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Table 4.

Grade 3 or greater‐non‐hematological adverse events

Arm Patient Serious adverse event Grade Onset timing Relating drug (causative)
Arm C (n = 32) #04 Hyperglycemia 3 6th cycle (day 4) CHOP (diabetes)
#07 Hyperglycemia 3 4th cycle (day 2) CHOP, rituximab
#13 Hypertension 3 1st cycle (day 3) CHOP, rituximab
#21 Total bilirubin elevation 3 2nd cycle (day 5) – (constitutional)
#23 Abdominal pain 3 1st cycle (day 9) CHOP, rituximab
#58 Acute cholangitis with elevated AST and ALT 3 3rd cycle (day 10) CHOP, rituximab
#59 Hyperglycemia, hypertension 3 5th cycle (day 6) CHOP, rituximab
Arm S (n = 33) #25 Total bilirubin elevation 3 6th cycle (day 132) – (constitutional)
#56 Diarrhea 4 1st cycle (day 13) – (alimentary)
Febrile neutropenia 3 3rd cycle (day 12) CHOP
Interstitial pneumonia 3 3rd cycle (day 15) CHOP
#62 Total bilirubin elevation 3 4th cycle (day 7) CHOP
#69 AST and ALT elevation 3 1st cycle (day 10) CHOP
2nd cycle (day 8) CHOP
6th cycle (day 29) CHOP

Grade 3 or greater adverse events other than hematological toxicities that were observed during the treatment and follow‐up period (for 6 months after the last cycle of CHOP for Arm C, and for 4 months after the last rituximab infusion for Arm S).

JCOG Toxicity Criteria, an expanded version of the NCI‐CTC, version 1.0.