Table 5.
Adverse events related to eflapegrastim or pegfilgrastim occurring in ≥ 10% of patients in any subgroup
| Adverse event | Korean | Asian | Non-Asian | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
|
|
|
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| Eflapegrastim (n=14) | Pegfilgrastim (n=14) | Eflapegrastim (n=29) | Pegfilgrastim (n=25) | Eflapegrastim (n=285) | Pegfilgrastim (n=301) | |||||||
|
|
|
|
|
|
|
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| Any grade | ≥ Grade 3 | Any grade | ≥ Grade 3 | Any grade | ≥ Grade 3 | Any grade | ≥ Grade 3 | Any grade | ≥ Grade 3 | Any grade | ≥ Grade 3 | |
| Musculoskeletal pain | ||||||||||||
|
| ||||||||||||
| Bone pain | 1 (7.1) | 0 | 0 | 0 | 6 (20.7) | 0 | 2 (8.0) | 0 | 97 (34.0) | 11 (3.9) | 110 (36.5) | 2 (0.7) |
|
| ||||||||||||
| Arthralgia | 0 | 0 | 0 | 0 | 2 (6.9) | 1 (3.4) | 0 | 0 | 45 (15.8) | 4 (1.4) | 33 (11.0) | 2 (0.7) |
|
| ||||||||||||
| Back pain | 0 | 0 | 1 (7.1) | 0 | 2 (6.9) | 1 (3.4) | 4 (16.0) | 0 | 41 (14.4) | 5 (1.8) | 25 (8.3) | 1 (0.3) |
|
| ||||||||||||
| Myalgia | 8 (57.1) | 0 | 7 (50.0) | 0 | 11 (37.9) | 1 (3.4) | 9 (36.0) | 0 | 36 (12.6) | 1 (0.4) | 21 (7.0) | 0 |
|
| ||||||||||||
| Subtotal | 9 (64.3) | 0 | 8 (57.1) | 0 | 21(72.4) | 3 (10.3) | 15 (60.0) | 0 | 219 (76.8) | 21 (7.4) | 189 (62.8) | 5 (1.7) |
|
| ||||||||||||
| Others | ||||||||||||
|
| ||||||||||||
| White blood cell count increaseda) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 34 (11.9) | 5 (1.8) | 18 (6.0) | 1 (0.3) |
|
| ||||||||||||
| Headache | 1 (7.1) | 0 | 1 (7.1) | 0 | 3 (10.3) | 0 | 4 (16.0) | 0 | 28 (9.8) | 1 (0.4) | 21 (7.0) | 2 (0.7) |
|
| ||||||||||||
| Fatigue | 0 | 0 | 0 | 0 | 1 (3.4) | 0 | 2 (8.0) | 0 | 23 (8.1) | 2 (0.7) | 30 (10.0) | 1 (0.3) |
|
| ||||||||||||
| Pain | 0 | 0 | 0 | 0 | 2 (6.9) | 0 | 2 (8.0) | 0 | 22 (7.7) | 1 (0.4) | 26 (8.6) | 3 (1.0) |
|
| ||||||||||||
| Nausea | 2 (14.3) | 0 | 1 (7.1) | 0 | 3 (10.3) | 0 | 1 (4.0) | 0 | 22 (7.7) | 0 | 13 (4.3) | 0 |
|
| ||||||||||||
| Diarrhea | 2 (14.3) | 1 (7.1) | 0 | 0 | 6 (20.7) | 1 (3.4) | 0 | 0 | 21 (7.4) | 1 (0.4) | 11 (3.7) | 1 (0.3) |
|
| ||||||||||||
| Pyrexia | 5 (35.7) | 0 | 1 (7.1) | 0 | 6 (20.7) | 1 (3.4) | 1 (4.0) | 0 | 17 (6.0) | 0 | 25 (8.3) | 1 (0.3) |
|
| ||||||||||||
| Pruritus | 2 (14.3) | 0 | 0 | 0 | 2 (6.9) | 0 | 0 | 0 | 5 (1.8) | 0 | 11 (3.7) | 0 |
|
| ||||||||||||
| Decreased appetite | 2 (14.3) | 0 | 0 | 0 | 2 (6.9) | 0 | 0 | 0 | 5 (1.8) | 0 | 5 (1.7) | 0 |
|
| ||||||||||||
| Vomiting | 2 (14.3) | 0 | 1 (7.1) | 0 | 3 (10.3) | 0 | 1 (4.0) | 0 | 3 (1.1) | 0 | 7 (2.3) | 1 (0.3) |
|
| ||||||||||||
| Abdominal pain, upper | 2 (14.3) | 0 | 0 | 0 | 2 (6.9) | 0 | 1 (4.0) | 0 | 1 (0.4) | 0 | 4 (1.3) | 0 |
|
| ||||||||||||
| Subtotal | 18 (128.6) | 1 (7.1) | 4 (28.6) | 0 | 30 (103.4) | 2 (6.9) | 12 (48.0) | 0 | 181(63.5) | 10 (3.5) | 171 (56.8) | 10 (3.5) |
Values are presented as number (%).
a)
Patient’s white blood cell (WBC) values were > 100×109/L, the criterion required for Common Terminology Criteria for Adverse Events (CTCAE) ver. 4.03 grade 3 WBC increased.