Skip to main content

Advertisement

Table 4 Treatment-emergent AE occurring during the study in the safety analysis set

From: CMAB009 plus irinotecan versus irinotecan-only as second-line treatment after fluoropyrimidine and oxaliplatin failure in KRAS wild-type metastatic colorectal cancer patients: promising findings from a prospective, open-label, randomized, phase III trial

Parameters CMAB009 plus irinotecan
(n = 338)
Irinotecan-only
(n = 165)
All grades grade Grade 3/4 All grades grade Grade 3/4
n % n % n % n %
Any drug-related AEa 334 98.8 187 55.3 150 90.9 62 37.6
Diarrhea 134 39.6 35 10.4 59 35.8 12 7.3
Emesis 64 18.9 14 4.1 61 37.0 13 7.9
Leucopenia 169 50.0 54 16.0 65 39.4 15 9.1
Neutropenia 103 30.5 54 16.0 32 19.4 14 8.5
Fatigue 75 22.2 9 2.7 27 16.4 6 3.6
Special AEb
Rash 226 66.9 22 6.5 9 5.5 1 0.6
Paronychia 33 9.8 4 1.2 0 0 0 0.0
Infusion reaction 2 0.6 1 0.3 1 0.6 0 0.0
Hypersensitivity reaction 3 0.9 1 0.3 1c 0.9c 0c 0.0c
  1. AE, adverse events
  2. aIncludes cases having special adverse events
  3. bSpecial adverse events were of categorized based on events that occurred in previous study and were reported for CMAB009 related-toxicities
  4. cSequential-CMAB009 arm (n = 115)