TABLE 4.
Most commonly reported drug-related AEs (occurring in at least two subjects in any treatment)
| AE reported | No. (%) of subjects in treatment group
|
|
|---|---|---|
| RFB (300 mg QD) (n = 17) | RFB (150 mg QOD) + FPV-RTV (700/100 mg BID) (n = 22) | |
| Any | 12 (71) | 19 (86) |
| Nervous system disorders (any event) | 6 (35) | 12 (55) |
| Headache | 6 (35) | 10 (45) |
| Renal and urinary disorders (any event) | 10 (59) | 13 (59) |
| Chromaturia | 10 (59) | 11 (50) |
| Pollakiuria | 0 | 4 (18) |
| Gastrointestinal disorders (any event) | 6 (35) | 12 (55) |
| Diarrhea | 2 (12) | 7 (32) |
| Nausea | 0 | 4 (18) |
| Investigations (any event) | 6 (35) | 9 (41) |
| Neutrophil count decreased | 3 (18) | 3 (14) |
| ALT increased | 0 | 5 (23) |
| Neutrophil count increased | 0 | 3 (14) |
| General disorders and administration site conditions (any event) | 3 (18) | 7 (32) |
| Fatigue | 0 | 4 (18) |
| Chills | 0 | 3 (14) |
| Pain | 2 (12) | 1 (5) |
| Musculoskeletal and connective tissue disorders (any event) | 2 (12) | 5 (23) |
| Myalgia | 0 | 4 (18) |
| Skin and subcutaneous tissue disorders (any event) | 0 | 6 (27) |
| Rash generalized | 0 | 2 (9) |
| Blood and lymphatic system disorders (any event) | 3 (18) | 3 (14) |
| Neutropenia | 2 (12) | 1 (5) |
| Thrombocytopenia | 0 | 3 (14) |
| Psychiatric disorders (any event) | 5 (29) | 1 (5) |
| Insomnia | 4 (24) | 1 (5) |