| |
Placebo n = 217
|
Cocculine
®
n = 214
|
All n = 431
|
p †
|
|
Missing data
|
39
|
20
|
59
| |
|
Number of patients evaluable
|
178
|
194
|
372
| |
|
Number of patient with at least 1 AE nausea (%)
|
91 (51.1)
|
92 (47.4)
|
83 (49.2)
|
0.48
|
|
Missing data
|
39
|
20
|
59
| |
|
Number of patients evaluable
|
178
|
194
|
372
| |
|
Number of patient with at least 1 AE vomiting, n (%)
|
35 (19.7)
|
41 (21.1)
|
76 (20.4)
|
0.72
|
|
Frequency of severe nausea and vomiting AE (Grade ≥ 2) during 1
st
cycle of chemotherapy
|
| |
Placebo n = 217
|
Cocculine n = 214
|
All n = 431
|
p †
|
|
Missing data
|
47
|
29
|
76
| |
|
Number of patients evaluable, n
|
170
|
185
|
355
| |
|
Number of patient with at least 1 severe nausea AE (i.e. Grade ≥2), n (%)
|
30 (17.6)
|
29 (15.7)
|
59 (16.6)
|
0.62
|
|
Missing data
|
41
|
22
|
63
| |
|
Number of patients evaluable
|
176
|
192
|
368
| |
|
Number of patient with at least 1 severe vomiting AE (i.e. Grade ≥ 2), n (%)
|
19 (10.8)
|
23 (12.0)
|
42 (11.4)
|
0.72
|
