Table 2.

Differences in mean individual predicted pharmacokinetic parameters for safety endpoints, assessed by calculation of GMRs and 90 % CI (n = 605^a)

Parameter	GMR (90 % CI)b
	Overall discontinuation	Adverse event (Stocrin PI)	CNS adverse event (Stocrin PI)	Adverse event (clinician decision)	Stopping due to adverse event (clinician decision)
AUC24	0.85 (0.76–0.95)	0.93 (0.86–1.01)	0.94 (0.88–1.02)	0.93 (0.87–1.00)	0.78 (0.67–0.92)
C max	0.84 (0.77–0.93)	0.92 (0.86–0.99)	0.94 (0.88–1.00)	0.93 (0.87–0.99)	0.77 (0.67–0.88)
C24	0.86 (0.74–1.01)	0.94 (0.85–1.05)	0.95 (0.86–1.05)	0.94 (0.85–1.04)	0.85 (0.68–1.06)
C12	0.86 (0.71–0.96)	0.94 (0.86–1.02)	0.95 (0.88–1.02)	0.93 (0.87–1.01)	0.81 (0.69–0.95)

GMRs geometric mean ratios, PI product information, CI confidence interval, AUC ₂₄ area under the curve over 24 h, C _max maximum concentration, C ₂₄ trough concentration 24 h post-dose, C ₁₂ concentration 12 h post-dose representing the mid-dose interval concentration

^a n = one patient excluded; received efavirenz 800 mg during pharmacokinetic sampling

^bNo event/event