Trial Outcomes & Findings for A Study of the Cataractogenic Potential of Seroquel and Risperdal in the Treatment of Participants With Schizophrenia or Schizoaffective Disorder (NCT NCT00206102)
NCT ID: NCT00206102
Last Updated: 2013-01-14
Results Overview
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.
COMPLETED
PHASE4
1098 participants
Randomization to Month 24
2013-01-14
Participant Flow
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.
Screening for eligibility and must be cross-tapered off of all previous antipsychotic medications
Participant milestones
| Measure |
Quetiapine Fumarate
Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
|
Risperidone
Risperidone - flexibly dosed (2 - 8 mg/day)
|
|---|---|---|
|
Overall Study
STARTED
|
596
|
502
|
|
Overall Study
COMPLETED
|
188
|
187
|
|
Overall Study
NOT COMPLETED
|
408
|
315
|
Reasons for withdrawal
| Measure |
Quetiapine Fumarate
Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
|
Risperidone
Risperidone - flexibly dosed (2 - 8 mg/day)
|
|---|---|---|
|
Overall Study
Adverse Event
|
119
|
82
|
|
Overall Study
Protocol Violation
|
0
|
2
|
|
Overall Study
Lack of therapeutic response
|
16
|
11
|
|
Overall Study
Lost to Follow-up
|
95
|
66
|
|
Overall Study
Withdrawal by Subject
|
118
|
101
|
|
Overall Study
Study-specific discontinuation criteria
|
18
|
17
|
|
Overall Study
None of those categories
|
42
|
36
|
Baseline Characteristics
A Study of the Cataractogenic Potential of Seroquel and Risperdal in the Treatment of Participants With Schizophrenia or Schizoaffective Disorder
Baseline characteristics by cohort
| Measure |
Quetiapine Fumarate
n=596 Participants
Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
|
Risperidone
n=502 Participants
Risperidone - flexibly dosed (2 - 8 mg/day)
|
Total
n=1098 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 40 years
|
265 Participants
n=5 Participants
|
223 Participants
n=7 Participants
|
488 Participants
n=5 Participants
|
|
Age, Customized
40 to 65 years
|
331 Participants
n=5 Participants
|
279 Participants
n=7 Participants
|
610 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
253 Participants
n=5 Participants
|
199 Participants
n=7 Participants
|
452 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
343 Participants
n=5 Participants
|
303 Participants
n=7 Participants
|
646 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Randomization to Month 24Population: 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.
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.
Outcome measures
| Measure |
Quetiapine Fumarate
n=161 Participants
Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
|
Risperidone
n=168 Participants
Risperidone - flexibly dosed (2 - 8 mg/day)
|
|---|---|---|
|
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
|
2 Participants with C type event
|
8 Participants with C type event
|
PRIMARY outcome
Timeframe: Randomization to Month 24Population: 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.
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.
Outcome measures
| Measure |
Quetiapine Fumarate
n=161 Participants
Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
|
Risperidone
n=168 Participants
Risperidone - flexibly dosed (2 - 8 mg/day)
|
|---|---|---|
|
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
|
0 Participants with N type event
|
2 Participants with N type event
|
PRIMARY outcome
Timeframe: Randomization to Month 24Population: 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.
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.
Outcome measures
| Measure |
Quetiapine Fumarate
n=161 Participants
Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
|
Risperidone
n=168 Participants
Risperidone - flexibly dosed (2 - 8 mg/day)
|
|---|---|---|
|
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
|
4 Participants with P type event
|
7 Participants with P type event
|
SECONDARY outcome
Timeframe: Randomization to Month 24Population: 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.
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.
Outcome measures
| Measure |
Quetiapine Fumarate
n=506 Participants
Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
|
Risperidone
n=428 Participants
Risperidone - flexibly dosed (2 - 8 mg/day)
|
|---|---|---|
|
Change in the Positive and Negative Syndrome Scale (PANSS) Total Score
|
-9.1 units on scale
Standard Deviation 15.4
|
-8.6 units on scale
Standard Deviation 16.6
|
SECONDARY outcome
Timeframe: Randomization to Month 24Population: 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.
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.
Outcome measures
| Measure |
Quetiapine Fumarate
n=506 Participants
Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
|
Risperidone
n=428 Participants
Risperidone - flexibly dosed (2 - 8 mg/day)
|
|---|---|---|
|
Change in the PANSS Positive Subscale Score
|
-2.7 units on scale
Standard Deviation 5.3
|
-2.8 units on scale
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: Randomization to Month 24Population: 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.
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.
Outcome measures
| Measure |
Quetiapine Fumarate
n=506 Participants
Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
|
Risperidone
n=428 Participants
Risperidone - flexibly dosed (2 - 8 mg/day)
|
|---|---|---|
|
Change in the PANSS Negative Subscale Score
|
-2.2 units on scale
Standard Deviation 5.5
|
-1.5 units on scale
Standard Deviation 5.7
|
SECONDARY outcome
Timeframe: Randomization to Month 24Population: 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.
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.
Outcome measures
| Measure |
Quetiapine Fumarate
n=161 Participants
Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
|
Risperidone
n=168 Participants
Risperidone - flexibly dosed (2 - 8 mg/day)
|
|---|---|---|
|
Change in the PANSS Psychopathology Subscale Score
|
-4.2 units on scale
Standard Deviation 7.7
|
-4.4 units on scale
Standard Deviation 8.8
|
SECONDARY outcome
Timeframe: Randomization to Month 24Population: 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.
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.
Outcome measures
| Measure |
Quetiapine Fumarate
n=506 Participants
Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
|
Risperidone
n=428 Participants
Risperidone - flexibly dosed (2 - 8 mg/day)
|
|---|---|---|
|
Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score
|
-0.7 units on scale
Standard Deviation 0.9
|
-0.5 units on scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Randomization to Month 24Population: 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.
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
Outcome measures
| Measure |
Quetiapine Fumarate
n=506 Participants
Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
|
Risperidone
n=428 Participants
Risperidone - flexibly dosed (2 - 8 mg/day)
|
|---|---|---|
|
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
|
2.4 units on scale
Standard Deviation 11.6
|
2.7 units on scale
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: Randomization to Month 24Population: 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.
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
Outcome measures
| Measure |
Quetiapine Fumarate
n=506 Participants
Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
|
Risperidone
n=428 Participants
Risperidone - flexibly dosed (2 - 8 mg/day)
|
|---|---|---|
|
Change in Personal Evaluation of Transitions in Treatment (PETiT) Total Score
|
1.2 units on scale
Standard Deviation 6.2
|
0.9 units on scale
Standard Deviation 6.0
|
SECONDARY outcome
Timeframe: At Month 24Population: 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.
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.
Outcome measures
| Measure |
Quetiapine Fumarate
n=506 Participants
Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
|
Risperidone
n=428 Participants
Risperidone - flexibly dosed (2 - 8 mg/day)
|
|---|---|---|
|
Number of Relapses of Schizophrenia or Schizoaffective Disorder
|
24 Relapses
|
33 Relapses
|
SECONDARY outcome
Timeframe: Randomization to Month 24Population: The Safety analysis set included all randomized participants who received at least 1 dose of study medication
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.
Outcome measures
| Measure |
Quetiapine Fumarate
n=586 Participants
Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
|
Risperidone
n=496 Participants
Risperidone - flexibly dosed (2 - 8 mg/day)
|
|---|---|---|
|
Change in Simpson-Angus Scale (SAS) Total Score
|
-0.7 units on scale
Standard Deviation 2.1
|
-0.4 units on scale
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: Randomization to Month 24Population: The Safety analysis set included all randomized participants who received at least 1 dose of study medication
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.
Outcome measures
| Measure |
Quetiapine Fumarate
n=586 Participants
Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
|
Risperidone
n=496 Participants
Risperidone - flexibly dosed (2 - 8 mg/day)
|
|---|---|---|
|
Change in Barnes Akathisia Rating Scale (BARS) Global Score
|
-0.1 units of scale
Standard Deviation 0.7
|
0.1 units of scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Randomization to Month 24Population: The Safety analysis set included all randomized participants who received at least 1 dose of study medication
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.
Outcome measures
| Measure |
Quetiapine Fumarate
n=586 Participants
Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
|
Risperidone
n=496 Participants
Risperidone - flexibly dosed (2 - 8 mg/day)
|
|---|---|---|
|
Change in Abnormal Involuntary Movement Scale (AIMS) Total Score
|
-0.2 units on scale
Standard Deviation 2.5
|
0.1 units on scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: From start of the study treatment to last dose plus 30 daysPopulation: The Safety analysis set included all randomized participants who received at least 1 dose of study medication
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
Outcome measures
| Measure |
Quetiapine Fumarate
n=586 Participants
Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
|
Risperidone
n=496 Participants
Risperidone - flexibly dosed (2 - 8 mg/day)
|
|---|---|---|
|
Number of Participants With Potential Extrapyramidal Symptoms (EPS)
|
73 Participants
|
106 Participants
|
Adverse Events
Quetiapine Fumarate
Risperidone
Serious adverse events
| Measure |
Quetiapine Fumarate
n=596 participants at risk
Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
|
Risperidone
n=502 participants at risk
Risperidone - flexibly dosed (2 - 8 mg/day)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.17%
1/586
|
0.20%
1/496
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/586
|
0.40%
2/496
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.34%
2/586
|
0.00%
0/496
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/586
|
0.20%
1/496
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/586
|
0.20%
1/496
|
|
Cardiac disorders
Diastolic Dysfunction
|
0.17%
1/586
|
0.00%
0/496
|
|
Cardiac disorders
Myocardial Infarction
|
0.17%
1/586
|
0.00%
0/496
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/586
|
0.20%
1/496
|
|
Endocrine disorders
Hypoparathyroidism
|
0.00%
0/586
|
0.20%
1/496
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/586
|
0.20%
1/496
|
|
Gastrointestinal disorders
Intestinal Ischaemia
|
0.00%
0/586
|
0.20%
1/496
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/586
|
0.20%
1/496
|
|
Gastrointestinal disorders
Pancreatic Insufficiency
|
0.00%
0/586
|
0.20%
1/496
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.17%
1/586
|
0.00%
0/496
|
|
Gastrointestinal disorders
Anal Fistula
|
0.17%
1/586
|
0.00%
0/496
|
|
Gastrointestinal disorders
Colitis
|
0.17%
1/586
|
0.00%
0/496
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.17%
1/586
|
0.00%
0/496
|
|
Gastrointestinal disorders
Pancreatitis
|
0.17%
1/586
|
0.00%
0/496
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.17%
1/586
|
0.00%
0/496
|
|
General disorders
Chest Pain
|
0.34%
2/586
|
0.00%
0/496
|
|
General disorders
Non-Cardiac Chest Pain
|
0.34%
2/586
|
0.00%
0/496
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/586
|
0.20%
1/496
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/586
|
0.20%
1/496
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.17%
1/586
|
0.00%
0/496
|
|
Infections and infestations
Pneumonia
|
0.68%
4/586
|
0.60%
3/496
|
|
Infections and infestations
Appendicitis
|
0.17%
1/586
|
0.20%
1/496
|
|
Infections and infestations
Cellulitis
|
0.00%
0/586
|
0.20%
1/496
|
|
Infections and infestations
Conjunctivitis Bacterial
|
0.00%
0/586
|
0.20%
1/496
|
|
Infections and infestations
Diarrhoea Infectious
|
0.00%
0/586
|
0.20%
1/496
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/586
|
0.20%
1/496
|
|
Infections and infestations
Gastroenteritis
|
0.17%
1/586
|
0.20%
1/496
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/586
|
0.20%
1/496
|
|
Infections and infestations
Skin Infection
|
0.00%
0/586
|
0.20%
1/496
|
|
Infections and infestations
Urinary Tract Infection
|
0.17%
1/586
|
0.20%
1/496
|
|
Infections and infestations
Bronchitis
|
0.17%
1/586
|
0.00%
0/496
|
|
Infections and infestations
Localised Infection
|
0.17%
1/586
|
0.00%
0/496
|
|
Infections and infestations
Pilonidal Cyst
|
0.17%
1/586
|
0.00%
0/496
|
|
Infections and infestations
Postoperative Wound Infection
|
0.17%
1/586
|
0.00%
0/496
|
|
Infections and infestations
Sepsis
|
0.17%
1/586
|
0.00%
0/496
|
|
Injury, poisoning and procedural complications
Alcohol Poisoning
|
0.17%
1/586
|
0.60%
3/496
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
0.34%
2/586
|
0.40%
2/496
|
|
Injury, poisoning and procedural complications
Drug Toxicity
|
0.00%
0/586
|
0.40%
2/496
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/586
|
0.20%
1/496
|
|
Injury, poisoning and procedural complications
Incisional Hernia
|
0.00%
0/586
|
0.20%
1/496
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/586
|
0.20%
1/496
|
|
Injury, poisoning and procedural complications
Intentional Overdose
|
0.00%
0/586
|
0.20%
1/496
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
0.00%
0/586
|
0.20%
1/496
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/586
|
0.20%
1/496
|
|
Injury, poisoning and procedural complications
Multiple Drug Overdose Accidental
|
0.00%
0/586
|
0.20%
1/496
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.00%
0/586
|
0.20%
1/496
|
|
Injury, poisoning and procedural complications
Therapeutic Agent Toxicity
|
0.00%
0/586
|
0.20%
1/496
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.17%
1/586
|
0.20%
1/496
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.17%
1/586
|
0.00%
0/496
|
|
Injury, poisoning and procedural complications
Contusion
|
0.17%
1/586
|
0.00%
0/496
|
|
Injury, poisoning and procedural complications
Respiratory Fume Inhalation Disorder
|
0.17%
1/586
|
0.00%
0/496
|
|
Injury, poisoning and procedural complications
Electrocardiogram Qt Prolonged
|
0.17%
1/586
|
0.00%
0/496
|
|
Injury, poisoning and procedural complications
Neutrophil Count Decreased
|
0.17%
1/586
|
0.00%
0/496
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.00%
0/586
|
0.60%
3/496
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/586
|
0.20%
1/496
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
0.00%
0/586
|
0.20%
1/496
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/586
|
0.20%
1/496
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/586
|
0.20%
1/496
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.17%
1/586
|
0.00%
0/496
|
|
Musculoskeletal and connective tissue disorders
Inguinal Mass
|
0.00%
0/586
|
0.20%
1/496
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/586
|
0.20%
1/496
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/586
|
0.20%
1/496
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.17%
1/586
|
0.00%
0/496
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.17%
1/586
|
0.00%
0/496
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Disorder
|
0.17%
1/586
|
0.00%
0/496
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.17%
1/586
|
0.00%
0/496
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
|
0.17%
1/586
|
0.00%
0/496
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix Carcinoma Stage 0
|
0.00%
0/586
|
0.20%
1/496
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Liver
|
0.17%
1/586
|
0.00%
0/496
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal Adenocarcinoma Metastatic
|
0.17%
1/586
|
0.00%
0/496
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma
|
0.17%
1/586
|
0.00%
0/496
|
|
Nervous system disorders
Dizziness
|
0.00%
0/586
|
0.40%
2/496
|
|
Nervous system disorders
Syncope
|
0.34%
2/586
|
0.00%
0/496
|
|
Nervous system disorders
Ataxia
|
0.00%
0/586
|
0.20%
1/496
|
|
Nervous system disorders
Convulsion
|
0.00%
0/586
|
0.20%
1/496
|
|
Nervous system disorders
Hemiparesis
|
0.17%
1/586
|
0.20%
1/496
|
|
Nervous system disorders
Migraine
|
0.00%
0/586
|
0.20%
1/496
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/586
|
0.20%
1/496
|
|
Nervous system disorders
Dysarthria
|
0.17%
1/586
|
0.00%
0/496
|
|
Nervous system disorders
Multiple Sclerosis
|
0.17%
1/586
|
0.00%
0/496
|
|
Nervous system disorders
Presyncope
|
0.17%
1/586
|
0.00%
0/496
|
|
Nervous system disorders
Subarachnoid Haemorrhage
|
0.17%
1/586
|
0.00%
0/496
|
|
Psychiatric disorders
Psychotic Disorder
|
6.5%
38/586
|
3.8%
19/496
|
|
Psychiatric disorders
Schizophrenia
|
4.3%
25/586
|
4.0%
20/496
|
|
Psychiatric disorders
Schizoaffective Disorder
|
3.2%
19/586
|
2.8%
14/496
|
|
Psychiatric disorders
Suicidal Ideation
|
2.0%
12/586
|
2.4%
12/496
|
|
Psychiatric disorders
Depression
|
2.2%
13/586
|
1.6%
8/496
|
|
Psychiatric disorders
Suicide Attempt
|
0.85%
5/586
|
1.2%
6/496
|
|
Psychiatric disorders
Schizophrenia, Paranoid Type
|
0.85%
5/586
|
0.60%
3/496
|
|
Psychiatric disorders
Anxiety
|
0.51%
3/586
|
0.40%
2/496
|
|
Psychiatric disorders
Aggression
|
0.34%
2/586
|
0.00%
0/496
|
|
Psychiatric disorders
Alcohol Abuse
|
0.34%
2/586
|
0.00%
0/496
|
|
Psychiatric disorders
Completed Suicide
|
0.34%
2/586
|
0.20%
1/496
|
|
Psychiatric disorders
Drug Abuse
|
0.34%
2/586
|
0.00%
0/496
|
|
Psychiatric disorders
Hallucination
|
0.34%
2/586
|
0.00%
0/496
|
|
Psychiatric disorders
Paranoia
|
0.34%
2/586
|
0.00%
0/496
|
|
Psychiatric disorders
Affective Disorder
|
0.00%
0/586
|
0.20%
1/496
|
|
Psychiatric disorders
Delusion
|
0.00%
0/586
|
0.20%
1/496
|
|
Psychiatric disorders
Homicidal Ideation
|
0.17%
1/586
|
0.20%
1/496
|
|
Psychiatric disorders
Major Depression
|
0.17%
1/586
|
0.20%
1/496
|
|
Psychiatric disorders
Acute Psychosis
|
0.17%
1/586
|
0.00%
0/496
|
|
Psychiatric disorders
Alcoholism
|
0.17%
1/586
|
0.00%
0/496
|
|
Psychiatric disorders
Catatonia
|
0.17%
1/586
|
0.00%
0/496
|
|
Psychiatric disorders
Drug Dependence
|
0.17%
1/586
|
0.00%
0/496
|
|
Psychiatric disorders
Flashback
|
0.17%
1/586
|
0.00%
0/496
|
|
Psychiatric disorders
Self Injurious Behaviour
|
0.17%
1/586
|
0.00%
0/496
|
|
Psychiatric disorders
Somatic Delusion
|
0.17%
1/586
|
0.00%
0/496
|
|
Psychiatric disorders
Substance Abuse
|
0.17%
1/586
|
0.00%
0/496
|
|
Psychiatric disorders
Suicidal Behaviour
|
0.17%
1/586
|
0.00%
0/496
|
|
Renal and urinary disorders
Bladder Disorder
|
0.00%
0/586
|
0.20%
1/496
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.17%
1/586
|
0.20%
1/496
|
|
Reproductive system and breast disorders
Breast Mass
|
0.17%
1/586
|
0.00%
0/496
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.68%
4/586
|
0.00%
0/496
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.34%
2/586
|
0.00%
0/496
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/586
|
0.20%
1/496
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis Chronic
|
0.00%
0/586
|
0.20%
1/496
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/586
|
0.20%
1/496
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/586
|
0.20%
1/496
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/586
|
0.20%
1/496
|
|
Vascular disorders
Substance Abuser
|
0.17%
1/586
|
0.00%
0/496
|
|
Vascular disorders
Hypertension
|
0.00%
0/586
|
0.20%
1/496
|
|
Vascular disorders
Malignant Hypertension
|
0.00%
0/586
|
0.20%
1/496
|
|
Vascular disorders
Arteriosclerosis
|
0.17%
1/586
|
0.00%
0/496
|
|
Vascular disorders
Hypotension
|
0.17%
1/586
|
0.00%
0/496
|
Other adverse events
| Measure |
Quetiapine Fumarate
n=596 participants at risk
Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
|
Risperidone
n=502 participants at risk
Risperidone - flexibly dosed (2 - 8 mg/day)
|
|---|---|---|
|
Gastrointestinal disorders
Dry Mouth
|
13.3%
78/586
|
7.9%
39/496
|
|
Gastrointestinal disorders
Nausea
|
8.0%
47/586
|
8.7%
43/496
|
|
Gastrointestinal disorders
Constipation
|
7.7%
45/586
|
5.6%
28/496
|
|
Gastrointestinal disorders
Vomiting
|
3.6%
21/586
|
7.3%
36/496
|
|
Gastrointestinal disorders
Toothache
|
6.5%
38/586
|
3.4%
17/496
|
|
Gastrointestinal disorders
Diarrhoea
|
4.3%
25/586
|
6.0%
30/496
|
|
General disorders
Fatigue
|
10.2%
60/586
|
9.3%
46/496
|
|
Infections and infestations
Nasopharyngitis
|
9.2%
54/586
|
10.1%
50/496
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.3%
31/586
|
6.5%
32/496
|
|
Infections and infestations
Weight Increased
|
11.8%
69/586
|
8.3%
41/496
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
7.2%
42/586
|
6.0%
30/496
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.1%
36/586
|
5.6%
28/496
|
|
Nervous system disorders
Somnolence
|
28.8%
169/586
|
12.9%
64/496
|
|
Nervous system disorders
Sedation
|
23.0%
135/586
|
10.9%
54/496
|
|
Nervous system disorders
Headache
|
16.4%
96/586
|
15.7%
78/496
|
|
Nervous system disorders
Dizziness
|
14.3%
84/586
|
9.9%
49/496
|
|
Nervous system disorders
Akathisia
|
4.4%
26/586
|
6.7%
33/496
|
|
Nervous system disorders
Tremor
|
4.3%
25/586
|
6.2%
31/496
|
|
Nervous system disorders
Extrapyramidal Disorder
|
1.5%
9/586
|
5.4%
27/496
|
|
Psychiatric disorders
Insomnia
|
15.2%
89/586
|
22.2%
110/496
|
|
Psychiatric disorders
Anxiety
|
12.1%
71/586
|
10.5%
52/496
|
|
Psychiatric disorders
Depression
|
8.9%
52/586
|
9.7%
48/496
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.3%
25/586
|
5.0%
25/496
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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
- Publication restrictions are in place
Restriction type: OTHER