Table 3.
Study participants with treatment-emergent adverse events at week 12
| 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 |
|
|
|
|
|
|
|
|
|
|
|
|
| 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 |
*TEAEs were AEs that emerged during treatment (absent pre-treatment or worsened relative to pre-treatment). TEAEs are defined as having a start date on/after the first dose of double-blind study medication and up to the first dose of open-label study medication for participants continuing into the open-label period; or, for early terminated participants, up to and including 14 days after the last dose date of double-blind study medication. All TEAEs are counted under the treatment the participant received from week 4 to week 12.
†Drug-related was defined as definitely, probably, or possibly related to randomized study medication.
‡TEAEs presented occurred in >5% and at least 3 study participants in any treatment group.
AE, adverse event; AML, amlodipine besylate; CVD, cardiovascular disease; CKD, chronic kidney disease; HCTZ, hydrochlorothiazide; OM, olmesartan medoxomil; TEAE, treatment-emergent adverse event.