Table 3.
TEAEs by CTCAE grade (safety analysis set; n = 16)
| Preferred terma | All grade, n (%) | Grade ≥ 3, n (%) |
|---|---|---|
| Pyrexia | 14 (87.5) | 2 (12.5) |
| Lymphopeniab | 13 (81.3) | 13 (81.3) |
| Neutropeniac | 13 (81.3) | 13 (81.3) |
| Thrombocytopeniad | 12 (75.0) | 10 (62.5) |
| Leukopeniae | 9 (56.3) | 9 (56.3) |
| Decreased appetite | 9 (56.3) | 4 (25.0) |
| Diarrhea | 8 (50.0) | 3 (18.8) |
| Nausea | 8 (50.0) | 0 (0.0) |
| Febrile neutropenia | 7 (43.8) | 7 (43.8) |
| Anemia | 7 (43.8) | 5 (31.3) |
| Alanine aminotransferase increased | 7 (43.8) | 1 (6.3) |
| Aspartate aminotransferase increased | 7 (43.8) | 1 (6.3) |
| Malaise | 6 (37.5) | 0 (0.0) |
| Headache | 5 (31.3) | 0 (0.0) |
| Hypoxia | 4 (25.0) | 1 (6.3) |
| Hypophosphatemia | 3 (18.8) | 3 (18.8) |
| Hypogammaglobulinemia | 3 (18.8) | 2 (12.5) |
| Hyponatremia | 3 (18.8) | 1 (6.3) |
| Hypotension | 3 (18.8) | 1 (6.3) |
| Vomiting | 3 (18.8) | 0 (0.0) |
| Upper respiratory tract infection | 3 (18.8) | 0 (0.0) |
| Insomnia | 3 (18.8) | 0 (0.0) |
| Nasopharyngitis | 3 (18.8) | 0 (0.0) |
CTCAE Version 4.03. TEAEs (all grade) that occurred in ≥ 3 patients are listed
CTCAE Common Terminology Criteria for Adverse Events, MedDRA Medical Dictionary for Regulatory Activities, TEAE treatment-emergent adverse event
aCoded per MedDRA version 21.0
bLymphopenia includes lymphopenia and lymphocyte count decreased
cNeutropenia includes neutropenia and neutrophil count decreased
dThrombocytopenia includes thrombocytopenia and platelet count decreased
eLeukopenia includes leukopenia and white blood cell count decreased