Skip to main content

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.