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Table 3 Study participants with treatment-emergent adverse events at week 12

From: Olmesartan/amlodipine/hydrochlorothiazide in participants with hypertension and diabetes, chronic kidney disease, or chronic cardiovascular disease: a subanalysis of the multicenter, randomized, double-blind, parallel-group TRINITY study

 

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

  1. *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.
  2. †Drug-related was defined as definitely, probably, or possibly related to randomized study medication.
  3. ‡TEAEs presented occurred in >5% and at least 3 study participants in any treatment group.
  4. AE, adverse event; AML, amlodipine besylate; CVD, cardiovascular disease; CKD, chronic kidney disease; HCTZ, hydrochlorothiazide; OM, olmesartan medoxomil; TEAE, treatment-emergent adverse event.