Table 5. Adverse Events (≥ Grade 2) During ADV or TDF Treatment of A5127 Study Subjects.
| ADV arm (N = 25) | ADF arm (N = 27) | |||
|---|---|---|---|---|
|
|
|
|||
| Variable | Grade 2 | Grades 3-4 | Grade 2 | Grades 3-4 |
| Any laboratory toxicity | 6 | 12 | 2 | 16 |
| Chemistry | 6 | 2 | 5 | 3 |
| Liver* | 5 | 9 | 4 | 9 |
| Metabolic | 3 | 0 | 5 | 2 |
| Endocrine | 2 | 0 | 0 | 1 |
| Pancreatic† | 1 | 3 | 0 | 8 |
| Hematology | 0 | 0 | 1 | 0 |
| Any signs/symptoms | 2 | 5 | 4 | 3 |
| General body | 2 | 5 | 2 | 0 |
| Respiratory | 1 | 0 | 0 | 0 |
| Gastrointestinal | 1 | 3 | 2 | 0 |
| Skin | 1 | 0 | 0 | 0 |
| Neurological | 0 | 2 | 1 | 3 |
note. ACTG website for grading criteria: http://rcc.tech-res-intl.com/DAIDS%20RCC%20Forms/TB_ToxicityTables_Adult_TRP_v01a.pdf
*
Total bilirubin elevation after baseline was reported in one subject on TDF (grade 2) and in 5 subjects on ADV (1 grade 2, 3 grade 3, and 1 grade 4).
†
Postentry elevations in serum amylase or lipase were reported in 6 subjects on TDF and 3 on ADV. However, only four episodes of chemical pancreatitis were reported in three subjects. One subject was receiving 3TC, zidovudine and nevirapine; one ddI, d4T, and 3TC; and another received no ddI.