Table 6.
Non-Hematological Adverse Effects.
| Adverse effects | Cohorts | Comparisons between cohorts | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ACT | PCB | |||||||||||||
| Treatment | Paclitaxel + Carboplatin | Paclitaxel + Carboplatin + Bevacizumab | ||||||||||||
| Women enrolled | 161 | 127 | p-value | |||||||||||
| Grade | 0 | 1 | 2 | 3 | 4 | 0 | 1 | 2 | 3 | 4 | ≥1 | ≥2 | ≥3 | 4 |
| Proteinuria | 154 (96) | 3 (2) | 2 (1) | 2 (1) | 0 (0) | 122 (96) | 2 (1) | 1 (1) | 1 (1) | 1 (1) | 0.999 | 0.999 | 0.999 | 0.441 |
| Hypertension | 145 (90) | 7 (4) | 4 (3) | 3 (2) | 2 (1) | 95 (75) | 10 (8) | 11 (9) | 6 (5) | 5 (3) | 0.001 | 0.002 | 0.067 | 0.245 |
| Thromboembolic event | 150 (94) | 5 (3) | 2 (1) | 2 (1) | 2 (1) | 111 (87) | 5 (4) | 5 (4) | 4 (3) | 2 (2) | 0.107 | 0.085 | 0.345 | 0.998 |
| Peripheral neuropathy | 147 (91) | 7 (5) | 5 (3) | 2 (1) | 0 (0) | 120 (94) | 5 (4) | 1 (1) | 1 (1) | 0 (0) | 0.365 | 0.307 | 0.997 | N/A |
| Gastrointestinal fistula | 137 (86) | 20 (12) | 2 (1) | 2 (1) | 0 (0) | 106 (83) | 7 (6) | 9 (7) | 3 (2) | 2 (2) | 0.745 | 0.006 | 0.247 | 0.194 |
| Gastrointestinal perforation | 156 (97) | 3 (2) | 2 (1) | 0 (0) | 0 (0) | 124 (97) | 2 (2) | 1 (1) | 0 (0) | 0 (0) | 0.998 | 0.997 | N/A | N/A |
| Bronchopulmonary hemorrhage | 152 (94) | 5 (3) | 2 (1) | 1 (1) | 1 (1) | 123 (96) | 1 (1) | 1 (1) | 1 (1) | 1 (1) | 0.399 | 0.997 | 0.994 | 0.992 |
| Total non-hematological events | 1,041 | 50 | 19 | 12 | 5 | 801 | 32 | 29 | 16 | 11 | 0.085 | 0.001 | 0.029 | 0.082 |
| Nonhematological events per woman | 6.47 | 0.31 | 0.12 | 0.07 | 0.03 | 6.31 | 0.25 | 0.23 | 0.13 | 0.09 | ||||
Abbreviation: N/A, not applicable.
a Data are presented as frequency. The Fisher exact was performed for statistical analysis. A P < .05 was considered as significant. Adverse effects defined as per CTCAE v5.0.