Treatment of Schizophrenic Patients With Ziprasidone | NCT00579670 | Trialant
NCT00579670
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Status
Completed
Last Update Posted
Mar 10, 2021Actual
Enrollment
450Actual
Phase
Not provided
Conditions
Schizophrenia
Interventions
Ziprasidone
Countries
Greece
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT00579670
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
A1281156
Secondary IDs
Not provided
Brief Title
Treatment of Schizophrenic Patients With Ziprasidone
Official Title
Treatment of Schizophrenic Patients With Geodon; Capsules/Oral Suspension/Solution for Injection (Ziprasidone)
Acronym
TRITON
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Feb 2021
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 2007
Primary Completion Date
Apr 2009Actual
Completion Date
Apr 2009Actual
First Submitted Date
Dec 20, 2007
First Submission Date that Met QC Criteria
Dec 20, 2007
First Posted Date
Dec 24, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 2, 2010
Results First Submitted that Met QC Criteria
Apr 27, 2010
Results First Posted Date
May 17, 2010Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 18, 2021
Last Update Posted Date
Mar 10, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
To determine whether ziprasidone provides good efficacy and tolerability in the treatment of schizophrenic Greek patients.
Detailed Description
Sampling Method Details: Non-interventional study (subjects chosen by physician in accordance to their usual practice).
Conditions Module
Conditions
Schizophrenia
Keywords
Ziprasidone in patients with schizophrenia
Design Module
Study Type
Observational
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Not provided
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
450Actual
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Ziprasidone
Drug
Ziprasidone 20mg, 40mg, 60mg, 80mg capsules, hard; Ziprasidone 10 mg/ml oral suspension Ziprasidone 20mg/ml powder and solvent for the reconstitution of solution for injection
Geodon, Zeldox
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Summary of Schizophrenia
Stage, symptoms and type of schizophrenia were recorded in addition to demographic and other clinical history data at the Baseline visit. The primary outcome was to assess the participants profile. Some assessments have been included in the Baseline demographics. This outcome presents results for the Summary of Schizophrenia.
Baseline
Summary of Metabolic Risk Factors
Baseline
Summary of Most Frequently Used Concomitant Drug Treatments
Most frequently concomitant drug treatments used by >15 participants.
Baseline
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
CGI-I: 7-point clinician rated scale ranging from 0 (not assessed) to 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
Week 12
Other Outcomes
Measure
Description
Time Frame
Number of Participants Continuing Treatment With Ziprasidone Following Completion of the Observation Period
Wang Z, Pang C, Meng Q, Zhang DZ, Hong ZX, He GB, Yang H, Xiang BD, Li X, Jiang TA, Li K, Tang Z, Huang F, Lu M, Yu XL, Cheng ZG, Liu FY, Han ZY, Dou JP, Wu SS, Yu J, Liang P. Laparoscopic hepatectomy versus microwave ablation for multifocal 3-5 cm hepatocellular carcinoma: a multi-centre, real-world study. Int J Surg. 2024 Nov 1;110(11):6911-6921. doi: 10.1097/JS9.0000000000001398.
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
The use and dosage of ziprasidone for this Non-interventional Post-Marketing Surveillance study was based on the approved summary of product characteristics (SmPC) document and adjusted solely according to medical and therapeutic necessity.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Ziprasidone < 80 mg
Ziprasidone up to 80 milligrams (mg) per day.
FG001
Ziprasidone 80 mg to < 120 mg
Ziprasidone between 80 mg and < 120 mg per day.
FG002
Ziprasidone 120 mg to < 160 mg
Ziprasidone between 120 mg and < 160 mg per day.
FG003
Ziprasidone >= 160 mg
Ziprasidone 160 mg or greater per day.
FG004
Ziprasidone Unknown
Details are unknown.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG00015 subjectsFull Analysis Set (FAS): at least 1 dose study medication and at least 1 efficacy measurement
FG00157 subjects
FG00288 subjects
FG003285 subjects
FG0045 subjects
Population: Within SmPC (Started)
FG00015 subjectsWithin summary of product characteristics (SmPC): FAS subjects who received all doses "Within SmPC"
FG00279 subjectsDC: AE N=1; Lack of efficacy N=1; Other unspecified N=1; Withdrawal by subject N=1
FG003
COMPLETED
FG00013 subjects
FG00156 subjects
FG00284 subjects
FG003263 subjects
FG004
NOT COMPLETED
FG0002 subjects
FG0011 subjects
FG0024 subjects
FG00322 subjects
FG004
Type
Comment
Reasons
Death
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Ziprasidone < 80 mg
Ziprasidone up to 80 milligrams (mg) per day.
BG001
Ziprasidone 80 mg to < 120 mg
Ziprasidone between 80 mg and < 120 mg per day.
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Number
Outcome Measures Module
Outcome Measures
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
Summary of Schizophrenia
Stage, symptoms and type of schizophrenia were recorded in addition to demographic and other clinical history data at the Baseline visit. The primary outcome was to assess the participants profile. Some assessments have been included in the Baseline demographics. This outcome presents results for the Summary of Schizophrenia.
All subjects randomized to a treatment group were included in the Baseline analysis.
Posted
Number
Participants
Baseline
ID
Title
Description
OG000
Ziprasidone < 80 mg
Ziprasidone up to 80 milligrams (mg) per day.
OG001
Ziprasidone 80 mg to < 120 mg
Ziprasidone between 80 mg and < 120 mg per day.
Adverse Events Module
Frequency Threshold
2
Time Frame
Not provided
Description
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Ziprasidone < 80 mg
Ziprasidone up to 80 mg per day.
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pyrexia
General disorders
MedDRA 12.1
Systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Fatigue
General disorders
MedDRA 12.1
Systematic Assessment
More Info Module
Limitations and Caveats
Additional descriptive tables were identified as required after review of the originally planned study tables; many subjects included in the tables had received ziprasidone doses above those specified in the summary of product characteristics (SmPC).
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Point of Contact
Title
Organization
Phone
Extension
Email
Pfizer ClinicalTrials.gov Call Center
Pfizer, Inc.
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D012559
Schizophrenia
Ancestor Terms
ID
Term
D019967
Schizophrenia Spectrum and Other Psychotic Disorders
D001523
Mental Disorders
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
MeSH Terms
ID
Term
C092292
ziprasidone
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
Not provided
Intervention Model Description
Not provided
Primary Purpose
Not provided
Observational Model
Cohort
Time Perspective
Prospective
Masking Info
No data available
No data is available for this block.
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
CGI-S: 7-point clinician rated scale to assess severity of subject's current illness state; range: 0 (not assessed) to 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. B = Baseline; F = Final Visit (Week 12)
Baseline, Week 12
Positive and Negative Syndrome Scale (PANSS) - Positive Subscale
Modified positive subscale: clinician-rated measurement that consists of 30 items, each rated from 1 (absent) to 7 (extreme). Positive subscale (ranging from 4 to 28) taking the sum of the following 4 items: P1, delusions; P2, conceptual disorganization; P3, hallucinatory behavior; and P6, suspiciousness/persecution. Higher scores indicated greater severity of symptoms. The positive subscale total was calculated as the sum of the 4 items in the positive subscale.
Baseline, Week 12
PANSS - Negative Subscale
Modified negative subscale: assesses negative symptoms associated with schizophrenia. 7 items make up the Negative scale (eg, blunted affect, emotional withdrawal, poor rapport, and passive/apathetic social withdrawal). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total Negative Subscale scores range from 7 to 49. This negative subscale total was calculated as the sum of 4 items in the negative subscale.
Baseline, Week 12
PANSS - Composite Subscale
The modified composite subscale total was calculated as the difference of the positive subscale total (7 items; total possible score of 49) and the negative subscale total (7 items; total possible score of 49). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The composite subscale total provided an indication of the level of dominance of the symptoms of one subscale over the symptoms of the other subscale. Higher scores indicated greater severity of symptoms.
Baseline, Week 12
Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Ability of the Medication to Prevent or Treat Your Condition?"
Week 12
Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Way the Medication Relieves Your Symptoms?"
Week 12
Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Amount of Time it Takes the Medication to Start Working?"
Week 12
Number of Participants Answering the Question "As a Result of Taking This Medication, do You Experience Any Side Effects at All?"
Week 12
Number of Participants Answering the Question "How Bothersome Are the Side Effects of the Medication You Take to Treat Your Condition?"
Week 12
Number of Participants Answering the Question "To What Extent do the Side Effects Interfere With Your Physical Health and Ability to Function (ie, Ability to Think Clearly, Stay Awake, Etc)?"
Week 12
Number of Participants Answering the Question "To What Extent do the Side Effects Interfere With Your Mental Function (ie, Ability to Think, Stay Awake, Etc)?"
Week 12
Number of Participants Answering the Question "To What Degree Have Medication Side Effects Affected Your Overall Satisfaction With the Medication?"
Week 12
Number of Participants Answering the Question "How Easy or Difficult is it to Use the Medication in Its Current Form?"
Week 12
Number of Participants Answering the Question "How Easy or Difficult is it to Plan When You Will Use the Medication Each Time?"
Week 12
Number of Participants Answering the Question "How Convenient or Inconvenient is it to Take the Medication as Instructed?"
Week 12
Number of Participants Answering the Question "Overall, How Confident Are You That Taking This Medication is a Good Thing?"
Week 12
Number of Participants Answering the Question "How Certain Are You That the Good Things About Your Medication Outweigh the Bad Things?"
Week 12
Number of Participants Answering the Question "Taking All Things Into Account, How Satisfied or Dissatisfied Are You With This Medication?"
Week 12
Percent Change From Baseline to Final Visit in Body Weight
Baseline, Week 12
Chaïdári
124 61
Greece
Pfizer Investigational Site
Chaïdári
12461
Greece
Pfizer Investigational Site
Chaïdári
12462
Greece
Pfizer Investigational Site
Corfu
49100
Greece
Pfizer Investigational Site
Crete
731-00
Greece
Pfizer Investigational Site
Giannitsá
58100
Greece
Pfizer Investigational Site
Haidari
12461
Greece
Pfizer Investigational Site
Kalamata
24100
Greece
Pfizer Investigational Site
Katerini
60100
Greece
Pfizer Investigational Site
Kozani
50100
Greece
Pfizer Investigational Site
Kozani
Greece
Pfizer Investigational Site
Lamia
35100
Greece
Pfizer Investigational Site
Larissa
Greece
Pfizer Investigational Site
Pátrai
26000
Greece
Pfizer Investigational Site
Pátrai
26001
Greece
Pfizer Investigational Site
Thessaloniki
564-29
Greece
Pfizer Investigational Site
Thessaloniki
56430
Greece
Pfizer Investigational Site
Thessaloniki
57010
Greece
Pfizer Investigational Site
Volos
38222
Greece
159 subjects
FG0040 subjects"Ziprasidone Unknown" reporting group is not applicable to the Within SmPC population
147 subjects
DC: AE N=2; Lack of efficacy N=5; LTFU N=3; Other unspecified N=2
FG0040 subjects
5 subjects
0 subjects
0 subjects
FG0040 subjects
Adverse Event
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0032 subjects
FG0040 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG00314 subjects
FG0040 subjects
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0034 subjects
FG0040 subjects
Other
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0032 subjects
FG0040 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
BG002
Ziprasidone 120 mg to < 160 mg
Ziprasidone between 120 mg and < 160 mg per day.
BG003
Ziprasidone >= 160 mg
Ziprasidone 160 mg or greater per day.
BG004
Ziprasidone Unknown
Details are unknown.
BG005
Total
Total of all reporting groups
15
BG00157
BG00288
BG003285
BG0045
BG005450
Participants
Title
Denominators
Categories
< 18 years
Title
Measurements
BG0000
BG0010
BG0021
BG0030
BG0040
BG0051
18 years through 44 years
Title
Measurements
BG0003
BG00122
BG00242
BG003
45 years through 64 years
Title
Measurements
BG0004
BG00119
BG00236
BG003
>= 65 years
Title
Measurements
BG0008
BG00116
BG0029
BG003
Sex/Gender, Customized
Number
Participants
Title
Denominators
Categories
Male
Title
Measurements
BG0009
BG00135
BG00242
BG003173
BG0043
BG005262
Female
Title
Measurements
BG0006
BG00122
BG00245
BG003
Unspecified
Title
Measurements
BG0000
BG0010
BG0021
BG003
Schizophrenia Duration
Mean
Full Range
Years
Title
Denominators
Categories
Title
Measurements
BG00033.9(0 to 63.1)
BG00121.4(0 to 58.5)
BG00216.9(0 to 52.4)
BG00312.8(0 to 50.3)
BG00415.6(0 to 41.4)
BG00515.4(0 to 63.1)
OG002
Ziprasidone 120 mg to < 160 mg
Ziprasidone between 120 mg and < 160 mg per day.
OG003
Ziprasidone >= 160 mg
Ziprasidone 160 mg or greater per day.
OG004
Ziprasidone Unknown
Details are unknown.
Units
Counts
Participants
OG00015
OG00157
OG00288
OG003285
OG0045
Title
Denominators
Categories
Stage: First episode
Title
Measurements
OG0001
OG0015
OG0029
OG00339
OG0040
Stage: Acute exacerbation
Title
Measurements
OG0001
OG0012
OG00212
OG003
Stage: Chronic, stable
Title
Measurements
OG00012
OG00146
OG00254
OG003
Stage: Refractory
Title
Measurements
OG0001
OG0014
OG00213
OG003
Symptoms: Positive
Title
Measurements
OG0002
OG00129
OG00247
OG003
Symptoms: Negative
Title
Measurements
OG0006
OG00113
OG00216
OG003
Symptoms: Depressive
Title
Measurements
OG0001
OG0019
OG0029
OG003
Symptoms: No predominant symptomatology
Title
Measurements
OG0006
OG0016
OG00216
OG003
Type: Catatonic
Title
Measurements
OG0001
OG0010
OG0020
OG003
Type: Disorganized
Title
Measurements
OG0000
OG0010
OG0025
OG003
Type: Paranoid
Title
Measurements
OG0002
OG00122
OG00243
OG003
Type: Residual
Title
Measurements
OG0007
OG00113
OG00214
OG003
Type: Undifferentiated
Title
Measurements
OG0002
OG0015
OG00210
OG003
Type: Schizoaffective disorder
Title
Measurements
OG0003
OG00115
OG00214
OG003
Type: Schizophrenia not otherwise specified (NOS)
Title
Measurements
OG0000
OG0012
OG0022
OG003
Primary
Summary of Metabolic Risk Factors
All subjects randomized to a treatment group were included in this baseline analysis.
Posted
Number
Participants
Baseline
ID
Title
Description
OG000
Ziprasidone Total
Ziprasidone all doses received combined.
Units
Counts
Participants
OG000450
Title
Denominators
Categories
No metabolic risk factors at Baseline
Title
Measurements
OG000205
≥1 metabolic risk factors at Baseline
Title
Measurements
OG000245
1 metabolic risk factor at Baseline
Title
Measurements
OG000133
2 metabolic risk factors at Baseline
Title
Measurements
OG00064
≥3 metabolic risk factors at Baseline
Title
Measurements
OG00048
Fasting glucose level (≥110 mg/dL)
Title
Measurements
OG00048
Triglycerides (≥150 mg/dL)
Title
Measurements
OG00076
HDL (men <40 mg/dL; women <50 mg/dL)
Title
Measurements
OG00077
Blood pressure (≥130/85 mm Hg)
Title
Measurements
OG00054
Centrally distributed obesity
Title
Measurements
OG000182
Primary
Summary of Most Frequently Used Concomitant Drug Treatments
Most frequently concomitant drug treatments used by >15 participants.
All subjects randomized to a treatment group were included in this baseline analysis.
Posted
Number
Participants
Baseline
ID
Title
Description
OG000
Ziprasidone < 80 mg
Ziprasidone up to 80 milligrams (mg) per day.
OG001
Ziprasidone 80 mg to < 120 mg
Ziprasidone between 80 mg and < 120 mg per day.
OG002
Ziprasidone 120 mg to < 160 mg
Ziprasidone between 120 mg and < 160 mg per day.
OG003
Ziprasidone >= 160 mg
Ziprasidone 160 mg or greater per day.
OG004
Ziprasidone Unknown
Details are unknown.
Units
Counts
Participants
OG00015
OG00157
OG00288
OG003
Title
Denominators
Categories
Akineton
Title
Measurements
OG0006
OG00111
OG00212
OG003
Secondary
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
CGI-I: 7-point clinician rated scale ranging from 0 (not assessed) to 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
The Full Analysis Set (FAS) - all subjects who received at least 1 dose of study medication and have at least 1 efficacy measurement.
Posted
Number
Participants
Week 12
ID
Title
Description
OG000
Ziprasidone < 80 mg
Ziprasidone up to 80 milligrams (mg) per day.
OG001
Ziprasidone 80 mg to < 120 mg
Ziprasidone between 80 mg and < 120 mg per day.
OG002
Ziprasidone 120 mg to < 160 mg
Ziprasidone between 120 mg and < 160 mg per day.
OG003
Ziprasidone >= 160 mg
Ziprasidone 160 mg or greater per day.
OG004
Ziprasidone Unknown
Details are unknown.
Units
Counts
Participants
OG00015
OG00157
OG00288
OG003
Title
Denominators
Categories
Not assessed
Title
Measurements
OG0000
OG0011
OG0022
OG003
Secondary
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
CGI-S: 7-point clinician rated scale to assess severity of subject's current illness state; range: 0 (not assessed) to 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. B = Baseline; F = Final Visit (Week 12)
FAS; Baseline Visit: 1 subject in the Ziprasidone >=160mg group had missing severity result. Final Visit: 2 subjects (1 subject in the Ziprasidone 120mg to <160mg and 1 subject in the Ziprasidone <80mg group) had missing severity results.
Posted
Number
Participants
Baseline, Week 12
ID
Title
Description
OG000
Ziprasidone < 80 mg
Ziprasidone up to 80 mg per day.
OG001
Ziprasidone 80 mg to < 120 mg
Ziprasidone between 80 mg and < 120 mg per day.
OG002
Ziprasidone 120 mg to < 160 mg
Ziprasidone between 120 mg and < 160 mg per day.
OG003
Ziprasidone >= 160 mg
Ziprasidone 160 mg or greater per day.
OG004
Ziprasodone Unknown
Details are unknown.
Units
Counts
Participants
OG00015
OG00157
OG00288
OG003
Title
Denominators
Categories
B - Not assessed
Title
Measurements
OG0000
OG0010
OG0021
OG003
Secondary
Positive and Negative Syndrome Scale (PANSS) - Positive Subscale
Modified positive subscale: clinician-rated measurement that consists of 30 items, each rated from 1 (absent) to 7 (extreme). Positive subscale (ranging from 4 to 28) taking the sum of the following 4 items: P1, delusions; P2, conceptual disorganization; P3, hallucinatory behavior; and P6, suspiciousness/persecution. Higher scores indicated greater severity of symptoms. The positive subscale total was calculated as the sum of the 4 items in the positive subscale.
FAS
Posted
Mean
Standard Deviation
Scores on a scale
Baseline, Week 12
ID
Title
Description
OG000
Ziprasidone < 80 mg
Ziprasidone up to 80 milligrams (mg) per day.
OG001
Ziprasidone 80 mg to < 120 mg
Ziprasidone between 80 mg and < 120 mg per day.
OG002
Ziprasidone 120 mg to < 160 mg
Ziprasidone between 120 mg and < 160 mg per day.
OG003
Ziprasidone >= 160 mg
Ziprasidone 160 mg or greater per day.
OG004
Ziprasidone Unknown
Details are unknown.
Units
Counts
Participants
OG00015
OG00157
OG00288
OG003
Title
Denominators
Categories
Baseline
Title
Measurements
OG00012.9± 4.12
OG00114.4± 4.35
OG00214.6± 4.82
OG003
Secondary
PANSS - Negative Subscale
Modified negative subscale: assesses negative symptoms associated with schizophrenia. 7 items make up the Negative scale (eg, blunted affect, emotional withdrawal, poor rapport, and passive/apathetic social withdrawal). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total Negative Subscale scores range from 7 to 49. This negative subscale total was calculated as the sum of 4 items in the negative subscale.
FAS
Posted
Mean
Standard Deviation
Scores on a scale
Baseline, Week 12
ID
Title
Description
OG000
Ziprasidone < 80 mg
Ziprasidone up to 80 milligrams (mg) per day.
OG001
Ziprasidone 80 mg to < 120 mg
Ziprasidone between 80 mg and < 120 mg per day.
OG002
Ziprasidone 120 mg to < 160 mg
Ziprasidone between 120 mg and < 160 mg per day.
OG003
Ziprasidone >= 160 mg
Ziprasidone 160 mg or greater per day.
OG004
Ziprasidone Unknown
Details are unknown.
Units
Counts
Participants
OG00015
OG00157
OG00288
OG003
Title
Denominators
Categories
Baseline
Title
Measurements
OG00016.7± 4.69
OG00116.1± 4.05
OG00214.6± 5.30
OG003
Secondary
PANSS - Composite Subscale
The modified composite subscale total was calculated as the difference of the positive subscale total (7 items; total possible score of 49) and the negative subscale total (7 items; total possible score of 49). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The composite subscale total provided an indication of the level of dominance of the symptoms of one subscale over the symptoms of the other subscale. Higher scores indicated greater severity of symptoms.
FAS
Posted
Mean
Standard Deviation
Scores on a scale
Baseline, Week 12
ID
Title
Description
OG000
Ziprasidone < 80 mg
Ziprasidone up to 80 milligrams (mg) per day.
OG001
Ziprasidone 80 mg to < 120 mg
Ziprasidone between 80 mg and < 120 mg per day.
OG002
Ziprasidone 120 mg to < 160 mg
Ziprasidone between 120 mg and < 160 mg per day.
OG003
Ziprasidone >= 160 mg
Ziprasidone 160 mg or greater per day.
OG004
Ziprasidone Unknown
Details are unknown.
Units
Counts
Participants
OG00015
OG00157
OG00288
OG003
Title
Denominators
Categories
Baseline
Title
Measurements
OG000-3.8± 3.57
OG001-1.7± 4.86
OG0020.0± 5.14
OG003
Secondary
Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Ability of the Medication to Prevent or Treat Your Condition?"
FAS
Posted
Number
Participants
Week 12
ID
Title
Description
OG000
Ziprasidone < 80 mg
Ziprasidone up to 80 milligrams (mg) per day.
OG001
Ziprasidone 80 mg to < 120 mg
Ziprasidone between 80 mg and < 120 mg per day.
OG002
Ziprasidone 120 mg to < 160 mg
Ziprasidone between 120 mg and < 160 mg per day.
OG003
Ziprasidone >= 160 mg
Ziprasidone 160 mg or greater per day.
OG004
Ziprasidone Unknown
Details are unknown.
Units
Counts
Participants
OG00015
OG00157
OG00288
OG003285
Title
Denominators
Categories
Extremely Dissatisfied
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Way the Medication Relieves Your Symptoms?"
Posted
Number
Participants
Week 12
ID
Title
Description
OG000
Ziprasidone < 80 mg
Ziprasidone up to 80 milligrams (mg) per day.
OG001
Ziprasidone 80 mg to < 120 mg
Ziprasidone between 80 mg and < 120 mg per day.
OG002
Ziprasidone 120 mg to < 160 mg
Ziprasidone between 120 mg and < 160 mg per day.
OG003
Ziprasidone >= 160 mg
Ziprasidone 160 mg or greater per day.
OG004
Ziprasidone Unknown
Details are unknown.
Units
Counts
Participants
OG00015
OG00157
OG00288
OG003285
OG004
Title
Denominators
Categories
Extremely Dissatisfied
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Amount of Time it Takes the Medication to Start Working?"
FAS
Posted
Number
Participants
Week 12
ID
Title
Description
OG000
Ziprasidone < 80 mg
Ziprasidone up to 80 milligrams (mg) per day.
OG001
Ziprasidone 80 mg to < 120 mg
Ziprasidone between 80 mg and < 120 mg per day.
OG002
Ziprasidone 120 mg to < 160 mg
Ziprasidone between 120 mg and < 160 mg per day.
OG003
Ziprasidone >= 160 mg
Ziprasidone 160 mg or greater per day.
OG004
Ziprasidone Unknown
Details are unknown.
Units
Counts
Participants
OG00015
OG00157
OG00288
OG003285
Title
Denominators
Categories
Extremely Dissatisfied
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Number of Participants Answering the Question "As a Result of Taking This Medication, do You Experience Any Side Effects at All?"
Posted
Number
Participant
Week 12
ID
Title
Description
OG000
Ziprasidone < 80 mg
Ziprasidone up to 80 milligrams (mg) per day.
OG001
Ziprasidone 80 mg to < 120 mg
Ziprasidone between 80 mg and < 120 mg per day.
OG002
Ziprasidone 120 mg to < 160 mg
Ziprasidone between 120 mg and < 160 mg per day.
OG003
Ziprasidone >= 160 mg
Ziprasidone 160 mg or greater per day.
OG004
Ziprasidone Unknown
Details are unknown.
Units
Counts
Participants
OG00015
OG00157
OG00288
OG003285
OG004
Title
Denominators
Categories
Yes
Title
Measurements
OG0003
OG00111
OG00213
OG003
Secondary
Number of Participants Answering the Question "How Bothersome Are the Side Effects of the Medication You Take to Treat Your Condition?"
Posted
Number
Participants
Week 12
ID
Title
Description
OG000
Ziprasidone < 80 mg
Ziprasidone up to 80 milligrams (mg) per day.
OG001
Ziprasidone 80 mg to < 120 mg
Ziprasidone between 80 mg and < 120 mg per day.
OG002
Ziprasidone 120 mg to < 160 mg
Ziprasidone between 120 mg and < 160 mg per day.
OG003
Ziprasidone >= 160 mg
Ziprasidone 160 mg or greater per day.
OG004
Ziprasidone Unknown
Details are unknown.
Units
Counts
Participants
OG00015
OG00157
OG00288
OG003285
OG004
Title
Denominators
Categories
Extremely Bothersome
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Number of Participants Answering the Question "To What Extent do the Side Effects Interfere With Your Physical Health and Ability to Function (ie, Ability to Think Clearly, Stay Awake, Etc)?"
FAS
Posted
Number
Participants
Week 12
ID
Title
Description
OG000
Ziprasidone < 80 mg
Ziprasidone up to 80 milligrams (mg) per day.
OG001
Ziprasidone 80 mg to < 120 mg
Ziprasidone between 80 mg and < 120 mg per day.
OG002
Ziprasidone 120 mg to < 160 mg
Ziprasidone between 120 mg and < 160 mg per day.
OG003
Ziprasidone >= 160 mg
Ziprasidone 160 mg or greater per day.
OG004
Ziprasidone Unknown
Details are unknown.
Units
Counts
Participants
OG00015
OG00157
OG00288
OG003285
Title
Denominators
Categories
A great deal
Title
Measurements
OG0000
OG0010
OG0021
OG003
Secondary
Number of Participants Answering the Question "To What Extent do the Side Effects Interfere With Your Mental Function (ie, Ability to Think, Stay Awake, Etc)?"
FAS
Posted
Number
Participants
Week 12
ID
Title
Description
OG000
Ziprasidone < 80 mg
Ziprasidone up to 80 milligrams (mg) per day.
OG001
Ziprasidone 80 mg to < 120 mg
Ziprasidone between 80 mg and < 120 mg per day.
OG002
Ziprasidone 120 mg to < 160 mg
Ziprasidone between 120 mg and < 160 mg per day.
OG003
Ziprasidone >= 160 mg
Ziprasidone 160 mg or greater per day.
OG004
Ziprasidone Unknown
Details are unknown.
Units
Counts
Participants
OG00015
OG00157
OG00288
OG003285
Title
Denominators
Categories
A great deal
Title
Measurements
OG0003
OG00111
OG00213
OG003
Secondary
Number of Participants Answering the Question "To What Degree Have Medication Side Effects Affected Your Overall Satisfaction With the Medication?"
FAS
Posted
Number
Participants
Week 12
ID
Title
Description
OG000
Ziprasidone < 80 mg
Ziprasidone up to 80 milligrams (mg) per day.
OG001
Ziprasidone 80 mg to < 120 mg
Ziprasidone between 80 mg and < 120 mg per day.
OG002
Ziprasidone 120 mg to < 160 mg
Ziprasidone between 120 mg and < 160 mg per day.
OG003
Ziprasidone >= 160 mg
Ziprasidone 160 mg or greater per day.
OG004
Ziprasidone Unknown
Details are unknown.
Units
Counts
Participants
OG00015
OG00157
OG00288
OG003285
Title
Denominators
Categories
A great deal
Title
Measurements
OG0000
OG0010
OG0021
OG003
Secondary
Number of Participants Answering the Question "How Easy or Difficult is it to Use the Medication in Its Current Form?"
FAS
Posted
Number
Participants
Week 12
ID
Title
Description
OG000
Ziprasidone < 80 mg
Ziprasidone up to 80 milligrams (mg) per day.
OG001
Ziprasidone 80 mg to < 120 mg
Ziprasidone between 80 mg and < 120 mg per day.
OG002
Ziprasidone 120 mg to < 160 mg
Ziprasidone between 120 mg and < 160 mg per day.
OG003
Ziprasidone >= 160 mg
Ziprasidone 160 mg or greater per day.
OG004
Ziprasidone Unknown
Details are unknown.
Units
Counts
Participants
OG00015
OG00157
OG00288
OG003285
OG004
Title
Denominators
Categories
Extremely difficult
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Number of Participants Answering the Question "How Easy or Difficult is it to Plan When You Will Use the Medication Each Time?"
FAS
Posted
Number
Participants
Week 12
ID
Title
Description
OG000
Ziprasidone < 80 mg
Ziprasidone up to 80 milligrams (mg) per day.
OG001
Ziprasidone 80 mg to < 120 mg
Ziprasidone between 80 mg and < 120 mg per day.
OG002
Ziprasidone 120 mg to < 160 mg
Ziprasidone between 120 mg and < 160 mg per day.
OG003
Ziprasidone >= 160 mg
Ziprasidone 160 mg or greater per day.
OG004
Ziprasidone Unknown
Details are unknown.
Units
Counts
Participants
OG00015
OG00157
OG00288
OG003285
OG004
Title
Denominators
Categories
Extremely difficult
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Number of Participants Answering the Question "How Convenient or Inconvenient is it to Take the Medication as Instructed?"
FAS
Posted
Number
Participants
Week 12
ID
Title
Description
OG000
Ziprasidone < 80 mg
Ziprasidone up to 80 milligrams (mg) per day.
OG001
Ziprasidone 80 mg to < 120 mg
Ziprasidone between 80 mg and < 120 mg per day.
OG002
Ziprasidone 120 mg to < 160 mg
Ziprasidone between 120 mg and < 160 mg per day.
OG003
Ziprasidone >= 160 mg
Ziprasidone 160 mg or greater per day.
OG004
Ziprasidone Unknown
Details are unknown.
Units
Counts
Participants
OG00015
OG00157
OG00288
OG003285
OG004
Title
Denominators
Categories
Extremely inconvenient
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Number of Participants Answering the Question "Overall, How Confident Are You That Taking This Medication is a Good Thing?"
FAS
Posted
Number
Participants
Week 12
ID
Title
Description
OG000
Ziprasidone < 80 mg
Ziprasidone up to 80 milligrams (mg) per day.
OG001
Ziprasidone 80 mg to < 120 mg
Ziprasidone between 80 mg and < 120 mg per day.
OG002
Ziprasidone 120 mg to < 160 mg
Ziprasidone between 120 mg and < 160 mg per day.
OG003
Ziprasidone >= 160 mg
Ziprasidone 160 mg or greater per day.
OG004
Ziprasidone Unknown
Details are unknown.
Units
Counts
Participants
OG00015
OG00157
OG00288
OG003285
OG004
Title
Denominators
Categories
Not at all confident
Title
Measurements
OG0000
OG0012
OG0022
OG003
Secondary
Number of Participants Answering the Question "How Certain Are You That the Good Things About Your Medication Outweigh the Bad Things?"
FAS
Posted
Number
Participants
Week 12
ID
Title
Description
OG000
Ziprasidone < 80 mg
Ziprasidone up to 80 milligrams (mg) per day.
OG001
Ziprasidone 80 mg to < 120 mg
Ziprasidone between 80 mg and < 120 mg per day.
OG002
Ziprasidone 120 mg to < 160 mg
Ziprasidone between 120 mg and < 160 mg per day.
OG003
Ziprasidone >= 160 mg
Ziprasidone 160 mg or greater per day.
OG004
Ziprasidone Unknown
Details are unknown.
Units
Counts
Participants
OG00015
OG00157
OG00288
OG003285
Title
Denominators
Categories
Not at all certain
Title
Measurements
OG0000
OG0011
OG0022
OG003
Secondary
Number of Participants Answering the Question "Taking All Things Into Account, How Satisfied or Dissatisfied Are You With This Medication?"
FAS
Posted
Number
Participants
Week 12
ID
Title
Description
OG000
Ziprasidone < 80 mg
Ziprasidone up to 80 milligrams (mg) per day.
OG001
Ziprasidone 80 mg to < 120 mg
Ziprasidone between 80 mg and < 120 mg per day.
OG002
Ziprasidone 120 mg to < 160 mg
Ziprasidone between 120 mg and < 160 mg per day.
OG003
Ziprasidone >= 160 mg
Ziprasidone 160 mg or greater per day.
OG004
Ziprasidone Unknown
Details are unknown.
Units
Counts
Participants
OG00015
OG00157
OG00288
OG003285
Title
Denominators
Categories
Extremely dissatisfied
Title
Measurements
OG0000
OG0010
OG0020
OG003
Other Pre-specified
Number of Participants Continuing Treatment With Ziprasidone Following Completion of the Observation Period
FAS. Four subjects did not answer the question of continuation of treatment.
Posted
Number
Participants
Week 12
ID
Title
Description
OG000
Ziprasidone < 80 mg
Ziprasidone up to 80 milligrams (mg) per day.
OG001
Ziprasidone 80 mg to < 120 mg
Ziprasidone between 80 mg and < 120 mg per day.
OG002
Ziprasidone 120 mg to < 160 mg
Ziprasidone between 120 mg and < 160 mg per day.
OG003
Ziprasidone >= 160 mg
Ziprasidone 160 mg or greater per day.
OG004
Ziprasidone Unknown
Details are unknown.
Units
Counts
Participants
OG00015
OG00157
OG00288
OG003285
Title
Denominators
Categories
Yes
Title
Measurements
OG00013
OG00156
OG00283
OG003
Secondary
Percent Change From Baseline to Final Visit in Body Weight
Safety population = all subjects who received at least 1 dose of study medication.
Posted
Mean
Standard Deviation
percent change
Baseline, Week 12
ID
Title
Description
OG000
Ziprasidone < 80 mg
Ziprasidone up to 80 milligrams (mg) per day.
OG001
Ziprasidone 80 mg to < 120 mg
Ziprasidone between 80 mg and < 120 mg per day.
OG002
Ziprasidone 120 mg to < 160 mg
Ziprasidone between 120 mg and < 160 mg per day.
OG003
Ziprasidone >= 160 mg
Ziprasidone 160 mg or greater per day.
OG004
Ziprasidone Unknown
Details are unknown.
Units
Counts
Participants
OG00015
OG00157
OG00288
OG003285
Title
Denominators
Categories
Title
Measurements
OG0001.2± 5.79
OG001-0.2± 3.67
OG002-1.0± 3.08
OG003
Post-Hoc
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I): Within Summary of Product Characteristics Population (SmPC)
CGI-I: 7-point clinician rated scale ranging from 0 (not assessed) to 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
Within SmPC population: participants in FAS population who received all doses within SmPC. Within SmPC defined as all PO doses up to and including 160 mg per day and all IM doses up to and including 40 mg per day.
Posted
Number
Participants
Week 12
ID
Title
Description
OG000
Ziprasidone < 80 mg
Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
OG001
Ziprasidone 80 mg to < 120 mg
Ziprasidone between 80 mg and < 120 mg PO per day.
OG002
Ziprasidone 120 mg to < 160 mg
Ziprasidone between 120 mg and < 160 mg PO per day.
OG003
Ziprasidone = 160 mg
Ziprasidone 160 mg PO per day.
Units
Counts
Participants
OG00015
OG00156
OG00283
OG003
Title
Denominators
Categories
Not assessed
Title
Measurements
OG0000
OG0011
OG0022
OG003
Post-Hoc
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S): Within SmPC
CGI-S: 7-point clinician rated scale to assess severity of subject's current illness state; range: 0 (not assessed) to 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. B = Baseline; F = Final Visit (Week 12)
Within SmPC
Posted
Number
Participants
Baseline, Week 12
ID
Title
Description
OG000
Ziprasidone < 80 mg
Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
OG001
Ziprasidone 80 mg to < 120 mg
Ziprasidone between 80 mg and < 120 mg PO per day.
OG002
Ziprasidone 120 mg to < 160 mg
Ziprasidone between 120 mg and < 160 mg PO per day.
OG003
Ziprasidone = 160 mg
Ziprasidone 160 mg PO per day.
Units
Counts
Participants
OG00015
OG00156
OG00283
OG003159
Title
Denominators
Categories
B - Not assessed
Title
Measurements
OG0000
OG0010
OG0021
OG003
Post-Hoc
Positive and Negative Syndrome Scale (PANSS) - Positive Subscale: Within SmPC
Modified positive subscale: clinician-rated measurement that consists of 30 items, each rated from 1 (absent) to 7 (extreme). Positive subscale (ranging from 4 to 28) taking the sum of the following 4 items: P1, delusions; P2, conceptual disorganization; P3, hallucinatory behavior; and P6, suspiciousness/persecution. Higher scores indicated greater severity of symptoms. The positive subscale total was calculated as the sum of the 4 items in the positive subscale.
Within SmPC; N=participants with evaluable data at observation
Posted
Mean
Standard Deviation
Scores on a scale
Baseline, Week 12
ID
Title
Description
OG000
Ziprasidone < 80 mg
Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
OG001
Ziprasidone 80 mg to < 120 mg
Ziprasidone between 80 mg and < 120 mg PO per day.
OG002
Ziprasidone 120 mg to < 160 mg
Ziprasidone between 120 mg and < 160 mg PO per day.
OG003
Ziprasidone = 160 mg
Ziprasidone 160 mg PO per day.
Units
Counts
Participants
OG00015
OG00156
OG00282
OG003
Title
Denominators
Categories
Baseline
Title
Measurements
OG00012.9± 4.12
OG00114.5± 4.37
OG00214.8± 4.85
OG003
Post-Hoc
PANSS - Negative Subscale: Within SmPC
Modified negative subscale: assesses negative symptoms associated with schizophrenia. 7 items make up the Negative scale (eg, blunted affect, emotional withdrawal, poor rapport, and passive/apathetic social withdrawal). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total Negative Subscale scores range from 7 to 49. This negative subscale total was calculated as the sum of 4 items in the negative subscale.
Within SmPC; N=participants with evaluable data at observation
Posted
Mean
Standard Deviation
Scores on a scale
Baseline, Week 12
ID
Title
Description
OG000
Ziprasidone < 80 mg
Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
OG001
Ziprasidone 80 mg to < 120 mg
Ziprasidone between 80 mg and < 120 mg PO per day.
OG002
Ziprasidone 120 mg to < 160 mg
Ziprasidone between 120 mg and < 160 mg PO per day.
OG003
Ziprasidone = 160 mg
Ziprasidone 160 mg PO per day.
Units
Counts
Participants
OG00015
OG00155
OG00282
OG003
Title
Denominators
Categories
Baseline
Title
Measurements
OG00016.7± 4.69
OG00116.0± 4.06
OG00214.8± 5.22
OG003
Post-Hoc
PANSS - Composite Subscale: Within SmPC
The modified composite subscale total was calculated as the difference of the positive subscale total (7 items; total possible score of 49) and the negative subscale total (7 items; total possible score of 49). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The composite subscale total provided an indication of the level of dominance of the symptoms of one subscale over the symptoms of the other subscale. Higher scores indicated greater severity of symptoms.
Within SmPC; N=participants with evaluable data at observation
Posted
Mean
Standard Deviation
Scores on a scale
Baseline, Week 12
ID
Title
Description
OG000
Ziprasidone < 80 mg
Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
OG001
Ziprasidone 80 mg to < 120 mg
Ziprasidone between 80 mg and < 120 mg PO per day.
OG002
Ziprasidone 120 mg to < 160 mg
Ziprasidone between 120 mg and < 160 mg PO per day.
OG003
Ziprasidone = 160 mg
Ziprasidone 160 mg PO per day.
Units
Counts
Participants
OG00015
OG00155
OG00282
OG003
Title
Denominators
Categories
Baseline
Title
Measurements
OG000-3.8± 3.57
OG001-1.5± 4.80
OG0020.0± 5.09
OG003
Post-Hoc
Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Ability of the Medication to Prevent or Treat Your Condition?": Within SmPC
Within SmPC; N=participants with evaluable data for specified question at observation
Posted
Number
Participants
Week 12
ID
Title
Description
OG000
Ziprasidone < 80 mg
Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
OG001
Ziprasidone 80 mg to < 120 mg
Ziprasidone between 80 mg and < 120 mg PO per day.
OG002
Ziprasidone 120 mg to < 160 mg
Ziprasidone between 120 mg and < 160 mg PO per day.
OG003
Ziprasidone = 160 mg
Ziprasidone 160 mg PO per day.
Units
Counts
Participants
OG00014
OG00155
OG00280
OG003153
Title
Denominators
Categories
Extremely Dissatisfied
Title
Measurements
OG0000
OG0010
OG0020
OG003
Post-Hoc
Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Way the Medication Relieves Your Symptoms?": Within SmPC
Within SmPC; N=participants with evaluable data for specified question at observation
Posted
Number
Participants
Week 12
ID
Title
Description
OG000
Ziprasidone < 80 mg
Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
OG001
Ziprasidone 80 mg to < 120 mg
Ziprasidone between 80 mg and < 120 mg PO per day.
OG002
Ziprasidone 120 mg to < 160 mg
Ziprasidone between 120 mg and < 160 mg PO per day.
OG003
Ziprasidone = 160 mg
Ziprasidone 160 mg PO per day.
Units
Counts
Participants
OG00014
OG00155
OG00280
OG003153
Title
Denominators
Categories
Extremely Dissatisfied
Title
Measurements
OG0000
OG0010
OG0020
OG003
Post-Hoc
Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Amount of Time it Takes the Medication to Start Working?": Within SmPC
Within SmPC; N=participants with evaluable data for specified question at observation
Posted
Number
Participants
Week 12
ID
Title
Description
OG000
Ziprasidone < 80 mg
Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
OG001
Ziprasidone 80 mg to < 120 mg
Ziprasidone between 80 mg and < 120 mg PO per day.
OG002
Ziprasidone 120 mg to < 160 mg
Ziprasidone between 120 mg and < 160 mg PO per day.
OG003
Ziprasidone = 160 mg
Ziprasidone 160 mg PO per day.
Units
Counts
Participants
OG00014
OG00155
OG00280
OG003153
Title
Denominators
Categories
Extremely Dissatisfied
Title
Measurements
OG0000
OG0010
OG0020
OG003
Post-Hoc
Number of Participants Answering the Question "As a Result of Taking This Medication, do You Experience Any Side Effects at All?": Within SmPC
Within SmPC; N=participants with evaluable data for specified question at observation
Posted
Number
Participant
Week 12
ID
Title
Description
OG000
Ziprasidone < 80 mg
Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
OG001
Ziprasidone 80 mg to < 120 mg
Ziprasidone between 80 mg and < 120 mg PO per day.
OG002
Ziprasidone 120 mg to < 160 mg
Ziprasidone between 120 mg and < 160 mg PO per day.
OG003
Ziprasidone = 160 mg
Ziprasidone 160 mg PO per day.
Units
Counts
Participants
OG00014
OG00155
OG00280
OG003152
Title
Denominators
Categories
Yes
Title
Measurements
OG0003
OG00111
OG00213
OG003
Post-Hoc
Number of Participants Answering the Question "How Bothersome Are the Side Effects of the Medication You Take to Treat Your Condition?": Within SmPC
Within SmPC; N=participants with evaluable data for specified question at observation
Posted
Number
Participants
Week 12
ID
Title
Description
OG000
Ziprasidone < 80 mg
Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
OG001
Ziprasidone 80 mg to < 120 mg
Ziprasidone between 80 mg and < 120 mg PO per day.
OG002
Ziprasidone 120 mg to < 160 mg
Ziprasidone between 120 mg and < 160 mg PO per day.
OG003
Ziprasidone = 160 mg
Ziprasidone 160 mg PO per day.
Units
Counts
Participants
OG0003
OG00111
OG00213
OG00341
Title
Denominators
Categories
Extremely Bothersome
Title
Measurements
OG0000
OG0010
OG0020
OG003
Post-Hoc
Number of Participants Answering the Question "To What Extent do the Side Effects Interfere With Your Physical Health and Ability to Function (ie, Ability to Think Clearly, Stay Awake, Etc)?": Within SmPC
Within SmPC; N=participants with evaluable data for specified question at observation
Posted
Number
Participants
Week 12
ID
Title
Description
OG000
Ziprasidone < 80 mg
Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
OG001
Ziprasidone 80 mg to < 120 mg
Ziprasidone between 80 mg and < 120 mg PO per day.
OG002
Ziprasidone 120 mg to < 160 mg
Ziprasidone between 120 mg and < 160 mg PO per day.
OG003
Ziprasidone = 160 mg
Ziprasidone 160 mg PO per day.
Units
Counts
Participants
OG0003
OG00111
OG00213
OG00341
Title
Denominators
Categories
A great deal
Title
Measurements
OG0000
OG0010
OG0021
OG003
Post-Hoc
Number of Participants Answering the Question "To What Extent do the Side Effects Interfere With Your Mental Function (ie, Ability to Think, Stay Awake, Etc)?": Within SmPC
Within SmPC; N=participants with evaluable data for specified question at observation
Posted
Number
Participants
Week 12
ID
Title
Description
OG000
Ziprasidone < 80 mg
Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
OG001
Ziprasidone 80 mg to < 120 mg
Ziprasidone between 80 mg and < 120 mg PO per day.
OG002
Ziprasidone 120 mg to < 160 mg
Ziprasidone between 120 mg and < 160 mg PO per day.
OG003
Ziprasidone = 160 mg
Ziprasidone 160 mg PO per day.
Units
Counts
Participants
OG0003
OG00111
OG00213
OG00341
Title
Denominators
Categories
A great deal
Title
Measurements
OG0003
OG00111
OG00213
OG003
Post-Hoc
Number of Participants Answering the Question "To What Degree Have Medication Side Effects Affected Your Overall Satisfaction With the Medication?": Within SmPC
Within SmPC; N=participants with evaluable data for specified question at observation
Posted
Number
Participants
Week 12
ID
Title
Description
OG000
Ziprasidone < 80 mg
Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
OG001
Ziprasidone 80 mg to < 120 mg
Ziprasidone between 80 mg and < 120 mg PO per day.
OG002
Ziprasidone 120 mg to < 160 mg
Ziprasidone between 120 mg and < 160 mg PO per day.
OG003
Ziprasidone = 160 mg
Ziprasidone 160 mg PO per day.
Units
Counts
Participants
OG0003
OG00111
OG00213
OG00341
Title
Denominators
Categories
A great deal
Title
Measurements
OG0000
OG0010
OG0021
OG003
Post-Hoc
Number of Participants Answering the Question "How Easy or Difficult is it to Use the Medication in Its Current Form?": Within SmPC
Within SmPC; N=participants with evaluable data for specified question at observation
Posted
Number
Participants
Week 12
ID
Title
Description
OG000
Ziprasidone < 80 mg
Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
OG001
Ziprasidone 80 mg to < 120 mg
Ziprasidone between 80 mg and < 120 mg PO per day.
OG002
Ziprasidone 120 mg to < 160 mg
Ziprasidone between 120 mg and < 160 mg PO per day.
OG003
Ziprasidone = 160 mg
Ziprasidone 160 mg PO per day.
Units
Counts
Participants
OG00014
OG00155
OG00280
OG003152
Title
Denominators
Categories
Extremely difficult
Title
Measurements
OG0000
OG0010
OG0020
OG003
Post-Hoc
Number of Participants Answering the Question "How Easy or Difficult is it to Plan When You Will Use the Medication Each Time?": Within SmPC
Within SmPC; N=participants with evaluable data for specified question at observation
Posted
Number
Participants
Week 12
ID
Title
Description
OG000
Ziprasidone < 80 mg
Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
OG001
Ziprasidone 80 mg to < 120 mg
Ziprasidone between 80 mg and < 120 mg PO per day.
OG002
Ziprasidone 120 mg to < 160 mg
Ziprasidone between 120 mg and < 160 mg PO per day.
OG003
Ziprasidone = 160 mg
Ziprasidone 160 mg PO per day.
Units
Counts
Participants
OG00014
OG00155
OG00280
OG003152
Title
Denominators
Categories
Extremely difficult
Title
Measurements
OG0000
OG0010
OG0020
OG003
Post-Hoc
Number of Participants Answering the Question "How Convenient or Inconvenient is it to Take the Medication as Instructed?": Within SmPC
Within SmPC; N=participants with evaluable data for specified question at observation
Posted
Number
Participants
Week 12
ID
Title
Description
OG000
Ziprasidone < 80 mg
Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
OG001
Ziprasidone 80 mg to < 120 mg
Ziprasidone between 80 mg and < 120 mg PO per day.
OG002
Ziprasidone 120 mg to < 160 mg
Ziprasidone between 120 mg and < 160 mg PO per day.
OG003
Ziprasidone = 160 mg
Ziprasidone 160 mg PO per day.
Units
Counts
Participants
OG00014
OG00155
OG00280
OG003152
Title
Denominators
Categories
Extremely inconvenient
Title
Measurements
OG0000
OG0010
OG0020
OG003
Post-Hoc
Number of Participants Answering the Question "Overall, How Confident Are You That Taking This Medication is a Good Thing?": Within SmPC
Within SmPC; N=participants with evaluable data for specified question at observation
Posted
Number
Participants
Week 12
ID
Title
Description
OG000
Ziprasidone < 80 mg
Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
OG001
Ziprasidone 80 mg to < 120 mg
Ziprasidone between 80 mg and < 120 mg PO per day.
OG002
Ziprasidone 120 mg to < 160 mg
Ziprasidone between 120 mg and < 160 mg PO per day.
OG003
Ziprasidone = 160 mg
Ziprasidone 160 mg PO per day.
Units
Counts
Participants
OG00014
OG00155
OG00280
OG003152
Title
Denominators
Categories
Not at all confident
Title
Measurements
OG0000
OG0012
OG0022
OG003
Post-Hoc
Number of Participants Answering the Question "How Certain Are You That the Good Things About Your Medication Outweigh the Bad Things?": Within SmPC
Within SmPC; N=participants with evaluable data for specified question at observation
Posted
Number
Participants
Week 12
ID
Title
Description
OG000
Ziprasidone < 80 mg
Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
OG001
Ziprasidone 80 mg to < 120 mg
Ziprasidone between 80 mg and < 120 mg PO per day.
OG002
Ziprasidone 120 mg to < 160 mg
Ziprasidone between 120 mg and < 160 mg PO per day.
OG003
Ziprasidone = 160 mg
Ziprasidone 160 mg PO per day.
Units
Counts
Participants
OG00014
OG00155
OG00280
OG003152
Title
Denominators
Categories
Not at all certain
Title
Measurements
OG0000
OG0011
OG0022
OG003
Post-Hoc
Number of Participants Answering the Question "Taking All Things Into Account, How Satisfied or Dissatisfied Are You With This Medication?": Within SmPC
Within SmPC; N=participants with evaluable data for specified question at observation
Posted
Number
Participants
Week 12
ID
Title
Description
OG000
Ziprasidone < 80 mg
Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
OG001
Ziprasidone 80 mg to < 120 mg
Ziprasidone between 80 mg and < 120 mg PO per day.
OG002
Ziprasidone 120 mg to < 160 mg
Ziprasidone between 120 mg and < 160 mg PO per day.
OG003
Ziprasidone = 160 mg
Ziprasidone 160 mg PO per day.
Units
Counts
Participants
OG00014
OG00155
OG00279
OG003152
Title
Denominators
Categories
Extremely dissatisfied
Title
Measurements
OG0000
OG0010
OG0020
OG003
Post-Hoc
Percent Change From Baseline to Final Visit in Body Weight: Within SmPC
Within SmPC
Posted
Mean
Standard Deviation
percent change
Baseline, Week 12
ID
Title
Description
OG000
Ziprasidone < 80 mg
Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
OG001
Ziprasidone 80 mg to < 120 mg
Ziprasidone between 80 mg and < 120 mg PO per day.
OG002
Ziprasidone 120 mg to < 160 mg
Ziprasidone between 120 mg and < 160 mg PO per day.
OG003
Ziprasidone = 160 mg
Ziprasidone 160 mg PO per day.
Units
Counts
Participants
OG00015
OG00156
OG00283
OG003159
Title
Denominators
Categories
Title
Measurements
OG0001.2± 5.79
OG001-0.2± 3.67
OG002-1.1± 2.75
OG003
Post-Hoc
Number of Participants Continuing Treatment With Ziprasidone Following Completion of the Observation Period: Within SmPC
Within SmPC
Posted
Number
Participants
Week 12
ID
Title
Description
OG000
Ziprasidone < 80 mg
Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
OG001
Ziprasidone 80 mg to < 120 mg
Ziprasidone between 80 mg and < 120 mg PO per day.
OG002
Ziprasidone 120 mg to < 160 mg
Ziprasidone between 120 mg and < 160 mg PO per day.
OG003
Ziprasidone = 160 mg
Ziprasidone 160 mg PO per day.
Units
Counts
Participants
OG00015
OG00156
OG00283
OG003159
Title
Denominators
Categories
Yes
Title
Measurements
OG00013
OG00155
OG00278
OG003
1
15
1
15
EG001
Ziprasidone 80 mg to < 120 mg
Ziprasidone between 80 mg and < 120 mg per day.
0
57
0
57
EG002
Ziprasidone 120 mg to < 160 mg
Ziprasidone between 120 mg and < 160 mg per day.
0
88
9
88
EG003
Ziprasidone >=160 mg
Ziprasidone 160 mg or greater per day.
1
285
34
285
EG004
Ziprasidone Unknown
Details are unknown.
0
5
1
5
EG005
Within SmPC Ziprasidone < 80 mg
Within SmPC < 80 mg per day; defined as all participants in the FAS population who had PO doses up to 80 mg per day and all IM doses up to and including 40 mg per day.
1
15
1
15
EG006
Within SmPC Ziprasidone 80 to < 120 mg
Within SmPC Ziprasidone 80 to < 120 mg; defined as all participants in the FAS population who had PO doses between 80 mg and < 120 mg per day.
0
56
0
56
EG007
Within SmPC Ziprasidone 120 to < 160 mg
Within SmPC Ziprasidone 120 to < 160 mg; defined as all participants in the FAS population who had PO doses between 120 mg and < 160 mg per day.
0
83
9
83
EG008
Within SmPC Ziprasidone = 160 mg
Within SmPC Ziprasidone = 160 mg; defined as all participants in the FAS population who had PO doses = 160 mg per day.
1
159
19
159
EG009
Above SmPC Ziprasidone > 160 mg
Above SmPC Ziprasidone > 160 mg per day; defined as all participants in FAS population who received at least 1 PO dose above 160 mg per day or any IM dose above 40 mg per day or with an unknown dose or formulation.