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. Author manuscript; available in PMC: 2020 Dec 7.
Published in final edited form as: N Engl J Med. 2020 Jun 4;382(23):2207–2219. doi: 10.1056/NEJMoa1915315

Table 3.

Acute Adverse Events.*

Event All Patients (N = 315) Chemotherapy Group (N = 153) Rituximab–Chemotherapy Group (N = 162) P Value
no. of patients (%)

During all therapy
≥1 Adverse event 306 (97.1) 148 (96.7) 158 (97.5)
≥1 Adverse event of grade ≥4 111 (35.2) 50 (32.7) 61 (37.7) 0.36
During COP prephase treatment
≥1 Adverse event 63 (20.0) 31 (20.3) 32 (19.8)
≥1 Adverse event of grade ≥4 27 (8.6) 17 (11.1) 10 (6.2) 0.12
After COP prephase treatment
≥1 Adverse event 303 (96.2) 147 (96.1) 156 (96.3)
≥1 Adverse event of grade ≥4 91 (28.9) 37 (24.2) 54 (33.3) 0.07
Most frequent adverse events after COP prephase treatment
Febrile neutropenia 289 (91.7) 139 (90.8) 150 (92.6)
 Grade 3 260 (82.5) 129 (84.3) 131 (80.9)
 Grade ≥4 29 (9.2) 10 (6.5) 19 (11.7) 0.11
Stomatitis 244 (77.5) 115 (75.2) 129 (79.6)
 Grade 3 224 (71.1) 108 (70.6) 116 (71.6)
 Grade ≥4 20 (6.3) 7 (4.6) 13 (8.0) 0.21
Enteritis 63 (20.0) 24 (15.7) 39 (24.1)
 Grade 3 62 (19.7) 24 (15.7) 38 (23.5)
 Grade ≥4 1 (0.3) 0 1 (0.6) 1.00
Infection 170 (54.0) 75 (49.0) 95 (58.6)
 Grade 3 123 (39.0) 58 (37.9) 65 (40.1)
 Grade ≥4 47 (14.9) 17 (11.1) 30 (18.5) 0.07
 Main types of infection
  Sepsis 45 (14.3) 17 (11.1) 28 (17.3)
  Central venous catheter–related infection 38 (12.1) 17 (11.1) 21 (13.0)
  Lung infection 32 (10.2) 13 (8.5) 19 (11.7)
  Enterocolitis infection 32 (10.2) 18 (11.8) 14 (8.6)
Biologic adverse events
 Alanine aminotransferase increased 41 (13.0) 18 (11.8) 23 (14.2)
  Grade 3 25 (7.9) 12 (7.8) 13 (8.0)
  Grade ≥4 16 (5.1) 6 (3.9) 10 (6.2) 0.36
 Hypokalemia 36 (11.4) 15 (9.8) 21 (13.0)
  Grade 3 28 (8.9) 11 (7.2) 17 (10.5)
  Grade ≥4 8 (2.5) 4 (2.6) 4 (2.5) 1.00
*

Shown are the numbers and percentages of patients who had at least one adverse event, those who had at least one adverse event of grade 4 or higher, and those who had the most frequent acute adverse events (i.e., events occurring in >10% of the patients overall). A total of 13 patients who did not have data on treatment or adverse events or who received only prephase treatment (a regimen of cyclophosphamide, vincristine, and prednisone [COP]) were not included in this analysis. Only nonhematologic adverse events of grade 3 or higher or cardiac adverse events of grade 2 or higher were recorded. P values are shown for events of grade 4 or higher.