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. 2021 May 13;7(6):869–877. doi: 10.1001/jamaoncol.2021.0848

Table 2. Toxic Effects Reported Within 9 Weeks of Starting Chemotherapy.

Allocation Randomization, No. (%)
CHEMO-INTENSITYa CHEMO-BSCa
Level A (n = 162) Level B (n = 162) Level C (n = 168) Level C (n = 18)
Max CTCAE grade (week 1-9)b ≥2 ≥3 ≥2 ≥3 ≥2 ≥3 ≥2 ≥3
Nausea or vomiting 47 (29) 14 (8.6) 33 (20) 8 (4.9) 29 (17) 12 (7.1) 2 (11) 0
Anorexia 45 (28) 11 (6.7) 46 (28) 14 (8.6) 32 (19) 3 (1.8) 13 (17) 0
Diarrhea 34 (21) 10 (6.2) 19 (12) 10 (6.2) 7 (4.2) 3 (1.8) 1 (5.6) 1 (5.6)
Peripheral neuropathy 24 (15) 4 (2.5) 11 (6.7) 1 (0.6) 6 (3.6) 1 (0.6) 2 (11) 0
Fatigue 86 (53) 24 (15) 72 (44) 20 (12) 67 (40) 18 (11) 6 (33) 4 (22)
Infection 7 (4.3) 4 (2.5) 15 (9.3) 9 (5.6) 5 (3.0) 1 (0.6) 0 0
Thrombosis 5 (3.1) 5 (3.1) 4 (2.5) 3 (1.9) 3 (1.8) 2 (1.2) 2 (11) 2 (11)
Any nonhematologicalc 125 (77) 62 (38) 116 (72) 58 (36) 101 (60) 38 (23) 10 (56) 7 (39)
WBC/neutrophils (×109/l) 10 (6.2) 1 (0.6) 3 (1.9) 0 5 (3.0) 1 (0.6) 0 0
Anaemia 26 (16) 1 (0.6) 33 (20) 6 (3.7) 22 (13) 3 (1.8) 2 (11) 0
Any hematologicald 33 (20) 3 (1.9) 36 (22) 6 (3.7) 27 (16) 4 (2.4) 2 (11) 0

Abbreviations: CTCAE, Common Terminology Criteria for Adverse Events; WBC, white blood cell count.

a

Treatment pathways are detailed in the Randomization section of Methods.

b

Maximum CTCAE grade experienced weeks 1-9 in patients receiving ≥1 cycle of their allocated chemotherapy. Individual listings are shown for more common toxic effects.

c

“Any nonhematological” is defined as any of the following: nausea, vomiting, anorexia, stomatitis, diarrhea, hand-foot syndrome, peripheral neuropathy, fatigue, infection, thrombosis, or dehydration.

d

“Any hematological” is defined as any of the following: low white blood cell count, low neutrophils/granulocytes, low platelets, or anemia.