TABLE 4.
Adverse Events by Treatment Group
| Adverse Drug Event | Doublets n = 1,088 n (%) | Pem-based n = 279 n (%) | P Value | Pem + Bev-based n = 38 n (%) | P Value | Bev-based n = 167 n (%) | P Value | Singlets n = 114 n (%) | P Value | TKI n = 395 n (%) | P Value |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Acute myocardial infarction | 39 (3.6) | 3 (1.1) | 0.030 | 0 (0.0) | 0.235 | 3 (1.8) | 0.102 | 2 (1.8) | 0.150 | 7 (1.8) | 0.075 |
| Anemia | 480 (44.1) | 121 (43.4) | 0.822 | 17 (44.7) | 0.940 | 65 (38.9) | 0.207 | 42 (36.8) | 0.136 | 107 (27.1) | < 0.001 |
| Angina | 35 (3.2) | 10 (3.6) | 0.759 | 0 (0.0) | 0.261 | 3 (1.8) | 0.134 | 3 (2.6) | 0.223 | 7 (1.8) | 0.138 |
| Bleeding events | 220 (20.2) | 57 (20.4) | 0.938 | 9 (23.7) | 0.602 | 42 (25.2) | 0.145 | 19 (16.7) | 0.366 | 78 (19.8) | 0.841 |
| Bone marrow depression | 234 (21.5) | 51 (18.3) | 0.236 | 3 (7.9) | 0.043 | 35 (21.0) | 0.872 | 26 (22.8) | 0.749 | 40 (10.1) | < 0.001 |
| Cerebrovascular stroke | 43 (4.0) | 13 (4.7) | 0.595 | 1 (2.6) | 0.343 | 8 (4.8) | 0.610 | 4 (3.5) | 0.202 | 21 (5.3) | 0.253 |
| Deep vein thrombosis | 7 (0.6) | 2 (0.7) | 0.892 | 0 (0.0) | 0.786 | 0 (0.0) | 0.367 | 0 (0.0) | 0.497 | 0 (0.0) | 0.114 |
| Delay in wound healing | 4 (0.4) | 0 (0.0) | 0.401 | 0 (0.0) | 0.872 | 2 (1.2) | 0.150 | 0 (0.0) | 0.671 | 2 (0.5) | 0.309 |
| Diarrhea | 156 (14.3) | 43 (15.4) | 0.650 | 7 (18.4) | 0.482 | 22 (13.2) | 0.688 | 15 (13.2) | 0.731 | 71 (18.0) | 0.086 |
| Fistula | 4 (0.4) | 1 (0.1) | 0.410 | 0 (0.0) | 0.872 | 2 (1.2) | 0.150 | 0 (0.0) | 0.671 | 1 (0.3) | 0.386 |
| Gastrointestinal perforations | 1 (0.1) | 0 (0.00) | 0.796 | 0 (0.0) | 0.966 | 1 (0.6) | 0.231 | 0 (0.0) | 0.905 | 0 (0.0) | 0.734 |
| Heart failure | 101 (9.3) | 22 (7.9) | 0.467 | 3 (7.9) | 0.227 | 10 (6.0) | 0.163 | 16 (14.0) | 0.103 | 36 (9.1) | 0.921 |
| Hepatotoxicity | 17 (1.6) | 8 (2.9) | 0.147 | 1 (2.6) | 0.343 | 4 (2.4) | 0.167 | 5 (4.4) | 0.036 | 11 (2.8) | 0.126 |
| Leukopenia | 52 (4.8) | 13 (4.7) | 0.933 | 1 (2.6) | 0.302 | 8 (4.8) | 0.995 | 4 (3.5) | 0.169 | 5 (1.3) | 0.002 |
| Neutropenia | 171 (15.7) | 31 (11.1) | 0.053 | 6 (15.8) | 0.990 | 29 (17.4) | 0.588 | 17 (14.9) | 0.822 | 21 (5.3) | < 0.001 |
| Peripheral neuropathy | 14 (1.3) | 5 (1.8) | 0.520 | 0 (0.0) | 0.617 | 3 (1.8) | 0.219 | 1 (0.9) | 0.354 | 2 (0.5) | 0.198 |
| Pruritus, skin rash | 98 (9.0) | 26 (9.3) | 0.872 | 3 (7.9) | 0.230 | 21 (12.6) | 0.143 | 12 (10.5) | 0.593 | 59 (14.9) | 0.001 |
| Pulmonary embolism | 83 (7.6) | 38 (13.6) | 0.002 | 3 (7.9) | 0.237 | 13 (7.8) | 0.944 | 10 (8.8) | 0.664 | 26 (6.6) | 0.495 |
| Thrombocytopenia | 135 (12.4) | 27 (9.7) | 0.208 | 3 (7.9) | 0.160 | 24 (14.4) | 0.478 | 10 (8.8) | 0.257 | 19 (4.8) | < 0.001 |
| Transient cerebral ischemia | 7 (0.6) | 1 (0.4) | 0.578 | 0 (0.0) | 0.786 | 4 (2.4) | 0.038 | 1 (0.9) | 0.379 | 3 (0.8) | 0.260 |
| Venous or arterial thrombosis | 226 (20.7) | 64 (22.9) | 0.430 | 6 (15.8) | 0.455 | 31 (18.6) | 0.510 | 21 (18.4) | 0.555 | 63 (16.0) | 0.038 |
| Visual disturbance | 36 (3.3) | 5 (1.8) | 0.185 | 1 (2.6) | 0.367 | 3 (1.8) | 0.125 | 2 (1.8) | 0.174 | 8 (2.0) | 0.064 |
| Any adverse event | 833 (76.6) | 220 (78.9) | 0.417 | 27 (71.1) | 0.432 | 130 (77.8) | 0.715 | 81 (71.1) | 0.189 | 262 (66.3) | < 0.001 |
Bev = bevacizumab; Pem = pemetrexed; TKI = tyrosine-kinase inhibitor.