Table 3.
Adverse Events.
| Adverse event | TCM (N=192) | Control (N=227) | Pa | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Any Grade | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Any Grade | Grade 1 | Grade 2 | Grade 3 | Grade 4 | ||
| Number of patients (percent) | |||||||||||
| White blood cell decreased | 102 (53) | 52 (27) | 45 (23) | 1 (<1) | 4 (2) | 154 (68) | 63 (28) | 64 (28) | 19 (8) | 8 (4) | 0.02 |
| Neutrophil count decreased | 113 (59) | 63 (33) | 29 (15) | 16 (8) | 5 (3) | 169 (74) | 92 (41) | 50 (22) | 16 (7) | 11 (5) | 0.94 |
| Anemia | 99 (52) | 71 (37) | 21 (11) | 3 (2) | 3 (2) | 147 (65) | 98 (43) | 39 (17) | 3 (1) | 7 (3) | 0.39 |
| Platelet count decreased | 34 (18) | 22 (12) | 5 (3) | 3 (2) | 4 (2) | 65 (29) | 47 (21) | 8 (4) | 3 (1) | 7 (3) | 0.52 |
| Alanine aminotransferase increased | 40 (21) | 28 (15) | 6 (3) | 0 | 6 (3) | 67 (30) | 43 (19) | 10 (4) | 3 (1) | 11 (5) | 0.56 |
| Aspartate aminotransferase increased | 26 (14) | 18 (9) | 2 (1) | 0 | 6 (3) | 48 (21) | 32 (14) | 5 (2) | 0 | 11 (5) | 0.94 |
| Gamma-glutamyltransferase increased | 29 (15) | 19 (10) | 3 (2) | 0 | 7 (4) | 76 (33) | 48 (21) | 11 (5) | 3 (1) | 14 (6) | 0.85 |
| Fatigue | 170 (89) | 130 (68) | 34 (18) | 6 (3) | / | 221 (97) | 85 (37) | 129 (57) | 7 (3) | / | <0.01 |
| Weight loss | 61 (32) | 56 (29) | 4 (2) | 1 (<1) | / | 107 (47) | 101 (45) | 6 (3) | 0 | / | 0.35 |
| Pain | 60 (31) | 58 (30) | 2 (1) | 0 | / | 122 (54) | 106 (47) | 16 (7) | 0 | / | 0.04 |
| Decreased appetite | 160 (83) | 129 (67) | 29 (15) | 2 (1) | 0 | 215 (95) | 125 (55) | 86 (38) | 4 (2) | 0 | <0.01 |
| Constipation | 51 (27) | 45 (23) | 4 (2) | 2 (1) | 0 | 66 (29) | 57 (25) | 9 (4) | 0 | 0 | 0.78 |
| Dry mouth | 101 (53) | 99 (52) | 2 (1) | 0 | / | 145 (64) | 135 (60) | 10 (4) | 0 | / | 0.08 |
| Nausea | 151 (79) | 123 (64) | 28 (15) | 0 | / | 207 (91) | 136 (60) | 66 (29) | 5 (2) | / | <0.01 |
| Vomiting | 65 (34) | 54 (28) | 10 (5) | 1 (<1) | 0 | 130 (57) | 106 (47) | 22 (10) | 2 (<1) | 0 | 0.82 |
| Diarrhea | 29 (15) | 24 (13) | 4 (2) | 1 (<1) | 0 | 44 (19) | 44 (19) | 0 | 0 | 0 | <0.01 |
| Alopecia | 91 (47) | 67 (35) | 24 (13) | / | / | 126 (56) | 82 (36) | 44 (19) | / | / | 0.18 |
| Pruritus | 32 (17) | 30 (16) | 2 (1) | 0 | / | 101 (44) | 93 (41) | 7 (3) | 1 (<1) | / | 0.67 |
| Rash acneiform | 39 (20) | 39 (20) | 0 | 0 | 0 | 81 (36) | 78 (34) | 2 (1) | 1 (<1) | 0 | 0.25 |
TCM, traditional Chinese medicine. aχ2 test for trend.