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Table 2 Population characteristics

From: Low-level laser therapy in treatment of chemoradiotherapy-induced mucositis in head and neck cancer: results of a randomised, triple blind, multicentre phase III trial

   Overall Arm A
(active LLLT/PBMT)
(N = 42)
ArmB
(placebo LLLT/PBMT)
(N = 41)
p-value
Gender Female 8 (9.6%) 5 (11.9%) 3 (7.3%) 0.74
  Male 75 (90.4%) 37 (88.1%) 38 (92.7%)  
Age (years) Mean ± SD 58 (53–65) 58 (53–62) 58 (53–68) 0.25
Tumour Location Oral cavity 17 (20.5%) 9 (21.4%) 8 (19.5%) 0.70
  Hypopharynx 19 (22.9%) 11 (26.2%) 8 (19.5%)  
Oropharynx 47 (56.6%) 22 (52.4%) 25 (61.0%)  
TNM classification T1 7 3 (7.1%) 4 (9.8%) 0.09
  T2 24 16 (38.1%) 8 (19.5%)  
T3 34 16 (38.1%) 18 (43.9%)  
T4a 13 7 (16.7%) 6 (14.6%)  
T4b 5 0 (0%) 5 (12.2%)  
N0 15 5 (11.9%) 10 (24.4%) 0.36
N1 6 2 (4.8%) 4 (9.8%)  
N2 56 31 (73.8%) 25 (61.0%)  
N3 5 3 (7.1%) 2 (4.9%)  
Nx 1 1 (2.4%) 0 (0%)  
M0 83 (100%) 42 (100%) 41 (100%)  
Histologic differentiation Well-differentiated 36 (43.4%) 17 (40.5%) 19 (46.3%) 0.25
  Unknown 6 (7.2%) 4 (9.5%) 2 (4.9%)  
Moderately differentiated 31 (37.3%) 18 (42.9%) 13 (31.7%)  
Poorly differentiated 10 (12.0%) 3 (7.1%) 7 (17.1%)  
Smoking status Never-smokers 12 (14.5%) 3 (7.1%) 9 (22%) 0.11
  Smokers 71 (85.5%) 39 (92.9%) 32 (78%)  
During CRT Smoking cessation 8 (11.3%) 4 (10.3%) 4 (12.5%) 0.95
  Active smokers 23 (32.4%) 13 (33.3%) 10 (31.3%)  
Unspecified 40 (56.3%) 22 (56.4%) 18 (56.3%)  
Alcohol consumption No 22 (26.5%) 11 (26.2%) 11 (26.8%) 0.92
  Unknown 3 (3.6%) 1 (2.4%) 2 (4.9%)  
Yes 58 (69.9%) 30 (71.4%) 28 (68.3%)  
During CRT Alcohol withdrawal 8 (13.8%) 3 (10.0%) 5 (17.9%) 0.72
  Active alcohol use 21 (36.2%) 11 (36.7%) 10 (35.7%)  
Unspecified 29 (50.0%) 16 (53.3%) 13 (46.4%)  
Feeding Enteral feeding 9 (10.8%) 3 (7.1%) 6 (14.6%) 0.39
  Liquid diet 1 (1.2%) 1 (2.4%) 0 (0%) (0.64 with binary data)
Minced food 23 (27.7%) 13 (31%) 10 (24.4%)
Unspecified 2 (2.4%) 0 (0%) 2 (4.9%)
Solid diet 48 (57.8%) 25 (59.5%) 23 (56.1%)  
  1. TNM Tumour/Node/Metastasis.
  2. CRT Chemoradiotherapy.