Table 8 Incidence of adverse events

AEs observed during the trial

46 (60.5)

98 (64.1)

218 (71.7)

0.084

AEs observed during the treatment

35 (46.1)

81 (52.9)

182 (59.9)

0.065

AEs observed at a rate of ≥ 5% of patients in any group

 Dry mouth

8 (10.5)

25 (16.3)

42 (13.8)

0.483

 Abdominal bloating

6 (7.9)

4 (2.6)

11 (3.6)

0.140

 Thirst

2 (2.6)

6 (3.9)

35 (11.5)

0.003

 Hypokalemia

6 (7.9)

13 (8.5)

21 (6.9)

0.823

 Hepatic encephalopathy

0.580

  Baseline

1 (1.32)

1 (0.65)

1 (0.33)

  Post-treatment

2 (2.63)

4 (2.61)

2 (0.66)

  Increased number (post-baseline)

1 (1.32)

3 (1.96)

1 (0.33)

ADRs observed during the trial

9 (11.8)

38 (24.8)

94 (30.9)

0.003

ADRs observed at a rate of ≥ 5% of patients in any group

 Dry mouth

6 (7.9)

25 (16.3)

38 (12.5)

0.188

 Thirst

2 (2.6)

6 (3.9)

34 (11.2)

0.005

SADRs

1 (1.3)

1 (0.7)

6 (2.0)

0.543

SAEs observed during the trial

9 (11.8)

10 (6.5)

20 (6.6)

0.262

 Upper gastrointestinal bleeding

5 (6.6)

4 (2.6)

4 (1.3)

0.029

 Deaths

3 (3.9)

4 (2.6)

8 (2.6)

0.812