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Table 1 Baseline characteristics of participants in the phase Ib and the phase II trials

From: Safety and efficacy of fruquintinib in patients with previously treated metastatic colorectal cancer: a phase Ib study and a randomized double-blind phase II study

Characteristics Phase Ib N (%) Phase II N (%)
  (n=42) Fruquintinib group (n=47) Placebo group (n=24) P value
Age (years)     
 Median, range 55.5, 33.0–70.0 50.0, 25.0–69.0 54.0, 38.0–70.0 0.090
Gender     
 Male 25 (59.5) 35 (74.5) 17 (70.8) 0.743
 Female 17 (40.5) 12 (25.5) 7 (29.2)  
Baseline ECOG PS score     
 0 8 (19.0) 6 (12.8) 5 (20.8) 0.374
 1 34 (81.0) 41 (87.2) 19 (79.2)  
Duration from first metastasis Diagnosis to randomization     
 ≤18 months NA 20 (42.6) 14 (58.3) 0.208
 >18 months NA 27 (57.4) 10 (41.7)  
Prior treatment line on or above metastatic disease     
 2–3 18 (42.9) 30 (63.8) 17 (70.8) 0.555
 >3 24 (57.1) 17 (36.2) 7 (29.2)  
Previous chemotherapy lines     
 2 5 (11.9) 12 (25.5) 7 (29.2) 0.743
 ≥3 37 (88.1) 35 (74.5) 17 (70.8)  
Prior VEGF inhibitor treatment     
 Yes 10 (23.8) 15 (31.9) 7 (29.2) 0.412
 No 32 (76.2) 29 (61.7) 17 (70.8)  
 Unknown 0 3 (6.4) 0  
Primary site     
 Colon 21 (50.0) 24 (51.1) 13 (54.2) 0.804
 Rectal 20 (47.6) 23 (48.9) 11 (45.8)  
 Cecum 1 (2.4) 0 0  
Metastatic site     
 Single 5 (11.9) 2 (4.3) 2 (8.3) 0.481
 Multiple 37 (88.1) 45 (95.7) 22 (91.7)  
Liver metastasis     
 Yes 29 (69.0) 29 (61.7) 17 (70.8) 0.446
 No 13 (31.0) 18 (38.3) 7 (29.2)  
  1. ECOG PS Eastern Cooperative Oncology Group performance status, VEGF vascular endothelial growth factor, NA not available