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| ID | Type | Description | Link |
|---|---|---|---|
| D1441C00089 |
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This Phase IV, randomized, parallel-group study is designed to evaluate the cataractogenic potential of quetiapine fumarate (SEROQUEL) compared with that of a putative non-cataractogenic antipsychotic medication risperidone (RISPERDAL). This study is being conducted to fulfill the SEROQUEL Phase IV commitment regarding evaluation of cataractogenic potential.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Quetiapine fumarate |
|
| 2 | Active Comparator | Risperidone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| quetiapine fumarate | Drug | flexible dose oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence of a Cortical (C) Type of Cataractogenic Potential Events in Participants as Assessed and Agreed by 2 Independent, Treatment-masked Ophthalmologists Using the Lens Opacities Classification System II (LOCS II ) Grading Scale | Presence of C type of cataractogenic potential event in participant was defined if any LOCS II grades of 2, 3, 4, 5 (with any grade of 0, trace,1 at randomization) assessed and agreed by 2 independent, treatment-masked ophthalmologists at any post-randomization assessment in one or both eyes. 0= no cataract; 5 is worst. There are no subscales. 0 is the best, 5 is the worst. | Randomization to Month 24 |
| Presence of a Nuclear Opalescence (N) Type of Cataractogenic Potential Events in Participants as Assessed and Agreed by 2 Independent, Treatment-masked Ophthalmologists Using the LOCS II Grading Scale | Presence of N type of cataractogenic potential event in Participants was defined if any LOCS II grades of 2, 3, 4 (with grade at rand equals 0,1), or if the LOCS II grades of 3,or 4 (with grade at randomization=2) assessed and agreed by 2 independent, treatment-masked ophthalmologists at any post-randomization assessment in one or both eyes. 0 is the best, 4 is the worst. | Randomization to Month 24 |
| Presence of a Posterior Subcapsular (P) Type Cataractogenic Potential Events in Participants as Assessed and Agreed by 2 Independent, Treatment-masked Ophthalmologists Using the LOCS II Grading Scale | Presence of P type of cataractogenic potential event in participant was defined if any LOCS II grades of 1, 2, 3 , 4 (with grade=0 at randomization) assessed and agreed by 2 independent, treatment-masked ophthalmologists at any post-randomization assessment in one or both eyes. 0 is the best, 4 is the worst. | Randomization to Month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Positive and Negative Syndrome Scale (PANSS) Total Score | PANSS total score equals sum of the 30-items scores (range: 30-210). Each item has ( 1-7 units), 1 indicates "absent" psychosis symptom, and 7 - "extreme" symptom degree. Change in PANSS total score : total score at month 24 minus total score at randomization.Alleviation of psychotic symptoms are indicated by a negative change in PANSS total score. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca Seroquel Medical Science Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Little Rock | Arkansas | United States | |||
| Research Site |
Screening for eligibility and must be cross-tapered off of all previous antipsychotic medications
A 24-month, multi-center, evaluator masked (ophthalmologist), open-label, flexible-dose, parallel-group study, 82 sites recruited Sept 2003 through Oct 2008. In total 1099 participants were randomized by Interactive Voice Response System (IVRS). One excluded participant was randomized before the rand visit, and never returned to any study visits.
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| ID | Title | Description |
|---|---|---|
| FG000 | Quetiapine Fumarate | Quetiapine fumarate - flexibly dosed (200 - 800 mg/day) |
| FG001 | Risperidone | Risperidone - flexibly dosed (2 - 8 mg/day) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| risperidone | Drug | flexible dose oral |
|
| Randomization to Month 24 |
| Change in the PANSS Positive Subscale Score | PANSS Positive subscale score equals sum of the 7-items scores(range:7-49). Each item has ( 1-7 units), 1 indicates "absent" psychosis symptom, and 7 - "extreme" symptom degree. | Randomization to Month 24 |
| Change in the PANSS Negative Subscale Score | PANSS Negative subscale score equals sum of the 7-items scores(range:7-49). Each item has ( 1-7 units), 1 indicates "absent" psychosis symptom, and 7 - "extreme" symptom degree. Change in PANSS Negative subscale score:score at month 24 minus score at randomization. Alleviation of negative psychotic symptoms are indicated by a negative change score. | Randomization to Month 24 |
| Change in the PANSS Psychopathology Subscale Score | PANSS psychopathology subscale score equals sum of the 16-items scores(range:16-112). Each item has ( 1-7 units),1= "absent" psychosis symptom, 7= "extreme" symptom degree.Change in PANSS psychopathology subscale:score at month 24 minus score at randomization. Alleviation of general psychopathology symptoms are indicated by a negative change score. | Randomization to Month 24 |
| Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score | CGI-S score is accessed on a seven-graded scale ranging from most extremely ill/ very much worse (7) to normal/very much improved (1) , 1 is best. Change : score at month 24 minus score at randomization. | Randomization to Month 24 |
| Change in Health-related Quality of Life as Measured by Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q SF) Total Score | Q-LES-Q total score is the sum of the 16 times of Q-LES-Q SF(range:16-80).Each item has a 5 point satisfaction level scale:from 1=very poor(worst value) to 5=very good(best).Larger values indicate a higher perceived quality of life enjoyment and satisfaction.Change in Q-LES-Q total score:total score at month 24 minus total score at randomization | Randomization to Month 24 |
| Change in Personal Evaluation of Transitions in Treatment (PETiT) Total Score | PETiT total score is the sum of the 30 items of PETiT questionnaire(range:0-60) on subjects perceived well-being, adherence, tolerability, satisfaction with treatment. Each item is rated by participant with a 3 point frequency scale:2=often, 1=sometimes, 0=never.Change in PETiT total score: total score at month 24 minus total score at randomization | Randomization to Month 24 |
| Number of Relapses of Schizophrenia or Schizoaffective Disorder | Relapse is defined as a hospital stay for psychiatric symptoms or a 2-point increase from baseline in the CGI severity score. CGI-S score ranges from 0-7 with 0 = Not Assessed, 1 = Normal, not at all and 7 = Among the most extremely ill subjects. | At Month 24 |
| Change in Simpson-Angus Scale (SAS) Total Score | SAS total score is the sum of the 10 individual-item scores (range:0-40), with the score for each item ranging from 0 to 4, higher scores indicate greater severity of Parkinsonian symptoms. Change : total score at month 24 minus total score at randomization. Increase in Change of total score indicates an increase in extrapyramidal motor symptoms. | Randomization to Month 24 |
| Change in Barnes Akathisia Rating Scale (BARS) Global Score | BARS global score is the 4th individual-item score on the BARS scale, the Global Assessment of Akathisia, with the score ranging from 0 (no evidence of akathisia) to 5 (severe akathisia). Change : score at month 24 minus score at randomization. Increase in Change of BARS global score indicates an increase in akathisia. | Randomization to Month 24 |
| Change in Abnormal Involuntary Movement Scale (AIMS) Total Score | AIMS total score is the sum of the 10 individual-item scores(range:0-40), with the score for each item ranging from 0 to 4. Change : total score at month 24 minus total score at randomization. Increase in Change of total score indicates an increase in abnormal voluntary movements. The lower score means lower intensity of abnormal voluntary Movements. 0 is best, 4 is worst. Increase in Change of total score indicates an increase in abnormal voluntary Movements. | Randomization to Month 24 |
| Number of Participants With Potential Extrapyramidal Symptoms (EPS) | Number of participants with adverse events potentially associated with EPS collected by MedDRA Preferred Terms as akathisia, bradykinesia, drooling, dyskinesia, dystonia, extrapyramidal disorder, grimacing, muscle rigidity, parkinsonism, restlessness, tardive dyskinesia, tremor | From start of the study treatment to last dose plus 30 days |
| Mabelvale |
| Arkansas |
| United States |
| Research Site | Morrilton | Arkansas | United States |
| Research Site | Anaheim | California | United States |
| Research Site | Cerritos | California | United States |
| Research Site | Chula Vista | California | United States |
| Research Site | Garden Grove | California | United States |
| Research Site | Long Beach | California | United States |
| Research Site | Los Angeles | California | United States |
| Research Site | Orange | California | United States |
| Research Site | San Diego | California | United States |
| Research Site | San Marcos | California | United States |
| Research Site | Denver | Colorado | United States |
| Research Site | New Britian | Connecticut | United States |
| Research Site | Boca Raton | Florida | United States |
| Research Site | Boynton Beach | Florida | United States |
| Research Site | Deerfield Beach | Florida | United States |
| Research Site | Fort Lauderdale | Florida | United States |
| Research Site | Orlando | Florida | United States |
| Research Site | Pompano Beach | Florida | United States |
| Research Site | Tampa | Florida | United States |
| Research Site | West Palm Beach | Florida | United States |
| Research Site | Atlanta | Georgia | United States |
| Research Site | Augusta | Georgia | United States |
| Research Site | Chicago | Illinois | United States |
| Research Site | Joliet | Illinois | United States |
| Research Site | Oak Brook Terrace | Illinois | United States |
| Research Site | Schaumburg | Illinois | United States |
| Research Site | Newton | Kansas | United States |
| Research Site | Wichita | Kansas | United States |
| Research Site | Metairie | Louisiana | United States |
| Research Site | New Orleans | Louisiana | United States |
| Research Site | Glen Burnie | Maryland | United States |
| Research Site | Minneapolis | Minnesota | United States |
| Research Site | St Louis | Missouri | United States |
| Research Site | Las Vegas | Nevada | United States |
| Research Site | Cherry Hill | New Jersey | United States |
| Research Site | Moorestown | New Jersey | United States |
| Research Site | Paramus | New Jersey | United States |
| Research Site | Stratford | New Jersey | United States |
| Research Site | Brooklyn | New York | United States |
| Research Site | New York | New York | United States |
| Research Site | Staten Island | New York | United States |
| Research Site | Beechwood | Ohio | United States |
| Research Site | Cincinnati | Ohio | United States |
| Research Site | Dayton | Ohio | United States |
| Research Site | Lyndhurst | Ohio | United States |
| Research Site | Medina | Ohio | United States |
| Research Site | Oklahoma City | Oklahoma | United States |
| Research Site | Portland | Oregon | United States |
| Research Site | Media | Pennsylvania | United States |
| Research Site | Philadelphia | Pennsylvania | United States |
| Research Site | Charleston | South Carolina | United States |
| Research Site | Austin | Texas | United States |
| Research Site | Dallas | Texas | United States |
| Research Site | Houston | Texas | United States |
| Research Site | Irving | Texas | United States |
| Research Site | McKinney | Texas | United States |
| Research Site | San Antonio | Texas | United States |
| Research Site | Midvale | Utah | United States |
| Research Site | Arlington | Virginia | United States |
| Research Site | Falls Church | Virginia | United States |
| Research Site | Richmond | Virginia | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Quetiapine Fumarate | Quetiapine fumarate - flexibly dosed (200 - 800 mg/day) |
| BG001 | Risperidone | Risperidone - flexibly dosed (2 - 8 mg/day) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
| |||||||||||||||||||
| Sex: Female, Male | Participants in the United States (USA) randomized by the study's Interactive Voice Response System (IVRS). | Count of Participants | 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 | Presence of a Cortical (C) Type of Cataractogenic Potential Events in Participants as Assessed and Agreed by 2 Independent, Treatment-masked Ophthalmologists Using the Lens Opacities Classification System II (LOCS II ) Grading Scale | Presence of C type of cataractogenic potential event in participant was defined if any LOCS II grades of 2, 3, 4, 5 (with any grade of 0, trace,1 at randomization) assessed and agreed by 2 independent, treatment-masked ophthalmologists at any post-randomization assessment in one or both eyes. 0= no cataract; 5 is worst. There are no subscales. 0 is the best, 5 is the worst. | The 2-year eye per protocol (E2PP) analysis included all randomized participants who met eye eligibility, had a valid baseline LOCS II evaluation, had reached the study endpoint of either a LOCS II identified cataractogenic potential event or dosed for 21 months without a LOCS II event, and had no major protocol deviations. | Posted | Number | Participants with C type event | Randomization to Month 24 |
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| Primary | Presence of a Nuclear Opalescence (N) Type of Cataractogenic Potential Events in Participants as Assessed and Agreed by 2 Independent, Treatment-masked Ophthalmologists Using the LOCS II Grading Scale | Presence of N type of cataractogenic potential event in Participants was defined if any LOCS II grades of 2, 3, 4 (with grade at rand equals 0,1), or if the LOCS II grades of 3,or 4 (with grade at randomization=2) assessed and agreed by 2 independent, treatment-masked ophthalmologists at any post-randomization assessment in one or both eyes. 0 is the best, 4 is the worst. | The 2-year eye per protocol (E2PP) analysis included all randomized participants who met eye eligibility, had a valid baseline LOCS II evaluation, had reached the study endpoint of either a LOCS II identified cataractogenic potential event or dosed for 21 months without a LOCS II event, and had no major protocol deviations. | Posted | Number | Participants with N type event | Randomization to Month 24 |
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| Primary | Presence of a Posterior Subcapsular (P) Type Cataractogenic Potential Events in Participants as Assessed and Agreed by 2 Independent, Treatment-masked Ophthalmologists Using the LOCS II Grading Scale | Presence of P type of cataractogenic potential event in participant was defined if any LOCS II grades of 1, 2, 3 , 4 (with grade=0 at randomization) assessed and agreed by 2 independent, treatment-masked ophthalmologists at any post-randomization assessment in one or both eyes. 0 is the best, 4 is the worst. | The 2-year eye per protocol (E2PP) analysis included all randomized participants who met eye eligibility, had a valid baseline LOCS II evaluation, had reached the study endpoint of either a LOCS II identified cataractogenic potential event or dosed for 21 months without a LOCS II event, and had no major protocol deviations. | Posted | Number | Participants with P type event | Randomization to Month 24 |
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| Secondary | Change in the Positive and Negative Syndrome Scale (PANSS) Total Score | PANSS total score equals sum of the 30-items scores (range: 30-210). Each item has ( 1-7 units), 1 indicates "absent" psychosis symptom, and 7 - "extreme" symptom degree. Change in PANSS total score : total score at month 24 minus total score at randomization.Alleviation of psychotic symptoms are indicated by a negative change in PANSS total score. | The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score, and received at least 1 dose of study medication. | Posted | Mean | Standard Deviation | units on scale | Randomization to Month 24 |
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| Secondary | Change in the PANSS Positive Subscale Score | PANSS Positive subscale score equals sum of the 7-items scores(range:7-49). Each item has ( 1-7 units), 1 indicates "absent" psychosis symptom, and 7 - "extreme" symptom degree. | The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score, and received at least 1 dose of study medication. | Posted | Mean | Standard Deviation | units on scale | Randomization to Month 24 |
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| Secondary | Change in the PANSS Negative Subscale Score | PANSS Negative subscale score equals sum of the 7-items scores(range:7-49). Each item has ( 1-7 units), 1 indicates "absent" psychosis symptom, and 7 - "extreme" symptom degree. Change in PANSS Negative subscale score:score at month 24 minus score at randomization. Alleviation of negative psychotic symptoms are indicated by a negative change score. | The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score, and received at least 1 dose of study medication. | Posted | Mean | Standard Deviation | units on scale | Randomization to Month 24 |
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| Secondary | Change in the PANSS Psychopathology Subscale Score | PANSS psychopathology subscale score equals sum of the 16-items scores(range:16-112). Each item has ( 1-7 units),1= "absent" psychosis symptom, 7= "extreme" symptom degree.Change in PANSS psychopathology subscale:score at month 24 minus score at randomization. Alleviation of general psychopathology symptoms are indicated by a negative change score. | The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score, and received at least 1 dose of study medication. | Posted | Mean | Standard Deviation | units on scale | Randomization to Month 24 |
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| Secondary | Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score | CGI-S score is accessed on a seven-graded scale ranging from most extremely ill/ very much worse (7) to normal/very much improved (1) , 1 is best. Change : score at month 24 minus score at randomization. | The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score (not related to CGI-S), and received at least 1 dose of study medication. | Posted | Mean | Standard Deviation | units on scale | Randomization to Month 24 |
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| Secondary | Change in Health-related Quality of Life as Measured by Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q SF) Total Score | Q-LES-Q total score is the sum of the 16 times of Q-LES-Q SF(range:16-80).Each item has a 5 point satisfaction level scale:from 1=very poor(worst value) to 5=very good(best).Larger values indicate a higher perceived quality of life enjoyment and satisfaction.Change in Q-LES-Q total score:total score at month 24 minus total score at randomization | The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score, and received at least 1 dose of study medication. | Posted | Mean | Standard Deviation | units on scale | Randomization to Month 24 |
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| Secondary | Change in Personal Evaluation of Transitions in Treatment (PETiT) Total Score | PETiT total score is the sum of the 30 items of PETiT questionnaire(range:0-60) on subjects perceived well-being, adherence, tolerability, satisfaction with treatment. Each item is rated by participant with a 3 point frequency scale:2=often, 1=sometimes, 0=never.Change in PETiT total score: total score at month 24 minus total score at randomization | The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score, and received at least 1 dose of study medication. | Posted | Mean | Standard Deviation | units on scale | Randomization to Month 24 |
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| Secondary | Number of Relapses of Schizophrenia or Schizoaffective Disorder | Relapse is defined as a hospital stay for psychiatric symptoms or a 2-point increase from baseline in the CGI severity score. CGI-S score ranges from 0-7 with 0 = Not Assessed, 1 = Normal, not at all and 7 = Among the most extremely ill subjects. | The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score, and received at least 1 dose of study medication. | Posted | Number | Relapses | At Month 24 |
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| Secondary | Change in Simpson-Angus Scale (SAS) Total Score | SAS total score is the sum of the 10 individual-item scores (range:0-40), with the score for each item ranging from 0 to 4, higher scores indicate greater severity of Parkinsonian symptoms. Change : total score at month 24 minus total score at randomization. Increase in Change of total score indicates an increase in extrapyramidal motor symptoms. | The Safety analysis set included all randomized participants who received at least 1 dose of study medication | Posted | Mean | Standard Deviation | units on scale | Randomization to Month 24 |
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| Secondary | Change in Barnes Akathisia Rating Scale (BARS) Global Score | BARS global score is the 4th individual-item score on the BARS scale, the Global Assessment of Akathisia, with the score ranging from 0 (no evidence of akathisia) to 5 (severe akathisia). Change : score at month 24 minus score at randomization. Increase in Change of BARS global score indicates an increase in akathisia. | The Safety analysis set included all randomized participants who received at least 1 dose of study medication | Posted | Mean | Standard Deviation | units of scale | Randomization to Month 24 |
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| Secondary | Change in Abnormal Involuntary Movement Scale (AIMS) Total Score | AIMS total score is the sum of the 10 individual-item scores(range:0-40), with the score for each item ranging from 0 to 4. Change : total score at month 24 minus total score at randomization. Increase in Change of total score indicates an increase in abnormal voluntary movements. The lower score means lower intensity of abnormal voluntary Movements. 0 is best, 4 is worst. Increase in Change of total score indicates an increase in abnormal voluntary Movements. | The Safety analysis set included all randomized participants who received at least 1 dose of study medication | Posted | Mean | Standard Deviation | units on scale | Randomization to Month 24 |
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| Secondary | Number of Participants With Potential Extrapyramidal Symptoms (EPS) | Number of participants with adverse events potentially associated with EPS collected by MedDRA Preferred Terms as akathisia, bradykinesia, drooling, dyskinesia, dystonia, extrapyramidal disorder, grimacing, muscle rigidity, parkinsonism, restlessness, tardive dyskinesia, tremor | The Safety analysis set included all randomized participants who received at least 1 dose of study medication | Posted | Number | Participants | From start of the study treatment to last dose plus 30 days |
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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 | Quetiapine Fumarate | Quetiapine fumarate - flexibly dosed (200 - 800 mg/day) | 151 | 596 | 476 | 596 | ||
| EG001 | Risperidone | Risperidone - flexibly dosed (2 - 8 mg/day) | 114 | 502 | 368 | 502 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Angina Pectoris | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Coronary Artery Disease | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Diastolic Dysfunction | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hyperparathyroidism | Endocrine disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hypoparathyroidism | Endocrine disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Intestinal Ischaemia | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pancreatic Insufficiency | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Anal Fistula | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Pancreatitis Acute | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA 11.1 | Systematic Assessment |
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| Non-Cardiac Chest Pain | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
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| Cholecystitis Acute | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Conjunctivitis Bacterial | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Diarrhoea Infectious | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Gastroenteritis Viral | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Skin Infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Localised Infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Pilonidal Cyst | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Postoperative Wound Infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Alcohol Poisoning | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Accidental Overdose | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
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| Drug Toxicity | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Incisional Hernia | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Intentional Overdose | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Joint Dislocation | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
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| Multiple Drug Overdose Accidental | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
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| Procedural Pain | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
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| Therapeutic Agent Toxicity | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
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| Thermal Burn | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
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| Ankle Fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Respiratory Fume Inhalation Disorder | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Electrocardiogram Qt Prolonged | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Neutrophil Count Decreased | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Diabetic Ketoacidosis | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Inguinal Mass | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Flank Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Intervertebral Disc Disorder | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Lumbar Spinal Stenosis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Cervix Carcinoma Stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
| |
| Metastases To Liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
| |
| Oesophageal Adenocarcinoma Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
| |
| Uterine Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Transient Ischaemic Attack | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Multiple Sclerosis | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Subarachnoid Haemorrhage | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Psychotic Disorder | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Schizoaffective Disorder | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Suicidal Ideation | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Suicide Attempt | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Schizophrenia, Paranoid Type | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Aggression | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Alcohol Abuse | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Completed Suicide | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Drug Abuse | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Paranoia | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Affective Disorder | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Delusion | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Homicidal Ideation | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Major Depression | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Acute Psychosis | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Alcoholism | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Catatonia | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Drug Dependence | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Flashback | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Self Injurious Behaviour | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Somatic Delusion | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Substance Abuse | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Suicidal Behaviour | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Bladder Disorder | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Renal Failure Acute | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Breast Mass | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Bronchitis Chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Substance Abuser | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Malignant Hypertension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry Mouth | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Weight Increased | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Sedation | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Akathisia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Extrapyramidal Disorder | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
The PI agrees to collaborate in good faith with AstraZeneca with regards to the contents and formation of any publication or disclosure to be made by the PI and to pay due consideration to the comments, views and opinions offered by AstraZeneca
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | AZTrial_Results_Posting@astrazeneca.com |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069348 | Quetiapine Fumarate |
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
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