|
Adverse events
|
Test group %, (n/N)
|
Reference group %, (n/N)
|
P
|
|---|
|
Pitting edema
|
31.40, (27/86)
|
46.51, (40/86)
|
0.0301
|
|
Increased urinary frequency
|
24.41, (21/86)
|
24.41, (21/86)
|
ns
|
|
Muscle cramps
|
4.65, (4/86)
|
2.32, (2/86)
|
ns
|
|
Rash on face/arms
|
2.32, (2/86)
|
0 (0/86)
|
ns
|
|
Headache
|
2.32, (2/86)
|
3.48, (3/86)
|
ns
|
|
Constipation
|
1.16, (1/86)
|
2.32 (2/86)
|
ns
|
|
Peri-orbital edema
|
1.16, (1/86)
|
0 (0/86)
|
ns
|
|
Vertigo & dizziness
|
0 (0/86)
|
1.16, (1/86)
|
ns
|
|
Vasculitic rash on lower limbs
|
0 (0/86)
|
1.16, (1/86)
|
ns
|
|
Death
|
1.16, (1/86)
|
0 (0/86)
|
ns
|
|
Total no. of AEs
|
68.60, (59/86)
|
81.39, (70/86)
|
0.03
|
- AE adverse event, N total number of patients, n number of AEs, Fisher’s exact test was applied. p < 0.05 = statistically significant, ns value not significant
