SUPPLEMENTARY MATERIALS. Rivaroxaban for Stroke Prevention in East Asian Patients from the ROCKET AF Trial

Transcription

1 1 SUPPLEMENTARY MATERIALS Rivaroxaban for Stroke Prevention in East Asian Patients from the ROCKET AF Trial Professor Ka Sing Lawrence Wong on behalf of The Executive Steering Committee and the ROCKET AF Study Investigators Table of contents Supplementary Tables... 2 Supplementary Table I. Intracranial hemorrhage: patients from East Asian versus non- East Asian patients within each treatment group.2 Supplementary Table II. Most frequent non-hemorrhagic serious treatment-emergent adverse events in the ROCKET AF East Asian cohort.*... 3 Supplementary Figures... 5 Supplementary figure I. ROCKET AF East Asian cohort flow diagram Supplementary figure II. Subgroup analyses for the primary efficacy endpoint in the intention-to-treat population until site notification of the ROCKET AF East Asian cohort... 6 Supplementary figure III. Subgroup analyses for the principal safety outcome in the safety population during treatment of the ROCKET AF East Asian cohort... 8 Supplementary figure IV. Subgroup analyses for major bleeding in the safety population during treatment of the ROCKET AF East Asian cohort... 10

2 2 Supplementary Tables Supplementary Table I. Intracranial hemorrhage: patients from East Asian versus non-east Asian patients within each treatment group. Treatment group East Asia vs non-east Asia Hazard ratio (95% CI)* Rivaroxaban 1 20 (0 43 to 3 31); P=0 73 Warfarin 3 89 (2 29 to 6 63); P< *Safety population during treatment. Event rates are shown in Figure 2. CI, confidence interval.

3 3 Supplementary Table II. Most frequent non-hemorrhagic serious treatment-emergent adverse events in the ROCKET AF East Asian cohort.* Rivaroxaban (N=466) n (%) Warfarin (N=462) n (%) Total patients with non-bleeding treatmentemergent 108 (23.2) 144 (31.2) serious adverse event Cardiac failure 9 (1.9) 16 (3.5) Pneumonia 7 (1.5) 8 (1.7) Cardiac failure congestive 5 (1.1) 10 (2.2) Lung infection 5 (1.1) 3 (0.6) Atrial fibrillation 4 (0.9) 7 (1.5) Coronary artery disease 4 (0.9) 2 (0.4) Dental caries 4 (0.9) 1 (0.2) Colon cancer 3 (0.6) 1 (0.2) Colonic polyp 3 (0.6) 1 (0.2) Hyperglycemia 3 (0.6) 2 (0.4) Pleural effusion 3 (0.6) 0 (0.0) Sudden death 3 (0.6) 2 (0.4) Urinary tract infection 3 (0.6) 2 (0.4) Angina pectoris 2 (0.4) 2 (0.4) Bronchitis 2 (0.4) 3 (0.6) Cardiogenic shock 2 (0.4) 0 (0.0) Femoral neck fracture 2 (0.4) 2 (0.4) Gastroenteritis 2 (0.4) 2 (0.4) Hypoglycemia 2 (0.4) 1 (0.2)

4 4 Intervertebral disc protrusion 2 (0.4) 0 (0.0) Lower respiratory tract infection 2 (0.4) 0 (0.0) Lung neoplasm malignant 2 (0.4) 1 (0.2) Spinal compression fracture 2 (0.4) 1 (0.2) Syncope 2 (0.4) 3 (0.6) Upper respiratory tract infection 2 (0.4) 1 (0.2) ALT >3 ULN and TBL >2 ULN either on 3 (0.7) 5 (1.1) same day or within following 30 days Based on safety population. *Most frequent based on the rivaroxaban treatment group. Events that started on or after the first dose of study medication and up to 2 days after the last dose of study medication. Prespecified laboratory abnormalities not included in the list of the 15 most frequent nonhemorrhagic treatment-emergent serious adverse events. ALT, alanine aminotransferase; TBL, total bilirubin; ULN, upper limit of normal.

5 5 Supplementary Figures Supplementary figure I. ROCKET AF East Asian cohort flow diagram.

6 6 Supplementary figure II. Subgroup analyses for the primary efficacy endpoint in the intention-to-treat population until site notification of the ROCKET AF East Asian cohort. This is a post hoc analysis that has not been corrected for multiple analyses. Interpretation of the interaction P-values requires consideration of the lack of a significant treatment effect between the two treatment groups. Hazard ratios displayed in the forest plots are calculated from event rates (%/year) whereas the numbers of events shown at left indicate the percentage of patients experiencing an event (n/n). *Hazard ratio (95% CI) from the Cox proportional hazard model with treatment as a covariate. P-value for the interaction of treatment group and each baseline subgroup based on the Cox proportional hazard model, including treatment group, baseline, subgroup, and their interaction. Statistically significant at nominal 0.05 (two-sided). ASA, acetylsalicylic acid; CI, confidence interval; CNS, central nervous system; TIA, transient ischemic attack.

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8 8 Supplementary figure III. Subgroup analyses for the principal safety outcome in the safety population during treatment of the ROCKET AF East Asian cohort. This is a post hoc analysis that has not been corrected for multiple analyses. Interpretation of the interaction P-values requires consideration of the lack of a significant treatment effect between the two treatment groups. Hazard ratios displayed in the forest plots are calculated from event rates (%/year) whereas the numbers of events shown at left indicate the percentage of patients experiencing an event (n/n). *Hazard ratio (95% CI) from the Cox proportional hazard model with treatment as a covariate. P-value for the interaction of treatment group and each baseline subgroup based on the Cox proportional hazard model, including treatment group, baseline subgroup, and their interaction. Statistically significant at nominal 0.05 (two-sided). ASA, acetylsalicylic acid; CI, confidence interval; CNS, central nervous system; TIA, transient ischemic attack.

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10 10 Supplementary figure IV. Subgroup analyses for major bleeding in the safety population during treatment of the ROCKET AF East Asian cohort. This is a post hoc analysis that has not been corrected for multiple analyses. Interpretation of the interaction P-values requires consideration of the lack of a significant treatment effect between the two treatment groups. Hazard ratios displayed in the forest plots are calculated from event rates (%/year) whereas the numbers of events shown at left indicate the percentage of patients experiencing an event (n/n). *Hazard ratio (95% CI) from the Cox proportional hazard model with treatment as a covariate. P-value for the interaction of treatment group and each baseline subgroup based on the Cox proportional hazard model, including treatment group, baseline subgroup, and their interaction. Statistically significant at nominal 0.05 (two-sided). ASA, acetylsalicylic acid; CI, confidence interval; CNS, central nervous system; TIA, transient ischemic attack.

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