Daily 800 mg versus 600 mg Efavirenz for HIV Patients Treating Tuberculosis with a Rifampicin-Based Regimen: An Open Label Randomized Controlled Trial

Table 3

Prevalence of severe and serious adverse events according to trial arm. Adverse events grades 3, 4 or serious adverse events were grouped according to WHO-ART guidelines and compared if there was a difference between the two arms.

	EFV600	EFV800	Total	Test stat.	P value
Total	31	40	71
WHO-ART Classification
Blood disorders	1/31 (3.2%)	0/40 (0.0%)	1/71 (1.4%)	Fisher’s exact test	0.44
Cardiovascular disorders	2/31 (6.5%)	4/40 (10.0%)	6/71 (8.5%)	Fisher’s exact test	0.69
Gastrointestinal disorders	6/31 (19.4%)	6/40 (15.0%)	12/71 (16.9%)	Chi square (1 df) = 0.03	0.87
Immune disorders and infections	10/31 (32.3%)	8/40 (20.0%)	18/71 (25.4%)	Chi square (1 df) = 0.81	0.37
Liver and biliary disorders	4/31 (12.9%)	5/40 (12.5%)	9/71 (12.7%)	Fisher’s exact test	1.00
Metabolic and nutritional disorders	0/31 (0.0%)	1/40 (2.5%)	1/71 (1.4%)	Fisher’s exact test	1.00
Musculoskeletal disorders	2/31 (6.5%)	1/40 (2.5%)	3/71 (4.2%)	Fisher’s exact test	0.58
Neurological disorders	1/31 (3.2%)	6/40 (15.0%)	7/71 (9.9%)	Fisher’s exact test	0.13
Psychiatric disorders	0/31 (0.0%)	3/40 (7.5%)	3/71 (4.2%)	Fisher’s exact test	0.25
Respiratory disorders	0/31 (0.0%)	1/40 (2.5%)	1/71 (1.4%)	Fisher’s exact test	1.00
Skin and appendages disorders	5/31 (16.1%)	2/40 (5.0%)	7/71 (9.9%)	Fisher’s exact test	0.23
Urinary tract disorders	0/31 (0.0%)	1/40 (2.5%)	1/71 (1.4%)	Fisher’s exact test	1.00
Vascular, bleeding, and clotting disorders	0/31 (0.0%)	2/40 (5.0%)	2/71 (2.8%)	Fisher’s exact test	0.50
Adverse Event Severity				Fisher’s exact test	0.92
Grade 2	1 (3.2%)	2 (5.0%)	3 (4.2%)
Grade 3	20 (64.5%)	24 (60.0%)	44 (62.0%)
Grade 4	10 (32.3%)	14 (35.0%)	24 (33.8%)
Serious Adverse Event Prevalence	12/31 (38.7%)	16/40 (40.0%)	28/71 (39.4%)	Chi square (1 df) = 0	1.00