Table 4. A summary of the incidence of TEAEs in the safety population.* .
TEAEs |
Treatment group
|
|||
---|---|---|---|---|
D3P (n = 111)
|
M3P (n = 109)
|
|||
All grades (n%) | Grade 3–5 (n%) | All grades (n%) | Grade 3–5 (n%) | |
Neutropenia | 65 (58.56) | 64 (57.66) | 58 (53.21) | 50 (45.87) |
Leukopenia | 22 (19.82) | 19 (17.12) | 33 (30.28) | 25 (22.94) |
Alopecia | 9 (8.11) | 4 (3.6) | 3 (2.75) | 1 (0.92) |
Infection | 6 (5.41) | 5 (4.5) | 6 (5.5) | 5 (4.59) |
Fever | 6 (5.41) | 4 (3.6) | 1 (0.92) | 1 (0.92) |
Anemia | 5 (4.5) | 4 (3.6) | 4 (3.67) | 3 (2.75) |
Nausea | 5 (4.5) | 0 (0.00) | 4 (3.67) | 1 (0.92) |
Fatigue | 4 (3.6) | 0 (0.00) | 10 (9.17) | 4 (3.67) |
Diarrhea | 4 (3.6) | 2 (1.8) | 0 (0.0) | 0 (0.0) |
Febrile neutropenia | 2 (1.8) | 2 (1.8) | 0 (0.0) | 0 (0.0) |
Pharyngitis | 2 (1.8) | 1 (0.9) | 2 (1.83) | 0 (0.0) |
Oral ulcer | 2 (1.8) | 1 (0.9) | 2 (1.83) | 0 (0.0) |
Hypokalemia | 2 (1.8) | 2 (1.8) | 1 (0.92) | 1 (0.92) |
Cardiac failure | 1 (0.9) | 1 (0.9) | 0 (0.0) | 0 (0.0) |
Peripheral edema | 1 (0.9) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Erythra | 1 (0.9) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Vomiting | 1 (0.9) | 0 (0.0) | 3 (2.75) | 1 (0.92) |
Bone pain | 1 (0.9) | 0 (0.0) | 3 (2.75) | 2 (1.83) |
Hyponatremia | 1 (0.9) | 1 (0.9) | 2 (1.83) | 2 (1.83) |
Allergic reactions | 1 (0.9) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Constipation | 1 (0.9) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Abbreviations: TEAEs = treatment-emergent-adverse-events;NCI-CTC = National Cancer Institute-Common Toxicity Criteria.
* The sequence of TEAEs was in the order of decreasing frequency, ordered by D3P arm.