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Table 9 Summary of the adverse events after fimasartan treatments (STEP II, Safety set)

From: Clinical characteristics and satisfaction with the fimasartan in Korean hypertensive patients: a prospective, cross-sectional and open-label, 8-week switching study (Kanarb-hypertension epidemiology medication satisfaction study; K-HEMS study)

System Organ Class

Preferred Term

AEs

N = 2183

ADRs

N = 2183

Number of Subjects with AEs, n (%) [events]

151 (6.9) [234]

39 (1.8) [50]

Nervous system disorders

59 (2.7) [67]

20 (0.9) [21]

 Dizziness

30 (1.4) [31]

9 (0.4) [9]

 Headache

23 (1.1) [23]

10 (0.5) [10]

 Syncope

7 (0.3) [7]

2 (0.1) [2]

General disorders and administration site conditions

25 (1.2) [25]

5 (0.2) [5]

 Chest pain

8 (0.4) [8]

1 (0.1) [1]

 Asthenia

3 (0.1) [3]

2 (0.1) [2]

Cardiac disorders

19 (0.9) [19]

2 (0.1) [2]

 Palpitations

17 (0.8) [17]

2 (0.1) [2]

Respiratory, thoracic and mediastinal disorders

14 (0.6) [15]

3 (0.1) [4]

 Cough

6 (0.3) [6]

2 (0.1) [2]

Investigations

11 (0.5) [11]

2 (0.1) [2]

 Blood pressure increased

9 (0.4) [9]

2 (0.1) [2]

Vascular disorders

10 (0.5) [13]

7 (0.3) [9]

 Hypotension

6 (0.3) [7]

6 (0.3) [7]

  1. Adverse reactions were coded using the MedDRA version 18.0
  2. AE Adverse event, ADR Adverse drug reaction