LAR must be available upon awakening, at approximately 7:00AM, to dispense the dose of test product for the duration of the study.
Subject is a male or female aged 6-17 years inclusive at the time of consent for the antecedent study (SPD489-325).
Subject satisfied all entry criteria for the antecedent study (SPD489-325), and completed a minimum of 4 weeks of double-blind treatment, reached Visit 4 and completed the 1-week post-treatment washout in the antecedent study (SPD489-325), without experiencing any clinically significant AEs that would preclude exposure to LDX.
Subject must have a satisfactory medical assessment with no clinically significant or relevant abnormalities as determined by medical history, physical examination findings and clinical laboratory test results.
Subject has blood pressure measurements within the 95th percentile for age, gender, and height.

Exclusion Criteria:

Subject was terminated from SPD489-325 for non-compliance and/or experienced an SAE or AE resulting in termination from the antecedent study.
Subject has a current, controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as any severe comorbid Axis II disorder or severe Axis I disorder (such as Post Traumatic Stress Disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder) or other symptomatic manifestations, such as agitated states, marked anxiety, or tension that, in the opinion of the examining clinician, will contraindicate treatment with LDX or confound efficacy or safety assessments. Comorbid psychiatric diagnoses will be established at the Screening Visit (Visit -1)of the antecedent study (SPD489-325)with the Screening interview of the Kiddie-SADS-Present and Lifetime-Diagnostic Interview (K-SADS-PL)and additional modules if warranted by the results of the initial interview. Participation in behavioural therapy is permitted provided the subject was receiving the therapy for at least 1 month at the time of the Baseline Visit (Visit 0) of the antecedent study (SPD489-325).
Subject has a conduct disorder. Oppositional defiant disorder is not exclusionary.
Subject has any concurrent chronic or acute illness or unstable medical condition that could confound the results of safety assessments, increase risk to the subject or lead to difficulty complying with the protocol.
Subject is currently considered a suicide risk, has previously made a suicide attempt or has a prior history of, or is currently, demonstrating active suicidal ideation.
Subject is female and is pregnant or lactating.
Subject has glaucoma.
Subject has any clinically significant ECG at Visit 8 of the antecedent study (SPD489-325) or clinically significant laboratory abnormalities at Visit 7 of the antecedent study (SPD489-325).
Subject has a documented allergy, hypersensitivity, or intolerance to amphetamine.
Subject has a recent history (within the past 6 months) of suspected substance abuse or dependence disorder (excluding nicotine)in accordance with the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR)criteria.
Subject has a history of seizures (other than infantile febrile seizures), a tic disorder, a current diagnosis and or a known family history of Tourette's Disorder.
Subject has a known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug.
Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
Subject is taking any medication that is excluded.
Subject is taking other medications that have central nervous system (CNS) effects, affect performance, such as sedating antihistamines and decongestant sympathomimetics, or are monoamine oxidase inhibitors (during or within 14 days of investigational medicinal product administration). Stable use of bronchodilator inhalers is not exclusionary.
Subject has a documented allergy, hypersensitivity, or intolerance to any excipients in the investigational medicinal product(s).

Name	Affiliation	Role
Study Director	Takeda	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Peninsula Research Associates, Inc.		Rolling Hills Estates	California	66212	United States
Miami Research Associates

PubMed Identifier	Type	Citation	Retractions
25139785	Derived	Banaschewski T, Johnson M, Lecendreux M, Zuddas A, Adeyi B, Hodgkins P, Squires LA, Coghill DR. Health-related quality of life and functional outcomes from a randomized-withdrawal study of long-term lisdexamfetamine dimesylate treatment in children and adolescents with attention-deficit/hyperactivity disorder. CNS Drugs. 2014 Dec;28(12):1191-203. doi: 10.1007/s40263-014-0193-z.
24839883

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Lisdexamfetamine Dimesylate (LDX)(Open-label Period)	Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours).

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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

Percent of Participants With Treatment Failures at End of The Randomized Withdrawal Period

Treatment failure defined as 50% increase (worsening) in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) total score and >= 2 point increase (worsening) in the Clinical Global Impression-Severity of Illness (CGI-S) score observed at any visit during the randomized withdrawal period compared to the respective scores at baseline of randomized withdrawal period. Subjects without an endpoint value were classed as treatment failures.

Randomized Full Analysis Set (Randomized FAS) includes all subjects who were randomized and received at least 1 dose of investigational product during the Randomized Withdrawal Period.

Posted

Number

percentage of participants

Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)

ID	Title	Description
OG000	Lisdexamfetamine Dimesylate (LDX)(Randomized Period)	Subjects receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for 6 weeks.
OG001	Placebo (Randomized Period)	Subjects receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for 6 weeks.

Units	Counts
Participants	OG00076 OG00177

Title

Denominators

Categories

Title	Measurements
	OG00015.8 OG00167.5

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		Cochran-Mantel-Haenszel		< 0.001						2-Sided	95							Superiority or Other (legacy)

Secondary

Change From Open-Label Baseline in The Attention Deficit Hyperactivity Disorder Rating Scale-Fourth Edition (ADHD-RS-IV) Total Score at Endpoint (Week-26) of The Open-label Period

ADHD-RS-IV consists of 18 items scored on a 4-point scale from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. A decrease in score indicates an improvement in ADHD symptomology.

Open-label Full Analysis set (Open-label FAS) includes all subjects who received at least 1 dose of investigational product during the Open-label Period.

Posted

Mean

Standard Deviation

Scores on a scale

Open-label baseline and Endpoint (Week-26)

ID	Title	Description
OG000	Lisdexamfetamine Dimesylate (LDX)(Open-label Period)	Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours).

Units	Counts
Participants	OG000

Secondary

Change From Randomized Withdrawal Baseline in The ADHD-RS-IV Total Score at Endpoint of The Randomized Withdrawal Period

Randomized FAS

Posted

Least Squares Mean

Standard Error

Scores on a scale

Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)

ID	Title	Description
OG000	Lisdexamfetamine Dimesylate (LDX)(Randomized Period)	Subjects receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
OG001	Placebo (Randomized Period)	Subjects receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.

Units	Counts
Participants	OG000

Secondary

Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Endpoint (Week-26) of The Open-label Period

CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)

Open-label FAS

Posted

Number

percentage of participants

At Week 26

ID	Title	Description
OG000	Lisdexamfetamine Dimesylate (LDX)(Open-label Period)	Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours).

Units	Counts
Participants	OG000

Other Pre-specified

Percent of Participants With CGI-S at Open-label Baseline

CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill).

Open-label FAS

Posted

Number

percentage of participants

Open-label baseline

ID	Title	Description
OG000	Lisdexamfetamine Dimesylate (LDX)(Open-label Period)	Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours ).

Units	Counts
Participants	OG000

Secondary

Percent of Participants With CGI-S at Endpoint of The Randomized Withdrawal Period, Last Observation Carried Forward (LOCF)

CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)

Randomized FAS

Posted

Number

percentage of participants

At endpoint of the randomized withdrawal period (Up to 6 weeks)

ID	Title	Description
OG000	Lisdexamfetamine Dimesylate (LDX)(Randomized Period)	Subjects receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
OG001	Placebo (Randomized Period)	Subjects receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.

Units	Counts
Participants	OG000

Secondary

Percent of Participants With Improvement on Clinical Global Impression - Improvement (CGI-I) at Endpoint (Week-26) of The Open-label Period

Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale. Improvement includes CGI-I categories of very much improved and much improved. No improvement includes all other assessed categories.

Open-label FAS

Posted

Number

percentage of improved participants

At Week 26

ID	Title	Description
OG000	Lisdexamfetamine Dimesylate (LDX)(Open-label Period)	Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours).

Units	Counts
Participants	OG000

Secondary

Change From Open-label Baseline in The Health Utilities Index-2 (HUI-2) Scores at Endpoint (Week-26) of The Open-label Period, LOCF

HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status.

Open-label FAS

Posted

Mean

Standard Deviation

scores on a scale

At open-label baseline and endpoint (Week-26) of the open-label period

ID	Title	Description
OG000	Lisdexamfetamine Dimesylate (LDX)(Open-label Period)	Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours).

Units	Counts
Participants	OG000

Secondary

Change From Randomized Withdrawal Baseline in The HUI-2 Scores at Endpoint of The Randomized Withdrawal Period

Randomized FAS

Posted

Mean

Standard Deviation

Scores on a scale

Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)

ID	Title	Description
OG000	Lisdexamfetamine Dimesylate (LDX)(Randomized Period)	Subjects receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
OG001	Placebo (Randomized Period)	Subjects receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.

Units	Counts
Participants

Secondary

Change From Open-label Baseline in The Child Health and Illness Profile, Child Edition: Parent Report Form (CHIP-CE:PRF) Global T-score at Endpoint (Week-26) of The Open-label Period

The CHIP-CE:PRF evaluates health-related quality of life. It is composed of 5 domains (satisfaction, comfort, resilience, avoidance, and achievement) consisting of a total of 76 items. The global score is an average of the scores for the 5 domains. The majority of items assess frequency of events using a 5-point response format. There is no range for a total score. Raw scale scores are used to generate T-scores. Higher scores indicate better health.

Open-label FAS

Posted

Mean

Standard Deviation

T-scores

At open-label baseline and endpoint (Week-26) of the open-label period

ID	Title	Description
OG000	Lisdexamfetamine Dimesylate (LDX)(Open-label Period)	Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours ).

Units	Counts
Participants	OG000

Secondary

Change From Randomized Withdrawal Baseline in The CHIP-CE:PRF Global T-score at Endpoint of The Randomized Withdrawal Period

Randomized FAS

Posted

Least Squares Mean

Standard Error

T-scores

Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)

ID	Title	Description
OG000	Lisdexamfetamine Dimesylate (LDX)(Randomized Period)	Subjects receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
OG001	Placebo (Randomized Period)	Subjects receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.

Units	Counts
Participants

Secondary

Change From Open-Label Baseline in The Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Endpoint (Week-26) of The Open-label Period

The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.

Open-label FAS

Posted

Mean

Standard Deviation

scores on a scale

At open-label baseline and endpoint (Week-26) of the open-label period

ID	Title	Description
OG000	Lisdexamfetamine Dimesylate (LDX)(Open-label Period)	Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours).

Units	Counts
Participants	OG000

Secondary

Change From Randomized Withdrawal Baseline in The WFIRS-P Global Score at Endpoint of The Randomized Withdrawal Period

The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.

Randomized FAS

Posted

Least Squares Mean

Standard Error

Scores on a scale

Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)

ID	Title	Description
OG000	Lisdexamfetamine Dimesylate (LDX)(Randomized Period)	Subjects receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
OG001	Placebo (Randomized Period)	Subjects receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Open-Label Baseline in The Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Endpoint (Week-26) of The Open-label Period

The BPRS-C characterizes psychopathology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology.

Open-label Safety Population includes all subjects who received at least 1 dose of investigational product in the Open-label period.

Posted

Mean

Standard Deviation

Scores on a scale

At open-label baseline and endpoint (Week-26) of the open-label period

ID	Title	Description
OG000	Lisdexamfetamine Dimesylate (LDX)(Open-label Period)	Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours ).

Units	Counts
Participants	OG000

Secondary

Change From Randomized Withdrawal Baseline in BPRS-C Total Score at Endpoint of The Randomized Withdrawal Period

Randomized Safety Population includes all subjects who received at least 1 dose of any investigational product during the Randomized Withdrawal Period

Posted

Mean

Standard Deviation

Scores on a scale

Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)

ID	Title	Description
OG000	Lisdexamfetamine Dimesylate (LDX)(Randomized Period)	Subjects receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
OG001	Placebo (Randomized Period)	Subjects receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.

Units	Counts
Participants

Other Pre-specified

Percent of Participants With CGI-S at Randomized Withdrawal Baseline

CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)

Randomized FAS

Posted

Number

percentage of participants

Randomized withdrawal baseline

ID	Title	Description
OG000	Lisdexamfetamine Dimesylate (LDX)(Randomized Period)	Subjects receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
OG001	Placebo (Randomized Period)	Subjects receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.

Units	Counts
Participants	OG000

Other Pre-specified

Columbia-Suicide Severity Rating Scale (C-SSRS) During The Open-label Period

C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.

Open-label Safety Population

Posted

Number

participants

From open-label baseline to Week-26

ID	Title	Description
OG000	Lisdexamfetamine Dimesylate (LDX)(Open-label Period)	Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours ).

Units	Counts
Participants	OG000

Other Pre-specified

C-SSRS During the Randomized Withdrawal Period

Randomized Safety Population

Posted

Number

participants

Baseline of the randomized withdrawal period to end of the study (Up to 6 weeks)

ID	Title	Description
OG000	Lisdexamfetamine Dimesylate (LDX)(Randomized Period)	Subjects receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
OG001	Placebo (Randomized Period)	Subjects receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Syncope	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected276 at risk EG0010 events0 affected78 at risk EG0020 events0 affected79 at risk
Aggression	Psychiatric disorders	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected276 at risk EG0010 events0 affected78 at risk EG0020 events0 affected79 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected276 at risk EG0010 events0 affected78 at risk EG0020 events0 affected79 at risk
Vomiting	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected276 at risk EG0010 events0 affected78 at risk EG0020 events0 affected79 at risk
Cellulitis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected276 at risk EG0010 events0 affected78 at risk EG0020 events0 affected79 at risk
Gastric infection	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected276 at risk EG0010 events0 affected78 at risk EG0020 events0 affected79 at risk
Wound	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected276 at risk EG0010 events0 affected78 at risk EG0020 events0 affected79 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected276 at risk EG0010 events0 affected78 at risk EG0020 events0 affected79 at risk
Abnormal behavior	Psychiatric disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected276 at risk EG0010 events0 affected78 at risk EG0020 events0 affected79 at risk
Anger	Psychiatric disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected276 at risk EG0010 events0 affected78 at risk EG0020 events0 affected79 at risk
Oppositional defiant disorder	Psychiatric disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected276 at risk EG0010 events0 affected78 at risk EG0020 events0 affected79 at risk
Treatment noncompliance	Social circumstances	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected276 at risk EG0010 events0 affected78 at risk EG0020 events0 affected79 at risk
Attention deficit/hyperactivity disorder	Psychiatric disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected276 at risk EG0010 events0 affected78 at risk EG0021 events1 affected79 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Decreased appetite	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG00091 events76 affected276 at risk EG0013 events3 affected78 at risk EG0020 events0 affected79 at risk
Headache	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG00080 events58 affected276 at risk EG0016 events6 affected78 at risk EG0027 events5 affected79 at risk
Weight decreased	Investigations	MedDRA (11.1)	Systematic Assessment	EG00060 events46 affected276 at risk EG0012 events2 affected78 at risk EG0021 events1 affected79 at risk
Nasopharyngitis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00064 events43 affected276 at risk EG0017 events7 affected78 at risk EG0023 events3 affected79 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG00048 events41 affected276 at risk EG0010 events0 affected78 at risk EG0020 events0 affected79 at risk
Insomnia	Psychiatric disorders	MedDRA (11.1)	Systematic Assessment	EG00044 events39 affected276 at risk EG0011 events1 affected78 at risk EG0021 events1 affected79 at risk
Vomiting	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG00043 events32 affected276 at risk EG0012 events2 affected78 at risk EG0021 events1 affected79 at risk
Nausea	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG00036 events27 affected276 at risk EG0012 events2 affected78 at risk EG0020 events0 affected79 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG00025 events23 affected276 at risk EG0014 events4 affected78 at risk EG0022 events2 affected79 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG00025 events20 affected276 at risk EG0012 events2 affected78 at risk EG0020 events0 affected79 at risk
Initial insomnia	Psychiatric disorders	MedDRA (11.1)	Systematic Assessment	EG00022 events20 affected276 at risk EG0011 events1 affected78 at risk EG0020 events0 affected79 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG00025 events19 affected276 at risk EG0012 events2 affected78 at risk EG0020 events0 affected79 at risk
Fatigue	General disorders	MedDRA (11.1)	Systematic Assessment	EG00022 events18 affected276 at risk EG0011 events1 affected78 at risk EG0020 events0 affected79 at risk
Pyrexia	General disorders	MedDRA (11.1)	Systematic Assessment	EG00025 events18 affected276 at risk EG0011 events1 affected78 at risk EG0021 events1 affected79 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG00018 events15 affected276 at risk EG0013 events3 affected78 at risk EG0024 events4 affected79 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00021 events14 affected276 at risk EG0011 events1 affected78 at risk EG0021 events1 affected79 at risk
Irritability	General disorders	MedDRA (11.1)	Systematic Assessment	EG00017 events13 affected276 at risk EG0010 events0 affected78 at risk EG0020 events0 affected79 at risk
Diarrhea	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG00012 events12 affected276 at risk EG0011 events1 affected78 at risk EG0020 events0 affected79 at risk
Depressed mood	Psychiatric disorders	MedDRA (11.1)	Systematic Assessment	EG00016 events11 affected276 at risk EG0010 events0 affected78 at risk EG0020 events0 affected79 at risk
Anxiety	Psychiatric disorders	MedDRA (11.1)	Systematic Assessment	EG0009 events9 affected276 at risk EG0010 events0 affected78 at risk EG0020 events0 affected79 at risk
Gastroenteritis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00011 events9 affected276 at risk EG0011 events1 affected78 at risk EG0022 events2 affected79 at risk
Dizziness	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0008 events8 affected276 at risk EG0010 events0 affected78 at risk EG0020 events0 affected79 at risk
Tic	Psychiatric disorders	MedDRA (11.1)	Systematic Assessment	EG00011 events8 affected276 at risk EG0010 events0 affected78 at risk EG0020 events0 affected79 at risk
Aggression	Psychiatric disorders	MedDRA (11.1)	Systematic Assessment	EG0007 events7 affected276 at risk EG0012 events2 affected78 at risk EG0020 events0 affected79 at risk
Sinusitis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0007 events7 affected276 at risk EG0011 events1 affected78 at risk EG0021 events1 affected79 at risk
Ear pain	Ear and labyrinth disorders	MedDRA (11.1)	Systematic Assessment	EG0006 events6 affected276 at risk EG0010 events0 affected78 at risk EG0020 events0 affected79 at risk
Tonsillitis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0006 events6 affected276 at risk EG0012 events1 affected78 at risk EG0020 events0 affected79 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0003 events3 affected276 at risk EG0012 events2 affected78 at risk EG0020 events0 affected79 at risk
Rhinitis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0002 events1 affected276 at risk EG0012 events2 affected78 at risk EG0020 events0 affected79 at risk
Attention deficit/hyperactivity disorder	Psychiatric disorders	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected276 at risk EG0010 events0 affected78 at risk EG0022 events2 affected79 at risk

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

ID	Term
D003913	Dextroamphetamine
D000661	Amphetamine
D000662	Amphetamines
D010627	Phenethylamines
D005021	Ethylamines
D000588	Amines
D009930	Organic Chemicals

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Lisdexamfetamine Dimesylate (LDX)(Open-label Period)	Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM).	12	276	227	276
EG001	Lisdexamfetamine Dimesylate (LDX)(Randomized Period)	After the Open-label Period, subjects were randomized to receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM for up to 6 weeks.	0	78	31	78
EG002	Placebo (Randomized Period)	After the Open-label Period, subjects were randomized to receive placebo once-daily orally at approximately 7:00 AM for up to 6 weeks.	1	79	20	79