Table 4.

Comparison of incidence of grades 3/4 nonhematological toxicities among randomized patients with and without DS

Induction DS/non-DS, %PConsolidation DS/non-DS, %PIM-1 DS/ non-DS, %PDI-1 DS/ non-DS, %PIM-2 DS/ non-DS, %PDI-2 DS/ non-DS, %PMaintenance DS/non-DS, %P
Cardiovascular 2.7/5.0 .65 1.3/1.2 .88 2.7/0.6 .032 1.4/1.1 .80 0/0 — 0/1.2 .56 3.0/0.8 .045 
Coagulation 5.3/6.0 .47 0/0.5 .54 1.4/0.1 .002 0/1.7 .26 0/0 — 0/1.7 .78 1.5/0.5 .25 
Gastrointestinal* 4.0/5.8 .56 6.7/4.0 .48 16.2/3.6 <.001 16.4/7.0 .007 20.3/4.2 <.001 17.9/7.7 .13 15.2/6.7 .027 
Hepatic 10.7/7.2 .52 16.0/10.8 .17 16.2/12.9 .38 9.6/4.8 .078 10.1/11.7 .92 3.6/6.0 .84 25.8/31.2 .14 
Infection/febrile neutropenia 14.7/15.3 .84 18.7/9.9 .014 12.2/8.3 .46 28.8/23.9 .43 11.6/8.5 .37 32.1/26.4 .73 50.0/42.1 .26 
Neurology 2.7/5.1 .60 6.7/4.2 .19 4.1/3.6 .88 1.4/2.9 .73 2.9/1.9 .82 7.1/3.0 .36 7.6/3.8 .18 
Renal/genitourinary 0/0.5 .83 0/0.4 .88 0/0.1 .85 0/0.2 .95 0/0.1 .85 0/0.2 .81 0/0.3 .64 
Induction DS/non-DS, %PConsolidation DS/non-DS, %PIM-1 DS/ non-DS, %PDI-1 DS/ non-DS, %PIM-2 DS/ non-DS, %PDI-2 DS/ non-DS, %PMaintenance DS/non-DS, %P
Cardiovascular 2.7/5.0 .65 1.3/1.2 .88 2.7/0.6 .032 1.4/1.1 .80 0/0 — 0/1.2 .56 3.0/0.8 .045 
Coagulation 5.3/6.0 .47 0/0.5 .54 1.4/0.1 .002 0/1.7 .26 0/0 — 0/1.7 .78 1.5/0.5 .25 
Gastrointestinal* 4.0/5.8 .56 6.7/4.0 .48 16.2/3.6 <.001 16.4/7.0 .007 20.3/4.2 <.001 17.9/7.7 .13 15.2/6.7 .027 
Hepatic 10.7/7.2 .52 16.0/10.8 .17 16.2/12.9 .38 9.6/4.8 .078 10.1/11.7 .92 3.6/6.0 .84 25.8/31.2 .14 
Infection/febrile neutropenia 14.7/15.3 .84 18.7/9.9 .014 12.2/8.3 .46 28.8/23.9 .43 11.6/8.5 .37 32.1/26.4 .73 50.0/42.1 .26 
Neurology 2.7/5.1 .60 6.7/4.2 .19 4.1/3.6 .88 1.4/2.9 .73 2.9/1.9 .82 7.1/3.0 .36 7.6/3.8 .18 
Renal/genitourinary 0/0.5 .83 0/0.4 .88 0/0.1 .85 0/0.2 .95 0/0.1 .85 0/0.2 .81 0/0.3 .64 

—, not calculated.

*

Differences in incidence mainly due to mucositis.