Measure:
Number of Participants With Adverse Events
TimeFrame:
From first dose date up to 30 days after last dose (up to 16 weeks)
Description:
An adverse event (AE) is any untoward medical occurrence, including the exacerbation of a pre-existing condition, in a subject or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect, or precaution. This includes any experience that results in death; is acutely life-threatening; requires inpatient hospitalization or prolongs the existing hospitalization; results in persistent or significant incapacity or substantial disruption of ability to conduct normal life functions; is a congenital anomaly/birth defect; or requires medical or surgical intervention to prevent one of the outcomes listed above.
Measure:
Change From Baseline in White Blood Cell Counts 24 Hours After Administration of G-CSF or Placebo on Day 0
TimeFrame:
Baseline and day 1
Description:
Change from baseline in white blood cell counts 24 hours after administration of G-CSF or placebo on day 0. Blood samples were collected 24 hours after adminstration of G-CSF on day 0.
Measure:
Change From Baseline in White Blood Cell Counts 24 Hours After Administration of G-CSF or Placebo on Day 28
TimeFrame:
Baseline and day 29
Description:
Change from baseline in white blood cell counts 24 hours after administration of G-CSF or placebo on day 28. Blood samples were collected 24 hours after adminstration of G-CSF on day 28.
Measure:
Change From Baseline in White Blood Cell Counts 24 Hours After Administration of G-CSF or Placebo on Day 56.
TimeFrame:
Baseline and day 57
Description:
Change from baseline in white blood cell counts 24 hours after administration of G-CSF or placebo on day 56. Blood samples were collected 24 hours after adminstration of G-CSF on day 56.
Measure:
Change From Baseline in White Blood Cell Counts on Day 84 (28 Days After Last Administration of G-CSF or Palcebo)
TimeFrame:
Baseline and day 84
Description:
Change from baseline in white blood cell counts on day 84. Blood samples were collected 24 hours after adminstration of G-CSF on day 84.
Measure:
Change From Baseline in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes at Week 4
TimeFrame:
Baseline and week 4
Description:
The frequency of moderate to severe hot flashes was the number of moderate to severe hot flashes per 24 hours. A daily frequency per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received.
Measure:
Change From Baseline in the Mean Frequency of Moderate and Severe (M+S) Hot Flashes at Week 12
TimeFrame:
Baseline and week 12
Description:
The frequency of moderate to severe hot flashes was the number of moderate to severe hot flashes per 24 hours. A daily frequency per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received.
Measure:
Change From Baseline in the Mean Composite Daily Severity of Hot Flashes (CDS) at Week 4
TimeFrame:
Baseline and week 4
Description:
CDS (Composite Daily Hot Flash Severity) was calculated as follows:
\[(number of mild hot flashes per day x 1) + (number of moderate hot flashes per day x 2) + (number of severe hot flashes per day x 3)\]. A daily frequency per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received.
Measure:
Change From Baseline in the Mean Composite Daily Severity of Hot Flashes (CDS) at Week 12
TimeFrame:
Baseline and week 12
Description:
CDS (Composite Daily Hot Flash Severity) was calculated as follows:
\[(number of mild hot flashes per day x 1) + (number of moderate hot flashes per day x 2) + (number of severe hot flashes per day x 3)\]. A daily frequency per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received.
Measure:
Change From Baseline in the Mean Daily Severity of Hot Flashes (HFSS) at Week 4
TimeFrame:
Baseline and week 4
Description:
HFSS (Daily Hot Flash Severity Score) was calculated as follows:
\[(number of mild hot flashes per day x 1) + (number of moderate hot flashes per day x 2) + (number of severe hot flashes per day x 3)\]/daily total hot flashes), where total hot flashes (THF) = number of daily mild, moderate, and severe hot flashes. A daily severity score per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received.
Measure:
Change From Baseline in the Mean Daily Severity of Hot Flashes (HFSS) at Week 12
TimeFrame:
Baseline and week 12
Description:
HFSS (Daily Hot Flash Severity Score) was calculated as follows:
\[(number of mild hot flashes per day x 1) + (number of moderate hot flashes per day x 2) + (number of severe hot flashes per day x 3)\]/daily total hot flashes), where total hot flashes (THF) = number of daily mild, moderate, and severe hot flashes. A daily severity score per week was derived by taking the mean of the data over 7 days. All subjects who were randomized and received at least one dose of study drug are included in this subset. Subjects are analysed according to the randomized treatment group regardless of treatment received.