Supplementary Table 3. Treatment-emergent AEs, n/N (%) by pooled treatment with nifedipine GITS
(N20, 30, 60 mg) and/or candesartan cilexetil (C4, 8, 16, 32 mg) or placebo in individuals treated for 8 weeks, categorized by gender, age and BMI
Pooled treatment group
Gender Age (years) BMI ( kg/m2 )
Male (n = 799)
Female (n = 582)
< 55 (n = 714)
55–64 (n = 466)
≥ 65 (n = 201)
< 25 (n = 172)
25–29 (n = 477) Any
treatme nt- emerge
nt AE
Total 295 (36.9%) 241 (41.4%) 291 (40.8%)
174 (37.3%)
71 (35.3%) 53 (30.8%)
174 (36.5%) Placebo 12/49
(24.5%)
13/39 (33.3%)
16/49 (32.7%)
7/24 (29.2%)
2/15 (13.3%)
2/10 (20.0%)
6/27 (22.2%)
C 56/204
(27.5%)
54/142 (38.0%)
63/181 (34.8%)
34/117 (29.1%)
13/48 (27.1%)
8/41 (19.5%)
34/118 (28.8%)
N 67/153
(43.8%)
42/101 (41.6%)
47/121 (38.8%)
48/95 (50.5%)
14/38 (36.8%)
12/35 (34.3%)
39/89 (43.8%)
NC 160/393
(40.7%)
132/300 (44.0%)
165/363 (45.5%)
85/230 (37.0%)
42/100 (42.0%)
31/86 (36.0%)
95/243 (39.1%) Any
study drug- related treatme
nt- emerge
nt AE
Placebo 3/49 (6.1%) 6/39 (15.4%) 8/49 (16.3%)
1/24 (4.2%)
0/15 2/10
(20.0%)
2/27 (7.4%)
C 17/204
(8.3%)
19/142 (13.4%)
24/181 (13.3%)
7/117 (6.0%)
5/48 (10.4%)
1/41 (2.4%) 14/118 (11.9%)
N 26/153
(17.0%)
26/101 (25.7%)
18/121 (14.9%)
27/95 (28.4%)
7/38 (18.4%)
6/35 (17.1%)
20/89 (22.5%)
NC 61/393
(15.5%)
66/300 (22.0%)
62/363 (17.1%)
39/230 (17.0%)
26/100 (26.0%)
9/86 (10.5%)
40/243 (16.5%)
Disconti nuation s due to treatme
nt- emerge
nt AEs
Placebo 0/49 1/39 (2.6%) 1/49 (2.0%)
0/24 0/15 1/10
(10.0%)
0/27
C 0/204 3/142 (2.1%) 3/181
(1.7%)
0/117 0/48 0/41 1/118
(0.8%) N 7/153 (4.6%) 3/101 (3.0%) 3/121
(2.5%)
6/95 (6.3%)
1/38 (2.6%)2/35 (5.7%) 5/89 (5.6%)
NC 10/393
(2.5%)
10/300 (3.3%)
8/363 (2.2%)
8/230 (3.5%)
4/100 (4.0%)
2/86 (2.3%) 12/243 (4.9%) Any
vasodila tory treatme
nt- emerge
nt AE
Placebo 4/49 (8.2%) 6/39 (15.4%) 7/49 (14.3%)
3/24 (12.5%)
0/15 1/10
(10.0%)
2/27 (7.4%)
C 18/204
(8.8%)
23/142 (16.2%)
24/181 (13.3%)
14/117 (12.0%)
3/48 (6.3%)1/41 (2.4%) 10/118 (8.5%)
N 28/153
(18.3%)
32/101 (31.7%)
25/121 (20.7%)
28/95 (29.5%)
7/38 (18.4%)
7/35 (20.0%)
19/89 (21.3%)
NC 57/393
(14.5%)
70/300 (23.3%)
66/363 (18.2%)
36/230 (15.7%)
25/100 (25.0%)
9/86 (10.5%)
31/243 (12.8%) Flushin
g
Placebo 0/49 0/39 0/49 0/24 0/25 0/10 0/27
C 0/204 0/142 0/181 0/117 0/48 0/41 0/118
N 0/153 1/101 (1.0%) 1/121
(0.8%)
0/95 0/38 0/35 0/89
1
NC 4/393 (1.0%) 2/300 (0.7%) 3/363 (0.8%)
3/230 (1.3%)
0/100 1/86 (1.2%) 3/243 (1.2%) Headac
he
Placebo 4/49 (8.2%) 2/39 (5.1%) 4/49 (8.2%)
2/24 (8.3%)
0/15 1/10
(10.0%)
2/27 (7.4%) C 7/204 (3.4%) 5/142 (3.5%) 7/181
(3.9%)
5/117 (4.3%)
0/48 0/41 4/118
(3.4%)
N 16/153
(10.5%)
12/101 (11.9%)
9/121 (7.4%)
16/95 (16.8%)
3/38 (7.9%)2/35 (5.7%) 11/89 (12.4%)
NC 17/393
(4.3%)
21/300 (7.0%)
26/363 (7.2%)
6/230 (2.6%)
6/100 (6.0%)
4/86 (4.7%) 13/243 (5.3%) Oedem
a
Placebo 0/49 4/39 (10.3%) 3/49 (6.1%)
1/24 (4.2%)
0/15 0/10 0/27
C 11/204
(5.4%)
19/142 (13.4%)
18/181 (9.9%)
9/117 (7.7%)
3/48 (6.3%)
1/41 (2.4%) 6/118 (5.1%)
N 15/153
(9.8%)
21/101 (20.8%)
15/121 (12.4%)
17/95 (17.9%)
4/38 (10.5%)
5/35 (14.3%)
10/89 (11.2%)
NC 39/393
(9.9%)
50/300 (16.7%)
41/363 (11.3%)
28/230 (12.2%)
20/100 (20.0%)
4/86 (4.7%) 17/243 (7.0%)
