|
n
|
56
|
58
|
58
|
58
|
|
Number of patients with AEs
|
25 (44.6%)
|
35 (60.3%)
|
31 (53.4%)
|
31 (53.4%)
|
|
Number of AEs
|
40
|
80
|
62
|
69
|
|
Number of patients with ADRs
|
4 (7.1%)
|
16 (27.6%)
|
15 (25.9%)
|
16 (27.6%)
|
|
Number of ADRs
|
6
|
24
|
26
|
24
|
|
Deaths
|
0 (0.0%)
|
0 (0.0%)
|
0 (0.0%)
|
0 (0.0%)
|
|
Serious AEs
|
2 (3.6%)*
|
2 (3.4%)†
|
0 (0.0%)
|
3 (5.2%)‡
|
|
Serious ADRs
|
0 (0.0%)
|
0 (0.0%)
|
0 (0.0%)
|
1 (1.7%)§
|
|
AEs leading to discontinuation
|
1 (1.8%)
|
1 (1.7%)
|
0 (0.0%)
|
2 (3.4%)
|
|
ADRs leading to discontinuation
|
0 (0.0%)
|
1 (1.7%)
|
0 (0.0%)
|
1 (1.7%)
|
|
AEs occurring in more than ≥5% of patients in any treatment groups
| |
|
Infections and infestations
| | | | |
|
Nasopharyngitis
|
12 (21.4%)
|
9 (15.5%)
|
6 (10.3%)
|
6 (10.3%)
|
|
Upper respiratory tract infection
|
1 (1.8%)
|
0 (0.0%)
|
3 (5.2%)
|
2 (3.4%)
|
|
Investigations
| | | | |
|
Hyperketonemia
|
1 (1.8%)
|
2 (3.4%)
|
7 (12.1%)
|
8 (13.8%)
|
|
Ketonuria
|
0 (0.0%)
|
1 (1.7%)
|
3 (5.2%)
|
0 (0.0%)
|
|
Increased urinary β-2 microglobulin
|
1 (1.8%)
|
3 (5.2%)
|
0 (0.0%)
|
0 (0.0%)
|
|
Renal and urinary disorders
| | | | |
|
Pollakiuria
|
1 (1.8%)
|
3 (5.2%)
|
4 (6.9%)
|
6 (10.3%)
|
|
Musculoskeletal and connective tissue disorders
| | | | |
|
Back pain
|
3 (5.4%)
|
3 (5.2%)
|
2 (3.4%)
|
1 (1.7%)
|
|
Nervous system disorders
| | | | |
|
Headache
|
0 (0.0%)
|
3 (5.2%)
|
0 (0.0%)
|
1 (1.7%)
|
|
Other events of special interest in <5% of patients
| |
|
Genitourinary infections
| | | | |
|
Cystitis
|
0 (0.0%)
|
0 (0.0%)
|
0 (0.0%)
|
1 (1.7)
|
|
Vulvitis
|
0 (0.0%)
|
0 (0.0%)
|
0 (0.0%)
|
1 (1.7)
|
|
Hypoglycemia
|
0 (0.0%)
|
1 (1.7)
|
0 (0.0%)
|
1 (1.7)
|
|
Increased urine volume
|
0 (0.0%)
|
0 (0.0%)
|
1 (1.7)
|
1 (1.7)
|
|
Volume-related events
| | | | |
|
Orthostatic hypotension
|
0 (0.0%)
|
0 (0.0%)
|
0 (0.0%)
|
1 (1.7)
|
|
Dizziness
|
1 (1.8%)
|
2 (3.4%)
|
0 (0.0%)
|
0 (0.0%)
|
|
Postural dizziness
|
0 (0.0%)
|
1 (1.7)
|
1 (1.7)
|
0 (0.0%)
|
