Table 3.
AE Category | Treatment Group | 0 | 1 | 2 | 3 | 4 | 5 | Total | % Grade 3 or worse |
---|---|---|---|---|---|---|---|---|---|
Neutrophils/AGC†† | −E −G | 75 | 21 | 82 | 314 | 633 | 0 | 1125 | 84 |
−E +G | 12 | 1 | 11 | 55 | 232 | 0 | 311 | 92 | |
+E −G | 4 | 4 | 16 | 52 | 165 | 0 | 241 | 90 | |
+E +G | 6 | 1 | 7 | 47 | 126 | 0 | 187 | 92 | |
Hemoglobin†† | −E −G | 110 | 424 | 482 | 97 | 12 | 0 | 1125 | 10 |
−E +G | 16 | 78 | 165 | 49 | 3 | 0 | 311 | 17 | |
+E −G | 3 | 41 | 156 | 36 | 5 | 0 | 241 | 17 | |
+E +G | 3 | 17 | 117 | 44 | 6 | 0 | 187 | 27 | |
Febrile Neutropenia†† | −E −G | 1099 | 0 | 0 | 23 | 3 | 0 | 1125 | 2 |
−E +G | 268 | 0 | 0 | 40 | 3 | 0 | 311 | 14 | |
+E −G | 234 | 0 | 0 | 6 | 1 | 0 | 241 | 3 | |
+E +G | 167 | 0 | 0 | 17 | 3 | 0 | 187 | 11 | |
Venous TE† | −E −G | 1115 | 0 | 1 | 4 | 5 | 0 | 1125 | 1 |
−E +G | 310 | 0 | 0 | 0 | 1 | 0 | 311 | < 1 | |
+E −G | 237 | 0 | 1 | 2 | 1 | 0 | 241 | 1 | |
+E +G | 181 | 0 | 0 | 1 | 5 | 0 | 187 | 3 | |
Other TE | −E −G | 1047 | 0 | 12 | 32 | 32 | 2 | 1125 | 6 |
−E +G | 292 | 1 | 3 | 9 | 6 | 0 | 311 | 5 | |
+E −G | 262 | 0 | 1 | 9 | 5 | 0 | 241 | 6 | |
+E +G | 170 | 1 | 4 | 7 | 5 | 0 | 187 | 6 |
Common Terminology Criteria for Adverse Events version 3.0. Onset of adverse event between start of study treatment and 30 days after date of last cycle of treatment.
p < 0.05,
p <0.001 for a two-sided exact test of the hypothesis that the incidence of a grade 3 or higher adverse event is independent of the treatment group.