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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
| 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† |
