Table 2.
Adverse events | Reporting Study (n) | SZC group (n/n) | Placebo group (n/n) | RR (95%CI) |
p value | |
---|---|---|---|---|---|---|
Any Adverse Event | 7 | 289/1205 | 116/492 | 1.25(0.98,1.60) | 0.07 | |
Serious Adverse Event | 4 | 27/480 | 14/271 | 1.42 (0.71, 2.84) | 0.33 | |
Gastrointestinal disorders | Nausea | 4 | 12/749 | 4/251 | 1.49(0.51, 4.42) | 0.47 |
Diarrhea | 4 | 20/950 | 11/337 | 0.77(0.36, 1.65) | 0.5 | |
vomiting | 2 | 4/655 | 3/188 | 0.47(0.04, 5.04) | 0.53 | |
Constipation | 4 | 17/517 | 9/267 | 0.91(0.22, 3.82) | 0.9 | |
Cardiac disorders | 3 | 18/945 | 2/293 | 1.72 (0.51, 576) | 0.38 | |
Urinary tract infection | 3 | 8/853 | 0/238 | 2.19 (0.39, 12.30) | 0.37 | |
Edema | 2 | 32/350 | 2/135 | 4.30 (1.17, 15.84) | 0.03 | |
Hypokalemia | 3 | 6/383 | 3/172 | 1.42 (0.39, 5.24) | 0.6 |
RR: Relative Risk; SZC: Sodium zirconium cyclosilicate