Hypertension severity: AEs were observed at similar rates in subjects with mild to moderate and severe hypertension.The small number of subjects with severe hypertension limits interpretation of data in this subgroup (Table 32, below). 32: Overview of Adverse Events Number (%) of Subjects by Period II Treatment Group – – Hypertension Severity Subgroup Set 2 (CS8635-A-E303) –Safety Mild or Moderate Severe Hypertension Hypertension N = 60 N = 746 TEAE n (%) 107 (14.3%) 8 (13.3%) Peripheral oedema 15 (2.0) 2 (3.3) URTI 11 ( 1.5) 1 ( 1.7) Drug-related TEAE n (%) 40 (5.4%) 3 (5.0%) Deaths n (%) 0 (0.0) 0 (0.0) SAE n (%) 4 (0.5%) 1 (1.7%) Discontinued due to AE n (%) 10 (1.3%) 0 (0.0) Diabetic Status: AEs were observed at similar in subjects with and without diabetes.The small number of subjects with diabetes limits interpretation of data in this subgroup (Table 33). Table 33: Overview of Adverse Events Number (%) of Subjects by Period II Treatment Group – – Diabetic Status Subgroup Set 2 (CS8635-A-E303) –Safety With Diabetes Without Diabetes N = 104 N = 702 TEAE n (%) 13 (12.5%) 102 (14.5%) Peripheral oedema 1 (1.0) 16 (2.3) URTI 0 (0.0) 12 (1.7) Bronchitis 2 (1.9) 5 (0.7) Hyperglycaemia 4 (3.8) 1 (0.1) Drug-related TEAE n (%) 3 (2.9%) 40 (5.7%) Deaths n (%) 0 (0.0) 0 (0.0) SAE n (%) 2 (1.9%) 3 (0.4%) Discontinued due to AE n 1 (1.0%) 9 (1.3%) (%) Safety related to drug-drug interactions and other interactions None reported in the submitted data.
Hypertension severity: AEs were observed at similar rates in subjects with mild to moderate and severe hypertension.The small number of subjects with severe hypertension limits interpretation of data in this subgroup (Table 32, below). 32: Overview of Adverse Events – Number (%) of Subjects by Period II Treatment Group – Hypertension Severity Subgroup –Safety Set 2 (CS8635-A-E303) Mild or Moderate Hypertension N = 746 Severe Hypertension N = 60 TEAE n (%) Peripheral oedema URTI 107 (14.3%) 15 (2.0) 11 ( 1.5) 8 (13.3%) 2 (3.3) 1 ( 1.7) Drug-related TEAE n (%) 40 (5.4%) 3 (5.0%) Deaths n (%) 0 (0.0) 0 (0.0) SAE n (%) 4 (0.5%) 1 (1.7%) Discontinued due to AE n (%) 10 (1.3%) 0 (0.0) Diabetic Status: AEs were observed at similar in subjects with and without diabetes.The small number of subjects with diabetes limits interpretation of data in this subgroup (Table 33). Table 33: Overview of Adverse Events – Number (%) of Subjects by Period II Treatment Group – Diabetic Status Subgroup –Safety Set 2 (CS8635-A-E303) With Diabetes N = 104 Without Diabetes N = 702 TEAE n (%) Peripheral oedema URTI Bronchitis Hyperglycaemia 13 (12.5%) 1 (1.0) 0 (0.0) 2 (1.9) 4 (3.8) 102 (14.5%) 16 (2.3) 12 (1.7) 5 (0.7) 1 (0.1) Drug-related TEAE n (%) 3 (2.9%) 40 (5.7%) Deaths n (%) 0 (0.0) 0 (0.0) SAE n (%) 2 (1.9%) 3 (0.4%) Discontinued due to AE n (%) 1 (1.0%) 9 (1.3%) Safety related to drug-drug interactions and other interactions None reported in the submitted data.
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