Table 3

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

*: Mann–Whitney U test †: Person’s chi-square test.

**: missing data i.e. number of patients with more than 5 missing items in the FLIE questionnaire.

n: number of patients.

Pérol et al.

Pérol et al. BMC Cancer 2012 12:603   doi:10.1186/1471-2407-12-603

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