Study to Measure Drug Satisfaction of Patients With Schiz... | NCT00535132

ID	Type	Description	Link
R076477SCH4013

Description Module

Detailed Description

Paliperidone ER has been shown to be effective compared to placebo ("a sugar pill") in the acute treatment and maintenance of patients with schizophrenia. Paliperidone ER combines an active metabolite of another antipsychotic, risperidone, with manufacturing technology allowing more gradual release of the drug and less difference in high and low blood levels of the drug. Side effects to medications are sometimes due to wide differences in these high and low blood levels. Recent research has shown that many patients with schizophrenia discontinue their antipsychotic medication due to "subject-choice". Therefore, it is important that research studies attempt to measure patients' satisfaction with antipsychotic medication, in addition to measuring how they respond on tests of effectiveness. This study has been designed to evaluate antipsychotic medication satisfaction in patients who continue to have symptoms of schizophrenia, and who say they are dissatisfied with their current risperidone treatment. The primary outcome is the change in the Medication Satisfaction Questionnaire (MSQ) score, from baseline to the Week 6 endpoint. These patients are randomized (like flipping a coin) as to when their risperidone (4 mg to 6 mg per day) is switched to paliperidone ER. Because the study is 'blinded', neither the study doctor nor the patient will know when treatment with risperidone is stopped and treatment with paliperidone ER begins. Throughout the study all patients continue to receive antipsychotic medication daily. Patients will continue on the same daily dose of risperidone until their randomly assigned switch to paliperidone ER. All patients will be switched to paliperidone ER over the course of study and once switched continue to take paliperidone ER for the remainder of the study. Paliperidone ER is started at 6 mg/day and can be increased to 9 mg/day or 12 mg/day at the doctor's discretion. Effectiveness and safety will be measured at visits scheduled weekly for the first four weeks and then at the Week 6 endpoint. At each visit, patients will be asked to complete psychiatric tests and questionnaires that will measure effectiveness and patient satisfaction with the medicine. They will also complete tests and evaluations for safety, including electrocardiograms (ECGs, electrical tracings of the heart) and blood samples at the beginning and end of the study. Each patient receives two blinded capsules by mouth once daily in the morning for 6 weeks. Patients taking risperidone receive either a 4-mg or 6-mg capsule plus a placebo capsule. When patients are switched, Paliperidone ER is started at 6 mg/day the day after risperidone is discontinued and can be increased to 9 mg/day or 12 mg/day at the doctor's discretion. Paliperidone 3-mg and 6-mg capsules are combined with placebo to equal the total dose in two capsules.

Label	Type	Description	Intervention Names
002	Experimental	Oral Risperidone 4 or 6 mg MG once daily for 0-2 weeks	Drug: Oral Risperidone
001	Experimental	Paliperidone ER 6, 9 or 12 MG once daily for 4-6 weeks	Drug: Paliperidone ER

Name	Type	Description	Arm Group Labels	Other Names
Oral Risperidone	Drug	4 or 6 mg MG once daily for 0-2 weeks	002
Paliperidone ER

Measure	Description	Time Frame
Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to the Week 6 Endpoint.	The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).	Change from Baseline in MSQ Score at Week 6 Last Observation Carried Forward (LOCF)

Measure	Description	Time Frame
Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 2 (Observed).	The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).

Measure	Description	Time Frame
Positive and Negative Syndrome Scale (PANSS) Total Score Change From Baseline to Week 6 Endpoint	The PANSS is a 30-item scale designed to capture numerous symptoms of schizophrenia, including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale as follows: 1=Absent, 2=Minimal, 3=Mild,4=Moderate, 5=Moderate Severe, 6=Severe, 7=Extreme. This scale has been shown to be sensitive to changes associated with medication treatment. In addition to a total score, this assessment yields separate scores along a Positive Syndrome, a Negative Syndrome, and a General Psychopathology Scales. Worst value is 210, best value is 30.

Name	Affiliation	Role
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Study Director

PubMed Identifier	Type	Citation	Retractions
20216424	Derived	Canuso CM, Grinspan A, Kalali A, Damaraju CV, Merriman U, Alphs L, Awad AG. Medication satisfaction in schizophrenia: a blinded-initiation study of paliperidone extended release in patients suboptimally responsive to risperidone. Int Clin Psychopharmacol. 2010 May;25(3):155-64. doi: 10.1097/YIC.0b013e3283372977.

Label	URL
A blinded-initiation study of medication satisfaction in subjects with schizophrenia treated with paliperidone ER after suboptimal response to oral risperidone	View source

ID	Title	Description
FG000	PALI ER Immediate Initiation	Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
FG001	PALI ER Delayed Initiation

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

Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to the Week 6 Endpoint.

The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).

Intent-to-Treat Population with non-missing values at this timepoint

Posted

Mean

Standard Deviation

Points on a scale

Change from Baseline in MSQ Score at Week 6 Last Observation Carried Forward (LOCF)

ID	Title	Description
OG000	PALI ER Immediate Initiation	Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
OG001	PALI ER Delayed Initiation	Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
OG002	Overall	Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.

Units	Counts
Participants	OG00095 OG00196 OG002191

Title

Denominators

Categories

Title	Measurements
	OG0002.5± 1.2 OG0012.3± 1.5 OG0022.4± 1.4

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
OG002	Sample size for this study was based on changes in the MSQ scores within subjects from baseline to endpoint using a one-sample paired t-test. A sample size of 97 subjects was shown to have 90% power at endpoint to detect a mean change from baseline of 0.5 units on the MSQ score, with a standard deviation of 1.5. Allowing for extra variability from subjects with prior generic risperidone (instead of branded risperidone) use, this number was increased to 150 subjects.	t-test, 2 sided		<0.001	p-value based on a paired t-test for a within-group comparison.	Mean Difference (Final Values)	2.4	Standard Deviation	1.4								No

Secondary

Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 2 (Observed).

Intent-to-Treat Population with non-missing values at this timepoint

Posted

Mean

Standard Deviation

Points on a scale

Change from Baseline in MSQ Score at Week 2

ID	Title	Description
OG000	PALI ER Immediate Initiation	Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
OG001	PALI ER Delayed Initiation	Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
OG002	Overall	Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.

Secondary

Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 4 (Observed).

Intent-to-Treat Population with non-missing values at this timepoint

Posted

Mean

Standard Deviation

Points on a scale

Change from Baseline in MSQ Score at Week 4

ID	Title	Description
OG000	PALI ER Immediate Initiation	Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
OG001	PALI ER Delayed Initiation	Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
OG002	Overall	Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.

Secondary

Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 6 (Observed).

Intent-to-Treat Population with non-missing values at this timepoint

Posted

Mean

Standard Deviation

Points on a scale

Change from Baseline in MSQ Score at Week 6

ID	Title	Description
OG000	PALI ER Immediate Initiation	Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
OG001	PALI ER Delayed Initiation	Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
OG002	Overall	Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.

Secondary

Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 2 (Observed).

Intent-to-Treat Population with non-missing values at this timepoint

Posted

Number

Participants

Week 2

ID	Title	Description
OG000	PALI ER Immediate Initiation	Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
OG001	PALI ER Delayed Initiation	Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
OG002	Overall	Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.

Secondary

Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 4 (Observed).

Intent-to-Treat Population with non-missing values at this timepoint

Posted

Number

Participants

Week 4

ID	Title	Description
OG000	PALI ER Immediate Initiation	Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
OG001	PALI ER Delayed Initiation	Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
OG002	Overall	Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.

Other Pre-specified

Positive and Negative Syndrome Scale (PANSS) Total Score Change From Baseline to Week 6 Endpoint

The PANSS is a 30-item scale designed to capture numerous symptoms of schizophrenia, including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale as follows: 1=Absent, 2=Minimal, 3=Mild,4=Moderate, 5=Moderate Severe, 6=Severe, 7=Extreme. This scale has been shown to be sensitive to changes associated with medication treatment. In addition to a total score, this assessment yields separate scores along a Positive Syndrome, a Negative Syndrome, and a General Psychopathology Scales. Worst value is 210, best value is 30.

Intent-to-Treat Population with non-missing values at this timepoint

Posted

Mean

Standard Deviation

Points on a scale

Change from Baseline to Week 6 LOCF

ID	Title	Description
OG000	PALI ER Immediate Initiation	Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
OG001	PALI ER Delayed Initiation	Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).

Other Pre-specified

Clinical Global Impression - Severity (CGI-S) Change From Baseline to Week 6 Endpoint

The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a subject. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill subjects". Worst value is 7 and best value is 1.

Intent-to-Treat Population with non-missing values at this timepoint

Posted

Mean

Standard Deviation

Points on a scale

Change from Baseline to Week 6 LOCF

ID	Title	Description
OG000	PALI ER Immediate Initiation	Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
OG001	PALI ER Delayed Initiation	Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
OG002	Overall	Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.

Secondary

Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 6 (Observed).

Intent-to-Treat Population with non-missing values at this timepoint

Posted

Number

Participants

Week 6

ID	Title	Description
OG000	PALI ER Immediate Initiation	Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
OG001	PALI ER Delayed Initiation	Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
OG002	Overall	Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.

Secondary

Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 6 LOCF.

Intent-to-Treat Population with non-missing values at this timepoint

Posted

Number

Participants

Week 6 LOCF

ID	Title	Description
OG000	PALI ER Immediate Initiation	Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
OG001	PALI ER Delayed Initiation	Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
OG002	Overall	Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.

Secondary

Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction Score Change From Baseline to the Week 6 Endpoint

The TSQM is a 14-item subject-assessed evaluation of treatment medication including 4 factors, Effectiveness (items 1-3), Side Effects (items 4-8), Convenience (items 9-11)and Global Satisfaction (items 12-14). Item 14 states "taking all things into account, how satisfied or dissatisfied are you with this medication?" and utilizes the following responses on a 7-point Likert scale: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 0 and best value is 100.

Intent-to-Treat Population with non-missing values at this timepoint

Posted

Mean

Standard Deviation

Points on a scale

Change from Baseline to Week 6 LOCF

ID	Title	Description
OG000	PALI ER Immediate Initiation	Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
OG001	PALI ER Delayed Initiation	Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).

Secondary

Short Form-36 Health Survey (SF-36) Physical Health Composite Score Change From Baseline to the Week 6 Endpoint

The SF-36 is a well-validated and widely used quality-of-life instrument employed in numerous disease states, including schizophrenia. It is a self-administered survey that measures eight domains of health including: physical functioning, role limitations due to physical health (role-physical), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems (role-emotional) and general mental health. Scoring of the SF-36 was based on the SF-36 Manual and Interpretation Guide. Worst value is 0 and best value is 100.

Intent-to-Treat Population with non-missing values at this timepoint

Posted

Mean

Standard Deviation

Scores on a scale

Change from Baseline to Week 6 LOCF

ID	Title	Description
OG000	PALI ER Immediate Initiation	Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
OG001	PALI ER Delayed Initiation	Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).

Secondary

Short Form-36 Health Survey (SF-36) Mental Health Composite Score Change From Baseline to the Week 6 Endpoint

Intent-to-Treat Population with non-missing values at this timepoint

Posted

Mean

Standard Deviation

Scores on a scale

Change from Baseline to Week 6 LOCF

ID	Title	Description
OG000	PALI ER Immediate Initiation	Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
OG001	PALI ER Delayed Initiation	Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).

Secondary

Pittsburgh Sleep Quality Index (PSQI) Change From Baseline to the Week 6 Endpoint

The PSQI is a 2-part questionnaire that assesses sleep quality and disturbances in seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each domain is rated on a 4-point scale as follows: 0=Not during the past month, 1=Less than once a week, 2=Once or twice a week, 3=Three or more times a week. Total scores range from zero to 21; increasing scores indicate poorer sleep quality and total scores greater than 5 suggest significant sleep disturbance.

Intent-to-Treat Population with non-missing values at this timepoint

Posted

Mean

Standard Deviation

Points on a scale

Change from Baseline to Week 6 LOCF

ID	Title	Description
OG000	PALI ER Immediate Initiation	Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
OG001	PALI ER Delayed Initiation	Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
OG002

Secondary

Modified COVI Anxiety Scale (m-COVI) Change From Baseline to the Week 6 Endpoint

The standard COVI Anxiety Scale is an investigator-assessed measure of the severity of anxiety symptoms on 4 items: verbal report, behavior, somatic symptoms, and relationship to study drug. Each dimension is assessed in 5 to 10 minutes using a 5-point scale as follows: 1=Not at all, 2=Somewhat, 3=Moderately, 4=Considerably, to 5=Very much. For this study, the standard COVI Anxiety Scale was modified to improve psychometric properties by incorporating anchor points for symptom severity, frequency, and duration and for functional impairment. Worst value is 20 and best value is 4.

Intent-to-Treat Population with non-missing values at this timepoint

Posted

Mean

Standard Deviation

Points on a scale

Change from Baseline to Week 6 LOCF

ID	Title	Description
OG000	PALI ER Immediate Initiation	Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
OG001	PALI ER Delayed Initiation	Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Palpitations	Cardiac disorders	MedDRA 9.1	Systematic Assessment	EG0002 events1 affected98 at risk EG0010 events0 affected99 at risk EG0022 events1 affected197 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 9.1	Systematic Assessment	EG0000 events0 affected98 at risk EG0011 events1 affected99 at risk EG0021 events1 affected197 at risk
Tachycardia	Cardiac disorders	MedDRA 9.1	Systematic Assessment	EG0002 events2 affected98 at risk EG0012 events2 affected99 at risk EG0024 events4 affected197 at risk
Hyperprolactinaemia	Endocrine disorders	MedDRA 9.1	Systematic Assessment	EG0001 events1 affected98 at risk EG0010 events0 affected99 at risk EG0021 events1 affected197 at risk
Vision blurred	Eye disorders	MedDRA 9.1	Systematic Assessment	EG0002 events2 affected98 at risk EG0010 events0 affected99 at risk EG0022 events2 affected197 at risk
Constipation	Gastrointestinal disorders	MedDRA 9.1	Systematic Assessment	EG0006 events6 affected98 at risk EG0019 events9 affected99 at risk EG00215 events15 affected197 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 9.1	Systematic Assessment	EG0002 events2 affected98 at risk EG0012 events2 affected99 at risk EG0024 events4 affected197 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 9.1	Systematic Assessment	EG0001 events1 affected98 at risk EG0013 events3 affected99 at risk EG0024 events4 affected197 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 9.1	Systematic Assessment	EG0001 events1 affected98 at risk EG0010 events0 affected99 at risk EG0021 events1 affected197 at risk
Gastritis	Gastrointestinal disorders	MedDRA 9.1	Systematic Assessment	EG0001 events1 affected98 at risk EG0010 events0 affected99 at risk EG0021 events1 affected197 at risk
Nausea	Gastrointestinal disorders	MedDRA 9.1	Systematic Assessment	EG0004 events3 affected98 at risk EG0016 events5 affected99 at risk EG00210 events8 affected197 at risk
Pancreatitus acute	Gastrointestinal disorders	MedDRA 9.1	Systematic Assessment	EG0001 events1 affected98 at risk EG0010 events0 affected99 at risk EG0021 events1 affected197 at risk
Salivary Hypersecretion	Gastrointestinal disorders	MedDRA 9.1	Systematic Assessment	EG0000 events0 affected98 at risk EG0011 events1 affected99 at risk EG0021 events1 affected197 at risk
Stomach discomfort	Gastrointestinal disorders	MedDRA 9.1	Systematic Assessment	EG0001 events1 affected98 at risk EG0010 events0 affected99 at risk EG0021 events1 affected197 at risk
Vomiting	Gastrointestinal disorders	MedDRA 9.1	Systematic Assessment	EG0002 events2 affected98 at risk EG0011 events1 affected99 at risk EG0023 events3 affected197 at risk
Asthenia	General disorders	MedDRA 9.1	Systematic Assessment	EG0001 events1 affected98 at risk EG0010 events0 affected99 at risk EG0021 events1 affected197 at risk
Chills	General disorders	MedDRA 9.1	Systematic Assessment	EG0001 events1 affected98 at risk EG0010 events0 affected99 at risk EG0021 events1 affected197 at risk
Fatigue	General disorders	MedDRA 9.1	Systematic Assessment	EG0002 events2 affected98 at risk EG0010 events0 affected99 at risk EG0022 events2 affected197 at risk
Irritability	General disorders	MedDRA 9.1	Systematic Assessment	EG0000 events0 affected98 at risk EG0011 events1 affected99 at risk EG0021 events1 affected197 at risk
Conjunctivitis viral	Infections and infestations	MedDRA 9.1	Systematic Assessment	EG0000 events0 affected98 at risk EG0011 events1 affected99 at risk EG0021 events1 affected197 at risk
Fungal infection	Infections and infestations	MedDRA 9.1	Systematic Assessment	EG0000 events0 affected98 at risk EG0012 events1 affected99 at risk EG0022 events1 affected197 at risk
Influenza	Infections and infestations	MedDRA 9.1	Systematic Assessment	EG0003 events3 affected98 at risk EG0011 events1 affected99 at risk EG0024 events4 affected197 at risk
Nasopharyngitis	Infections and infestations	MedDRA 9.1	Systematic Assessment	EG0001 events1 affected98 at risk EG0013 events2 affected99 at risk EG0024 events3 affected197 at risk
Tooth abscess	Infections and infestations	MedDRA 9.1	Systematic Assessment	EG0001 events1 affected98 at risk EG0010 events0 affected99 at risk EG0021 events1 affected197 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 9.1	Systematic Assessment	EG0001 events1 affected98 at risk EG0011 events1 affected99 at risk EG0022 events2 affected197 at risk
Eye injury	Injury, poisoning and procedural complications	MedDRA 9.1	Systematic Assessment	EG0001 events1 affected98 at risk EG0010 events0 affected99 at risk EG0021 events1 affected197 at risk
Blood prolactin increased	Investigations	MedDRA 9.1	Systematic Assessment	EG0003 events3 affected98 at risk EG0012 events2 affected99 at risk EG0025 events5 affected197 at risk
Liver function test abnormal	Investigations	MedDRA 9.1	Systematic Assessment	EG0000 events0 affected98 at risk EG0011 events1 affected99 at risk EG0021 events1 affected197 at risk
Weight increased	Investigations	MedDRA 9.1	Systematic Assessment	EG0002 events2 affected98 at risk EG0013 events3 affected99 at risk EG0025 events5 affected197 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA 9.1	Systematic Assessment	EG0001 events1 affected98 at risk EG0010 events0 affected99 at risk EG0021 events1 affected197 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 9.1	Systematic Assessment	EG0001 events1 affected98 at risk EG0011 events1 affected99 at risk EG0022 events2 affected197 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 9.1	Systematic Assessment	EG0001 events1 affected98 at risk EG0010 events0 affected99 at risk EG0021 events1 affected197 at risk
Akathisia	Nervous system disorders	MedDRA 9.1	Systematic Assessment	EG0000 events0 affected98 at risk EG0013 events3 affected99 at risk EG0023 events3 affected197 at risk
Balance disorder	Nervous system disorders	MedDRA 9.1	Systematic Assessment	EG0001 events1 affected98 at risk EG0010 events0 affected99 at risk EG0021 events1 affected197 at risk
Bradykinesia	Nervous system disorders	MedDRA 9.1	Systematic Assessment	EG0001 events1 affected98 at risk EG0010 events0 affected99 at risk EG0021 events1 affected197 at risk
Disturbance in attention	Nervous system disorders	MedDRA 9.1	Systematic Assessment	EG0000 events0 affected98 at risk EG0011 events1 affected99 at risk EG0021 events1 affected197 at risk
Dizziness	Nervous system disorders	MedDRA 9.1	Systematic Assessment	EG0001 events1 affected98 at risk EG0015 events5 affected99 at risk EG0026 events6 affected197 at risk
Dizziness postural	Nervous system disorders	MedDRA 9.1	Systematic Assessment	EG0003 events3 affected98 at risk EG0013 events3 affected99 at risk EG0026 events6 affected197 at risk
Dyskinesia	Nervous system disorders	MedDRA 9.1	Systematic Assessment	EG0000 events0 affected98 at risk EG0013 events3 affected99 at risk EG0023 events3 affected197 at risk
Dystonia	Nervous system disorders	MedDRA 9.1	Systematic Assessment	EG0000 events0 affected98 at risk EG0012 events2 affected99 at risk EG0022 events2 affected197 at risk
Headache	Nervous system disorders	MedDRA 9.1	Systematic Assessment	EG0009 events8 affected98 at risk EG0017 events7 affected99 at risk EG00216 events15 affected197 at risk
Hypertonia	Nervous system disorders	MedDRA 9.1	Systematic Assessment	EG0001 events1 affected98 at risk EG0012 events2 affected99 at risk EG0023 events3 affected197 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 9.1	Systematic Assessment	EG0001 events1 affected98 at risk EG0010 events0 affected99 at risk EG0021 events1 affected197 at risk
Sedation	Nervous system disorders	MedDRA 9.1	Systematic Assessment	EG0003 events3 affected98 at risk EG0013 events3 affected99 at risk EG0026 events6 affected197 at risk
Somnolence	Nervous system disorders	MedDRA 9.1	Systematic Assessment	EG0005 events5 affected98 at risk EG0019 events8 affected99 at risk EG00214 events13 affected197 at risk
Tremor	Nervous system disorders	MedDRA 9.1	Systematic Assessment	EG0002 events2 affected98 at risk EG0014 events3 affected99 at risk EG0026 events5 affected197 at risk
Abulia	Psychiatric disorders	MedDRA 9.1	Systematic Assessment	EG0001 events1 affected98 at risk EG0011 events1 affected99 at risk EG0022 events2 affected197 at risk
Agitation	Psychiatric disorders	MedDRA 9.1	Systematic Assessment	EG0001 events1 affected98 at risk EG0015 events2 affected99 at risk EG0026 events3 affected197 at risk
Anxiety	Psychiatric disorders	MedDRA 9.1	Systematic Assessment	EG0003 events3 affected98 at risk EG0012 events2 affected99 at risk EG0025 events5 affected197 at risk
Delusion	Psychiatric disorders	MedDRA 9.1	Systematic Assessment	EG0000 events0 affected98 at risk EG0013 events2 affected99 at risk EG0023 events2 affected197 at risk
Depressed mood	Psychiatric disorders	MedDRA 9.1	Systematic Assessment	EG0001 events1 affected98 at risk EG0010 events0 affected99 at risk EG0021 events1 affected197 at risk
Depression	Psychiatric disorders	MedDRA 9.1	Systematic Assessment	EG0000 events0 affected98 at risk EG0011 events1 affected99 at risk EG0021 events1 affected197 at risk
Hallucination	Psychiatric disorders	MedDRA 9.1	Systematic Assessment	EG0000 events0 affected98 at risk EG0012 events2 affected99 at risk EG0022 events2 affected197 at risk
Insomnia	Psychiatric disorders	MedDRA 9.1	Systematic Assessment	EG00010 events9 affected98 at risk EG00110 events9 affected99 at risk EG00220 events18 affected197 at risk
Libido decreased	Psychiatric disorders	MedDRA 9.1	Systematic Assessment	EG0002 events2 affected98 at risk EG0013 events3 affected99 at risk EG0025 events5 affected197 at risk
Libido increased	Psychiatric disorders	MedDRA 9.1	Systematic Assessment	EG0000 events0 affected98 at risk EG0011 events1 affected99 at risk EG0021 events1 affected197 at risk
Mood altered	Psychiatric disorders	MedDRA 9.1	Systematic Assessment	EG0001 events1 affected98 at risk EG0010 events0 affected99 at risk EG0021 events1 affected197 at risk
Paranoia	Psychiatric disorders	MedDRA 9.1	Systematic Assessment	EG0001 events1 affected98 at risk EG0010 events0 affected99 at risk EG0021 events1 affected197 at risk
Psychotic disorder	Psychiatric disorders	MedDRA 9.1	Systematic Assessment	EG0001 events1 affected98 at risk EG0011 events1 affected99 at risk EG0022 events2 affected197 at risk
Restlessness	Psychiatric disorders	MedDRA 9.1	Systematic Assessment	EG0001 events1 affected98 at risk EG0010 events0 affected99 at risk EG0021 events1 affected197 at risk
Schizophrenia	Psychiatric disorders	MedDRA 9.1	Systematic Assessment	EG0003 events2 affected98 at risk EG0017 events4 affected99 at risk EG00210 events6 affected197 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 9.1	Systematic Assessment	EG0000 events0 affected98 at risk EG0012 events2 affected99 at risk EG0022 events2 affected197 at risk
Amenorrhoea	Reproductive system and breast disorders	MedDRA 9.1	Systematic Assessment	EG0001 events1 affected98 at risk EG0010 events0 affected99 at risk EG0021 events1 affected197 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 9.1	Systematic Assessment	EG0001 events1 affected98 at risk EG0012 events2 affected99 at risk EG0023 events3 affected197 at risk
Galactorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 9.1	Systematic Assessment	EG0002 events1 affected98 at risk EG0010 events0 affected99 at risk EG0022 events1 affected197 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA 9.1	Systematic Assessment	EG0001 events1 affected98 at risk EG0010 events0 affected99 at risk EG0021 events1 affected197 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 9.1	Systematic Assessment	EG0001 events1 affected98 at risk EG0010 events0 affected99 at risk EG0021 events1 affected197 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 9.1	Systematic Assessment	EG0002 events2 affected98 at risk EG0010 events0 affected99 at risk EG0022 events2 affected197 at risk
Dry throat	Respiratory, thoracic and mediastinal disorders	MedDRA 9.1	Systematic Assessment	EG0002 events2 affected98 at risk EG0010 events0 affected99 at risk EG0022 events2 affected197 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 9.1	Systematic Assessment	EG0001 events1 affected98 at risk EG0010 events0 affected99 at risk EG0021 events1 affected197 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 9.1	Systematic Assessment	EG0001 events1 affected98 at risk EG0010 events0 affected99 at risk EG0021 events1 affected197 at risk
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 9.1	Systematic Assessment	EG0001 events1 affected98 at risk EG0012 events2 affected99 at risk EG0023 events3 affected197 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 9.1	Systematic Assessment	EG0002 events2 affected98 at risk EG0010 events0 affected99 at risk EG0022 events2 affected197 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Cerritos	California		United States

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

ID	Term
D011744	Pyrimidinones
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D007555	Isoxazoles
D001393	Azoles

ID	Title	Description
BG000	PALI ER Immediate Initiation	Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
BG001	PALI ER Delayed Initiation	Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were then to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
BG002	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	PALI ER Immediate Initiation	Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).	3	98	49	98
EG001	PALI ER Delayed Initiation	Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).	4	99	56	99
EG002	Overall	Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.	7	197	105	197

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pancreatitis acute	Gastrointestinal disorders	MedDRA 9.1	Systematic Assessment	EG0001 affected98 at risk EG0010 affected99 at risk EG0021 affected197 at risk
Schizophrenia	Psychiatric disorders	MedDRA 9.1	Systematic Assessment	EG0002 affected98 at risk EG0014 affected99 at risk EG0026 affected197 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 9.1	Systematic Assessment	EG0001 affected98 at risk EG0010 affected99 at risk EG0021 affected197 at risk