Outcome Measures
The primary outcome measure was
the change in daily Hot Flush
Score at 12 weeks from randomisation based on the validated composite
score B calculation24 (Supplementary Document 1, p49).
This was calculated based on frequency and severity as recorded by
participants in Sloan Diaries. The secondary outcome measures were the
changes at weeks 4, 8 and 12 from randomisation in the following (1) hot
flushes frequency as calculated using the frequency score B, (2) hot
flushes severity as calculated using the severity score B, (3)
occurrence of a response (defined as a reduction in Hot Flush Score of
≥50%) as calculated using composite score B, (4) other menopausal
symptoms as measured by the Greene Climacteric Scale, (5) longitudinal
QoL data as measured by the Utian QoL Scale. The trial investigated the
treatment effect on outcomes in specific prognostic subgroups of healthy
women versus breast or endometrial cancer survivors and BMI ≤30versus >30.