Fine and Gray cumulative incidence of the primary endpoint in the three patient subgroups at 12 and 36 months in the Phase 1 analysis, i.e. the analysis excluding cardiac magnetic resonance imaging parameters, and in the Phase 2 analysis, i.e. the analysis including cardiac magnetic resonance imaging parameters
| Time point (months after time zero) . | ICD patients incidence (95% confidence interval) of the endpoint, first appropriate therapy . | Non-ICD patients ≤35% incidence (95% confidence interval) of the endpoint, sudden cardiac deatha . | Non-ICD patients >35% incidence (95% confidence interval) of the endpoint, sudden cardiac deatha . |
|---|---|---|---|
| Phase 1 analysis (excluding cardiac magnetic resonance imaging parameters) | |||
| 12 | 9.12% (8.48%, 9.77%) | 1.84% (1.68%, 2.01%) | 0.38% (0.34%, 0.41%) |
| 36 | 18.42% (17.44%, 19.39%) | 3.41% (3.18%, 3.63%) | 0.87% (0.81%, 0.92%) |
| Phase 2 analysis (including cardiac magnetic resonance imaging parameters) | |||
| 12 | 7.49% (5.19%, 9.78%) | 3.66% (2.12%, 5.19%) | 0.41% (0.01%, 0.81%) |
| 36 | 17.43% (14.05%, 20.82%) | 7.34% (5.14%, 9.54%) | 1.89% (1.02%, 2.75%) |
| Time point (months after time zero) . | ICD patients incidence (95% confidence interval) of the endpoint, first appropriate therapy . | Non-ICD patients ≤35% incidence (95% confidence interval) of the endpoint, sudden cardiac deatha . | Non-ICD patients >35% incidence (95% confidence interval) of the endpoint, sudden cardiac deatha . |
|---|---|---|---|
| Phase 1 analysis (excluding cardiac magnetic resonance imaging parameters) | |||
| 12 | 9.12% (8.48%, 9.77%) | 1.84% (1.68%, 2.01%) | 0.38% (0.34%, 0.41%) |
| 36 | 18.42% (17.44%, 19.39%) | 3.41% (3.18%, 3.63%) | 0.87% (0.81%, 0.92%) |
| Phase 2 analysis (including cardiac magnetic resonance imaging parameters) | |||
| 12 | 7.49% (5.19%, 9.78%) | 3.66% (2.12%, 5.19%) | 0.41% (0.01%, 0.81%) |
| 36 | 17.43% (14.05%, 20.82%) | 7.34% (5.14%, 9.54%) | 1.89% (1.02%, 2.75%) |
ICD patients, patients with left ventricular ejection fraction ≤ 35% who had received a cardioverter-defibrillator implantation for primary prevention of sudden cardiac death. Non-ICD patients ≤35%, patients who did not carry a cardioverter-defibrillator and had a left ventricular ejection fraction ≤ 35%. Non-ICD patients >35%, patients who did not carry a cardioverter-defibrillator and had a left ventricular ejection fraction > 35%.
aIn two data sets, the primary outcome included additionally life-threatening ventricular arrhythmias (ventricular fibrillation or ventricular tachycardia).
Fine and Gray cumulative incidence of the primary endpoint in the three patient subgroups at 12 and 36 months in the Phase 1 analysis, i.e. the analysis excluding cardiac magnetic resonance imaging parameters, and in the Phase 2 analysis, i.e. the analysis including cardiac magnetic resonance imaging parameters
| Time point (months after time zero) . | ICD patients incidence (95% confidence interval) of the endpoint, first appropriate therapy . | Non-ICD patients ≤35% incidence (95% confidence interval) of the endpoint, sudden cardiac deatha . | Non-ICD patients >35% incidence (95% confidence interval) of the endpoint, sudden cardiac deatha . |
|---|---|---|---|
| Phase 1 analysis (excluding cardiac magnetic resonance imaging parameters) | |||
| 12 | 9.12% (8.48%, 9.77%) | 1.84% (1.68%, 2.01%) | 0.38% (0.34%, 0.41%) |
| 36 | 18.42% (17.44%, 19.39%) | 3.41% (3.18%, 3.63%) | 0.87% (0.81%, 0.92%) |
| Phase 2 analysis (including cardiac magnetic resonance imaging parameters) | |||
| 12 | 7.49% (5.19%, 9.78%) | 3.66% (2.12%, 5.19%) | 0.41% (0.01%, 0.81%) |
| 36 | 17.43% (14.05%, 20.82%) | 7.34% (5.14%, 9.54%) | 1.89% (1.02%, 2.75%) |
| Time point (months after time zero) . | ICD patients incidence (95% confidence interval) of the endpoint, first appropriate therapy . | Non-ICD patients ≤35% incidence (95% confidence interval) of the endpoint, sudden cardiac deatha . | Non-ICD patients >35% incidence (95% confidence interval) of the endpoint, sudden cardiac deatha . |
|---|---|---|---|
| Phase 1 analysis (excluding cardiac magnetic resonance imaging parameters) | |||
| 12 | 9.12% (8.48%, 9.77%) | 1.84% (1.68%, 2.01%) | 0.38% (0.34%, 0.41%) |
| 36 | 18.42% (17.44%, 19.39%) | 3.41% (3.18%, 3.63%) | 0.87% (0.81%, 0.92%) |
| Phase 2 analysis (including cardiac magnetic resonance imaging parameters) | |||
| 12 | 7.49% (5.19%, 9.78%) | 3.66% (2.12%, 5.19%) | 0.41% (0.01%, 0.81%) |
| 36 | 17.43% (14.05%, 20.82%) | 7.34% (5.14%, 9.54%) | 1.89% (1.02%, 2.75%) |
ICD patients, patients with left ventricular ejection fraction ≤ 35% who had received a cardioverter-defibrillator implantation for primary prevention of sudden cardiac death. Non-ICD patients ≤35%, patients who did not carry a cardioverter-defibrillator and had a left ventricular ejection fraction ≤ 35%. Non-ICD patients >35%, patients who did not carry a cardioverter-defibrillator and had a left ventricular ejection fraction > 35%.
aIn two data sets, the primary outcome included additionally life-threatening ventricular arrhythmias (ventricular fibrillation or ventricular tachycardia).
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