Table 4.

Number experiencing adverse events by treatment arm in the COMBINE trial

Adverse Event	N-L (n=53)	N-p (n=51)	p-L (n=50)	p-p (n=51)
Any laboratory or symptom-related adverse eventa	33	30	29	26
Prespecified laboratory adverse events
Serum phosphate ≥5.9 mg/dl	1	0	1	0
Serum phosphate <1.5 mg/dl	1	0	0	0
Platelet <100,000/mm2	1	0	0	2
Liver function abnormalities	0	0	0	0
Creatine kinase >800 U/L	1	0	0	0
Prespecified symptom-related adverse events (questionnaire)
Nausea (severe)	11	4	9	4
Heartburn (severe)	2	0	3	4
Diarrhea (severe)	12	8	5	7
Flushing (Y/N)	1	4	5	4
Hives (Y/N)	1	9	5	0
Bruising (Y/N)	20	21	16	18
Bleeding (Y/N)	10	10	13	7
Serious adverse events
Reached ESRD (dialysis or transplant)	4	2	1	1
Hospitalizations	17	13	14	13
Deaths	1	1	0	1

N-L, nicotinamide active/lanthanum carbonate active; N-p, nicotinamide active/lanthanum carbonate placebo; p-L, nicotinamide placebo/lanthanum carbonate active; p-p, nicotinamide placebo/lanthanum carbonate placebo; Y/N, yes/no.

^aP=0.71 (Fisher exact test).