Table 3 Summary of the most common (≥5%) adverse eventsa (ASaT population)
Fosaprepitant regimen | Control regimen | |||||||
|---|---|---|---|---|---|---|---|---|
AE, n (% | GI or colorectal cancers (n = 135) | Lung cancer (n = 130) | Breast cancer (n = 110) | Gynecologic cancer (n = 81) | GI or colorectal cancers (n = 132) | Lung cancer (n = 124) | Breast cancer (n = 121) | Gynecologic cancer (n = 71) |
Any | 83 (61.5) | 73 (56.2) | 86 (78.2) | 41 (50.6) | 80 (60.6) | 66 (53.2) | 88 (72.7) | 42 (59.2) |
Neutropenia | 2 (1.5) | 7 (5.4) | 27 (24.5) | 3 (3.7) | 1 (0.8) | 5 (4.0) | 23 (19.0) | 5 (7.0) |
Diarrhea | 25 (18.5) | 8 (6.2) | 19 (17.3) | 5 (6.2) | 23 (17.4) | 4 (3.2) | 24 (19.8) | 4 (5.6) |
Fatigue | 18 (13.3) | 17 (13.1) | 26 (23.6) | 10 (12.3) | 13 (9.8) | 12 (9.7) | 25 (20.7) | 10 (14.1) |
Constipation | 18 (13.3) | 7 (5.4) | 12 (10.9) | 8 (9.9) | 10 (7.6) | 10 (8.1) | 20 (16.5) | 8 (11.3) |
Headache | 11 (8.1) | 4 (3.1) | 12 (10.9) | 2 (2.5) | 12 (9.1) | 3 (2.4) | 16 (13.2) | 2 (2.8) |
Decreased appetite | 11 (8.1) | 5 (3.8) | 5 (4.5) | 5 (6.2) | 11 (8.3) | 7 (5.6) | 10 (8.3) | 3 (4.2) |
Dysgeusia | 4 (3.0) | 3 (2.3) | 9 (8.2) | 2 (2.5) | 7 (5.3) | 0 | 13 (10.7) | 1 (1.4) |
Arthralgia | 2 (1.5) | 4 (3.1) | 6 (5.5) | 6 (7.4) | 2 (1.5) | 6 (4.8) | 6 (5.0) | 4 (5.6) |
Peripheral neuropathy | 10 (7.4) | 1 (0.8) | 0 | 1 (1.2) | 5 (3.8) | 0 | 2 (1.7) | 4 (5.6) |
Bone pain | 0 | 0 | 8 (7.3) | 0 | 1 (0.8) | 3 (2.4) | 6 (5.0) | 0 |
Abdominal pain | 8 (5.9) | 2 (1.5) | 2 (1.8) | 1 (1.2) | 6 (4.5) | 1 (0.8) | 3 (2.5) | 3 (4.2) |
Myalgia | 1 (0.7) | 3 (2.3) | 4 (3.6) | 4 (4.9) | 2 (1.5) | 4 (3.2) | 6 (5.0) | 7 (9.9) |
Alopecia | 2 (1.5) | 2 (1.5) | 5 (4.5) | 2 (2.5) | 3 (2.3) | 5 (4.0) | 13 (10.7) | 4 (5.6) |
Asthenia | 6 (4.4) | 7 (5.4) | 3 (2.7) | 2 (2.5) | 9 (6.8) | 3 (2.4) | 1 (0.8) | 1 (1.4) |
Dizziness | 2 (1.5) | 2 (1.5) | 5 (4.5) | 3 (3.7) | 2 (1.5) | 2 (1.6) | 7 (5.8) | 0 |
Febrile neutropenia | 1 (0.7) | 1 (0.8) | 5 (4.5) | 2 (2.5) | 0 | 3 (2.4) | 7 (5.8) | 0 |
Nausea | 4 (3.0) | 5 (3.8) | 3 (2.7) | 4 (4.9) | 10 (7.6) | 5 (4.0) | 2 (1.7) | 3 (4.2) |
Paresthesia | 6 (4.4) | 0 | 0 | 0 | 8 (6.1) | 0 | 0 | 1 (1.4) |
Rash | 2 (1.5) | 1 (0.8) | 4 (3.6) | 1 (1.2) | 0 | 3 (2.4) | 6 (5.0) | 0 |
Decreased neutrophil count | 0 | 1 (0.8) | 3 (2.7) | 0 | 0 | 0 | 7 (5.8) | 1 (1.4) |
Stomatitis | 3 (2.2) | 1 (0.8) | 1 (0.9) | 1 (1.2) | 2 (1.5) | 1 (0.8) | 10 (8.3) | 0 |
Dyspnea | 1 (0.7) | 8 (6.2) | 0 | 0 | 2 (1.5) | 0 | 1 (0.8) | 0 |
Musculoskeletal pain | 0 | 1 (0.8) | 3 (2.7) | 1 (1.2) | 0 | 3 (2.4) | 5 (4.1) | 7 (9.9) |