Table 6.

Adverse events, safety variables, and adjudicated cardiovascular events throughout the study

	Placebo (n=65)	Dalcetrapib (n=63)
Patients with adverse events
At least one adverse event	59 (91%)	56 (89%)
Drug-related adverse event	18 (28%)	11 (17%)
Clinical adverse event leading to discontinuation of study drug*	2 (3%)	1 (2%)
Drug-related adverse event leading to discontinuation of study drug	5 (8%)	4 (6%)
Serious adverse event	13 (20%)	12 (19%)
Drug-related serious adverse event	2 (3%)	0
Diarrhoea	4 (6%)	5 (8%)
Dizziness	5 (8%)	3 (5%)
Key safety variables
Patients with increase to high† systolic BP	20 (31%)	18 (29%)
Patients with increase to high† diastolic BP	8 (12%)	11 (17%)
Patients with decrease to low‡ systolic BP	13 (20%)	10 (16%)
Patients with decrease to low‡ diastolic BP	10 (15%)	12 (19%)
Adjudicated cardiovascular events§
Patients with event	7 (11%)	2 (3%)

BP=blood pressure.

^*In all three cases the clinical adverse event was death (see text).

^†High BP: systolic ≥180 mm Hg or ≥20 mm Hg increase from baseline; diastolic ≥105 mm Hg or ≥15 mm Hg increase from baseline.

^‡Low BP: systolic ≤90 mm Hg or ≥20 mm Hg decrease from baseline; diastolic ≤50 mm Hg or ≥15 mm Hg decrease from baseline.

^§Clinical endpoints were adjudicated by an independent clinical endpoint committee (CEC).