Table 3 Renal Events During 12-Week Follow-up Period by Cohort (Full Analysis Set)

No. of patients with events

28

62

1450

-

-

% of patients (95% CI)

2.3 (1.4, 3.1)

5.6 (4.3, 7.0)

3.2 (3.1, 3.4)

< 0.001

0.070

Incidence Rate for All Renal Events

No. of valid patients^a

1221

1039

45112

-

-

No. of patients with events (%)

26 (2.13)

52 (5.00)

1450 (3.21)

-

-

Incidence rate (patient-month) (95% CI)

7.89

(5.15, 11.56)

18.76

(14.01, 24.61)

11.98

(11.37, 12.61)

< 0.001

0.034

Incidence rate ratio^b

(95% CI)

-

2.38

(1.49, 3.81)

1.52

(1.03, 2.24)

-

-

Confirmed Renal Events

No. of patients with events

9

29

1106

% of patients (95% CI)

0.7 (0.3, 1.2)

2.6 (1.7, 3.6)

2.5 (2.3, 2.6)

< 0.001

< 0.001

Incidence Rate for Confirmed Renal Events

No. of valid patients^a

1223

1048

45112

-

-

No. of patients with events (%)

9 (0.74)

28 (2.67)

1106 (2.45)

-

-

Incidence rate (patient-month) (95% CI)

2.69

(1.23, 5.10)

9.84

(6.54, 14.23)

9.09

(8.56, 9.64)

0.004

< 0.001

Incidence rate ratio^b

(95% CI)

-

3.66

(1.72, 7.56)

3.38

(1.75, 6.52)

-

-