Table 3.
Summary of treatment-emergent adverse events at 75 mg/m2 docetaxel in ≥ 20% East Asian and non–East Asian patients in the docetaxel+ramucirumab combination treatment arm
| Variable | Docetaxel+ramucirumab combination treatment (75 mg/m2) |
Docetaxel (docetaxel+placebo) (75 mg/m2) |
||||||
|---|---|---|---|---|---|---|---|---|
| East Asian (n=32) |
Non–East Asian (n=584) |
East Asian (n=33) |
Non–East Asian (n=572) |
|||||
| Any grade | Grade ≥ 3 | Any grade | Grade ≥ 3 | Any grade | Grade ≥ 3 | Any grade | Grade ≥ 3 | |
| Adverse event | ||||||||
| Decreased appetite | 21 (65.6) | 0 | 158 (27.1) | 14 (2.4) | 12 (36.4) | 0 | 136 (23.8) | 8 (1.4) |
| Stomatitis | 16 (50.0) | 1 (3.1) | 124 (21.2) | 26 (4.5) | 12 (36.4) | 0 | 66 (11.5) | 10 (1.7) |
| Dyspnea | 14 (43.8) | 0 | 122 (20.9) | 23 (3.9) | 8 (24.2) | 1 (3.0) | 140 (24.5) | 50 (8.7) |
| Fatiguea) | 15 (46.9) | 1 (3.1) | 324 (55.5) | 87 (14.9) | 13 (9.4) | 0 | 291 (50.9) | 65 (11.4) |
| Diarrhea | 12 (37.5) | 1 (3.1) | 186 (31.8) | 28 (4.8) | 8 (24.2) | 0 | 160 (28.0) | 19 (3.3) |
| Myalgia | 12 (37.5) | 0 | 64 (11.0) | 4 (0.7) | 12 (36.4) | 0 | 52 (9.1) | 4 (0.7) |
| Productive cough | 12 (37.5) | 0 | 26 (4.5) | 1 (0.2) | 4 (12.1) | 0 | 25 (4.4) | 2 (0.3) |
| Pyrexia | 12 (37.5) | 0 | 92 (15.8) | 3 (0.5) | 5 (15.2) | 0 | 72 (12.6) | 2 (0.3) |
| Alopecia | 11 (34.4) | 0 | 146 (25.0) | 0 | 15 (45.5) | 0 | 138 (24.1) | 0 |
| Anemiaa) | 10 (31.3) | 3 (9.4) | 118 (20.2) | 15 (2.6) | 9 (27.3) | 2 (6.1) | 163 (28.5) | 33 (5.8) |
| Insomnia | 10 (31.3) | 0 | 57 (9.8) | 3 (0.5) | 4 (12.1) | 0 | 42 (7.3) | 1 (0.2) |
| Cough | 9 (28.1) | 0 | 121 (20.7) | 3 (0.5) | 7(21.2) | 0 | 116 (20.3) | 5 (0.9) |
| Nausea | 9 (28.1) | 0 | 159 (27.2) | 7 (1.2) | 4 (12.1) | 0 | 164 (28.7) | 9 (1.6) |
| Oropharyngeal pain | 8 (25.0) | 0 | 38 (6.5) | 0 | 5 (15.2) | 0 | 26 (4.5) | 0 |
| Peripheral sensory neuropathya) | 8 (25.0) | 0 | 63 (10.8) | 13 (2.2) | 8 (24.2) | 0 | 50 (8.7) | 4 (0.7) |
| Hematologic adverse events | ||||||||
| Neutropeniaa) | 27 (84.4) | 26 (81.3) | 312 (53.4) | 274 (46.9) | 24 (72.7) | 24 (72.7) | 255 (44.6) | 217 (37.9) |
| Febrile neutropenia | 14 (43.8) | 14 (43.8) | 86 (14.7) | 86 (14.7) | 4 (12.1) | 4 (12.1) | 57 (10.0) | 57 (10.0) |
| Anemia | 10 (31.3) | 3 (9.4) | 118 (20.2) | 15 (2.6) | 9 (27.3) | 2 (6.1) | 160 (20.8) | 32 (5.6) |
| Thrombocytopeniaa) | 3 (9.4) | 2 (6.3) | 79 (13.5) | 15 (2.6) | 0 | 0 | 32 (5.6) | 4 (0.7) |
| AESIs (categories) | ||||||||
| Bleeding/Hemorrhage | 11 (34.4) | 0 | 167 (28.6) | 15 (2.6) | 4 (12.1) | 0 | 88 (15.4) | 14 (2.4) |
| Pulmonary/Hemorrhage | 5 (15.6) | 0 | 42 (7.2) | 8 (1.4) | 3 (9.1) | 0 | 42 (7.3) | 8 (1.4) |
| GI hemorrhage | 2 (6.3) | 0 | 15 (2.6) | 4 (0.7) | 0 | 0 | 10 (1.7) | 2 (0.3) |
| GI perforation | 2 (6.3) | 2 (6.3) | 4 (0.7) | 3 (0.5) | 0 | 0 | 2 (0.3) | 2 (0.3) |
| Infusion-related reaction | 1 (3.1) | 0 | 22 (3.8) | 5 (0.9) | 3 (9.1) | 0 | 22 (3.8) | 3 (0.5) |
| Proteinuria | 1 (3.1) | 0 | 18 (3.1) | 1 (0.2) | 0 | 0 | 5 (0.9) | 0 |
Values are presented as number (%). AESIs, adverse events of special interest; GI, gastrointestinal.
a)
Consolidated adverse event category comprising synonymous MedDRA ver. 16.1 preferred terms.