Table 2.

 Cox proportional hazard models comparing time to first serious morbidity or death, in study monitoring efficacy of ART, Tororo and Busia Districts, Uganda, 2003-7

	Events/participants	Person-years of follow-up	Rate per 100 person years	Hazard ratio (95% CI); P value
				Unadjusted			Adjusted*
				Compared with viral load arm	Compared with CD4 arm		Compared with viral load arm	Compared with CD4 arm
Severe morbidity and mortality
Intention to treat†:
Viral load arm	47/368	979.4	4.8	—	—		—	—
CD4 arm	58/371	971.6	6.0	1.24 (0.85 to 1.83); 0.269	—		1.23 (0.82 to 1.84); 0.309	—
Clinical arm	72/377	950.9	7.6	1.54 (1.06 to 2.22); 0.022	1.24 (0.88 to 1.75); 0.227		1.83 (1.25 to 2.69); 0.002	1.49 (1.03 to 2.13); 0.032
Per protocol analysis‡:
Viral load arm	24/349	884.4	2.7	—	—		—	—
CD4 arm	29/346	877.8	3.3	1.22 (0.71 to 2.10); 0.466	—		1.32 (0.76 to 2.31); 0.323	—
Clinical arm	47/352	852.3	5.5	2.01 (1.23 to 3.29); 0.005	1.64 (1.03 to 2.61); 0.035		2.31 (1.38 to 3.84); 0.001	1.74 (1.09 to 2.79); 0.021
All cause mortality
Intention to treat†:
Viral load arm	37/368	1002.6	3.7	—	—		—	—
CD4 arm	40/371	1008.7	4.0	1.08 (0.69 to 1.69); 0.738	—		1.10 (0.69 to 1.75); 0.698	—
Clinical arm	49/377	1003.4	4.9	1.31 (0.85 to 2.01); 0.217	1.21 (0.80 to 1.84); 0.366		1.57 (1.00 to 2.46); 0.049	1.43 (0.92 to 2.21); 0.109
Per protocol analysis‡:
Viral load arm	20/349	891.9	2.2	—	—		—	—
CD4 arm	18/346	897.8	2.0	0.90 (0.48 to 1.70); 0.744	—		1.00 (0.52 to 1.92); 0.99	—
Clinical arm	28/352	890.1	3.1	1.40 (0.79 to 2.48); 0.255	1.55 (0.86 to 2.80); 0.146		1.63 (0.90 to 2.98); 0.109	1.63 (0.89 to 2.99); 0.110

*Adjusted for age, sex, baseline CD4 cell count, baseline viral load, and baseline BMI.

†Includes all randomised participants, irrespective of whether they had started ART.

‡Includes only those participants who survived beyond first 90 days of receipt of ART and includes only events that occurred after this point.