Table 3.

Number (%) of Participants Reporting the Most Common (≥15%) Adverse Events and Grades 3 and 4 Laboratory Abnormalities

Randomized Period
ABC/3TC/ZDV
(n = 102)
3TC/ZDV
(n = 103)
Clinical adverse events
Nausea and vomiting47 (46)31 (30)
Cough47 (46)26 (25)
ENT infection35 (34)31 (30)
Fever and/or chills37 (36)28 (27)
Diarrhea20 (20)27 (26)
Nasal signs/symptoms23 (23)20 (19)
Headache21 (21)16 (16)
Skin rashes16 (16)16 (16)
Viral ENT infection15 (15)13 (13)
Grade 3 and 4 laboratory
abnormalities
Neutropenia2 (2)8 (8)
Leukopenia4 (4)2 (2)
Anemia1 (<1)3 (3)
Elevated ALT2 (2)2 (2)
Elevated AST3 (3)1 (<1)
Elevated bilirubin2 (2)1 (<1)
Hyperglycemia2 (2)
Hypoglycemia1 (<1)
Elevated amylase4 (4)7 (7)
Hyperkalemia3 (3)2 (2)
Hypokalemia1 (<1)
Hypernatremia5 (5)1 (<1)
Hyponatremia3 (3)2 (2)
Elevated creatinine1 (<1)
  • ENT indicates ear, nose, and throat; ALT, alanine aminotransferase; AST, asparate aminotransferase.

  • * Participants who added abacavir and/or other antiretroviral agents after week 16.

  • P < .05.