Table 4.
AEs occurring in ≥ 15% of the overall population or in Japanese patients in either treatment arm (all causality; as-treated population: data cutoff date: December 5, 2014)
| Overall population | Japanese patients | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PAL + FUL (n = 345) | PBO + FUL (n = 172) | PAL + FUL (n = 27) | PBO + FUL (n = 8) | |||||||||
| Any grade | Grade 3 | Grade 4 | Any grade | Grade 3 | Grade 4 | Any grade | Grade 3 | Grade 4 | Any grade | Grade 3 | Grade 4 | |
| Any AE, n (%) | 337 (98) | 202 (59) | 37 (11) | 153 (89) | 28 (16) | 3 (2) | 27 (100) | 18 (67) | 7 (26) | 8 (100) | 1 (13) | 0 |
| Nonhematologic AEs, n (%) | ||||||||||||
| Neutropeniaa | 272 (79) | 184 (53) | 30 (9) | 6 (4) | 0 | 1 (< 1) | 25 (93) | 18 (67) | 7 (26) | 2 (25) | 0 | 0 |
| Leukopeniaa | 157 (46) | 85 (25) | 2 (< 1) | 7 (4) | 0 | 1 (< 1) | 20 (74) | 9 (33) | 1 (4) | 1 (13) | 0 | 0 |
| Thrombocytopeniaa | 67 (19) | 6 (2) | 2 (< 1) | 0 | 0 | 0 | 10 (37) | 0 | 0 | 0 | 0 | 0 |
| Anemiaa | 90 (26) | 9 (3) | 0 | 17 (10) | 3 (2) | 0 | 8 (30) | 1 (4) | 0 | 2 (25) | 1 (13) | 0 |
| Nonhematologic AEs, n (%) | ||||||||||||
| Stomatitisa | 87 (25) | 2 (< 1) | 0 | 19 (11) | 0 | 0 | 12 (44) | 0 | 0 | 2 (25) | 0 | 0 |
| Rasha | 48 (14) | 2 (< 1) | 0 | 8 (5) | 0 | 0 | 8 (30) | 1 (4) | 0 | 0 | 0 | 0 |
| Naso pharyngitis | 25 (7) | 0 | 0 | 9 (5) | 0 | 0 | 7 (26) | 0 | 0 | 1 (13) | 0 | 0 |
| Nausea | 100 (29) | 0 | 0 | 45 (26) | 1 (< 1) | 0 | 7 (26) | 0 | 0 | 2 (25) | 0 | 0 |
| Fatigue | 131 (38) | 7 (2) | 0 | 46 (27) | 2 (1) | 0 | 6 (22) | 0 | 0 | 2 (25) | 0 | 0 |
| Headache | 73 (21) | 1 (< 1) | 0 | 30 (17) | 0 | 0 | 5 (19) | 0 | 0 | 2 (25) | 0 | 0 |
| Pyrexia | 30 (9) | 1 (< 1) | 0 | 7 (4) | 0 | 0 | 5 (19) | 0 | 0 | 1 (13) | 0 | 0 |
AE adverse event, FUL fulvestrant, PAL palbociclib, PBO placebo
aClusters of preferred terms were used to represent multiple preferred terms