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Investigation of the impact of Zeldox on metabolic parametres in patients with bipolar disorder or with schizophrenia and impact of the treatment for the quality of life
observational survey consecutive patient sampling
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| schizophrenic | patients with schizophrenia |
| |
| bipolar disorder | patients with bipolar disorder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| no intervention | Other | no intervention |
| |
| no intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression of Severity (CGI-S) Scores (Bipolar Population) | CGI-S assesses the severity of the condition at baseline using a scale that ranges from (1)Normal, not ill at all to (7) Among the most severely ill patients. | Baseline |
| Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Mental Health? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction. | Baseline and final visit (week 12) |
| Young Mania Rating Scale (YMRS) Scores (Bipolar Population): Change From Baseline | The YMRS is an 11-item questionnaire that rates the severity of bipolar disorder, with higher score indicating greater severity of disease. Change: score at final visit minus score at baseline. | Baseline to final visit (12 weeks) |
| Montgomery Asberg Depression Rating Scale (MADRS) Scores (Bipolar Population): Change From Baseline | MADRS measures treatment effect on depression severity. MADRS assesses apparent and reported sadness, inner tension, sleep, appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Higher score indicates greater severity of disease. Change: score at final visit minus score at baseline. | Baseline to final visit (12 weeks) |
| Clinical Global Impressions Change (CGI-C) Scores (Bipolar Population) | CGI-C assesses change in severity of the conditionusing a scale that ranges from (1) very much improved to (7) very much worse. Higher score indicates increasing severity of disease. | Final visit (week 12) |
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Inclusion Criteria:
Manic and mixed episodes of up to moderate severity in patients with type I and II bipolar disorder and schizophrenia; either first diagnosed or repeated episodes.
Exclusion Criteria:
Patients with a history of hypersenzitivity to Ziprasidone. Previous insufficiency of the Ziprasidone´s treatment. The break of the previous therapeutic condition.
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psychiatric outpatients
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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Subjects enrolled had to have taken at least 1 dose of 40, 60, or 80 milligrams of ziprasidone. The study included subjects with diagnosed Type I or II bipolar disorder with manic and mixed episodes (n=223) and subjects with schizophrenia of up to moderate severity, either first diagnosed or repeated episodes (n=248).
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| ID | Title | Description |
|---|---|---|
| FG000 | Ziprasidone | Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ziprasidone | Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 | Clinical Global Impression of Severity (CGI-S) Scores (Bipolar Population) | CGI-S assesses the severity of the condition at baseline using a scale that ranges from (1)Normal, not ill at all to (7) Among the most severely ill patients. | The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication. | Posted | Number | Participants | Baseline |
|
|
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ziprasidone | Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia | General disorders | MedDRA11.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
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| Other |
no intervention |
|
| Clinical Global Impressions Change (CGI-C) Scores (Schizoprenia Population) | CGI-C assesses change in severity of the conditionusing a scale that ranges from (1) very much improved to (7) very much worse. Higher score indicates increasing severity of disease. | Final visit (week 12) |
| Brief Psychiatric Rating Scale (BPRS) Scores (Schizophrenia Population): Change From Baseline | BPRS is an 18-item scale with 11 general symptom items, 5 positive-symptom items, and 2 negative symptom items. The physician completes the BPRS, and each item is scored on a 7-point scale, with higher score indicating greater severity of symptom. Change: score at final visit minus score at baseline. | Baseline to final visit (week 12) |
| Extrapyramidal Symptom (EPS) Scores (Schizophrenia Population: Baseline and Final Visit | EPS assesses 4 items: akathisia, dystonia, dyskinesia, and parkinsonism. Each item is scored on a 5-point severity scale ranging from 1 to 5, with higher score indicating greater severity of symptom. Change: score at final visit minus score at baseline. | Baseline and final visit (week 12) |
| Global Efficacy Evaluation Scores (Bipolar Population) | The Global Efficacy Evaluation assesses the final efficacy of ziprasidone on bipolar symptoms using a 5-point scale that ranges from very good to worsening of the original disease. | Final visit (week 12) |
| Global Efficacy Evaluation Scores (Schizophrenia Population) | The Global Efficacy Evaluation assesses the final efficacy of ziprasidone on schizophrenia symptoms using a 5-point scale that ranges from very good to worsening of the original disease. | Final visit (week 12) |
| Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Life as a Whole Today? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction. | Baseline and final visit (week 12) |
| Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Job? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction. | Baseline and final visit (week 12) |
| Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Financial Situation? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction. | Baseline and final visit (week 12) |
| Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: Do You Have Anyone You Would Call a Close Friend? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction. | Baseline and final visit (week 12) |
| Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: In the Last Week Have You Seen a Friend? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction. | Baseline and final visit (week 12) |
| Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the Number and Quality of Your Friendships? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction. | Baseline and final visit (week 12) |
| Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Accomodation? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction. | Baseline and final visit (week 12) |
| Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Leisure Activities? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction. | Baseline and final visit (week 12) |
| Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: In the Past Year Have You Been Accused of a Crime? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction. | Baseline and final visit (week 12) |
| Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: In the Past Year, Have You Been a Victim of Physical Violence? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction. | Baseline and final visit (week 12) |
| Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Personal Safety? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction. | Baseline and final visit (week 12) |
| Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the People You Live With? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction. | Baseline and final visit (week 12) |
| Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Sex Life? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction. | Baseline and final visit (week 12) |
| Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction. | Baseline and final visit (week 12) |
| Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Health? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction. | Baseline and final visit (week 12) |
| Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Mental Health? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction. | Baseline and final visit (week 12) |
| Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Life as a Whole Today? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction. | Baseline and final visit (week 12) |
| Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Job? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction. | Baseline and final visit (week 12) |
| Manchester Short Assessment of Quality of Life (MANSA) Scores(Schizophrenia Population) in Answer to: How Satisfied Are You With Your Financial Situation? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction. | Baseline and final visit (week 12) |
| Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: Do You Have Anyone You Would Call a Close Friend? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction. | Baseline and final visit (week 12) |
| Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: In the Last Week Have You Seen a Friend? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction. | Baseline and final visit (week 12) |
| Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the Number and Quality of Your Friendships? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction. | Baseline and final visit (week 12) |
| Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Leisure Activities? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction. | Baseline and final visit (week 12) |
| Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Accomodation? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction. | Baseline and final visit (week 12) |
| Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: In the Past Year, Have You Been Accused of a Crime? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction. | Baseline and final visit |
| Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: In the Past Year, Have You Been a Victim of Physical Violence? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction. | Baseline and final visit (week 12) |
| Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Personal Safety? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction. | Baseline and final visit (week 12) |
| Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the People You Live With? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction. | Baseline and final visit (week 12) |
| Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Sex Life? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction. | Baseline and final visit (week 12) |
| Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction. | Baseline and final visit (week 12) |
| Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Health? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction. | Baseline to final visit (week 12) |
| Clinical Global Impression of Severity (CGI-S) Scores (Schizophrenia Population) | CGI-S assesses the severity of the condition at baseline using a scale that ranges from (1)Normal, not ill at all to (7) Among the most severely ill patients. | Baseline |
| Lost to Follow-up |
|
| Subject's untimely distrust of medicine |
|
| Participants |
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| Sex/Gender, Customized | Count of Participants | Participants |
|
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|
| Primary | Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Mental Health? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction. | The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure. | Posted | Number | Participants | Baseline and final visit (week 12) |
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| Primary | Young Mania Rating Scale (YMRS) Scores (Bipolar Population): Change From Baseline | The YMRS is an 11-item questionnaire that rates the severity of bipolar disorder, with higher score indicating greater severity of disease. Change: score at final visit minus score at baseline. | The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication. If the final visit measurement was missing, the follow-up measurement could be carried forward. If any individual item was missing, the total score was set to missing. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Score on scale | Baseline to final visit (12 weeks) |
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| Primary | Montgomery Asberg Depression Rating Scale (MADRS) Scores (Bipolar Population): Change From Baseline | MADRS measures treatment effect on depression severity. MADRS assesses apparent and reported sadness, inner tension, sleep, appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Higher score indicates greater severity of disease. Change: score at final visit minus score at baseline. | The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication. If any individual item was missing, the total score was set to missing. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Score on scale | Baseline to final visit (12 weeks) |
|
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| Primary | Clinical Global Impressions Change (CGI-C) Scores (Bipolar Population) | CGI-C assesses change in severity of the conditionusing a scale that ranges from (1) very much improved to (7) very much worse. Higher score indicates increasing severity of disease. | The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication. | Posted | Number | Participants | Final visit (week 12) |
|
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|
| Primary | Clinical Global Impressions Change (CGI-C) Scores (Schizoprenia Population) | CGI-C assesses change in severity of the conditionusing a scale that ranges from (1) very much improved to (7) very much worse. Higher score indicates increasing severity of disease. | The schizophrenia full analysis set included all subjects who had been diagnosed with schizophrenia and had received at least 1 dose of study medication. | Posted | Number | Participants | Final visit (week 12) |
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| Primary | Brief Psychiatric Rating Scale (BPRS) Scores (Schizophrenia Population): Change From Baseline | BPRS is an 18-item scale with 11 general symptom items, 5 positive-symptom items, and 2 negative symptom items. The physician completes the BPRS, and each item is scored on a 7-point scale, with higher score indicating greater severity of symptom. Change: score at final visit minus score at baseline. | The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication. If any individual item was missing, the total score was set to missing. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Score on scale | Baseline to final visit (week 12) |
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| Primary | Extrapyramidal Symptom (EPS) Scores (Schizophrenia Population: Baseline and Final Visit | EPS assesses 4 items: akathisia, dystonia, dyskinesia, and parkinsonism. Each item is scored on a 5-point severity scale ranging from 1 to 5, with higher score indicating greater severity of symptom. Change: score at final visit minus score at baseline. | The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication. If any individual item was missing, the total score was set to missing. | Posted | Mean | Standard Deviation | Score on scale | Baseline and final visit (week 12) |
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| Primary | Global Efficacy Evaluation Scores (Bipolar Population) | The Global Efficacy Evaluation assesses the final efficacy of ziprasidone on bipolar symptoms using a 5-point scale that ranges from very good to worsening of the original disease. | The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication. | Posted | Number | Participants | Final visit (week 12) |
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| Primary | Global Efficacy Evaluation Scores (Schizophrenia Population) | The Global Efficacy Evaluation assesses the final efficacy of ziprasidone on schizophrenia symptoms using a 5-point scale that ranges from very good to worsening of the original disease. | The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication. | Posted | Number | Participants | Final visit (week 12) |
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| Primary | Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Life as a Whole Today? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction. | The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication. | Posted | Number | Participants | Baseline and final visit (week 12) |
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| Primary | Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Job? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction. | The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication. | Posted | Number | Participants | Baseline and final visit (week 12) |
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| Primary | Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Financial Situation? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction. | The bipolar full analysis set included all subjects who had been diagnosed with bipolar mania and had received at least 1 dose of study medication. | Posted | Number | Participants | Baseline and final visit (week 12) |
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| Primary | Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: Do You Have Anyone You Would Call a Close Friend? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction. | The bipolar full analysis set included all subjects who had been diagnosed with bipolar mania and had received at least 1 dose of study medication. | Posted | Number | Participants | Baseline and final visit (week 12) |
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| Primary | Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: In the Last Week Have You Seen a Friend? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction. | The bipolar full analysis set included all subjects who had been diagnosed with bipolar mania and had received at least 1 dose of study medication. | Posted | Number | Participants | Baseline and final visit (week 12) |
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| Primary | Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the Number and Quality of Your Friendships? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction. | The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication | Posted | Number | Participants | Baseline and final visit (week 12) |
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| Primary | Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Accomodation? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction. | The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication. | Posted | Number | Participants | Baseline and final visit (week 12) |
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| Primary | Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Leisure Activities? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction. | The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication. | Posted | Number | Participants | Baseline and final visit (week 12) |
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| Primary | Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: In the Past Year Have You Been Accused of a Crime? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction. | The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication. | Posted | Number | Participants | Baseline and final visit (week 12) |
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| Primary | Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: In the Past Year, Have You Been a Victim of Physical Violence? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction. | The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication. | Posted | Number | Participants | Baseline and final visit (week 12) |
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| Primary | Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Personal Safety? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction. | The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication. | Posted | Number | Participants | Baseline and final visit (week 12) |
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| Primary | Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the People You Live With? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction. | The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication | Posted | Number | Participants | Baseline and final visit (week 12) |
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| Primary | Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Sex Life? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction. | The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication. | Posted | Number | Participants | Baseline and final visit (week 12) |
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| Primary | Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction. | The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication. | Posted | Number | Participants | Baseline and final visit (week 12) |
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| Primary | Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Health? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction. | The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication. | Posted | Number | Participants | Baseline and final visit (week 12) |
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|
| Primary | Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Mental Health? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction. | The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication. | Posted | Number | Participants | Baseline and final visit (week 12) |
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|
| Primary | Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Life as a Whole Today? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction. | The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication. | Posted | Number | Participants | Baseline and final visit (week 12) |
|
|
|
| Primary | Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Job? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction. | The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication. | Posted | Number | Participants | Baseline and final visit (week 12) |
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|
|
| Primary | Manchester Short Assessment of Quality of Life (MANSA) Scores(Schizophrenia Population) in Answer to: How Satisfied Are You With Your Financial Situation? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction. | The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication. | Posted | Number | Participants | Baseline and final visit (week 12) |
|
|
|
| Primary | Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: Do You Have Anyone You Would Call a Close Friend? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction. | The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication. | Posted | Number | Participants | Baseline and final visit (week 12) |
|
|
|
| Primary | Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: In the Last Week Have You Seen a Friend? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction. | The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication. | Posted | Number | Participants | Baseline and final visit (week 12) |
|
|
|
| Primary | Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the Number and Quality of Your Friendships? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction. | The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication. | Posted | Number | Participants | Baseline and final visit (week 12) |
|
|
|
| Primary | Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Leisure Activities? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction. | The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication. | Posted | Number | Participants | Baseline and final visit (week 12) |
|
|
|
| Primary | Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Accomodation? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction. | The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication. | Posted | Number | Participants | Baseline and final visit (week 12) |
|
|
|
| Primary | Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: In the Past Year, Have You Been Accused of a Crime? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction. | The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication. | Posted | Number | Participants | Baseline and final visit |
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|
|
| Primary | Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: In the Past Year, Have You Been a Victim of Physical Violence? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction. | The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication. | Posted | Number | Participants | Baseline and final visit (week 12) |
|
|
|
| Primary | Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Personal Safety? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction. | The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication. | Posted | Number | Participants | Baseline and final visit (week 12) |
|
|
|
| Primary | Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the People You Live With? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction. | The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication. | Posted | Number | Participants | Baseline and final visit (week 12) |
|
|
|
| Primary | Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Sex Life? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction. | The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia and who had received at least 1 dose of study medication. | Posted | Number | Participants | Baseline and final visit (week 12) |
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|
| Primary | Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction. | The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication. | Posted | Number | Participants | Baseline and final visit (week 12) |
|
|
|
| Primary | Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Health? | MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction. | The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication. | Posted | Number | Participants | Baseline to final visit (week 12) |
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|
| Primary | Clinical Global Impression of Severity (CGI-S) Scores (Schizophrenia Population) | CGI-S assesses the severity of the condition at baseline using a scale that ranges from (1)Normal, not ill at all to (7) Among the most severely ill patients. | The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication | Posted | Number | Participants | Baseline |
|
|
|
| 0 |
| 471 |
| 15 |
| 471 |
| Condition aggrevated | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Ill-defined disorder | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Akathisia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dyskinesia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Extrapyramidal disorder | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Parkinsonism | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Sedation | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
|
| Baseline: Mostly dissatisfied |
|
|
| Baseline: Mixed |
|
|
| Baseline: Mostly satisfied |
|
|
| Baseline: Pleased |
|
|
| Baseline: Could not be better |
|
|
| Baseline: Missing |
|
|
| Final: Could not be worse |
|
|
| Final: Displeased |
|
|
| Final: Mostly dissatisfied |
|
|
| Final: Mixed |
|
|
| Final: Mostly satisfied |
|
|
| Final: Pleased |
|
|
| Final: Could not be better |
|
|
| Final: Missing |
|
|
|
| Change from baseline |
|
|
|
| Change from baseline |
|
|
| Title | Measurements |
|---|---|
|
| (4) No change |
|
| (5) Minimally worse |
|
| (6) Much worse |
|
| (7) Very much worse |
|
| Missing |
|
| Title | Measurements |
|---|---|
|
| (4) No change |
|
| (5) Minimally worse |
|
| (6) Much worse |
|
| (7) Very much worse |
|
| Missing |
|
|
| Change from baseline |
|
|
|
| Title | Measurements |
|---|
|
| Poor |
|
| Worsening of the original disease |
|
| Missing |
|
| Title | Measurements |
|---|
|
| Poor |
|
| Worsening of the original disease |
|
| Missing |
|
| Title | Measurements |
|---|---|
|
| Baseline: Mixed |
|
| Baseline: Mostly satisfied |
|
| Baseline: Pleased |
|
| Baseline: Could not be better |
|
| Baseline: Missing |
|
| Final: Could not be worse |
|
| Final: Displeased |
|
| Final: Mostly dissatisfied |
|
| Final: Mixed |
|
| Final: Mostly satisfied |
|
| Final: Pleased |
|
| Final: Could not be better |
|
| Final: Missing |
|
| Title | Measurements |
|---|---|
|
| Baseline: Mixed |
|
| Baseline: Mostly satisfied |
|
| Baseline: Pleased |
|
| Baseline: Could not be better |
|
| Baseline: Missing |
|
| Final: Could not be worse |
|
| Final: Displeased |
|
| Final: Mostly dissatisfied |
|
| Final: Mixed |
|
| Final: Mostly satisfied |
|
| Final: Pleased |
|
| Final: Could not be better |
|
| Final: Missing |
|
| Title | Measurements |
|---|---|
|
| Baseline: Mixed |
|
| Baseline: Mostly satisfied |
|
| Baseline: Pleased |
|
| Baseline: Could not be better |
|
| Baseline: Missing |
|
| Final: Could not be worse |
|
| Final: Displeased |
|
| Final: Mostly dissatisfied |
|
| Final: Mixed |
|
| Final: Mostly satisfied |
|
| Final: Pleased |
|
| Final: Could not be better |
|
| Final: Missing |
|
| Title | Measurements |
|---|---|
|
| Final: Yes |
|
| Final: No |
|
| Final: Missing |
|
| Title | Measurements |
|---|---|
|
| Final: Yes |
|
| Final: No |
|
| Final: Missing |
|
| Title | Measurements |
|---|---|
|
| Baseline: Mixed |
|
| Baseline: Mostly satisfied |
|
| Baseline: Pleased |
|
| Baseline: Could not be better |
|
| Baseline: Missing |
|
| Final: Could not be worse |
|
| Final: Displeased |
|
| Final: Mostly dissatisfied |
|
| Final: Mixed |
|
| Final: Mostly satisfied |
|
| Final: Pleased |
|
| Final: Could not be better |
|
| Final: Missing |
|
| Title | Measurements |
|---|---|
|
| Baseline: Mixed |
|
| Baseline: Mostly satisfied |
|
| Baseline: Pleased |
|
| Baseline: Could not be better |
|
| Baseline: Missing |
|
| Final: Could not be worse |
|
| Final: Displeased |
|
| Final: Mostly dissatisfied |
|
| Final: Mixed |
|
| Final: Mostly satisfied |
|
| Final: Pleased |
|
| Final: Could not be better |
|
| Final: Missing |
|
| Title | Measurements |
|---|---|
|
| Baseline: Mixed |
|
| Baseline: Mostly satisfied |
|
| Baseline: Pleased |
|
| Baseline: Could not be better |
|
| Baseline: Missing |
|
| Final: Could not be worse |
|
| Final: Displeased |
|
| Final: Mostly dissatisfied |
|
| Final: Mixed |
|
| Final: Mostly satisfied |
|
| Final: Pleased |
|
| Final: Could not be better |
|
| Final: Missing |
|
| Title | Measurements |
|---|---|
|
| Final: Yes |
|
| Final: No |
|
| Final: Missing |
|
| Title | Measurements |
|---|---|
|
| Final: Yes |
|
| Final: No |
|
| Final: Missing |
|
| Title | Measurements |
|---|---|
|
| Baseline: Mixed |
|
| Baseline: Mostly satisfied |
|
| Baseline: Pleased |
|
| Baseline: Could not be better |
|
| Baseline: Missing |
|
| Final: Could not be worse |
|
| Final: Displeased |
|
| Final: Mostly dissatisfied |
|
| Final: Mixed |
|
| Final: Mostly satisfied |
|
| Final: Pleased |
|
| Final: Could not be better |
|
| Final: Missing |
|
| Title | Measurements |
|---|---|
|
| Baseline: Mixed |
|
| Baseline: Mostly satisfied |
|
| Baseline: Pleased |
|
| Baseline: Could not be better |
|
| Baseline: Missing |
|
| Final: Could not be worse |
|
| Final: Displeased |
|
| Final: Mostly dissatisfied |
|
| Final: Mixed |
|
| Final: Mostly satisfied |
|
| Final: Pleased |
|
| Final: Could not be better |
|
| Final: Missing |
|
| Title | Measurements |
|---|---|
|
| Baseline: Mixed |
|
| Baseline: Mostly satisfied |
|
| Baseline: Pleased |
|
| Baseline: Could not be better |
|
| Baseline: Missing |
|
| Final: Could not be worse |
|
| Final: Displeased |
|
| Final: Mostly dissatisfied |
|
| Final: Mixed |
|
| Final: Mostly satisfied |
|
| Final: Pleased |
|
| Final: Could not be better |
|
| Final: Missing |
|
| Title | Measurements |
|---|---|
|
| Baseline: Mixed |
|
| Baseline: Mostly satisfied |
|
| Baseline: Pleased |
|
| Baseline: Could not be better |
|
| Baseline: Missing |
|
| Final: Could not be worse |
|
| Final: Displeased |
|
| Final: Mostly dissatisfied |
|
| Final: Mixed |
|
| Final: Mostly satisfied |
|
| Final: Pleased |
|
| Final: Could not be better |
|
| Final: Missing |
|
| Title | Measurements |
|---|---|
|
| Baseline: Mixed |
|
| Baseline: Mostly satisfied |
|
| Baseline: Pleased |
|
| Baseline: Could not be better |
|
| Baseline: Missing |
|
| Final: Could not be worse |
|
| Final: Displeased |
|
| Final: Mostly dissatisfied |
|
| Final: Mixed |
|
| Final: Mostly satisfied |
|
| Final: Pleased |
|
| Final: Could not be better |
|
| Final: Missing |
|
| Title | Measurements |
|---|---|
|
| Baseline: Mixed |
|
| Baseline: Mostly satisfied |
|
| Baseline: Pleased |
|
| Baseline: Could not be better |
|
| Baseline: Missing |
|
| Final: Could not be worse |
|
| Final: Displeased |
|
| Final: Mostly dissatisfied |
|
| Final: Mixed |
|
| Final: Mostly satisfied |
|
| Final: Pleased |
|
| Final: Could not be better |
|
| Final: Missing |
|
| Title | Measurements |
|---|---|
|
| Baseline: Mixed |
|
| Baseline: Mostly satisfied |
|
| Baseline: Pleased |
|
| Baseline: Could not be better |
|
| Baseline: Missing |
|
| Final: Could not be worse |
|
| Final: Displeased |
|
| Final: Mostly dissatisfied |
|
| Final: Mixed |
|
| Final: Mostly satisfied |
|
| Final: Pleased |
|
| Final: Could not be better |
|
| Final: Missing |
|
| Title | Measurements |
|---|---|
|
| Baseline: Mixed |
|
| Baseline: Mostly satisfied |
|
| Baseline: Pleased |
|
| Baseline: Could not be better |
|
| Baseline: Missing |
|
| Final: Could not be worse |
|
| Final: Displeased |
|
| Final: Mostly dissatisfied |
|
| Final: Mixed |
|
| Final: Mostly satisfied |
|
| Final: Pleased |
|
| Final: Could not be better |
|
| Final: Missing |
|
| Title | Measurements |
|---|---|
|
| Baseline: Mixed |
|
| Baseline: Mostly satisfied |
|
| Baseline: Pleased |
|
| Baseline: Could not be better |
|
| Baseline: Missing |
|
| Final: Could not be worse |
|
| Final: Displeased |
|
| Final: Mostly dissatisfied |
|
| Final: Mixed |
|
| Final: Mostly satisfied |
|
| Final: Pleased |
|
| Final: Could not be better |
|
| Final: Missing |
|
| Title | Measurements |
|---|---|
|
| Final: Yes |
|
| Final: No |
|
| Final: Missing |
|
| Title | Measurements |
|---|---|
|
| Final: Yes |
|
| Final: No |
|
| Final: Missing |
|
| Title | Measurements |
|---|---|
|
| Baseline: Mixed |
|
| Baseline: Mostly satisfied |
|
| Baseline: Pleased |
|
| Baseline: Could not be better |
|
| Baseline: Missing |
|
| Final: Could not be worse |
|
| Final: Displeased |
|
| Final: Mostly dissatisfied |
|
| Final: Mixed |
|
| Final: Mostly satisfied |
|
| Final: Pleased |
|
| Final: Could not be better |
|
| Final: Missing |
|
| Title | Measurements |
|---|---|
|
| Baseline: Mixed |
|
| Baseline: Mostly satisfied |
|
| Baseline: Pleased |
|
| Baseline: Could not be better |
|
| Baseline: Missing |
|
| Final: Could not be worse |
|
| Final: Displeased |
|
| Final: Mostly dissatisfied |
|
| Final: Mixed |
|
| Final: Mostly satisfied |
|
| Final: Pleased |
|
| Final: Could not be better |
|
| Final: Missing |
|
| Title | Measurements |
|---|---|
|
| Baseline: Mixed |
|
| Baseline: Mostly satisfied |
|
| Baseline: Pleased |
|
| Baseline: Could not be better |
|
| Baseline: Missing |
|
| Final: Could not be worse |
|
| Final: Displeased |
|
| Final: Mostly dissatisfied |
|
| Final: Mixed |
|
| Final: Mostly satisfied |
|
| Final: Pleased |
|
| Final: Could not be better |
|
| Final: Missing |
|
| Title | Measurements |
|---|---|
|
| Final: Yes |
|
| Final: No |
|
| Final: Missing |
|
| Title | Measurements |
|---|---|
|
| Final: Yes |
|
| Final: No |
|
| Final: Missing |
|
| Title | Measurements |
|---|---|
|
| Baseline: Mixed |
|
| Baseline: Mostly satisfied |
|
| Baseline: Pleased |
|
| Baseline: Could not be better |
|
| Baseline: Missing |
|
| Final: Could not be worse |
|
| Final: Displeased |
|
| Final: Mostly dissatisfied |
|
| Final: Mixed |
|
| Final: Mostly satisfied |
|
| Final: Pleased |
|
| Final: Could not be better |
|
| Final: Missing |
|
| Title | Measurements |
|---|---|
|
| Baseline: Mixed |
|
| Baseline: Mostly satisfied |
|
| Baseline: Pleased |
|
| Baseline: Could not be better |
|
| Baseline: Missing |
|
| Final: Could not be worse |
|
| Final: Displeased |
|
| Final: Mostly dissatisfied |
|
| Final: Mixed |
|
| Final: Mostly satisfied |
|
| Final: Pleased |
|
| Final: Could not be better |
|
| Final: Missing |
|
| Title | Measurements |
|---|---|
|
| Baseline: Mixed |
|
| Baseline: Mostly satisfied |
|
| Baseline: Pleased |
|
| Baseline: Could not be better |
|
| Baseline: Missing |
|
| Final: Could not be worse |
|
| Final: Displeased |
|
| Final: Mostly dissatisfied |
|
| Final: Mixed |
|
| Final: Mostly satisfied |
|
| Final: Pleased |
|
| Final: Could not be better |
|
| Final: Missing |
|
| Title | Measurements |
|---|---|
|
| Baseline: Mixed |
|
| Baseline: Mostly satisfied |
|
| Baseline: Pleased |
|
| Baseline: Could not be better |
|
| Baseline: Missing |
|
| Final: Could not be worse |
|
| Final: Displeased |
|
| Final: Mostly dissatisfied |
|
| Final: Mixed |
|
| Final: Mostly satisfied |
|
| Final: Pleased |
|
| Final: Could not be better |
|
| Final: Missing |
|
| Title | Measurements |
|---|---|
|
| Baseline: Mixed |
|
| Baseline: Mostly satisfied |
|
| Baseline: Pleased |
|
| Baseline: Could not be better |
|
| Baseline: Missing |
|
| Final: Could not be worse |
|
| Final: Displeased |
|
| Final: Mostly dissatisfied |
|
| Final: Mixed |
|
| Final: Mostly satisfied |
|
| Final: Pleased |
|
| Final: Could not be better |
|
| Final: Missing |
|
| Title | Measurements |
|---|---|
|
| (4) Moderately ill |
|
| (5) Absolutely clearly ill |
|
| (6) Severely ill |
|
| (7) Among the most severely ill subjects |
|
| Missing |
|