Table 4.
Summary of treatment-emergent adverse events at reduced (60 mg/m2) dose of docetaxel in ≥ 20% East Asian patients in the docetaxel+ramucirumab combination treatment arm
| Variable | Docetaxel+ramucirumab combination (60 mg/m2) (n=11) |
Docetaxel (docetaxel+placebo) (60 mg/m2) (n=13) |
||
|---|---|---|---|---|
| Any grade | Grade ≥ 3 | Any grade | Grade ≥ 3 | |
| Adverse event | ||||
| Decreased appetite | 3 (27.3) | 0 | 6 (46.2) | 0 |
| Stomatitis | 6 (54.5) | 0 | 2 (15.4) | 0 |
| Fatiguea) | 4 (36.4) | 0 | 5 (38.5) | 0 |
| Alopecia | 5 (45.5) | 0 | 3 (23.1) | 0 |
| Anemiaa) | 3 (27.3) | 0 | 2 (15.4) | 0 |
| Cough | 3 (27.3) | 0 | 5 (38.5) | 0 |
| Pneumonia | 3 (27.3) | 3 (27.3) | 1 (7.7) | 1 (7.7) |
| Hypertension | 3 (27.3) | 1 (9.1) | 0 | 0 |
| Hematologic adverse events | ||||
| Neutropeniaa) | 6 (54.5) | 6 (54.5) | 5 (38.5) | 5 (38.5) |
| Febrile neutropenia | 0 | 0 | 1 (7.7) | 1 (7.7) |
| Anemia | 3 (27.3) | 0 | 2 (15.4) | 0 |
| Thrombocytopenia | 2 (18.2) | 1 (9.1) | 0 | 0 |
| AESIs (categories)b) | ||||
| Bleeding/Hemorrhage | 3 (27.3) | 0 | 2 (15.4) | 0 |
| Pulmonary/Hemorrhage | 2 (18.2) | 0 | 1 (7.7) | 0 |
| Proteinuria | 2 (18.2) | 0 | 0 | 0 |
| Hypertension | 3 (27.3) | 1 (9.1) | 0 | 0 |
Values are presented number (%). AESIs, adverse events of special interest.
a)
Consolidated adverse event category comprising synonymous MedDRA ver. 16.1 preferred terms,
b)
Not subjected to the ≥ 20% criterion.