Table 3 Number (%) of subjects experiencing adverse events (incidence ⩾2%) overall and drug-related over 52 weeks in L50/H12.5 filter study (all subjects as treated population)

From: Efficacy and safety of losartan 100 mg/hydrochlorothiazide 12.5 mg in Japanese subjects with essential hypertension: two randomized, controlled trials

 

L50/H12.5 (L100/H12.5)

L100/H12.5 (L100/H12.5)

Total

 

Overall n (%)

Drug related a n (%)

Overall n (%)

Drug related a n (%)

Overall n (%)

Drug related a n (%)

Subjects in population

131

131

134

134

265

265

 With ⩾1 adverse events

93 (71.0)

14 (10.7)

97 (72.4)

18 (13.4)

190 (71.7)

32 (12.1)

 Atrial fibrillation

3 (2.3)

0 (0.0)

0 (0.0)

0 (0.0)

3 (1.1)

0 (0.0)

 Back pain

3 (2.3)

0 (0.0)

4 (3.0)

0 (0.0)

7 (2.6)

0 (0.0)

 Bronchitis

4 (3.1)

0 (0.0)

3 (2.2)

0 (0.0)

7 (2.6)

0 (0.0)

 Diabetes mellitus

7 (5.3)

0 (0.0)

5 (3.7)

0 (0.0)

12 (4.5)

0 (0.0)

 Eczema

2 (1.5)

0 (0.0)

3 (2.2)

0 (0.0)

5 (1.9)

0 (0.0)

 Gastritis

6 (4.6)

0 (0.0)

3 (2.2)

1 (0.7)

9 (3.4)

1 (0.4)

 Gastroenteritis

2 (1.5)

0 (0.0)

5 (3.7)

0 (0.0)

7 (2.6)

0 (0.0)

 Gastroesophageal reflux disease

3 (2.3)

0 (0.0)

2 (1.5)

0 (0.0)

5 (1.9)

0 (0.0)

 Headache

3 (2.3)

0 (0.0)

2 (1.5)

0 (0.0)

5 (1.9)

0 (0.0)

 Hyperuricemia

3 (2.3)

2 (1.5)

4 (3.0)

2 (1.5)

7 (2.6)

4 (1.5)

 Musculoskeletal stiffness

1 (0.8)

0 (0.0)

3 (2.2)

1 (0.7)

4 (1.5)

1 (0.4)

 Nasopharyngitis

22 (16.8)

0 (0.0)

33 (24.6)

0 (0.0)

55 (20.8)

0 (0.0)

 Osteoarthritis

1 (0.8)

0 (0.0)

3 (2.2)

0 (0.0)

4 (1.5)

0 (0.0)

 Pharyngitis

4 (3.1)

0 (0.0)

4 (3.0)

0 (0.0)

8 (3.0)

0 (0.0)

 Rash

1 (0.8)

0 (0.0)

3 (2.2)

0 (0.0)

4 (1.5)

0 (0.0)

 Rhinitis

4 (3.1)

0 (0.0)

1 (0.7)

0 (0.0)

5 (1.9)

0 (0.0)

 Rhinitis allergic

2 (1.5)

0 (0.0)

3 (2.2)

0 (0.0)

5 (1.9)

0 (0.0)

 Seasonal allergy

3 (2.3)

0 (0.0)

3 (2.2)

0 (0.0)

6 (2.3)

0 (0.0)

 Upper respiratory tract infection

10 (7.6)

0 (0.0)

7 (5.2)

0 (0.0)

17 (6.4)

0 (0.0)

 Upper respiratory tract inflammation

7 (5.3)

0 (0.0)

5 (3.7)

0 (0.0)

12 (4.5)

0 (0.0)

 Vertigo

3 (2.3)

0 (0.0)

2 (1.5)

0 (0.0)

5 (1.9)

0 (0.0)

Laboratory values

      

 Alanine aminotransferase increased

2 (1.5)

0 (0.0)

5 (3.7)

2 (1.5)

7 (2.6)

2 (0.8)

 Aspartate aminotransferase increased

2 (1.5)

0 (0.0)

4 (3.0)

3 (2.2)

6 (2.3)

3 (1.1)

 Blood creatinine increased

4 (3.1)

0 (0.0)

5 (3.7)

2 (1.5)

9 (3.4)

2 (0.8)

 Blood potassium decreased

4 (3.1)

2 (1.5)

1 (0.7)

0 (0.0)

5 (1.9)

2 (0.8)

 Blood uric acid increased

6 (4.6)

4 (3.1)

11 (8.2)

3 (2.2)

17 (6.4)

7 (2.6)

 Brain natriuretic peptide increased

2 (1.5)

2 (1.5)

3 (2.2)

1 (0.7)

5 (1.9)

3 (1.1)

 Urine albumin/creatinine ratio increase

3 (2.3)

1 (0.8)

1 (0.7)

0 (0.0)

4 (1.5)

1 (0.4)

  1. Abbreviations: H12.5, hydrochlorothiazide 12.5 mg; L50, losartan 50 mg; L100, losartan 100 mg.
  2. Every subject is counted a single time for each applicable row and column.
  3. A system organ class or specific adverse event appears on this report only if its incidence in ⩾1 of the ‘Overall’ columns meets the incidence criterion in the report title, after rounding.
  4. The L50/H12.5 (L100/H12.5) group includes data only from extension period (44 weeks); L100/H12.5 (L100/H12.5) group includes data from entire study period (52 weeks).
  5. aDetermined by the investigator to be related to the drug.
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