TRITON: Treatment of Schizophrenic Patients With Ziprasidone

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00579670
• Collaborator: (none)
• Enrollment: 450
• Locations: 20
• Duration (Months): 18
• Patients Per Site: 22.5
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

To determine whether ziprasidone provides good efficacy and tolerability in the treatment of schizophrenic Greek patients.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: Ziprasidone

Detailed Description

Sampling Method Details: Non-interventional study (subjects chosen by physician in accordance to their usual practice).

Study Design

• Study Type: Observational
• Actual Enrollment: 450 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Treatment of Schizophrenic Patients With Geodon; Capsules/Oral Suspension/Solution for Injection (Ziprasidone)
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Apr 1, 2009
• Actual Study Completion Date: Apr 1, 2009

Outcome Measures

Primary Outcome Measures

1. Summary of Schizophrenia [Baseline]

   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.

2. Summary of Metabolic Risk Factors [Baseline]

3. Summary of Most Frequently Used Concomitant Drug Treatments [Baseline]

   Most frequently concomitant drug treatments used by >15 participants.

Secondary Outcome Measures

1. Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) [Week 12]

   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.

2. Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) [Baseline, Week 12]

   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)

3. Positive and Negative Syndrome Scale (PANSS) - Positive Subscale [Baseline, Week 12]

   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.

4. PANSS - Negative Subscale [Baseline, Week 12]

   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.

5. PANSS - Composite Subscale [Baseline, Week 12]

   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.

6. 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]

7. Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Way the Medication Relieves Your Symptoms?" [Week 12]

8. 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]

9. Number of Participants Answering the Question "As a Result of Taking This Medication, do You Experience Any Side Effects at All?" [Week 12]

10. Number of Participants Answering the Question "How Bothersome Are the Side Effects of the Medication You Take to Treat Your Condition?" [Week 12]

11. 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]

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]

13. Number of Participants Answering the Question "To What Degree Have Medication Side Effects Affected Your Overall Satisfaction With the Medication?" [Week 12]

14. Number of Participants Answering the Question "How Easy or Difficult is it to Use the Medication in Its Current Form?" [Week 12]

15. Number of Participants Answering the Question "How Easy or Difficult is it to Plan When You Will Use the Medication Each Time?" [Week 12]

16. Number of Participants Answering the Question "How Convenient or Inconvenient is it to Take the Medication as Instructed?" [Week 12]

17. Number of Participants Answering the Question "Overall, How Confident Are You That Taking This Medication is a Good Thing?" [Week 12]

18. Number of Participants Answering the Question "How Certain Are You That the Good Things About Your Medication Outweigh the Bad Things?" [Week 12]

19. Number of Participants Answering the Question "Taking All Things Into Account, How Satisfied or Dissatisfied Are You With This Medication?" [Week 12]

20. Percent Change From Baseline to Final Visit in Body Weight [Baseline, Week 12]

Other Outcome Measures

1. Number of Participants Continuing Treatment With Ziprasidone Following Completion of the Observation Period [Week 12]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Usual clinical practice of physician

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Athens		Greece	12461
2	Pfizer Investigational Site	Chaidari		Greece	124 61
3	Pfizer Investigational Site	Chaidari		Greece	12461
4	Pfizer Investigational Site	Chaidari		Greece	12462
5	Pfizer Investigational Site	Corfu		Greece	49100
6	Pfizer Investigational Site	Crete		Greece	731-00
7	Pfizer Investigational Site	Giannitsa		Greece	58100
8	Pfizer Investigational Site	Haidari		Greece	12461
9	Pfizer Investigational Site	Kalamata		Greece	24100
10	Pfizer Investigational Site	Katerini		Greece	60100
11	Pfizer Investigational Site	Kozani		Greece	50100
12	Pfizer Investigational Site	Kozani		Greece
13	Pfizer Investigational Site	Lamia		Greece	35100
14	Pfizer Investigational Site	Larisa		Greece
15	Pfizer Investigational Site	Patra		Greece	26000
16	Pfizer Investigational Site	Patra		Greece	26001
17	Pfizer Investigational Site	Thessaloniki		Greece	564-29
18	Pfizer Investigational Site	Thessaloniki		Greece	56430
19	Pfizer Investigational Site	Thessaloniki		Greece	57010
20	Pfizer Investigational Site	Volos		Greece	38222

Sponsors and Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• ClinicalTrials.gov Identifier: NCT00579670
• Other Study ID Numbers: A1281156
• First Posted: Dec 24, 2007
• Last Update Posted: Mar 10, 2021
• Last Verified: Feb 1, 2021

• Keywords provided by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: Ziprasidone in patients with schizophrenia
• Additional relevant MeSH terms: Schizophrenia; Ziprasidone

Study Results

Participant Flow

Pre-assignment Detail	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.

Arm/Group Title	Ziprasidone < 80 mg	Ziprasidone 80 mg to < 120 mg	Ziprasidone 120 mg to < 160 mg	Ziprasidone >= 160 mg	Ziprasidone Unknown
Arm/Group Description	Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone between 80 mg and < 120 mg per day.	Ziprasidone between 120 mg and < 160 mg per day.	Ziprasidone 160 mg or greater per day.	Details are unknown.
Period Title: Overall Study
STARTED	15	57	88	285	5
Population: Within SmPC (Started)	15	56	83	159	0
Population: Within SmPC (Completed)	13	55	79	147	0
COMPLETED	13	56	84	263	5
NOT COMPLETED	2	1	4	22	0

Baseline Characteristics

Arm/Group Title	Ziprasidone < 80 mg	Ziprasidone 80 mg to < 120 mg	Ziprasidone 120 mg to < 160 mg	Ziprasidone >= 160 mg	Ziprasidone Unknown	Total
Arm/Group Description	Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone between 80 mg and < 120 mg per day.	Ziprasidone between 120 mg and < 160 mg per day.	Ziprasidone 160 mg or greater per day.	Details are unknown.	Total of all reporting groups
Overall Participants	15	57	88	285	5	450
Age, Customized (Number) [Number]
< 18 years	0 0%	0 0%	1 1.1%	0 0%	0 0%	1 0.2%
18 years through 44 years	3 20%	22 38.6%	42 47.7%	169 59.3%	2 40%	238 52.9%
45 years through 64 years	4 26.7%	19 33.3%	36 40.9%	96 33.7%	2 40%	157 34.9%
>= 65 years	8 53.3%	16 28.1%	9 10.2%	20 7%	1 20%	54 12%
Sex/Gender, Customized (Number) [Number]
Male	9 60%	35 61.4%	42 47.7%	173 60.7%	3 60%	262 58.2%
Female	6 40%	22 38.6%	45 51.1%	110 38.6%	2 40%	185 41.1%
Unspecified	0 0%	0 0%	1 1.1%	2 0.7%	0 0%	3 0.7%
Schizophrenia Duration (Years) [Mean (Full Range) ]
Mean (Full Range) [Years]	33.9	21.4	16.9	12.8	15.6	15.4

Outcome Measures

1. Primary Outcome

Title	Summary of Schizophrenia
Description	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.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All subjects randomized to a treatment group were included in the Baseline analysis.

Arm/Group Title	Ziprasidone < 80 mg	Ziprasidone 80 mg to < 120 mg	Ziprasidone 120 mg to < 160 mg	Ziprasidone >= 160 mg	Ziprasidone Unknown
Arm/Group Description	Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone between 80 mg and < 120 mg per day.	Ziprasidone between 120 mg and < 160 mg per day.	Ziprasidone 160 mg or greater per day.	Details are unknown.
Measure Participants	15	57	88	285	5
Stage: First episode	1 6.7%	5 8.8%	9 10.2%	39 13.7%	0 0%
Stage: Acute exacerbation	1 6.7%	2 3.5%	12 13.6%	89 31.2%	2 40%
Stage: Chronic, stable	12 80%	46 80.7%	54 61.4%	117 41.1%	3 60%
Stage: Refractory	1 6.7%	4 7%	13 14.8%	40 14%	0 0%
Symptoms: Positive	2 13.3%	29 50.9%	47 53.4%	191 67%	3 60%
Symptoms: Negative	6 40%	13 22.8%	16 18.2%	49 17.2%	0 0%
Symptoms: Depressive	1 6.7%	9 15.8%	9 10.2%	12 4.2%	0 0%
Symptoms: No predominant symptomatology	6 40%	6 10.5%	16 18.2%	32 11.2%	2 40%
Type: Catatonic	1 6.7%	0 0%	0 0%	7 2.5%	0 0%
Type: Disorganized	0 0%	0 0%	5 5.7%	30 10.5%	0 0%
Type: Paranoid	2 13.3%	22 38.6%	43 48.9%	148 51.9%	3 60%
Type: Residual	7 46.7%	13 22.8%	14 15.9%	30 10.5%	1 20%
Type: Undifferentiated	2 13.3%	5 8.8%	10 11.4%	30 10.5%	0 0%
Type: Schizoaffective disorder	3 20%	15 26.3%	14 15.9%	35 12.3%	1 20%
Type: Schizophrenia not otherwise specified (NOS)	0 0%	2 3.5%	2 2.3%	5 1.8%	0 0%

2. Primary Outcome

Title	Summary of Metabolic Risk Factors
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All subjects randomized to a treatment group were included in this baseline analysis.

Arm/Group Title	Ziprasidone Total
Arm/Group Description	Ziprasidone all doses received combined.
Measure Participants	450
No metabolic risk factors at Baseline	205 1366.7%
≥1 metabolic risk factors at Baseline	245 1633.3%
1 metabolic risk factor at Baseline	133 886.7%
2 metabolic risk factors at Baseline	64 426.7%
≥3 metabolic risk factors at Baseline	48 320%
Fasting glucose level (≥110 mg/dL)	48 320%
Triglycerides (≥150 mg/dL)	76 506.7%
HDL (men <40 mg/dL; women <50 mg/dL)	77 513.3%
Blood pressure (≥130/85 mm Hg)	54 360%
Centrally distributed obesity	182 1213.3%

3. Primary Outcome

Title	Summary of Most Frequently Used Concomitant Drug Treatments
Description	Most frequently concomitant drug treatments used by >15 participants.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All subjects randomized to a treatment group were included in this baseline analysis.

Arm/Group Title	Ziprasidone < 80 mg	Ziprasidone 80 mg to < 120 mg	Ziprasidone 120 mg to < 160 mg	Ziprasidone >= 160 mg	Ziprasidone Unknown
Arm/Group Description	Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone between 80 mg and < 120 mg per day.	Ziprasidone between 120 mg and < 160 mg per day.	Ziprasidone 160 mg or greater per day.	Details are unknown.
Measure Participants	15	57	88	285	5
Akineton	6 40%	11 19.3%	12 13.6%	24 8.4%	0 0%
Aloperidine	0 0%	6 10.5%	7 8%	13 4.6%	0 0%
Biperiden	0 0%	2 3.5%	5 5.7%	38 13.3%	0 0%
Clozapine	3 20%	4 7%	5 5.7%	4 1.4%	0 0%
Haloperidol	1 6.7%	4 7%	7 8%	45 15.8%	1 20%
Lorazepam	0 0%	3 5.3%	8 9.1%	33 11.6%	1 20%
Olanzapine	0 0%	1 1.8%	6 6.8%	20 7%	0 0%
Quetiapine	0 0%	4 7%	1 1.1%	10 3.5%	1 20%
Risperidone	3 20%	7 12.3%	7 8%	31 10.9%	1 20%
Tavor	1 6.7%	2 3.5%	4 4.5%	9 3.2%	1 20%

4. Secondary Outcome

Title	Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
Description	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.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS) - all subjects who received at least 1 dose of study medication and have at least 1 efficacy measurement.

Arm/Group Title	Ziprasidone < 80 mg	Ziprasidone 80 mg to < 120 mg	Ziprasidone 120 mg to < 160 mg	Ziprasidone >= 160 mg	Ziprasidone Unknown
Arm/Group Description	Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone between 80 mg and < 120 mg per day.	Ziprasidone between 120 mg and < 160 mg per day.	Ziprasidone 160 mg or greater per day.	Details are unknown.
Measure Participants	15	57	88	285	5
Not assessed	0 0%	1 1.8%	2 2.3%	12 4.2%	0 0%
Very much improved	1 6.7%	2 3.5%	7 8%	60 21.1%	1 20%
Much improved	7 46.7%	18 31.6%	39 44.3%	105 36.8%	2 40%
Minimally improved	3 20%	33 57.9%	36 40.9%	79 27.7%	1 20%
No change	3 20%	3 5.3%	3 3.4%	23 8.1%	1 20%
Minimally worse	0 0%	0 0%	0 0%	6 2.1%	0 0%

5. Secondary Outcome

Title	Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
Description	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)
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Ziprasidone < 80 mg	Ziprasidone 80 mg to < 120 mg	Ziprasidone 120 mg to < 160 mg	Ziprasidone >= 160 mg	Ziprasodone Unknown
Arm/Group Description	Ziprasidone up to 80 mg per day.	Ziprasidone between 80 mg and < 120 mg per day.	Ziprasidone between 120 mg and < 160 mg per day.	Ziprasidone 160 mg or greater per day.	Details are unknown.
Measure Participants	15	57	88	285	5
B - Not assessed	0 0%	0 0%	1 1.1%	0 0%	0 0%
F - Not assessed	0 0%	1 1.8%	2 2.3%	12 4.2%	0 0%
F (only) - Normal, not at all ill	1 6.7%	0 0%	1 1.1%	18 6.3%	0 0%
B - Borderline mentally ill	4 26.7%	0 0%	2 2.3%	2 0.7%	1 20%
F - Borderline mentally ill	3 20%	7 12.3%	16 18.2%	47 16.5%	4 80%
B - Mildly ill	4 26.7%	11 19.3%	6 6.8%	17 6%	2 40%
F - Mildly ill	7 46.7%	25 43.9%	33 37.5%	90 31.6%	0 0%
B - Moderately ill	6 40%	26 45.6%	45 51.1%	80 28.1%	0 0%
F - Moderately ill	3 20%	17 29.8%	17 19.3%	62 21.8%	0 0%
B - Markedly ill	1 6.7%	16 28.1%	24 27.3%	108 37.9%	1 20%
F - Markedly ill	0 0%	5 8.8%	17 19.3%	40 14%	0 0%
B - Severely ill	0 0%	4 7%	10 11.4%	71 24.9%	1 20%
F - Severely ill	0 0%	2 3.5%	1 1.1%	13 4.6%	1 20%
B - Among the most extremely ill	0 0%	0 0%	0 0%	6 2.1%	0 0%
F - Among the most extremely ill	0 0%	0 0%	0 0%	3 1.1%	0 0%

6. Secondary Outcome

Title	Positive and Negative Syndrome Scale (PANSS) - Positive Subscale
Description	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.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Ziprasidone < 80 mg	Ziprasidone 80 mg to < 120 mg	Ziprasidone 120 mg to < 160 mg	Ziprasidone >= 160 mg	Ziprasidone Unknown
Arm/Group Description	Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone between 80 mg and < 120 mg per day.	Ziprasidone between 120 mg and < 160 mg per day.	Ziprasidone 160 mg or greater per day.	Details are unknown.
Measure Participants	15	57	88	285	5
Baseline	12.9 (4.12)	14.4 (4.35)	14.6 (4.82)	16.6 (5.28)	12.6 (2.30)
Final	10.2 (3.60)	11.2 (4.35)	10.5 (4.41)	10.4 (4.92)	7.8 (3.03)

7. Secondary Outcome

Title	PANSS - Negative Subscale
Description	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.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Ziprasidone < 80 mg	Ziprasidone 80 mg to < 120 mg	Ziprasidone 120 mg to < 160 mg	Ziprasidone >= 160 mg	Ziprasidone Unknown
Arm/Group Description	Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone between 80 mg and < 120 mg per day.	Ziprasidone between 120 mg and < 160 mg per day.	Ziprasidone 160 mg or greater per day.	Details are unknown.
Measure Participants	15	57	88	285	5
Baseline	16.7 (4.69)	16.1 (4.05)	14.6 (5.30)	14.7 (5.70)	12.8 (5.81)
Final	14.1 (4.27)	12.8 (4.67)	11.3 (4.78)	10.6 (5.05)	8.6 (5.18)

8. Secondary Outcome

Title	PANSS - Composite Subscale
Description	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.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Ziprasidone < 80 mg	Ziprasidone 80 mg to < 120 mg	Ziprasidone 120 mg to < 160 mg	Ziprasidone >= 160 mg	Ziprasidone Unknown
Arm/Group Description	Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone between 80 mg and < 120 mg per day.	Ziprasidone between 120 mg and < 160 mg per day.	Ziprasidone 160 mg or greater per day.	Details are unknown.
Measure Participants	15	57	88	285	5
Baseline	-3.8 (3.57)	-1.7 (4.86)	0.0 (5.14)	1.9 (6.83)	-0.2 (6.14)
Final	-3.9 (2.82)	-1.5 (3.92)	-0.7 (3.60)	-0.2 (4.57)	-0.8 (2.95)

9. Secondary Outcome

Title	Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Ability of the Medication to Prevent or Treat Your Condition?"
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Ziprasidone < 80 mg	Ziprasidone 80 mg to < 120 mg	Ziprasidone 120 mg to < 160 mg	Ziprasidone >= 160 mg	Ziprasidone Unknown
Arm/Group Description	Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone between 80 mg and < 120 mg per day.	Ziprasidone between 120 mg and < 160 mg per day.	Ziprasidone 160 mg or greater per day.	Details are unknown.
Measure Participants	15	57	88	285	5
Extremely Dissatisfied	0 0%	0 0%	0 0%	1 0.4%	0 0%
Very Dissatisfied	0 0%	0 0%	1 1.1%	5 1.8%	0 0%
Dissatisfied	1 6.7%	5 8.8%	3 3.4%	22 7.7%	0 0%
Somewhat Satisfied	3 20%	15 26.3%	23 26.1%	69 24.2%	1 20%
Satisfied	6 40%	25 43.9%	40 45.5%	102 35.8%	1 20%
Very Satisfied	4 26.7%	11 19.3%	15 17%	48 16.8%	3 60%
Extremely Satisfied	0 0%	0 0%	3 3.4%	27 9.5%	0 0%

10. Secondary Outcome

Title	Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Way the Medication Relieves Your Symptoms?"
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ziprasidone < 80 mg	Ziprasidone 80 mg to < 120 mg	Ziprasidone 120 mg to < 160 mg	Ziprasidone >= 160 mg	Ziprasidone Unknown
Arm/Group Description	Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone between 80 mg and < 120 mg per day.	Ziprasidone between 120 mg and < 160 mg per day.	Ziprasidone 160 mg or greater per day.	Details are unknown.
Measure Participants	15	57	88	285	5
Extremely Dissatisfied	0 0%	0 0%	0 0%	1 0.4%	0 0%
Very Dissatisfied	0 0%	0 0%	2 2.3%	6 2.1%	0 0%
Dissatisfied	1 6.7%	5 8.8%	1 1.1%	18 6.3%	0 0%
Somewhat Satisfied	2 13.3%	14 24.6%	24 27.3%	80 28.1%	1 20%
Satisfied	7 46.7%	22 38.6%	38 43.2%	86 30.2%	0 0%
Very Satisfied	4 26.7%	14 24.6%	16 18.2%	54 18.9%	2 40%
Extremely Satisfied	0 0%	1 1.8%	4 4.5%	29 10.2%	2 40%

11. Secondary Outcome

Title	Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Amount of Time it Takes the Medication to Start Working?"
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Ziprasidone < 80 mg	Ziprasidone 80 mg to < 120 mg	Ziprasidone 120 mg to < 160 mg	Ziprasidone >= 160 mg	Ziprasidone Unknown
Arm/Group Description	Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone between 80 mg and < 120 mg per day.	Ziprasidone between 120 mg and < 160 mg per day.	Ziprasidone 160 mg or greater per day.	Details are unknown.
Measure Participants	15	57	88	285	5
Extremely Dissatisfied	0 0%	0 0%	0 0%	2 0.7%	0 0%
Very Dissatisfied	0 0%	1 1.8%	1 1.1%	4 1.4%	0 0%
Dissatisfied	1 6.7%	6 10.5%	6 6.8%	29 10.2%	0 0%
Somewhat Satisfied	5 33.3%	21 36.8%	31 35.2%	79 27.7%	0 0%
Satisfied	6 40%	21 36.8%	32 36.4%	96 33.7%	2 40%
Very satisfied	2 13.3%	7 12.3%	12 13.6%	41 14.4%	3 60%
Extremely satisfied	0 0%	0 0%	3 3.4%	23 8.1%	0 0%

12. Secondary Outcome

Title	Number of Participants Answering the Question "As a Result of Taking This Medication, do You Experience Any Side Effects at All?"
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ziprasidone < 80 mg	Ziprasidone 80 mg to < 120 mg	Ziprasidone 120 mg to < 160 mg	Ziprasidone >= 160 mg	Ziprasidone Unknown
Arm/Group Description	Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone between 80 mg and < 120 mg per day.	Ziprasidone between 120 mg and < 160 mg per day.	Ziprasidone 160 mg or greater per day.	Details are unknown.
Measure Participants	15	57	88	285	5
Yes	3	11	13	84	1
No	11	45	72	189	4

13. Secondary Outcome

Title	Number of Participants Answering the Question "How Bothersome Are the Side Effects of the Medication You Take to Treat Your Condition?"
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ziprasidone < 80 mg	Ziprasidone 80 mg to < 120 mg	Ziprasidone 120 mg to < 160 mg	Ziprasidone >= 160 mg	Ziprasidone Unknown
Arm/Group Description	Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone between 80 mg and < 120 mg per day.	Ziprasidone between 120 mg and < 160 mg per day.	Ziprasidone 160 mg or greater per day.	Details are unknown.
Measure Participants	15	57	88	285	5
Extremely Bothersome	0 0%	0 0%	0 0%	1 0.4%	0 0%
Very Bothersome	0 0%	0 0%	1 1.1%	9 3.2%	0 0%
Somewhat Bothersome	0 0%	8 14%	3 3.4%	29 10.2%	0 0%
A Little Bothersome	3 20%	3 5.3%	7 8%	41 14.4%	1 20%
Not At All Bothersome	0 0%	0 0%	2 2.3%	4 1.4%	0 0%

14. Secondary Outcome

Title	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)?"
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Ziprasidone < 80 mg	Ziprasidone 80 mg to < 120 mg	Ziprasidone 120 mg to < 160 mg	Ziprasidone >= 160 mg	Ziprasidone Unknown
Arm/Group Description	Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone between 80 mg and < 120 mg per day.	Ziprasidone between 120 mg and < 160 mg per day.	Ziprasidone 160 mg or greater per day.	Details are unknown.
Measure Participants	15	57	88	285	5
A great deal	0 0%	0 0%	1 1.1%	6 2.1%	0 0%
Quite a bit	0 0%	1 1.8%	1 1.1%	11 3.9%	0 0%
Somewhat	1 6.7%	4 7%	3 3.4%	31 10.9%	0 0%
Minimally	2 13.3%	3 5.3%	7 8%	28 9.8%	1 20%
Not at all	0 0%	3 5.3%	1 1.1%	8 2.8%	0 0%

15. Secondary Outcome

Title	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)?"
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Ziprasidone < 80 mg	Ziprasidone 80 mg to < 120 mg	Ziprasidone 120 mg to < 160 mg	Ziprasidone >= 160 mg	Ziprasidone Unknown
Arm/Group Description	Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone between 80 mg and < 120 mg per day.	Ziprasidone between 120 mg and < 160 mg per day.	Ziprasidone 160 mg or greater per day.	Details are unknown.
Measure Participants	15	57	88	285	5
A great deal	3 20%	11 19.3%	13 14.8%	84 29.5%	1 20%
Quite a bit	0 0%	0 0%	0 0%	0 0%	0 0%
Somewhat	0 0%	0 0%	0 0%	0 0%	0 0%
Minimally	0 0%	0 0%	0 0%	0 0%	0 0%
Not at all	0 0%	0 0%	0 0%	0 0%	0 0%

16. Secondary Outcome

Title	Number of Participants Answering the Question "To What Degree Have Medication Side Effects Affected Your Overall Satisfaction With the Medication?"
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Ziprasidone < 80 mg	Ziprasidone 80 mg to < 120 mg	Ziprasidone 120 mg to < 160 mg	Ziprasidone >= 160 mg	Ziprasidone Unknown
Arm/Group Description	Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone between 80 mg and < 120 mg per day.	Ziprasidone between 120 mg and < 160 mg per day.	Ziprasidone 160 mg or greater per day.	Details are unknown.
Measure Participants	15	57	88	285	5
A great deal	0 0%	0 0%	1 1.1%	2 0.7%	0 0%
Quite a bit	0 0%	0 0%	1 1.1%	18 6.3%	0 0%
Somewhat	1 6.7%	5 8.8%	2 2.3%	26 9.1%	0 0%
Minimally	1 6.7%	2 3.5%	4 4.5%	27 9.5%	1 20%
Not at all	1 6.7%	4 7%	5 5.7%	10 3.5%	0 0%

17. Secondary Outcome

Title	Number of Participants Answering the Question "How Easy or Difficult is it to Use the Medication in Its Current Form?"
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Ziprasidone < 80 mg	Ziprasidone 80 mg to < 120 mg	Ziprasidone 120 mg to < 160 mg	Ziprasidone >= 160 mg	Ziprasidone Unknown
Arm/Group Description	Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone between 80 mg and < 120 mg per day.	Ziprasidone between 120 mg and < 160 mg per day.	Ziprasidone 160 mg or greater per day.	Details are unknown.
Measure Participants	15	57	88	285	5
Extremely difficult	0 0%	0 0%	0 0%	2 0.7%	0 0%
Very difficult	0 0%	0 0%	1 1.1%	2 0.7%	0 0%
Difficult	0 0%	1 1.8%	3 3.4%	13 4.6%	0 0%
Somewhat easy	0 0%	9 15.8%	18 20.5%	45 15.8%	0 0%
Easy	8 53.3%	25 43.9%	39 44.3%	117 41.1%	3 60%
Very easy	4 26.7%	15 26.3%	16 18.2%	71 24.9%	2 40%
Extremely easy	2 13.3%	6 10.5%	8 9.1%	22 7.7%	0 0%

18. Secondary Outcome

Title	Number of Participants Answering the Question "How Easy or Difficult is it to Plan When You Will Use the Medication Each Time?"
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Ziprasidone < 80 mg	Ziprasidone 80 mg to < 120 mg	Ziprasidone 120 mg to < 160 mg	Ziprasidone >= 160 mg	Ziprasidone Unknown
Arm/Group Description	Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone between 80 mg and < 120 mg per day.	Ziprasidone between 120 mg and < 160 mg per day.	Ziprasidone 160 mg or greater per day.	Details are unknown.
Measure Participants	15	57	88	285	5
Extremely difficult	0 0%	0 0%	0 0%	0 0%	0 0%
Very difficult	0 0%	0 0%	1 1.1%	4 1.4%	0 0%
Difficult	1 6.7%	1 1.8%	7 8%	25 8.8%	0 0%
Somewhat easy	3 20%	14 24.6%	21 23.9%	57 20%	1 20%
Easy	7 46.7%	25 43.9%	37 42%	108 37.9%	1 20%
Very easy	1 6.7%	7 12.3%	15 17%	54 18.9%	3 60%
Extremely easy	2 13.3%	9 15.8%	4 4.5%	24 8.4%	0 0%

19. Secondary Outcome

Title	Number of Participants Answering the Question "How Convenient or Inconvenient is it to Take the Medication as Instructed?"
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Ziprasidone < 80 mg	Ziprasidone 80 mg to < 120 mg	Ziprasidone 120 mg to < 160 mg	Ziprasidone >= 160 mg	Ziprasidone Unknown
Arm/Group Description	Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone between 80 mg and < 120 mg per day.	Ziprasidone between 120 mg and < 160 mg per day.	Ziprasidone 160 mg or greater per day.	Details are unknown.
Measure Participants	15	57	88	285	5
Extremely inconvenient	0 0%	0 0%	0 0%	1 0.4%	0 0%
Very inconvenient	0 0%	0 0%	1 1.1%	4 1.4%	0 0%
Inconvenient	1 6.7%	4 7%	6 6.8%	25 8.8%	0 0%
Somewhat convenient	2 13.3%	12 21.1%	30 34.1%	71 24.9%	1 20%
Convenient	7 46.7%	26 45.6%	35 39.8%	111 38.9%	1 20%
Very convenient	2 13.3%	6 10.5%	7 8%	39 13.7%	3 60%
Extremely convenient	2 13.3%	8 14%	6 6.8%	21 7.4%	0 0%

20. Secondary Outcome

Title	Number of Participants Answering the Question "Overall, How Confident Are You That Taking This Medication is a Good Thing?"
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Ziprasidone < 80 mg	Ziprasidone 80 mg to < 120 mg	Ziprasidone 120 mg to < 160 mg	Ziprasidone >= 160 mg	Ziprasidone Unknown
Arm/Group Description	Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone between 80 mg and < 120 mg per day.	Ziprasidone between 120 mg and < 160 mg per day.	Ziprasidone 160 mg or greater per day.	Details are unknown.
Measure Participants	15	57	88	285	5
Not at all confident	0 0%	2 3.5%	2 2.3%	13 4.6%	0 0%
A little confident	2 13.3%	10 17.5%	9 10.2%	33 11.6%	1 20%
Somewhat confident	6 40%	21 36.8%	33 37.5%	88 30.9%	3 60%
Very confident	6 40%	22 38.6%	34 38.6%	100 35.1%	0 0%
Extremely confident	0 0%	1 1.8%	7 8%	36 12.6%	1 20%

21. Secondary Outcome

Title	Number of Participants Answering the Question "How Certain Are You That the Good Things About Your Medication Outweigh the Bad Things?"
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Ziprasidone < 80 mg	Ziprasidone 80 mg to < 120 mg	Ziprasidone 120 mg to < 160 mg	Ziprasidone >= 160 mg	Ziprasidone Unknown
Arm/Group Description	Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone between 80 mg and < 120 mg per day.	Ziprasidone between 120 mg and < 160 mg per day.	Ziprasidone 160 mg or greater per day.	Details are unknown.
Measure Participants	15	57	88	285	5
Not at all certain	0 0%	1 1.8%	2 2.3%	15 5.3%	0 0%
A little certain	3 20%	13 22.8%	7 8%	36 12.6%	0 0%
Somewhat certain	6 40%	21 36.8%	26 29.5%	81 28.4%	2 40%
Very certain	5 33.3%	20 35.1%	44 50%	101 35.4%	3 60%
Extremely certain	0 0%	1 1.8%	6 6.8%	39 13.7%	0 0%

22. Secondary Outcome

Title	Number of Participants Answering the Question "Taking All Things Into Account, How Satisfied or Dissatisfied Are You With This Medication?"
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Ziprasidone < 80 mg	Ziprasidone 80 mg to < 120 mg	Ziprasidone 120 mg to < 160 mg	Ziprasidone >= 160 mg	Ziprasidone Unknown
Arm/Group Description	Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone between 80 mg and < 120 mg per day.	Ziprasidone between 120 mg and < 160 mg per day.	Ziprasidone 160 mg or greater per day.	Details are unknown.
Measure Participants	15	57	88	285	5
Extremely dissatisfied	0 0%	0 0%	0 0%	2 0.7%	0 0%
Very dissatisfied	0 0%	0 0%	0 0%	6 2.1%	0 0%
Dissatisfied	1 6.7%	5 8.8%	3 3.4%	17 6%	0 0%
Somewhat satisfied	1 6.7%	19 33.3%	16 18.2%	64 22.5%	1 20%
Satisfied	7 46.7%	17 29.8%	37 42%	89 31.2%	1 20%
Very satisfied	5 33.3%	15 26.3%	23 26.1%	61 21.4%	2 40%
Extremely satisfied	0 0%	0 0%	5 5.7%	32 11.2%	1 20%

23. Other Pre-specified Outcome

Title	Number of Participants Continuing Treatment With Ziprasidone Following Completion of the Observation Period
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

FAS. Four subjects did not answer the question of continuation of treatment.

Arm/Group Title	Ziprasidone < 80 mg	Ziprasidone 80 mg to < 120 mg	Ziprasidone 120 mg to < 160 mg	Ziprasidone >= 160 mg	Ziprasidone Unknown
Arm/Group Description	Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone between 80 mg and < 120 mg per day.	Ziprasidone between 120 mg and < 160 mg per day.	Ziprasidone 160 mg or greater per day.	Details are unknown.
Measure Participants	15	57	88	285	5
Yes	13 86.7%	56 98.2%	83 94.3%	245 86%	4 80%
No	2 13.3%	1 1.8%	4 4.5%	38 13.3%	0 0%

24. Secondary Outcome

Title	Percent Change From Baseline to Final Visit in Body Weight
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Safety population = all subjects who received at least 1 dose of study medication.

Arm/Group Title	Ziprasidone < 80 mg	Ziprasidone 80 mg to < 120 mg	Ziprasidone 120 mg to < 160 mg	Ziprasidone >= 160 mg	Ziprasidone Unknown
Arm/Group Description	Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone between 80 mg and < 120 mg per day.	Ziprasidone between 120 mg and < 160 mg per day.	Ziprasidone 160 mg or greater per day.	Details are unknown.
Measure Participants	15	57	88	285	5
Mean (Standard Deviation) [percent change]	1.2 (5.79)	-0.2 (3.67)	-1.0 (3.08)	0.1 (4.70)	-1.0 (2.05)

25. Post-Hoc Outcome

Title	Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I): Within Summary of Product Characteristics Population (SmPC)
Description	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.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Ziprasidone < 80 mg	Ziprasidone 80 mg to < 120 mg	Ziprasidone 120 mg to < 160 mg	Ziprasidone = 160 mg
Arm/Group Description	Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.	Ziprasidone between 80 mg and < 120 mg PO per day.	Ziprasidone between 120 mg and < 160 mg PO per day.	Ziprasidone 160 mg PO per day.
Measure Participants	15	56	83	159
Not assessed	0 0%	1 1.8%	2 2.3%	6 2.1%
Very much improved	1 6.7%	2 3.5%	6 6.8%	22 7.7%
Much improved	7 46.7%	17 29.8%	39 44.3%	62 21.8%
Minimally improved	3 20%	33 57.9%	32 36.4%	52 18.2%
No change	3 20%	3 5.3%	3 3.4%	14 4.9%
Minimally worse	0 0%	0 0%	0 0%	3 1.1%

26. Post-Hoc Outcome

Title	Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S): Within SmPC
Description	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)
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Within SmPC

Arm/Group Title	Ziprasidone < 80 mg	Ziprasidone 80 mg to < 120 mg	Ziprasidone 120 mg to < 160 mg	Ziprasidone = 160 mg
Arm/Group Description	Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.	Ziprasidone between 80 mg and < 120 mg PO per day.	Ziprasidone between 120 mg and < 160 mg PO per day.	Ziprasidone 160 mg PO per day.
Measure Participants	15	56	83	159
B - Not assessed	0 0%	0 0%	1 1.1%	0 0%
F - Not assessed	0 0%	1 1.8%	2 2.3%	6 2.1%
F (only) - Normal, not at all ill	1 6.7%	0 0%	1 1.1%	6 2.1%
B - Borderline mentally ill	4 26.7%	0 0%	2 2.3%	1 0.4%
F - Borderline mentally ill	3 20%	7 12.3%	14 15.9%	24 8.4%
B - Mildly ill	4 26.7%	11 19.3%	5 5.7%	10 3.5%
F - Mildly ill	7 46.7%	24 42.1%	31 35.2%	53 18.6%
B - Moderately ill	6 40%	25 43.9%	41 46.6%	53 18.6%
F - Moderately ill	3 20%	17 29.8%	16 18.2%	38 13.3%
B - Markedly ill	1 6.7%	16 28.1%	24 27.3%	59 20.7%
F - Markedly ill	0 0%	5 8.8%	17 19.3%	22 7.7%
B - Severely ill	0 0%	4 7%	10 11.4%	33 11.6%
F - Severely ill	0 0%	2 3.5%	1 1.1%	8 2.8%
B - Among the most extremely ill	0 0%	0 0%	0 0%	2 0.7%
F - Among the most extremely ill	0 0%	0 0%	0 0%	2 0.7%

27. Post-Hoc Outcome

Title	Positive and Negative Syndrome Scale (PANSS) - Positive Subscale: Within SmPC
Description	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.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Within SmPC; N=participants with evaluable data at observation

Arm/Group Title	Ziprasidone < 80 mg	Ziprasidone 80 mg to < 120 mg	Ziprasidone 120 mg to < 160 mg	Ziprasidone = 160 mg
Arm/Group Description	Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.	Ziprasidone between 80 mg and < 120 mg PO per day.	Ziprasidone between 120 mg and < 160 mg PO per day.	Ziprasidone 160 mg PO per day.
Measure Participants	15	56	82	158
Baseline	12.9 (4.12)	14.5 (4.37)	14.8 (4.85)	15.3 (5.27)
Final	10.2 (3.60)	11.3 (4.38)	10.7 (4.47)	10.0 (4.51)

28. Post-Hoc Outcome

Title	PANSS - Negative Subscale: Within SmPC
Description	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.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Within SmPC; N=participants with evaluable data at observation

Arm/Group Title	Ziprasidone < 80 mg	Ziprasidone 80 mg to < 120 mg	Ziprasidone 120 mg to < 160 mg	Ziprasidone = 160 mg
Arm/Group Description	Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.	Ziprasidone between 80 mg and < 120 mg PO per day.	Ziprasidone between 120 mg and < 160 mg PO per day.	Ziprasidone 160 mg PO per day.
Measure Participants	15	55	82	157
Baseline	16.7 (4.69)	16.0 (4.06)	14.8 (5.22)	14.5 (5.91)
Final	14.1 (4.27)	12.7 (4.71)	11.4 (4.76)	11.1 (5.33)

29. Post-Hoc Outcome

Title	PANSS - Composite Subscale: Within SmPC
Description	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.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Within SmPC; N=participants with evaluable data at observation

Arm/Group Title	Ziprasidone < 80 mg	Ziprasidone 80 mg to < 120 mg	Ziprasidone 120 mg to < 160 mg	Ziprasidone = 160 mg
Arm/Group Description	Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.	Ziprasidone between 80 mg and < 120 mg PO per day.	Ziprasidone between 120 mg and < 160 mg PO per day.	Ziprasidone 160 mg PO per day.
Measure Participants	15	55	82	157
Baseline	-3.8 (3.57)	-1.5 (4.80)	0.0 (5.09)	0.7 (7.32)
Final	-3.9 (2.82)	-1.5 (3.91)	-0.6 (3.58)	-1.1 (4.61)

30. Post-Hoc Outcome

Title	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
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Within SmPC; N=participants with evaluable data for specified question at observation

Arm/Group Title	Ziprasidone < 80 mg	Ziprasidone 80 mg to < 120 mg	Ziprasidone 120 mg to < 160 mg	Ziprasidone = 160 mg
Arm/Group Description	Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.	Ziprasidone between 80 mg and < 120 mg PO per day.	Ziprasidone between 120 mg and < 160 mg PO per day.	Ziprasidone 160 mg PO per day.
Measure Participants	14	55	80	153
Extremely Dissatisfied	0 0%	0 0%	0 0%	0 0%
Very Dissatisfied	0 0%	0 0%	1 1.1%	3 1.1%
Dissatisfied	1 6.7%	5 8.8%	3 3.4%	12 4.2%
Somewhat Satisfied	3 20%	15 26.3%	23 26.1%	43 15.1%
Satisfied	6 40%	24 42.1%	36 40.9%	56 19.6%
Very Satisfied	4 26.7%	11 19.3%	14 15.9%	30 10.5%
Extremely Satisfied	0 0%	0 0%	3 3.4%	9 3.2%

31. Post-Hoc Outcome

Title	Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Way the Medication Relieves Your Symptoms?": Within SmPC
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Within SmPC; N=participants with evaluable data for specified question at observation

Arm/Group Title	Ziprasidone < 80 mg	Ziprasidone 80 mg to < 120 mg	Ziprasidone 120 mg to < 160 mg	Ziprasidone = 160 mg
Arm/Group Description	Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.	Ziprasidone between 80 mg and < 120 mg PO per day.	Ziprasidone between 120 mg and < 160 mg PO per day.	Ziprasidone 160 mg PO per day.
Measure Participants	14	55	80	153
Extremely Dissatisfied	0 0%	0 0%	0 0%	0 0%
Very Dissatisfied	0 0%	0 0%	2 2.3%	3 1.1%
Dissatisfied	1 6.7%	5 8.8%	1 1.1%	11 3.9%
Somewhat Satisfied	2 13.3%	14 24.6%	24 27.3%	48 16.8%
Satisfied	7 46.7%	21 36.8%	34 38.6%	48 16.8%
Very Satisfied	4 26.7%	14 24.6%	15 17%	34 11.9%
Extremely Satisfied	0 0%	1 1.8%	4 4.5%	9 3.2%

32. Post-Hoc Outcome

Title	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
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Within SmPC; N=participants with evaluable data for specified question at observation

Arm/Group Title	Ziprasidone < 80 mg	Ziprasidone 80 mg to < 120 mg	Ziprasidone 120 mg to < 160 mg	Ziprasidone = 160 mg
Arm/Group Description	Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.	Ziprasidone between 80 mg and < 120 mg PO per day.	Ziprasidone between 120 mg and < 160 mg PO per day.	Ziprasidone 160 mg PO per day.
Measure Participants	14	55	80	153
Extremely Dissatisfied	0 0%	0 0%	0 0%	0 0%
Very Dissatisfied	0 0%	1 1.8%	1 1.1%	3 1.1%
Dissatisfied	1 6.7%	6 10.5%	6 6.8%	17 6%
Somewhat Satisfied	5 33.3%	20 35.1%	30 34.1%	42 14.7%
Satisfied	6 40%	21 36.8%	28 31.8%	58 20.4%
Very satisfied	2 13.3%	7 12.3%	12 13.6%	26 9.1%
Extremely satisfied	0 0%	0 0%	3 3.4%	7 2.5%

33. Post-Hoc Outcome

Title	Number of Participants Answering the Question "As a Result of Taking This Medication, do You Experience Any Side Effects at All?": Within SmPC
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Within SmPC; N=participants with evaluable data for specified question at observation

Arm/Group Title	Ziprasidone < 80 mg	Ziprasidone 80 mg to < 120 mg	Ziprasidone 120 mg to < 160 mg	Ziprasidone = 160 mg
Arm/Group Description	Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.	Ziprasidone between 80 mg and < 120 mg PO per day.	Ziprasidone between 120 mg and < 160 mg PO per day.	Ziprasidone 160 mg PO per day.
Measure Participants	14	55	80	152
Yes	3	11	13	41
No	11	44	67	111

34. Post-Hoc Outcome

Title	Number of Participants Answering the Question "How Bothersome Are the Side Effects of the Medication You Take to Treat Your Condition?": Within SmPC
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Within SmPC; N=participants with evaluable data for specified question at observation

Arm/Group Title	Ziprasidone < 80 mg	Ziprasidone 80 mg to < 120 mg	Ziprasidone 120 mg to < 160 mg	Ziprasidone = 160 mg
Arm/Group Description	Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.	Ziprasidone between 80 mg and < 120 mg PO per day.	Ziprasidone between 120 mg and < 160 mg PO per day.	Ziprasidone 160 mg PO per day.
Measure Participants	3	11	13	41
Extremely Bothersome	0 0%	0 0%	0 0%	0 0%
Very Bothersome	0 0%	0 0%	1 1.1%	4 1.4%
Somewhat Bothersome	0 0%	8 14%	3 3.4%	18 6.3%
A Little Bothersome	3 20%	3 5.3%	7 8%	18 6.3%
Not At All Bothersome	0 0%	0 0%	2 2.3%	1 0.4%

35. Post-Hoc Outcome

Title	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
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Within SmPC; N=participants with evaluable data for specified question at observation

Arm/Group Title	Ziprasidone < 80 mg	Ziprasidone 80 mg to < 120 mg	Ziprasidone 120 mg to < 160 mg	Ziprasidone = 160 mg
Arm/Group Description	Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.	Ziprasidone between 80 mg and < 120 mg PO per day.	Ziprasidone between 120 mg and < 160 mg PO per day.	Ziprasidone 160 mg PO per day.
Measure Participants	3	11	13	41
A great deal	0 0%	0 0%	1 1.1%	1 0.4%
Quite a bit	0 0%	1 1.8%	1 1.1%	7 2.5%
Somewhat	1 6.7%	4 7%	3 3.4%	18 6.3%
Minimally	2 13.3%	3 5.3%	7 8%	12 4.2%
Not at all	0 0%	3 5.3%	1 1.1%	3 1.1%

36. Post-Hoc Outcome

Title	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
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Within SmPC; N=participants with evaluable data for specified question at observation

Arm/Group Title	Ziprasidone < 80 mg	Ziprasidone 80 mg to < 120 mg	Ziprasidone 120 mg to < 160 mg	Ziprasidone = 160 mg
Arm/Group Description	Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.	Ziprasidone between 80 mg and < 120 mg PO per day.	Ziprasidone between 120 mg and < 160 mg PO per day.	Ziprasidone 160 mg PO per day.
Measure Participants	3	11	13	41
A great deal	3 20%	11 19.3%	13 14.8%	41 14.4%
Quite a bit	0 0%	0 0%	0 0%	0 0%
Somewhat	0 0%	0 0%	0 0%	0 0%
Minimally	0 0%	0 0%	0 0%	0 0%
Not at all	0 0%	0 0%	0 0%	0 0%

37. Post-Hoc Outcome

Title	Number of Participants Answering the Question "To What Degree Have Medication Side Effects Affected Your Overall Satisfaction With the Medication?": Within SmPC
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Within SmPC; N=participants with evaluable data for specified question at observation

Arm/Group Title	Ziprasidone < 80 mg	Ziprasidone 80 mg to < 120 mg	Ziprasidone 120 mg to < 160 mg	Ziprasidone = 160 mg
Arm/Group Description	Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.	Ziprasidone between 80 mg and < 120 mg PO per day.	Ziprasidone between 120 mg and < 160 mg PO per day.	Ziprasidone 160 mg PO per day.
Measure Participants	3	11	13	41
A great deal	0 0%	0 0%	1 1.1%	2 0.7%
Quite a bit	0 0%	0 0%	1 1.1%	8 2.8%
Somewhat	1 6.7%	5 8.8%	2 2.3%	15 5.3%
Minimally	1 6.7%	2 3.5%	4 4.5%	12 4.2%
Not at all	1 6.7%	4 7%	5 5.7%	4 1.4%

38. Post-Hoc Outcome

Title	Number of Participants Answering the Question "How Easy or Difficult is it to Use the Medication in Its Current Form?": Within SmPC
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Within SmPC; N=participants with evaluable data for specified question at observation

Arm/Group Title	Ziprasidone < 80 mg	Ziprasidone 80 mg to < 120 mg	Ziprasidone 120 mg to < 160 mg	Ziprasidone = 160 mg
Arm/Group Description	Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.	Ziprasidone between 80 mg and < 120 mg PO per day.	Ziprasidone between 120 mg and < 160 mg PO per day.	Ziprasidone 160 mg PO per day.
Measure Participants	14	55	80	152
Extremely difficult	0 0%	0 0%	0 0%	2 0.7%
Very difficult	0 0%	0 0%	1 1.1%	1 0.4%
Difficult	0 0%	1 1.8%	3 3.4%	9 3.2%
Somewhat easy	0 0%	9 15.8%	17 19.3%	22 7.7%
Easy	8 53.3%	24 42.1%	36 40.9%	65 22.8%
Very easy	4 26.7%	15 26.3%	15 17%	44 15.4%
Extremely easy	2 13.3%	6 10.5%	8 9.1%	9 3.2%

39. Post-Hoc Outcome

Title	Number of Participants Answering the Question "How Easy or Difficult is it to Plan When You Will Use the Medication Each Time?": Within SmPC
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Within SmPC; N=participants with evaluable data for specified question at observation

Arm/Group Title	Ziprasidone < 80 mg	Ziprasidone 80 mg to < 120 mg	Ziprasidone 120 mg to < 160 mg	Ziprasidone = 160 mg
Arm/Group Description	Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.	Ziprasidone between 80 mg and < 120 mg PO per day.	Ziprasidone between 120 mg and < 160 mg PO per day.	Ziprasidone 160 mg PO per day.
Measure Participants	14	55	80	152
Extremely difficult	0 0%	0 0%	0 0%	0 0%
Very difficult	0 0%	0 0%	1 1.1%	3 1.1%
Difficult	1 6.7%	1 1.8%	6 6.8%	16 5.6%
Somewhat easy	3 20%	14 24.6%	20 22.7%	32 11.2%
Easy	7 46.7%	24 42.1%	35 39.8%	60 21.1%
Very easy	1 6.7%	7 12.3%	14 15.9%	30 10.5%
Extremely easy	2 13.3%	9 15.8%	4 4.5%	11 3.9%

40. Post-Hoc Outcome

Title	Number of Participants Answering the Question "How Convenient or Inconvenient is it to Take the Medication as Instructed?": Within SmPC
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Within SmPC; N=participants with evaluable data for specified question at observation

Arm/Group Title	Ziprasidone < 80 mg	Ziprasidone 80 mg to < 120 mg	Ziprasidone 120 mg to < 160 mg	Ziprasidone = 160 mg
Arm/Group Description	Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.	Ziprasidone between 80 mg and < 120 mg PO per day.	Ziprasidone between 120 mg and < 160 mg PO per day.	Ziprasidone 160 mg PO per day.
Measure Participants	14	55	80	152
Extremely inconvenient	0 0%	0 0%	0 0%	1 0.4%
Very inconvenient	0 0%	0 0%	1 1.1%	2 0.7%
Inconvenient	1 6.7%	4 7%	6 6.8%	13 4.6%
Somewhat convenient	2 13.3%	12 21.1%	28 31.8%	38 13.3%
Convenient	7 46.7%	25 43.9%	33 37.5%	67 23.5%
Very convenient	2 13.3%	6 10.5%	6 6.8%	20 7%
Extremely convenient	2 13.3%	8 14%	6 6.8%	11 3.9%

41. Post-Hoc Outcome

Title	Number of Participants Answering the Question "Overall, How Confident Are You That Taking This Medication is a Good Thing?": Within SmPC
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Within SmPC; N=participants with evaluable data for specified question at observation

Arm/Group Title	Ziprasidone < 80 mg	Ziprasidone 80 mg to < 120 mg	Ziprasidone 120 mg to < 160 mg	Ziprasidone = 160 mg
Arm/Group Description	Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.	Ziprasidone between 80 mg and < 120 mg PO per day.	Ziprasidone between 120 mg and < 160 mg PO per day.	Ziprasidone 160 mg PO per day.
Measure Participants	14	55	80	152
Not at all confident	0 0%	2 3.5%	2 2.3%	7 2.5%
A little confident	2 13.3%	10 17.5%	9 10.2%	23 8.1%
Somewhat confident	6 40%	20 35.1%	32 36.4%	49 17.2%
Very confident	6 40%	22 38.6%	30 34.1%	57 20%
Extremely confident	0 0%	1 1.8%	7 8%	16 5.6%

42. Post-Hoc Outcome

Title	Number of Participants Answering the Question "How Certain Are You That the Good Things About Your Medication Outweigh the Bad Things?": Within SmPC
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Within SmPC; N=participants with evaluable data for specified question at observation

Arm/Group Title	Ziprasidone < 80 mg	Ziprasidone 80 mg to < 120 mg	Ziprasidone 120 mg to < 160 mg	Ziprasidone = 160 mg
Arm/Group Description	Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.	Ziprasidone between 80 mg and < 120 mg PO per day.	Ziprasidone between 120 mg and < 160 mg PO per day.	Ziprasidone 160 mg PO per day.
Measure Participants	14	55	80	152
Not at all certain	0 0%	1 1.8%	2 2.3%	8 2.8%
A little certain	3 20%	13 22.8%	7 8%	23 8.1%
Somewhat certain	6 40%	21 36.8%	26 29.5%	47 16.5%
Very certain	5 33.3%	19 33.3%	39 44.3%	56 19.6%
Extremely certain	0 0%	1 1.8%	6 6.8%	18 6.3%

43. Post-Hoc Outcome

Title	Number of Participants Answering the Question "Taking All Things Into Account, How Satisfied or Dissatisfied Are You With This Medication?": Within SmPC
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Within SmPC; N=participants with evaluable data for specified question at observation

Arm/Group Title	Ziprasidone < 80 mg	Ziprasidone 80 mg to < 120 mg	Ziprasidone 120 mg to < 160 mg	Ziprasidone = 160 mg
Arm/Group Description	Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.	Ziprasidone between 80 mg and < 120 mg PO per day.	Ziprasidone between 120 mg and < 160 mg PO per day.	Ziprasidone 160 mg PO per day.
Measure Participants	14	55	79	152
Extremely dissatisfied	0 0%	0 0%	0 0%	1 0.4%
Very dissatisfied	0 0%	0 0%	0 0%	2 0.7%
Dissatisfied	1 6.7%	5 8.8%	3 3.4%	10 3.5%
Somewhat satisfied	1 6.7%	19 33.3%	16 18.2%	43 15.1%
Satisfied	7 46.7%	16 28.1%	33 37.5%	47 16.5%
Very satisfied	5 33.3%	15 26.3%	22 25%	37 13%
Extremely satisfied	0 0%	0 0%	5 5.7%	12 4.2%

44. Post-Hoc Outcome

Title	Percent Change From Baseline to Final Visit in Body Weight: Within SmPC
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Within SmPC

Arm/Group Title	Ziprasidone < 80 mg	Ziprasidone 80 mg to < 120 mg	Ziprasidone 120 mg to < 160 mg	Ziprasidone = 160 mg
Arm/Group Description	Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.	Ziprasidone between 80 mg and < 120 mg PO per day.	Ziprasidone between 120 mg and < 160 mg PO per day.	Ziprasidone 160 mg PO per day.
Measure Participants	15	56	83	159
Mean (Standard Deviation) [percent change]	1.2 (5.79)	-0.2 (3.67)	-1.1 (2.75)	-0.0 (4.31)

45. Post-Hoc Outcome

Title	Number of Participants Continuing Treatment With Ziprasidone Following Completion of the Observation Period: Within SmPC
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Within SmPC

Arm/Group Title	Ziprasidone < 80 mg	Ziprasidone 80 mg to < 120 mg	Ziprasidone 120 mg to < 160 mg	Ziprasidone = 160 mg
Arm/Group Description	Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.	Ziprasidone between 80 mg and < 120 mg PO per day.	Ziprasidone between 120 mg and < 160 mg PO per day.	Ziprasidone 160 mg PO per day.
Measure Participants	15	56	83	159
Yes	13 86.7%	55 96.5%	78 88.6%	136 47.7%
No	2 13.3%	1 1.8%	4 4.5%	23 8.1%

Adverse Events

Adverse Event Reporting 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.
Arm/Group Title	Ziprasidone < 80 mg		Ziprasidone 80 mg to < 120 mg		Ziprasidone 120 mg to < 160 mg		Ziprasidone >=160 mg		Ziprasidone Unknown		Within SmPC Ziprasidone < 80 mg		Within SmPC Ziprasidone 80 to < 120 mg		Within SmPC Ziprasidone 120 to < 160 mg		Within SmPC Ziprasidone = 160 mg		Above SmPC Ziprasidone > 160 mg
Arm/Group Description	Ziprasidone up to 80 mg per day.		Ziprasidone between 80 mg and < 120 mg per day.		Ziprasidone between 120 mg and < 160 mg per day.		Ziprasidone 160 mg or greater per day.		Details are unknown.		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.		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.		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.		Within SmPC Ziprasidone = 160 mg; defined as all participants in the FAS population who had PO doses = 160 mg per day.		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.
All Cause Mortality
	Ziprasidone < 80 mg		Ziprasidone 80 mg to < 120 mg		Ziprasidone 120 mg to < 160 mg		Ziprasidone >=160 mg		Ziprasidone Unknown		Within SmPC Ziprasidone < 80 mg		Within SmPC Ziprasidone 80 to < 120 mg		Within SmPC Ziprasidone 120 to < 160 mg		Within SmPC Ziprasidone = 160 mg		Above SmPC Ziprasidone > 160 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Ziprasidone < 80 mg		Ziprasidone 80 mg to < 120 mg		Ziprasidone 120 mg to < 160 mg		Ziprasidone >=160 mg		Ziprasidone Unknown		Within SmPC Ziprasidone < 80 mg		Within SmPC Ziprasidone 80 to < 120 mg		Within SmPC Ziprasidone 120 to < 160 mg		Within SmPC Ziprasidone = 160 mg		Above SmPC Ziprasidone > 160 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/15 (6.7%)		0/57 (0%)		0/88 (0%)		1/285 (0.4%)		0/5 (0%)		1/15 (6.7%)		0/56 (0%)		0/83 (0%)		1/159 (0.6%)		0/128 (0%)
General disorders
Pyrexia	1/15 (6.7%)		0/57 (0%)		0/88 (0%)		0/285 (0%)		0/5 (0%)		1/15 (6.7%)		0/56 (0%)		0/83 (0%)		0/159 (0%)		0/128 (0%)
Injury, poisoning and procedural complications
Fall	0/15 (0%)		0/57 (0%)		0/88 (0%)		1/285 (0.4%)		0/5 (0%)		0/15 (0%)		0/56 (0%)		0/83 (0%)		1/159 (0.6%)		0/128 (0%)
Investigations
Weight decreased	1/15 (6.7%)		0/57 (0%)		0/88 (0%)		0/285 (0%)		0/5 (0%)		1/15 (6.7%)		0/56 (0%)		0/83 (0%)		0/159 (0%)		0/128 (0%)
Other (Not Including Serious) Adverse Events
	Ziprasidone < 80 mg		Ziprasidone 80 mg to < 120 mg		Ziprasidone 120 mg to < 160 mg		Ziprasidone >=160 mg		Ziprasidone Unknown		Within SmPC Ziprasidone < 80 mg		Within SmPC Ziprasidone 80 to < 120 mg		Within SmPC Ziprasidone 120 to < 160 mg		Within SmPC Ziprasidone = 160 mg		Above SmPC Ziprasidone > 160 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/15 (6.7%)		0/57 (0%)		9/88 (10.2%)		34/285 (11.9%)		1/5 (20%)		1/15 (6.7%)		0/56 (0%)		9/83 (10.8%)		19/159 (11.9%)		17/128 (13.3%)
General disorders
Fatigue	0/15 (0%)		0/57 (0%)		2/88 (2.3%)		0/285 (0%)		0/5 (0%)		0/15 (0%)		0/56 (0%)		2/83 (2.4%)		0/159 (0%)		0/128 (0%)
Nervous system disorders
Dizziness	0/15 (0%)		0/57 (0%)		2/88 (2.3%)		9/285 (3.2%)		0/5 (0%)		0/15 (0%)		0/56 (0%)		2/83 (2.4%)		3/159 (1.9%)		6/128 (4.7%)
Extrapyramidal disorder	0/15 (0%)		0/57 (0%)		0/88 (0%)		7/285 (2.5%)		0/5 (0%)		0/15 (0%)		0/56 (0%)		0/83 (0%)		3/159 (1.9%)		4/128 (3.1%)
Somnolence	0/15 (0%)		0/57 (0%)		4/88 (4.5%)		15/285 (5.3%)		1/5 (20%)		0/15 (0%)		0/56 (0%)		4/83 (4.8%)		9/159 (5.7%)		6/128 (4.7%)
Psychomotor hyperactivity	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/15 (0%)		0/56 (0%)		0/83 (0%)		1/159 (0.6%)		3/128 (2.3%)
Psychiatric disorders
Anxiety	1/15 (6.7%)		0/57 (0%)		1/88 (1.1%)		4/285 (1.4%)		0/5 (0%)		1/15 (6.7%)		0/56 (0%)		1/83 (1.2%)		3/159 (1.9%)		0/128 (0%)
Stress	1/15 (6.7%)		0/57 (0%)		0/88 (0%)		0/285 (0%)		0/5 (0%)		1/15 (6.7%)		0/56 (0%)		0/83 (0%)		0/159 (0%)		0/128 (0%)

Limitations/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).

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.