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. Author manuscript; available in PMC: 2013 Dec 1.
Published in final edited form as: Gynecol Oncol. 2012 Sep 19;127(3):495–501. doi: 10.1016/j.ygyno.2012.09.002

Table 3.

Select Adverse Events*

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.