TABLE 2.
Adverse Effects
| Study | Group | Rash, No. (%) | Diarrhea, No. (%) | Elevated ALT, No. (%) | Elevated AST, No. (%) | Stomatitis, No. (%) | Nausea, No. (%) | Leucopenia, No. (%) | Fatigue, No. (%) | Neutropenia, No. (%) | Anorexia, No. (%) | Anemia, No. (%) | Cough, No. (%) | Vomiting, No. (%) | Fever, No. (%) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ADJUVANT/CTONG110419 | Treatment | 43 (40.6) | 28 (26.4) | 29 (27.4) | 12 (11.3) | 8 (7.5) | 3 (2.8) | 4 (3.7) | 4 (3.7) | 3 (2.9) | 2 (1.8) | 2 (1.8) | 11 (10.4) | 5 (4.7) | 1 (0.9) |
| Control | 0 (0) | 4 (4.6) | 3 (3.5) | 1 (1.2) | 5 (5.7) | 38 (43.7) | 41 (47) | 4 (4.6) | 46 (52.9) | 20 (23) | 44 (50.6) | 15 (17.2) | 36 (41.4) | 9 (10.3) | |
| LUX LUNG 620 | Treatment | 144 (82.3) | 153 (87.4) | 39 (22.3) | 32 (18.3) | 88 (50.3) | 11 (6.3) | 5 (2.8) | 14 (8) | 3 (1.7) | 11 (6.3) | 9 (5.2) | — | 14 (8) | — |
| Control | 9 (9.5) | 10 (10.5) | 16 (17) | 10 (10.5) | 5 (5.3) | 72 (75.8) | 53 (55.8) | 37 (39) | 53 (55.8) | 39 (41) | 26 (27.4) | — | 75 (78.9) | — | |
| CONVINCE21 | Treatment | 22 (15) | 11 (7.4) | 10 (6.7) | 12 (81) | — | 4 (2.7) | 11 (7.4) | 5 (3.4) | 5 (3.4) | 3 (2) | 4 (2.7) | 2 (1.4) | 2 (1.4) | 0 (0) |
| Control | 2 (1.5) | 6 (4.3) | 19 (13.9) | 15 (11) | — | 63 (46) | 60 (43.8) | 20 (14.6) | 58 (42.3) | 32 (23.4) | 17 (12.4) | 3 (2.2) | 40 (29.2) | 4 (2.9) | |
| IMPRESS22 | Treatment | 14 (11) | 44 (33.3) | 17 (12.9) | 30 (22.7%) | 14 (10.6) | 85 (64.4) | 27 (20.5) | 28 (21.2) | 29 (22) | 65 (49.2) | 0 (0) | 18 (13.6) | 55 (41.6) | 22 (16.7) |
| Control | 11 (8) | 19 (14.9) | 23 (17) | 29 (22%) | 5 (3.7) | 81 (61.4) | 22 (16.7) | 23 (17.4) | 28 (21.2) | 45 (34.1) | 1 (0.7) | 15 (11.4) | 44 (33.3) | 14 (10.6) | |
| NCIC CTG BR1923 | Treatment | 21 (8.5) | 18 (7.2) | — | — | — | 6 (2.4) | — | 15 (6) | — | — | — | — | 3 (1.2) | — |
| Control | 1 (0.5) | 5 (2) | — | — | — | 1 (0.4) | — | 6 (2.5) | — | — | — | — | 0 (0) | — | |
| KCSG-LU08-0124 | Treatment | 31 (46) | 18 (26) | — | — | — | 11 (16.2) | — | 15 (22.1) | 0 (0) | 22 (32.4) | — | 25 (36.7) | — | — |
| Control | 3 (4.5) | 3 (4.4) | — | — | — | 11 (16.4) | — | 14 (21) | 1 (1.5) | 20 (29.8) | — | 24 (35.8) | — | — | |
| WJTOG340525 | Treatment | 74 (85) | 47 (54) | 61 (70) | 61 (70%) | 19 (21.8) | 15 (17.2) | 13 (14.9) | 34 (39.1) | 7 (8.1) | — | 33 (37.9) | — | — | — |
| Control | 7 (8) | 35 (40) | 35 (40) | 17 (19.3%) | 13 (14.7) | 83 (94) | 82 (93.2) | 73 (82.9) | 81 (92) | — | 79 (89.7) | — | — | — | |
| ISTANAl26 | Treatment | 61 (75) | 21 (26) | — | — | 3 (3.7) | 13 (16) | — | 20 (24.7) | — | 29 (35.8) | — | 25 (30.8) | 4 (4.9) | 4 (4.9) |
| Control | 6 (8) | 12 (15.7) | — | — | 9 (1.8) | 14 (18.4) | — | 28 (36.9) | — | 36 (47.4) | — | 25 (32.9) | 8 (10.5) | 8 (10.5) | |
| INTEREST27 | Treatment | 360 (49) | 255 (35) | — | — | 67 (9.2) | 148 (20.3) | — | 182 (25) | 35 (4.8) | 159 (21.8) | 34 (4.7) | 108 (14.8) | 109 (15) | — |
| Control group | 73 (10.3) | 177 (24.7) | — | — | 93 (13) | 187 (26.2) | — | 334 (46.7) | 514 (72) | 151 (21.2) | 84 (11.7) | 102 (14.3) | 123 (17.2) | — |
Abbreviations ALT, alanine transaminase; AST, aspartate aminotransferase.