TABLE 4.

Most Common^* Specific Drug-Related^† Clinical Adverse Events of Moderate to Severe Intensity^‡

	Raltegravir Group N = 281	Efavirenz Group N = 282
	n (%)	n (%)
Rash§	0 (0.0)	19 (6.7)
Headache	11 (3.9)	13 (4.6)
Dizziness	4 (1.4)	18 (6.4)
Insomnia	10 (3.6)	9 (3.2)
Nausea	8 (2.8)	10 (3.5)
Fatigue	5 (1.8)	8 (2.8)
Diarrhea	3 (1.1)	8 (2.8)

^*All treated patients were included in the safety analysis. All adverse events occurring during the study or within 14 days of study discontinuation through 6-May-2009 (the day when the last patient remaining in the study had their 96-week assessment) were counted. The frequencies of adverse events were not adjusted for the duration of follow-up.

^†Determined by investigator to be possibly, probably, or definitely related to any drug in the study regimen.

^‡Present in ≥2% of either treatment group.

^§Rash includes the MedDRA terms for unspecified, generalized, macular, and/or papular rashes (but not for allergic dermatitis, drug eruption, eczema, and skin lesion) under the category of “Skin and Subcutaneous Tissue Disorders”. The tabulation excluded 1 efavirenz recipient with a “viral rash” under the “Infections and Infestations” category.

N, total number of treated patients in each group.

n, number of patients with the specified clinical adverse event.