Schizophrenia
Conditions
Brief summary
The purpose of the study is to determine whether there is an increased all-cause mortality in sertindole-treated patients in comparison to patients treated with a well-known antipsychotic (risperidone) when used under normal marketed conditions in the treatment of schizophrenia.
Detailed description
The Committee for Medicinal Products for Human Use (CHMP) requested a post-marketing study to ascertain that the favourable benefit-risk profile and low mortality rates seen in the clinical studies with sertindole would not be offset by higher mortality rates when sertindole was used under more normal conditions of use. It was recognised that, in a clinical trial setting, strict patient selection and monitoring could lead to higher compliance in patient management and thereby to a lower mortality rate. Study 99824 was therefore designed in collaboration with the CHMP as an open-label, randomised study with minimum study management that focused on mortality and general patient safety. The duration of the treatment period was not fixed. No efficacy measures were included.
Interventions
DRUGSertindole
Sertindole was supplied as 4, 12, 16, and 20 mg tablets. The start and maintenance dosages as well as dose titration were set by the investigator, in accordance with the national Summary of Product Characteristics (SPC) for sertindole; in countries where sertindole was not marketed, the European Union (EU) SPC applied (all national and EU SPCs were essentially identical). Recommended dose range: 12 to 20 mg/day. The investigators were instructed to contact H. Lundbeck A/S if they deemed it necessary to increase the dose of sertindole to 24 mg/day, which was allowed in exceptional cases
DRUGRisperidone
Risperidone was supplied as 1, 2, 3, and 4 mg tablets. The start and maintenance dosages as well as dose titration were set by the investigator, in accordance with the national SPC for risperidone. Recommended dose range: 2 to 8 mg/day
Sponsors
H. Lundbeck A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient has signed the Informed Consent Form or, if he/she is not able to sign it (according to the ICH GCP guidelines and the Declaration of Helsinki), the patient's legal representative has signed the Informed Consent Form * The patient has been diagnosed with schizophrenia * Based on the patient's clinical status, new or change of antipsychotic treatment is indicated * The patient is at least 18 years of age * The patient meets the criteria set out in the national SPCs for sertindole and risperidone. For those countries in which sertindole was not marketed, the EU SPC applied
Exclusion criteria
* The last treatment taken by the patient was sertindole or risperidone * The patient has never previously received any antipsychotic drug therapy * The patient has contraindications to treatment with either sertindole or risperidone * In addition to sertindole/risperidone, treatment with another antipsychotic is indicated * The patient is homeless * The patient has previously been included in one of the two H. Lundbeck A/S post-marketing studies, 99823 or 99824 * The patient is, in the opinion of the investigator, unlikely to comply with the study protocol or unsuitable for any other reason
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With All-cause Mortality | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months | The analysis was based on all deaths from the Whole Randomised Treatment (WRT)+30 days period and the Only Randomised Treatment (ORT) period, respectively |
| Second Primary Outcome: Number of Participants With Cardiac Events, Including Arrhythmias, Requiring Hospitalisation | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months | Second primary endpoint: a serious adverse event where the patient was hospitalised and for which the Independent Safety Committee (ISC) classified the event as a cardiac event with documented arrhythmia. The analysis of this outcome was not performed due to low number of events. The presented analysis is a replacement analysis using all cardiac events, including arrhythmias, that required hospitalisation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cause-specific Mortality: Number of Participants With Other Than Cardiac Deaths and Completed Suicides - ISC | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months | The analysis was based on all deaths from the WRT+30 days period using the classification performed by the ISC. The ISC reviewed and classified those adverse events which resulted in death or hospitalisation or were possible suicide attempts and this review was blinded to exposure. The definition of cardiac death was intentionally wide; sudden or unexplained deaths were assumed to be cardiac if there was no non-cardiac explanation. To ensure consistent evaluation and classification, the ISC decided a priori to classify all instances of self harm as possible suicide. |
| Cause-specific Mortality: Number of Participants With Cardiac Deaths - MedDRA | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months | The analysis was based on all deaths from the WRT+30 days period using the classification based upon the Medical Dictionary for Regulatory Activities (MedDRA) terminology, that is, as reported by the investigator |
| Cause-specific Mortality: Number of Participants With Completed Suicides - MedDRA | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months | The analysis was based on all deaths from the WRT+30 days period using the classification based upon MedDRA terminology, that is, as reported by the investigator |
| Cause-specific Mortality: Number of Participants With Other Than Cardiac Deaths and Completed Suicides - MedDRA | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months | The analysis was based on all deaths from the WRT+30 days period using the classification based upon MedDRA terminology, that is, as reported by the investigator |
| Cause-specific Mortality: Number of Participants With Cardiac Deaths - ISC | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months | The analysis was based on all deaths from the WRT+30 days period using the classification performed by the ISC. The ISC reviewed and classified those adverse events which resulted in death or hospitalisation or were possible suicide attempts and this review was blinded to exposure. The definition of cardiac death was intentionally wide; sudden or unexplained deaths were assumed to be cardiac if there was no non-cardiac explanation. To ensure consistent evaluation and classification, the ISC decided a priori to classify all instances of self harm as possible suicide. |
| Number of Participants With Suicide Attempts (Fatal and Non-fatal) - MedDRA | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months | The analysis was based on all suicides and suicide attempts from the WRT+30 days period using the classification based upon MedDRA terminology, that is, as reported by the investigator |
| Number of Participants With Hospitalisations, Excluding Hospitalisations Related to the Primary Psychiatric Disease | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months | The analysis was based on time from start of study drug to first hospitalisation during the WRT+30 days period |
| Number of Participants With Discontinuation of Treatment for Any Reason Other Than Study Closure | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months | The analysis was based on time from start of study drug until stop of study drug for any reason other than sponsor closure of the study |
| Number of Participants With Suicide Attempts (Fatal and Non-fatal) - ISC | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months | The analysis was based on all suicides and suicide attempts from the WRT+30 days period using the classification performed by the ISC. The ISC reviewed and classified those adverse events which resulted in death or hospitalisation or were possible suicide attempts and this review was blinded to exposure. The definition of cardiac death was intentionally wide; sudden or unexplained deaths were assumed to be cardiac if there was no non-cardiac explanation. To ensure consistent evaluation and classification, the ISC decided a priori to classify all instances of self harm as possible suicide. |
| Cause-specific Mortality: Number of Participants With Completed Suicides - ISC | As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months | The analysis was based on all deaths from the WRT+30 days period using the classification performed by the ISC. The ISC reviewed and classified those adverse events which resulted in death or hospitalisation or were possible suicide attempts and this review was blinded to exposure. The definition of cardiac death was intentionally wide; sudden or unexplained deaths were assumed to be cardiac if there was no non-cardiac explanation. To ensure consistent evaluation and classification, the ISC decided a priori to classify all instances of self harm as possible suicide. |
Participant flow
Recruitment details
593 centres in 38 countries (Europe and Asia). First patient first visit: 11 July 2002. Last patient last visit: 22 February 2008.
Participants by arm
| Arm | Count |
|---|---|
| Sertindole Normally in the range of 4 to 20 mg/day | 4,905 |
| Risperidone Normally in the range of 2 to 8 mg/day | 4,904 |
| Total | 9,809 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 389 | 377 |
| Overall Study | Non-compliance | 305 | 262 |
| Overall Study | Non-evaluable: Patient on Polytherapy | 694 | 604 |
| Overall Study | Non-SAE: Mostly Asymptomatic ECGs | 393 | 179 |
| Overall Study | Other | 92 | 104 |
| Overall Study | Physician Decision | 59 | 82 |
| Overall Study | Pregnancy | 14 | 5 |
| Overall Study | Serious Adverse Event (SAE) | 99 | 65 |
| Overall Study | Withdrawal by Subject | 1,092 | 919 |
Baseline characteristics
| Characteristic | Total | Risperidone | Sertindole |
|---|---|---|---|
| Age Continuous | 38.3 years STANDARD_DEVIATION 11.8 | 38.3 years STANDARD_DEVIATION 11.7 | 38.4 years STANDARD_DEVIATION 11.8 |
| Age, Customized 18 to 65 years | 9626 participants | 4820 participants | 4806 participants |
| Age, Customized > 65 years | 183 participants | 84 participants | 99 participants |
| Duration of schizophrenia > 10 years | 4147 participants | 2071 participants | 2076 participants |
| Duration of schizophrenia 5 to 10 years | 2532 participants | 1278 participants | 1254 participants |
| Duration of schizophrenia < 5 years | 2918 participants | 1468 participants | 1450 participants |
| Duration of schizophrenia Unknown | 212 participants | 87 participants | 125 participants |
| Number of previous suicide attempts 0 previous suicide attempts | 8569 participants | 4288 participants | 4281 participants |
| Number of previous suicide attempts 1 previous suicide attempt | 755 participants | 377 participants | 378 participants |
| Number of previous suicide attempts 2 previous suicide attempts | 251 participants | 126 participants | 125 participants |
| Number of previous suicide attempts 3 previous suicide attempts | 105 participants | 53 participants | 52 participants |
| Number of previous suicide attempts 4 previous suicide attempts | 31 participants | 13 participants | 18 participants |
| Number of previous suicide attempts >= 5 previous suicide attempts | 70 participants | 36 participants | 34 participants |
| Number of previous suicide attempts Unknown | 28 participants | 11 participants | 17 participants |
| Reasons for prescription of study drug Adverse drug reaction | 2193 participants | 1072 participants | 1121 participants |
| Reasons for prescription of study drug Lack of efficacy | 5122 participants | 2580 participants | 2542 participants |
| Reasons for prescription of study drug None or poor compliance | 330 participants | 169 participants | 161 participants |
| Reasons for prescription of study drug Other | 193 participants | 104 participants | 89 participants |
| Reasons for prescription of study drug Patient's choice | 1971 participants | 979 participants | 992 participants |
| Sex: Female, Male Female | 4383 Participants | 2188 Participants | 2195 Participants |
| Sex: Female, Male Male | 5426 Participants | 2716 Participants | 2710 Participants |
| Time since last suicide attempt 1 to 5 years | 444 participants | 218 participants | 226 participants |
| Time since last suicide attempt < 1 year | 239 participants | 117 participants | 122 participants |
| Time since last suicide attempt > 5 years | 527 participants | 268 participants | 259 participants |
| Time since last suicide attempt No previous suicide attempt or unknown | 8599 participants | 4301 participants | 4298 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 397 / 4,905 | 11 / 4,904 |
| serious Total, serious adverse events | 266 / 4,905 | 217 / 4,904 |
Outcome results
Primary
Number of Participants With All-cause Mortality
The analysis was based on all deaths from the Whole Randomised Treatment (WRT)+30 days period and the Only Randomised Treatment (ORT) period, respectively
Time frame: As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months
Population: The analysis population included all patients who took at least one dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sertindole | Number of Participants With All-cause Mortality | Number of deaths (WRT+30 days) | 64 participants |
| Sertindole | Number of Participants With All-cause Mortality | Number of deaths (ORT) | 40 participants |
| Risperidone | Number of Participants With All-cause Mortality | Number of deaths (WRT+30 days) | 61 participants |
| Risperidone | Number of Participants With All-cause Mortality | Number of deaths (ORT) | 44 participants |
Comparison: The basis for the statistical analysis of the first primary outcome was the null hypothesis of an excess mortality in sertindole-treated patients compared to the mortality in risperidone-treated patients for the WRT+30 days period.p-value: 0.0590% CI: [0.831, 1.5]Cox Proportional Hazard
Comparison: The basis for the statistical analysis of the first primary outcome was the null hypothesis of an excess mortality in sertindole-treated patients compared to the mortality in risperidone-treated patients for the ORT period.p-value: <0.0590% CI: [0.684, 1.405]Cox Proportional Hazard
Primary
Second Primary Outcome: Number of Participants With Cardiac Events, Including Arrhythmias, Requiring Hospitalisation
Second primary endpoint: a serious adverse event where the patient was hospitalised and for which the Independent Safety Committee (ISC) classified the event as a cardiac event with documented arrhythmia. The analysis of this outcome was not performed due to low number of events. The presented analysis is a replacement analysis using all cardiac events, including arrhythmias, that required hospitalisation
Time frame: As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months
Population: The analysis population included all patients who took at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sertindole | Second Primary Outcome: Number of Participants With Cardiac Events, Including Arrhythmias, Requiring Hospitalisation | 10 participants |
| Risperidone | Second Primary Outcome: Number of Participants With Cardiac Events, Including Arrhythmias, Requiring Hospitalisation | 6 participants |
Comparison: The basis for the statistical analysis of time to 1st occurence of the secondary primary outcome (one patient in the risperidone group reported more than one occurrence of this event) was the null hypothesis of hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.p-value: 0.2995% CI: [0.63, 4.78]Cox Proportional Hazard
Secondary
Cause-specific Mortality: Number of Participants With Cardiac Deaths - ISC
The analysis was based on all deaths from the WRT+30 days period using the classification performed by the ISC. The ISC reviewed and classified those adverse events which resulted in death or hospitalisation or were possible suicide attempts and this review was blinded to exposure. The definition of cardiac death was intentionally wide; sudden or unexplained deaths were assumed to be cardiac if there was no non-cardiac explanation. To ensure consistent evaluation and classification, the ISC decided a priori to classify all instances of self harm as possible suicide.
Time frame: As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months
Population: The analysis population included all patients who took at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sertindole | Cause-specific Mortality: Number of Participants With Cardiac Deaths - ISC | 31 participants |
| Risperidone | Cause-specific Mortality: Number of Participants With Cardiac Deaths - ISC | 12 participants |
Comparison: The basis for the statistical analysis of this secondary outcome was the null hypothesis of mortality hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.p-value: 0.002295% CI: [1.45, 5.55]Cox Proportional Hazard
Secondary
Cause-specific Mortality: Number of Participants With Cardiac Deaths - MedDRA
The analysis was based on all deaths from the WRT+30 days period using the classification based upon the Medical Dictionary for Regulatory Activities (MedDRA) terminology, that is, as reported by the investigator
Time frame: As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sertindole | Cause-specific Mortality: Number of Participants With Cardiac Deaths - MedDRA | 17 participants |
| Risperidone | Cause-specific Mortality: Number of Participants With Cardiac Deaths - MedDRA | 8 participants |
Comparison: The basis for the statistical analysis of this secondary outcome was the null hypothesis of mortality hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.p-value: 0.08195% CI: [0.91, 4.98]Cox Proportional Hazard
Secondary
Cause-specific Mortality: Number of Participants With Completed Suicides - ISC
The analysis was based on all deaths from the WRT+30 days period using the classification performed by the ISC. The ISC reviewed and classified those adverse events which resulted in death or hospitalisation or were possible suicide attempts and this review was blinded to exposure. The definition of cardiac death was intentionally wide; sudden or unexplained deaths were assumed to be cardiac if there was no non-cardiac explanation. To ensure consistent evaluation and classification, the ISC decided a priori to classify all instances of self harm as possible suicide.
Time frame: As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sertindole | Cause-specific Mortality: Number of Participants With Completed Suicides - ISC | 14 participants |
| Risperidone | Cause-specific Mortality: Number of Participants With Completed Suicides - ISC | 21 participants |
Comparison: The basis for the statistical analysis of this secondary outcome was the null hypothesis of mortality hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.p-value: 0.3495% CI: [0.36, 1.41]Cox Proportional Hazard
Secondary
Cause-specific Mortality: Number of Participants With Completed Suicides - MedDRA
The analysis was based on all deaths from the WRT+30 days period using the classification based upon MedDRA terminology, that is, as reported by the investigator
Time frame: As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sertindole | Cause-specific Mortality: Number of Participants With Completed Suicides - MedDRA | 13 participants |
| Risperidone | Cause-specific Mortality: Number of Participants With Completed Suicides - MedDRA | 21 participants |
Comparison: The basis for the statistical analysis of this secondary outcome was the null hypothesis of mortality hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.p-value: 0.2495% CI: [0.33, 1.32]Cox Proportional Hazard
Secondary
Cause-specific Mortality: Number of Participants With Other Than Cardiac Deaths and Completed Suicides - ISC
The analysis was based on all deaths from the WRT+30 days period using the classification performed by the ISC. The ISC reviewed and classified those adverse events which resulted in death or hospitalisation or were possible suicide attempts and this review was blinded to exposure. The definition of cardiac death was intentionally wide; sudden or unexplained deaths were assumed to be cardiac if there was no non-cardiac explanation. To ensure consistent evaluation and classification, the ISC decided a priori to classify all instances of self harm as possible suicide.
Time frame: As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sertindole | Cause-specific Mortality: Number of Participants With Other Than Cardiac Deaths and Completed Suicides - ISC | 19 participants |
| Risperidone | Cause-specific Mortality: Number of Participants With Other Than Cardiac Deaths and Completed Suicides - ISC | 28 participants |
Comparison: The basis for the statistical analysis of this secondary outcome was the null hypothesis of mortality hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.p-value: 0.2695% CI: [0.4, 1.28]Cox Proportional Hazard
Secondary
Cause-specific Mortality: Number of Participants With Other Than Cardiac Deaths and Completed Suicides - MedDRA
The analysis was based on all deaths from the WRT+30 days period using the classification based upon MedDRA terminology, that is, as reported by the investigator
Time frame: As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sertindole | Cause-specific Mortality: Number of Participants With Other Than Cardiac Deaths and Completed Suicides - MedDRA | 34 participants |
| Risperidone | Cause-specific Mortality: Number of Participants With Other Than Cardiac Deaths and Completed Suicides - MedDRA | 32 participants |
Comparison: The basis for the statistical analysis of this secondary outcome was the null hypothesis of mortality hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.p-value: 0.5995% CI: [0.7, 1.85]Cox Proportional Hazard
Secondary
Number of Participants With Discontinuation of Treatment for Any Reason Other Than Study Closure
The analysis was based on time from start of study drug until stop of study drug for any reason other than sponsor closure of the study
Time frame: As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months
Population: The analysis population included all patients who took at least one dose of study drug.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Sertindole | Number of Participants With Discontinuation of Treatment for Any Reason Other Than Study Closure | 3136 participants | — |
| Risperidone | Number of Participants With Discontinuation of Treatment for Any Reason Other Than Study Closure | 2597 participants | 433 |
Comparison: The basis for the statistical analysis of this secondary outcome was the null hypothesis of hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.p-value: <0.000195% CI: [1.28, 1.43]Cox Proportional Hazard
Secondary
Number of Participants With Hospitalisations, Excluding Hospitalisations Related to the Primary Psychiatric Disease
The analysis was based on time from start of study drug to first hospitalisation during the WRT+30 days period
Time frame: As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months
Population: The analysis population included all patients who took at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sertindole | Number of Participants With Hospitalisations, Excluding Hospitalisations Related to the Primary Psychiatric Disease | 174 participants |
| Risperidone | Number of Participants With Hospitalisations, Excluding Hospitalisations Related to the Primary Psychiatric Disease | 149 participants |
Comparison: The basis for the statistical analysis of time to 1st occurence of this secondary outcome was the null hypothesis of hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.p-value: 0.0495% CI: [1.01, 1.57]Cox Proportional Hazard
Secondary
Number of Participants With Suicide Attempts (Fatal and Non-fatal) - ISC
The analysis was based on all suicides and suicide attempts from the WRT+30 days period using the classification performed by the ISC. The ISC reviewed and classified those adverse events which resulted in death or hospitalisation or were possible suicide attempts and this review was blinded to exposure. The definition of cardiac death was intentionally wide; sudden or unexplained deaths were assumed to be cardiac if there was no non-cardiac explanation. To ensure consistent evaluation and classification, the ISC decided a priori to classify all instances of self harm as possible suicide.
Time frame: As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months
Population: The analysis population included all patients who took at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sertindole | Number of Participants With Suicide Attempts (Fatal and Non-fatal) - ISC | 68 participants |
| Risperidone | Number of Participants With Suicide Attempts (Fatal and Non-fatal) - ISC | 76 participants |
Comparison: The basis for the statistical analysis of time to 1st occurence of this secondary outcome was the null hypothesis of hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.p-value: 0.6595% CI: [0.66, 1.29]Cox Proportional Hazard
Secondary
Number of Participants With Suicide Attempts (Fatal and Non-fatal) - MedDRA
The analysis was based on all suicides and suicide attempts from the WRT+30 days period using the classification based upon MedDRA terminology, that is, as reported by the investigator
Time frame: As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sertindole | Number of Participants With Suicide Attempts (Fatal and Non-fatal) - MedDRA | 43 participants |
| Risperidone | Number of Participants With Suicide Attempts (Fatal and Non-fatal) - MedDRA | 65 participants |
Comparison: The basis for the statistical analysis of time to 1st occurence of this secondary outcome was the null hypothesis of hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.p-value: 0.04495% CI: [0.45, 0.99]Cox Proportional Hazard