Table 3.
Total Adverse Events by Treatment Arm
| Toxicity Category/Toxicity (CTCAE version 4) | Continuous B + L (N = 20) |
Intermittent B + L (N = 31) |
||||||
|---|---|---|---|---|---|---|---|---|
| Total |
Grade 3 |
Total |
Grade 3 |
|||||
| No. | % | No. | % | No. | % | No. | % | |
| GI disorders | ||||||||
| Nausea | 13 | 65.0 | 8 | 25.8 | ||||
| Diarrhea | 10 | 50.0 | 11 | 35.5 | ||||
| Mucositis (oral) | 3 | 15.0 | 2 | 6.5 | ||||
| Vomiting | 3 | 15.0 | 4 | 12.9 | ||||
| Constipation | 4 | 20.0 | 7 | 22.6 | ||||
| General disorders | ||||||||
| Fatigue | 14 | 70.0 | 1 | 5 | 13 | 41.9 | ||
| Investigations | ||||||||
| Transaminase elevation | 15 | 75.0 | 3 | 15 | 14 | 45.2 | 3 | 9 |
| Alkaline phosphatase increased | 12 | 60.0 | 6 | 19.4 | ||||
| Metabolism and nutrition disorders | ||||||||
| Hyperglycemia | 14 | 70.0 | 2 | 10 | 15 | 48.4 | ||
| Anorexia | 4 | 20.0 | 9 | 29.0 | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| Rash maculopapular | 8 | 40.0 | 1 | 5 | 9 | 29.0 | 1 | 3 |
| Pruritus | 7 | 35.0 | 5 | 16.1 | ||||
| Rash acneiform | 7 | 35.0 | 1 | 3.2 | ||||
| Dry skin | 4 | 20.0 | 1 | 3.2 | ||||
| Psychiatric (mood) disorders | ||||||||
| Anxiety | 9 | 45.0 | 1 | 5 | 13 | 41.9 | ||
| Depression | 11 | 55.0 | 1 | 5 | 10 | 32.3 | 1 | 3 |
| Irritability | 4 | 20.0 | ||||||
| Nervous system disorders | ||||||||
| Dizziness | 4 | 20.0 | 6 | 19.4 | ||||
| Ataxia | 3 | 15.0 | ||||||
| Concentration impairment | 2 | 10.0 | ||||||
| Blood and lymphatic system disorders | ||||||||
| Anemia | 11 | 55.0 | 6 | 19.4 | ||||
Abbreviations: B + L, buparlisib + letrozole; CTCAE, Common Terminology Criteria for Adverse Events.