Table 5

Grade 3 and 4 toxicities, according to WHO grading system, observed during consolidation

ToxicityFirst cycle (n = 749 patients), no. (%)Second cycle (n = 730 patients), no. (%)Third cycle (n = 683 patients), no. (%)P
Hemorrhage 3 (0.40) 5 (0.69) 4 (0.59) .7693 
Liver 4 (0.53) 7 (0.96) 4 (0.59) .6156 
Renal 2 (0.29) .0997 
Cardiac rhythm 2 (0.27) .2136 
Cardiac function 1 (0.13) 3 (0.41) .2776 
Oral mucositis 2 (0.27) 27 (3.70) 4 (0.59) < .0001* 
Nausea/vomiting 5 (0.67) 8 (1.10) 7 (1.02) .6542 
Diarrhea 1 (0.13) 2 (0.27) 2 (0.29) .7485 
Total 16 54 23 < .0001 
ToxicityFirst cycle (n = 749 patients), no. (%)Second cycle (n = 730 patients), no. (%)Third cycle (n = 683 patients), no. (%)P
Hemorrhage 3 (0.40) 5 (0.69) 4 (0.59) .7693 
Liver 4 (0.53) 7 (0.96) 4 (0.59) .6156 
Renal 2 (0.29) .0997 
Cardiac rhythm 2 (0.27) .2136 
Cardiac function 1 (0.13) 3 (0.41) .2776 
Oral mucositis 2 (0.27) 27 (3.70) 4 (0.59) < .0001* 
Nausea/vomiting 5 (0.67) 8 (1.10) 7 (1.02) .6542 
Diarrhea 1 (0.13) 2 (0.27) 2 (0.29) .7485 
Total 16 54 23 < .0001 
*

First cycle vs second cycle (P < .0001), second cycle vs third cycle (P < .0001), and first cycle vs third cycle (P = .4332).

First cycle vs second cycle (P < .0001), second cycle vs third cycle (P = .0009), and first cycle vs third cycle (P = .1568).

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