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.