| Diabetes | CKD | Chronic CVD | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
All data n (%) | OM 40/ AML 10 mg | OM 40/ HCTZ 25 mg | AML 10/ HCTZ 25 mg | OM 40/ AML 10/ HCTZ 25 mg | OM 40/ AML 10 mg | OM 40/ HCTZ 25 mg | AML 10/ HCTZ 25 mg | OM 40/ AML 10/ HCTZ 25 mg | OM 40/ AML 10 mg | OM 40/ HCTZ 25 mg | AML 10/ HCTZ 25 mg | OM 40/ AML 10/ HCTZ 25 mg |
 | (n=96) | (n=91) | (n=85) | (n=92) | (n=29) | (n=22) | (n=28) | (n=18) | (n=53) | (n=54) | (n=50) | (n=49) |
All TEAEs* | 47 (49.0) | 49 (53.8) | 51 (60.0) | 58 (63.0) | 16 (55.2) | 11 (50.0) | 20 (71.4) | 9 (50.0) | 23 (43.4) | 32 (59.3) | 30 (60.0) | 34 (69.4) |
Severe TEAEs | 4 (4.2) | 4 (4.4) | 5 (5.9) | 6 (6.5) | 0 | 2 (9.1) | 2 (7.1) | 1 (5.6) | 2 (3.8) | 2 (3.7) | 2 (4.0) | 5 (10.2) |
Drug-related TEAEs †| 21 (21.9) | 16 (17.6) | 17 (20.0) | 25 (27.2) | 5 (17.2) | 8 (36.4) | 10 (35.7) | 3 (16.7) | 9 (17.0) | 11 (20.4) | 13 (26.0) | 17 (34.7) |
Discontinuations | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
TEAEs | 2 (2.1) | 2 (2.2) | 2 (2.4) | 5 (5.4) | 0 | 1 (4.5) | 2 (7.1) | 0 | 0 | 3 (5.6) | 0 | 3 (6.1) |
Drug-related TEAEs†| 1 (1.0) | 0 | 0 | 5 (5.4) | 0 | 0 | 1 (3.6) | 0 | 0 | 0 | 0 | 2 (4.1) |
TEAEs (>5% in any treatment group) ‡ |  |  |  |  |  |  |  |  |  |  |  |  |
Dizziness | 3 (3.1) | 3 (3.3) | 3 (3.5) | 7 (7.6) | 1 (3.4) | 1 (4.5) | 3 (10.7) | 1 (5.6) | 1 (1.9) | 5 (9.3) | 2 (4.0) | 7 (14.3) |
Headache | 5 (5.2) | 8 (8.8) | 2 (2.4) | 5 (5.4) | 1 (3.4) | 3 (13.6) | 1 (3.6) | 0 | 1 (1.9) | 3 (5.6) | 1 (2.0) | 2 (4.1) |
Urinary tract infection | 3 (3.1) | 3 (3.3) | 3 (3.5) | 6 (6.5) | 0 | 0 | 0 | 3 (16.7) | 0 | 0 | 1 (2.0) | 2 (4.1) |
Upper respiratory tract infection | 2 (2.1) | 2 (2.2) | 2 (2.4) | 2 (2.2) | 3 (10.3) | 0 | 1 (3.6) | 2 (11.1) | 0 | 0 | 1 (2.0) | 0 |
Bronchitis | 2 (2.1) | 0 | 1 (1.2) | 3 (3.3) | 0 | 1 (4.5) | 0 | 2 (11.1) | 0 | 3 (5.6) | 2 (4.0) | 1 (2.0) |
Edema, peripheral | 9 (9.4) | 1 (1.1) | 4 (4.7) | 9 (9.8) | 1 (3.4) | 1 (4.5) | 5 (17.9) | 1 (5.6) | 3 (5.7) | 1 (1.9) | 4 (8.0) | 4 (8.2) |
Fatigue | 5 (5.2) | 10 (11.0) | 6 (7.1) | 2 (2.2) | 0 | 1 (4.5) | 2 (7.1) | 0 | 2 (3.8) | 5 (9.3) | 1 (2.0) | 3 (6.1) |
Joint swelling | 1 (1.0) | 0 | 2 (2.4) | 1 (1.1) | 4 (13.8) | 0 | 0 | 1 (5.6) | 1 (1.9) | 1 (1.9) | 3 (6.0) | 3 (6.1) |
Muscle spasms | 4 (4.2) | 2 (2.2) | 0 | 3 (3.3) | 1 (3.4) | 2 (9.1) | 0 | 0 | 0 | 3 (5.6) | 3 (6.0) | 0 |
Nausea | 0 | 3 (3.3) | 2 (2.4) | 4 (4.3) | 1 (3.4) | 0 | 2 (7.1) | 0 | 0 | 2 (3.7) | 0 | 4 (8.2) |
Diarrhea | 1 (1.0) | 2 (2.2) | 2 (2.4) | 2 (2.2) | 4 (13.8) | 0 | 1 (3.6) | 0 | 2 (3.8) | 0 | 1 (2.0) | 0 |
Constipation | 0 | 0 | 0 | 5 (5.4) | 0 | 1 (4.5) | 1 (3.6) | 0 | 1 (1.9) | 0 | 0 | 2 (4.1) |
Hypokalemia | 0 | 0 | 2 (2.4) | 1 (1.1) | 0 | 0 | 4 (14.3) | 0 | 0 | 2 (3.7) | 3 (6.0) | 0 |