TABLE 3.
Grade 2 to 4 adverse events or laboratory abnormalities through week 12a
| Event or abnormality | No. of cases
|
Pearson χ2 test, P value | ||
|---|---|---|---|---|
| ATV/SQV/RTV (n = 49) | ATV/RTV/NRTI (n = 72) | SQV/RTV/NRTI (n = 90) | ||
| Hematology | ||||
| Hemoglobin < 10 mg/dl | 7 | 0.008 | ||
| Thrombocytes < 25,000 | 1 | NS | ||
| Lymphopenia 1.0-1.4/nl | 1 | NS | ||
| Cytokine kinase increase > 2.0 × ULN | 1 | NS | ||
| Metabolic abnormalities | ||||
| Cholesterol > 250 mg/dl | 1 | NS | ||
| Amylase/lipase > 2.1 × ULN | 1 | NS | ||
| Pathological oral glucose tolerance test | 1 | NS | ||
| Liver | ||||
| Bilirubin > 3.0 × ULN | 2 | 5 | 0.047 | |
| Aspartate-aminotransferase, alanine-aminotransferase > 2.6 × ULN | 2 | NS | ||
| Alkaline phosphatase > 2.6 × ULN | 1 | NS | ||
| Gastrointestinal | ||||
| Diarrhea (grade 3) | 4 | 4 | 1 | NS |
| Vomiting (grade 3) | 4 | NS | ||
| Ulcus ventriculi | 1 | NS | ||
| Constitutional symptoms | ||||
| Asthenia, sleepiness | 1 | 1 | 7 | 0.028 |
| Skin | ||||
| Exanthema | 3 | NS | ||
| Eczema | 2 | NS | ||
| Other | 2 | 3 | 1 | NS |
| Peripheral nervous system | ||||
| Polyneuropathy | 1 | NS | ||
| Other | ||||
| Pancreatitis | 1 | NS | ||
| Psychiatric disorders | 1 | 2 | NS | |
| Orthostatic dizziness | 1 | NS | ||
a
Adverse events are reported according to the common terminology criteria for adverse events (CTCAE) v3.0, http://safetyprofiler-ctep.nci.nih.gov/CTC/CTC.aspx. NS, not statistically significant.