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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.