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 |