Trial Outcomes & Findings for Study to Measure the Safety of Paliperidone ER (Extended-release) in Patients With Liver Disease (NCT NCT00535145)
NCT ID: NCT00535145
Last Updated: 2014-07-25
Results Overview
Adverse Event summary for both serious adverse events and other adverse events. Please see the Clinical Study Report Synopsis for results on this primary outcome measure or the AE section for a detailed breakdown of each adverse event preferred term in both categories.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
121 participants
Primary outcome timeframe
Day 1 - Day 62
Results posted on
2014-07-25
Participant Flow
One-hundred-twenty-one (121) participants were enrolled but only 114 entered Phase 1 of the study (5 participants enrolled twice and only had their first entrance included and 2 participants did not sign the required HIPAA form).
Participant milestones
| Measure |
Study Treatment
Phase 1; Day 1 through Day 27: Patients took therapy for schizophrenia as prescribed before study entry (referred to "treatment as usual" abbreviated as "TAU") for 4 weeks. Phase 2; Day 28 through Day 62: The dose of TAU was then tapered (reduced and stopped) over a 1-week period and treatment started with paliperidone extended-release (ER) tablets, 6 mg, orally (by mouth) once daily followed by 4 weeks of paliperidone ER, 3-12 mg once daily as monotherapy (treatment with Paliperidone ER alone)
|
|---|---|
|
Phase I
STARTED
|
114
|
|
Phase I
COMPLETED
|
85
|
|
Phase I
NOT COMPLETED
|
29
|
|
Phase II
STARTED
|
84
|
|
Phase II
COMPLETED
|
69
|
|
Phase II
NOT COMPLETED
|
15
|
Reasons for withdrawal
| Measure |
Study Treatment
Phase 1; Day 1 through Day 27: Patients took therapy for schizophrenia as prescribed before study entry (referred to "treatment as usual" abbreviated as "TAU") for 4 weeks. Phase 2; Day 28 through Day 62: The dose of TAU was then tapered (reduced and stopped) over a 1-week period and treatment started with paliperidone extended-release (ER) tablets, 6 mg, orally (by mouth) once daily followed by 4 weeks of paliperidone ER, 3-12 mg once daily as monotherapy (treatment with Paliperidone ER alone)
|
|---|---|
|
Phase I
Adverse Event
|
3
|
|
Phase I
Lost to Follow-up
|
7
|
|
Phase I
Withdrawal by Subject
|
6
|
|
Phase I
(eligibility)
|
8
|
|
Phase I
(protocol violation)
|
1
|
|
Phase I
(PI decision)
|
1
|
|
Phase I
(diagnosis)
|
3
|
|
Phase II
Adverse Event
|
2
|
|
Phase II
Lack of Efficacy
|
1
|
|
Phase II
Lost to Follow-up
|
5
|
|
Phase II
Withdrawal by Subject
|
5
|
|
Phase II
Subject non-compliance
|
2
|
Baseline Characteristics
Study to Measure the Safety of Paliperidone ER (Extended-release) in Patients With Liver Disease
Baseline characteristics by cohort
| Measure |
Study Treatment
n=84 Participants
Phase 1; Day 1 through Day 27: Patients took therapy for schizophrenia as prescribed before study entry (referred to "treatment as usual" abbreviated as "TAU") for 4 weeks. Phase 2; Day 28 through Day 62: The dose of TAU was then tapered (reduced and stopped) over a 1-week period and treatment started with paliperidone extended-release (ER) tablets, 6 mg, orally (by mouth) once daily followed by 4 weeks of paliperidone ER, 3-12 mg once daily as monotherapy (treatment with Paliperidone ER alone).
|
|---|---|
|
Age, Continuous
|
48.9 years
STANDARD_DEVIATION 6.73 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 - Day 62Population: Safety Analysis Set
Adverse Event summary for both serious adverse events and other adverse events. Please see the Clinical Study Report Synopsis for results on this primary outcome measure or the AE section for a detailed breakdown of each adverse event preferred term in both categories.
Outcome measures
| Measure |
Study Treatment
n=84 Participants
Day 1 through Day 27: Antipsychotic treatment as usual (TAU); Day 28 through Day 62: Paliperidone ER (1 week cross titration plus 4 weeks mono-therapy).
|
Paliperidone ER Phase
n=84 Participants
Day 28 through Day 62 (1 week cross titration plus 4 weeks mono-therapy).
|
|---|---|---|
|
The Difference in the Incidence of Any Adverse Events When Patients Switch Their Antipsychotic From Treatment as Usual (TAU) to Paliperidone ER
Serious Adverse Events
|
0 Participants
|
2 Participants
|
|
The Difference in the Incidence of Any Adverse Events When Patients Switch Their Antipsychotic From Treatment as Usual (TAU) to Paliperidone ER
Other Adverse Events
|
27 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: Day 1 - Day 62Population: Efficacy Analysis Set
The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale (1="Absent", 2="Minimal", 3="Mild", 4="Moderate", 5="Moderate/Severe", 6="Severe", 7="Extreme").The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate more severe neuropsychiatric symptoms of schizophrenia.
Outcome measures
| Measure |
Study Treatment
n=79 Participants
Day 1 through Day 27: Antipsychotic treatment as usual (TAU); Day 28 through Day 62: Paliperidone ER (1 week cross titration plus 4 weeks mono-therapy).
|
Paliperidone ER Phase
Day 28 through Day 62 (1 week cross titration plus 4 weeks mono-therapy).
|
|---|---|---|
|
Positive and Negative Symptoms of Schizophrenia (PANSS) Change From Baseline
Day 27 (n=79)
|
-1.7 Scores on a scale
Standard Deviation 7.35
|
—
|
|
Positive and Negative Symptoms of Schizophrenia (PANSS) Change From Baseline
Day 48 (n=74)
|
-5.4 Scores on a scale
Standard Deviation 8.72
|
—
|
|
Positive and Negative Symptoms of Schizophrenia (PANSS) Change From Baseline
Day 62 (n=77)
|
-7.2 Scores on a scale
Standard Deviation 9.91
|
—
|
|
Positive and Negative Symptoms of Schizophrenia (PANSS) Change From Baseline
Post Day 27 Endpoint (n=79)
|
-7.6 Scores on a scale
Standard Deviation 10.43
|
—
|
SECONDARY outcome
Timeframe: Day 1 - Day 62Population: Efficacy Analysis Set
The CGI-S (range 1-7) is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness.
Outcome measures
| Measure |
Study Treatment
n=79 Participants
Day 1 through Day 27: Antipsychotic treatment as usual (TAU); Day 28 through Day 62: Paliperidone ER (1 week cross titration plus 4 weeks mono-therapy).
|
Paliperidone ER Phase
Day 28 through Day 62 (1 week cross titration plus 4 weeks mono-therapy).
|
|---|---|---|
|
Clinical Global Impression of Severity (CGI-S) Change From Baseline
Day 13 (n=78)
|
-0.1 Scores on a scale
Standard Deviation 0.39
|
—
|
|
Clinical Global Impression of Severity (CGI-S) Change From Baseline
Day 27 Paliperidone ER Baseline (n=79)
|
-0.1 Scores on a scale
Standard Deviation 0.37
|
—
|
|
Clinical Global Impression of Severity (CGI-S) Change From Baseline
Day 48 (n=74)
|
-0.3 Scores on a scale
Standard Deviation 0.60
|
—
|
|
Clinical Global Impression of Severity (CGI-S) Change From Baseline
Day 62 (n=77)
|
-0.4 Scores on a scale
Standard Deviation 0.65
|
—
|
|
Clinical Global Impression of Severity (CGI-S) Change From Baseline
Post Day 27 Endpoint (n=79)
|
-0.4 Scores on a scale
Standard Deviation 0.67
|
—
|
SECONDARY outcome
Timeframe: Day 1 - Day 62Population: Includes participants in the efficacy analysis set for with PSP scores available.
The PSP (range 1-100) is a validated clinician-rated assessment of functioning. Four areas of functioning (socially useful activities, personal/social relationships, self-care, disturbing/aggressive behaviors) are assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function.
Outcome measures
| Measure |
Study Treatment
n=78 Participants
Day 1 through Day 27: Antipsychotic treatment as usual (TAU); Day 28 through Day 62: Paliperidone ER (1 week cross titration plus 4 weeks mono-therapy).
|
Paliperidone ER Phase
Day 28 through Day 62 (1 week cross titration plus 4 weeks mono-therapy).
|
|---|---|---|
|
Personal and Social Performance Score (PSP) Change From Baseline
Day 27 Paliperidone ER Baseline (n=78)
|
1.2 Scores on a scale
Standard Deviation 7.25
|
—
|
|
Personal and Social Performance Score (PSP) Change From Baseline
Day 62 (n=76)
|
2.8 Scores on a scale
Standard Deviation 7.23
|
—
|
Adverse Events
TAU - Pali ER
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Paliperidone ER Phase
Serious events: 2 serious events
Other events: 43 other events
Deaths: 0 deaths
TAU - All Enrolled Participants
Serious events: 2 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TAU - Pali ER
n=84 participants at risk
Phase 1; Day 1 through Day 27: Patients took therapy for schizophrenia as prescribed before study entry (referred to "treatment as usual" abbreviated as "TAU") for 4 weeks who went on to participate in Phase 2 (Paliperidone ER Phase).
|
Paliperidone ER Phase
n=84 participants at risk
Phase 2; Day 28 through Day 62: The dose of TAU was then tapered (reduced and stopped) over a 1-week period and treatment started with paliperidone extended-release (ER) tablets, 6 mg, orally (by mouth) once daily followed by 4 weeks of paliperidone ER, 3-12 mg once daily as monotherapy (treatment with Paliperidone ER alone).
|
TAU - All Enrolled Participants
n=114 participants at risk
Phase 1; Day 1 through Day 27: Patients took therapy for schizophrenia as prescribed before study entry (referred to "treatment as usual" abbreviated as "TAU") for 4 weeks. Phase 2; Day 28 through Day 62: The dose of TAU was then tapered (reduced and stopped) over a 1-week period and treatment started with paliperidone extended-release (ER) tablets, 6 mg, orally (by mouth) once daily followed by 4 weeks of paliperidone ER, 3-12 mg once daily as monotherapy (treatment with Paliperidone ER alone).
|
|---|---|---|---|
|
Nervous system disorders
Dystonia
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Psychiatric disorders
Psychotic Disorder
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.88%
1/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.88%
1/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
Other adverse events
| Measure |
TAU - Pali ER
n=84 participants at risk
Phase 1; Day 1 through Day 27: Patients took therapy for schizophrenia as prescribed before study entry (referred to "treatment as usual" abbreviated as "TAU") for 4 weeks who went on to participate in Phase 2 (Paliperidone ER Phase).
|
Paliperidone ER Phase
n=84 participants at risk
Phase 2; Day 28 through Day 62: The dose of TAU was then tapered (reduced and stopped) over a 1-week period and treatment started with paliperidone extended-release (ER) tablets, 6 mg, orally (by mouth) once daily followed by 4 weeks of paliperidone ER, 3-12 mg once daily as monotherapy (treatment with Paliperidone ER alone).
|
TAU - All Enrolled Participants
n=114 participants at risk
Phase 1; Day 1 through Day 27: Patients took therapy for schizophrenia as prescribed before study entry (referred to "treatment as usual" abbreviated as "TAU") for 4 weeks. Phase 2; Day 28 through Day 62: The dose of TAU was then tapered (reduced and stopped) over a 1-week period and treatment started with paliperidone extended-release (ER) tablets, 6 mg, orally (by mouth) once daily followed by 4 weeks of paliperidone ER, 3-12 mg once daily as monotherapy (treatment with Paliperidone ER alone).
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
3.6%
3/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.88%
1/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
2.4%
2/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.88%
1/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Psychiatric disorders
Sleep Disorder
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Eye disorders
Vision Blurred
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Gastrointestinal disorders
Nausea
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
6.0%
5/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.88%
1/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Gastrointestinal disorders
Dry Mouth
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
3.6%
3/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.88%
1/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Gastrointestinal disorders
Food Poisoning
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Gastrointestinal disorders
Gingival Pain
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
General disorders
Facial Pain
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.88%
1/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
General disorders
Hernia Pain
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
General disorders
Oedema
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
General disorders
Pain
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
2.4%
2/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
2.4%
2/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
1.8%
2/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Infections and infestations
Influenza
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Infections and infestations
Nasopharyngitis
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.88%
1/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Injury, poisoning and procedural complications
Facial Bones Fracture
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.88%
1/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Investigations
Blood Pressure Increased
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
3.6%
3/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.88%
1/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Investigations
Blood Prolactin Increased
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
3.6%
3/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.88%
1/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Investigations
Weight Increased
|
6.0%
5/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
3.6%
3/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
4.4%
5/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Investigations
Weight Decreased
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Metabolism and nutrition disorders
Increased Appetite
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
2.4%
2/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.4%
2/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
1.8%
2/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.88%
1/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.88%
1/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Nervous system disorders
Tremor
|
2.4%
2/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
8.3%
7/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
1.8%
2/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Nervous system disorders
Headache
|
3.6%
3/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
7.1%
6/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
2.6%
3/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Nervous system disorders
Somnolence
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
2.4%
2/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Nervous system disorders
Akathisia
|
2.4%
2/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
1.8%
2/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Nervous system disorders
Dyskinesia
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.88%
1/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Nervous system disorders
Extrapyramidal Disorder
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
4.8%
4/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Psychiatric disorders
Bradyphrenia
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Psychiatric disorders
Homicidal Ideation
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Reproductive system and breast disorders
Galactorrhoea
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Reproductive system and breast disorders
Vaginal Haemorrhage
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
2.4%
2/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Vascular disorders
Hypertension
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Cardiac disorders
Tachycardia
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.88%
1/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.88%
1/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Gastrointestinal disorders
Constipation
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.88%
1/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.88%
1/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Hepatobiliary disorders
Liver Disorder
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.88%
1/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Infections and infestations
Respiratory Tract Infection
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.88%
1/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Injury, poisoning and procedural complications
Back Injury
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.88%
1/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Injury, poisoning and procedural complications
Neck Injury
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.88%
1/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.88%
1/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Injury, poisoning and procedural complications
Tooth Fracture
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.88%
1/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Investigations
Blood Potassium Increased
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.88%
1/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Investigations
Blood Pressure Diastolic Decreased
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.88%
1/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.88%
1/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Nervous system disorders
Drooling
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.88%
1/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Psychiatric disorders
Thinking Abnormal
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.88%
1/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.2%
1/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.88%
1/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.88%
1/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Gastrointestinal disorders
Feces discolores
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.88%
1/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.88%
1/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.88%
1/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Investigations
Blood Potassium Decreased
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.88%
1/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.00%
0/84
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
0.88%
1/114
This was a single-arm crossover study. Data are provided for 3 groups: Treatment As Usual (TAU) - Pali ER (participants who completed Phase 1 and went on to receive study drug in Phase 2; n=84), Paliperidone ER (Phase 2; n=84), and TAU - All enrolled participants; N=114).
|
Additional Information
Vice President, Medical Affairs, CNS
Ortho-McNeil Janssen Scientific Affairs, LLC
Phone: 609-730-2136
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60