Total | Fatigue | Hand-foot syndrome | Oral mucosal inflammation | Diarrhea | Gastrointestinal symptoms | Hypertension | Anorexia | |
---|---|---|---|---|---|---|---|---|
Frequency of AEs, N (%) | 210 (100.0) | 50 (23.8) | 25 (11.9) | 25 (11.9) | 30 (14.3) | 23 (11.00) | 24 (11.4) | 33 (15.7) |
95% C.I.* | (18.22, 30.16) | (7.85, 17.07) | (7.85, 17.07) | (9.85, 19.76) | (7.07, 15.98) | (7.46, 16.53) | (11.07, 21.35) | |
AE grades, N (%) | ||||||||
1 Mild | 122 (58.1) | 34 (68.0) | 8 (32.0) | 12 (48.0) | 24 (80.0) | 18 (78.3) | 14 (58.3) | 12 (36.4) |
2 Moderate | 68 (32.4) | 12 (24.0) | 14 (56.0) | 13 (52.0) | 4 (13.3) | 3 (13.0) | 8 (33.3) | 14 (42.4) |
3 Severe | 20 (9.5) | 4 (8.0) | 3 (12.0) | 0 (0.0) | 2 (6.7) | 2 (8.7) | 2 (8.3) | 7 (21.2) |
4, 5 Life-threatening & Death-related | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
AE management, N (%) | ||||||||
Very poor | 5 (2.6) | 2 (4.4) | 1 (4.4) | 0 (0.0) | 2 (6.9) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Poor | 37 (19.2) | 10 (21.7) | 3 (13.0) | 5 (21.7) | 3 (10.3) | 4 (19.1) | 5 (23.8) | 7 (23.8) |
Well | 141 (73.1) | 33 (71.7) | 19 (82.6) | 17 (73.9) | 23 (79.3) | 15 (71.4) | 12 (57.1) | 22 (57.1) |
Very well | 10 (5.2) | 1 (2.2) | 0 (0.0) | 1 (4.4) | 1 (3.5) | 2 (9.5) | 4 (19.1) | 1 (19.1) |
AE grade changes, N (%) | ||||||||
Worsened | 13 (6.7) | 5 (10.9) | 2 (8.7) | 1 (4.3) | 0 (0.0) | 1 (3.6) | 1 (3.7) | 3 (8.6) |
Steady | 114 (58.8) | 24 (52.2) | 14 (60.9) | 15 (65.2) | 19 (65.5) | 12 (42.9) | 15 (55.6) | 15 (42.9 |
Improved | 27 (13.9) | 6 (13.0) | 4 (17.4) | 5 (21.7) | 3 (10.3) | 8 (28.6) | 6 (22.2) | 12 (34.3) |
Resolved | 40 (20.6) | 11 (23.9) | 3 (13.0) | 2 (8.7) | 7 (24.1) | 7 (25.0) | 5 (18.5) | 5 (14.3) |
Grades of remaining AEs†, N (%) | ||||||||
1 Mild | 96 (62.3) | 21 (60.0) | 8 (40.0) | 15 (71.4) | 20 (90.9) | 12 (85.7) | 10 (58.8) | 10 (40.0) |
2 Moderate | 53 (34.4) | 14 (40.0) | 8 (40.0) | 6 (28.6) | 2 (9.1) | 2 (14.3) | 7 (41.2) | 14 (56.0) |
3 Severe | 5 (3.3) | 0 (0.0) | 4 (20.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (4.0) |
4, 5 Life-threatening & Death-related | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |