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Table 3 Impact of nausea on quality of life during cycle 1 of chemotherapy: nausea dimension of the FLIE score in ITT population

From: Can treatment with Cocculine improve the control of chemotherapy-induced emesis in early breast cancer patients? A randomized, multi-centered, double-blind, placebo-controlled Phase III trial

  Placebo Cocculine All patients p
All patients n=217 n=214 n=431  
missing data** 15 13 28  
number of patients evaluable 202 201 403  
Quantitative     0.84*
Median nausea Score (Min-Max) 6.02 (1.11 – 7) 6.07 (1.22 – 7) 6.02 (1.11 – 7)
Mean ± sd 5.43 ± 1.57 5.45 ± 1.57 5.44 ± 1.57
Qualitative     
Patients with no impact of nausea on daily life (i.e. a median score > 6), n (%) 103 (51.0) 102 (50.7) 205 (50.9) 0.96†
Stratum FAC-FEC n=135 n=131 n=266  
missing data ** 9 7 16  
number of patients evaluable 126 124 250
Quantitative     
Median nausea score (min-max) 5.93 (1.11–7) 6.08 (1.65–7) 6.03 (1.11–7) 0.69*
Mean ± sd 5.37 (1.66) 5.48 (1.52) 5.42 (1.49)  
Qualitative     
Patients with no impact of nausea on daily life (i.e. mean score > 6), n (%) 63 (50.0) 63 (50.8) 126 (50.4) 0.90†
Stratum TAC n=82 n=83 n=165  
missing data** 6 6 12  
number of patients evaluable 76 77 153  
Quantitative     
Median nausea score (min-max)   6.07 (1.90-7)   6.02 (1.22-7)
Mean ± sd 5.54 (1.43) 5.39 (1.66) 5.47 (1.55)
Qualitative     
Patients with no impact of nausea on daily life (i.e. mean score > 6), n (%) 40 (52.6) 39 (50.6) 79 (51.6) 0.81†
Patients with susceptibility to NV (Yes) n=61 n=66 n=127  
missing data** 2 4 6
number of patients evaluable 59 62 121
Quantitative    
Median nausea score (min-max) 5.85 (1.11–7) 5.81 (1.22–7) 5.83 (1.11–7) 0.36*
Mean ± sd 5.29 (1.66) 5.04 (1.71) 5.16 (1.69)
Qualitative     
Patients with no impact of nausea on daily life (i.e. mean score > 6), n (%) 30 (49.2) 28 (42.4) 58 (45.7) 0.45†
  1. *: Mann–Whitney U test †: Person’s chi-square test.
  2. **: missing data i.e. number of patients with more than 5 missing items in the FLIE questionnaire.
  3. n: number of patients.