Safety
The proportion of subjects experiencing AEs were similar in all
vestipitant treatment groups and the ondansetron group (Supplementary
Table S2). As expected in this post-surgical population,
procedural pain was the most frequently reported AE
across all treatment groups. The frequency of reported AEs
related to administration site was generally low across treatment
groups (Supplementary Table S3). There were 12 AEs in
seven patients (5.3%) that were considered related to vestipitant
treatment; the AEs were most frequently observed in the
vestipitant 18 mg group (five AEs in three patients, 13.0%)
and the vestipitant 24 mg group (four AEs in two patients,
10.0%). There were seven SAEs reported in five patients
(3.8%), in the vestipitant 6, 18, and 36mggroups, all unrelated
to vestipitant. The SAEs were most frequently reported in the
vestipitant 18 mg group (four SAEs in two patients, 8.7%).
In the ondansetron group, there were no related AEs and no
SAEs. There were no AEs leading to withdrawal and no deaths
reported in any treatment group in this study.
There were no clinically significant changes in clinical
laboratory values (chemistry, haematology, and urinalysis),
vital signs, or ECGs during this study.