Table 4.
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.