. 2021 Jun 29;42(48):4905–4914. doi: 10.1093/eurheartj/ehab411

Table 2.

Death, hospitalization, and adverse events according to treatment assignment

Parameter	Standard of care (n = 38)	Ferric carboxymaltose (n = 37)	Risk difference (95% CI)	P-value
All
Death, hospitalization or adverse event	12 (32%)	11 (30%)	−0.019	0.862
Death, hospitalization or adverse event	12 (32%)	11 (30%)	(−0.229, 0.197)	0.862
Deaths
Death	3 (8%)	0 (0%)	−0.079	0.081
Death	3 (8%)	0 (0%)	(−0.214, 0.024)	0.081
Cardiovascular death	2 (5%)	0 (0%)	−0.053	0.157
Cardiovascular death	2 (5%)	0 (0%)	(−0.178, 0.047)	0.157
Heart failure death	2 (5%)	0 (0%)	−0.053	0.157
Heart failure death	2 (5%)	0 (0%)	(−0.178, 0.047)	0.157
Hospitalization
Cardiovascular hospitalization	7 (18%)	4 (11%)	−0.076	0.352
Cardiovascular hospitalization	7 (18%)	4 (11%)	(−0.25, 0.094)	0.352
Heart failure hospitalization	4 (11%)	1 (3%)	− 0.078	0.174
Heart failure hospitalization	4 (11%)	1 (3%)	(−0.022, 0.050)	0.174
Adverse events
Serious adverse event	0 (0%)	0 (0%)	NA	NA
Adverse events total	3 (8%)	7 (19%)	0.110	0.160
Adverse events total	3 (8%)	7 (19%)	(−0.052, 0.282)	0.160
Adverse event general	1 (3%)	2 (5%)	0.028	0.540
Adverse event general	1 (3%)	2 (5%)	(−0.093, 0.158)	0.540
Adverse event cutaneous	1 (3%)	−	0.028	0.540
Adverse event cutaneous	1 (3%)	−	(−0.093, 0.158)	0.540
Adverse event neurological	0 (0%)	0 (0%)	NA	NA
Adverse event gastro-intestinal	1 (3%)	3 (8%)	0.055	0.291
Adverse event gastro-intestinal	1 (3%)	3 (8%)	(−0.067, 0.197)	0.291
Adverse event cardiac	0 (0%)	1 (3%)	0.027	0.308
Adverse event cardiac	0 (0%)	1 (3%)	(−0.069, 0.145)	0.308

P-values are from Fisher’s exact test/chi-square test. Negative estimate of risk difference indicates lower risk in the ferric carboxymaltose vs. standard of care group. None of the risk differences reached statistical significance as indicated by the 95% CI.

CI, confidence interval; NA, not available.