Table 6.
Adverse events (Intention to treat analysis, N = 172)
| 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