Trial Outcomes & Findings for A Neoadjuvant Study of Abemaciclib (LY2835219) in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer (NCT NCT02441946)
NCT ID: NCT02441946
Last Updated: 2020-06-17
Results Overview
Tumor tissue collected through a core biopsy at baseline and at the end of cycle 1 was used to determine Ki67 expression. Ki67 expression is defined as the percent of cells staining positive by validated central assay.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
224 participants
Primary outcome timeframe
Baseline, 2 Weeks
Results posted on
2020-06-17
Participant Flow
Participants who had progressive disease at the end of the study but off study drug were considered to have completed the study. Participants were randomized to anastrozole, or abemaciclib, and abemaciclib + anastrozole in cycle 1. All participants received abemaciclib + anastrozole post cycle 1.
Participant milestones
| Measure |
Abemaciclib + Anastrozole
Participants were given 150 milligram (mg) of abemaciclib orally every 12 hours (Q12H) plus 1 mg of anastrozole orally once daily (QD) for 2 weeks.
All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.
Total treatment duration was 16 weeks.
|
Abemaciclib
Participants received 150 mg of abemaciclib orally Q12H for 2 weeks.
All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole QD for an additional 14 weeks.
Total treatment duration was 16 weeks.
|
Anastrozole
Participants received 1 mg of anastrozole orally QD for 2 weeks.
All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.
Total treatment duration was 16 weeks.
|
|---|---|---|---|
|
Cycle 1 Period 1 (2 Weeks)
STARTED
|
74
|
76
|
74
|
|
Cycle 1 Period 1 (2 Weeks)
Received at Least One Dose of Study Drug
|
74
|
75
|
74
|
|
Cycle 1 Period 1 (2 Weeks)
COMPLETED
|
72
|
71
|
74
|
|
Cycle 1 Period 1 (2 Weeks)
NOT COMPLETED
|
2
|
5
|
0
|
|
Cycle 2-5 Period 2 (14 Weeks)
STARTED
|
217
|
0
|
0
|
|
Cycle 2-5 Period 2 (14 Weeks)
Received at Least One Dose of Study Drug
|
217
|
0
|
0
|
|
Cycle 2-5 Period 2 (14 Weeks)
Progressive Disease
|
5
|
0
|
0
|
|
Cycle 2-5 Period 2 (14 Weeks)
COMPLETED
|
190
|
0
|
0
|
|
Cycle 2-5 Period 2 (14 Weeks)
NOT COMPLETED
|
27
|
0
|
0
|
|
Extension Period (8 Weeks)
STARTED
|
42
|
0
|
0
|
|
Extension Period (8 Weeks)
COMPLETED
|
40
|
0
|
0
|
|
Extension Period (8 Weeks)
NOT COMPLETED
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
Abemaciclib + Anastrozole
Participants were given 150 milligram (mg) of abemaciclib orally every 12 hours (Q12H) plus 1 mg of anastrozole orally once daily (QD) for 2 weeks.
All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.
Total treatment duration was 16 weeks.
|
Abemaciclib
Participants received 150 mg of abemaciclib orally Q12H for 2 weeks.
All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole QD for an additional 14 weeks.
Total treatment duration was 16 weeks.
|
Anastrozole
Participants received 1 mg of anastrozole orally QD for 2 weeks.
All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.
Total treatment duration was 16 weeks.
|
|---|---|---|---|
|
Cycle 1 Period 1 (2 Weeks)
Adverse Event
|
1
|
1
|
0
|
|
Cycle 1 Period 1 (2 Weeks)
Physician Decision
|
1
|
0
|
0
|
|
Cycle 1 Period 1 (2 Weeks)
Withdrawal by Subject
|
0
|
3
|
0
|
|
Cycle 1 Period 1 (2 Weeks)
Never Treated
|
0
|
1
|
0
|
|
Cycle 2-5 Period 2 (14 Weeks)
Adverse Event
|
15
|
0
|
0
|
|
Cycle 2-5 Period 2 (14 Weeks)
Noncompliance with study drug
|
1
|
0
|
0
|
|
Cycle 2-5 Period 2 (14 Weeks)
Physician Decision
|
1
|
0
|
0
|
|
Cycle 2-5 Period 2 (14 Weeks)
Protocol Deviation
|
1
|
0
|
0
|
|
Cycle 2-5 Period 2 (14 Weeks)
Withdrawal by Subject
|
9
|
0
|
0
|
|
Extension Period (8 Weeks)
Adverse Event
|
1
|
0
|
0
|
|
Extension Period (8 Weeks)
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
A Neoadjuvant Study of Abemaciclib (LY2835219) in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer
Baseline characteristics by cohort
| Measure |
Abemaciclib + Anastrozole
n=74 Participants
Participants were given 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for 2 weeks.
All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.
Total treatment duration was 16 weeks.
|
Abemaciclib
n=76 Participants
Participants received 150 mg of abemaciclib orally Q12H for 2 weeks.
All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole QD for an additional 14 weeks.
Total treatment duration was 16 weeks.
|
Anastrozole
n=74 Participants
Participants received 1 mg of anastrozole orally QD for 2 weeks.
All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.
Total treatment duration was 16 weeks.
|
Total
n=224 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.9 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
63.8 years
STANDARD_DEVIATION 7.9 • n=7 Participants
|
64.9 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
64.2 years
STANDARD_DEVIATION 8.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
224 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
61 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
182 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
55 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
167 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Region of Enrollment
Austria
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Region of Enrollment
Netherlands
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
Belgium
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
26 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
|
Region of Enrollment
Taiwan
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Region of Enrollment
South Korea
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0 (Fully Active)
|
69 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
202 Participants
n=4 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1 (Restricted, able to do light sedentary work)
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Unreported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ki67 at Baseline
|
27.24 Percent Cells Positive
STANDARD_DEVIATION 13.56 • n=5 Participants
|
27.88 Percent Cells Positive
STANDARD_DEVIATION 12.13 • n=7 Participants
|
26.86 Percent Cells Positive
STANDARD_DEVIATION 12.32 • n=5 Participants
|
27.33 Percent Cells Positive
STANDARD_DEVIATION 12.63 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 2 WeeksPopulation: All randomized participants who received at least one dose of study drug and a valid baseline Ki67 measurement of at least 5% and a valid 2-week measurement of any magnitude.
Tumor tissue collected through a core biopsy at baseline and at the end of cycle 1 was used to determine Ki67 expression. Ki67 expression is defined as the percent of cells staining positive by validated central assay.
Outcome measures
| Measure |
Abemaciclib + Anastrozole
n=59 Participants
Participants were given 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for 2 weeks.
All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.
Total treatment duration was 16 weeks.
|
Abemaciclib
n=52 Participants
Participants received 150 mg of abemaciclib orally Q12H for 2 weeks.
All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole QD for an additional 14 weeks.
Total treatment duration was 16 weeks.
|
Anastrozole
n=56 Participants
Participants received 1 mg of anastrozole orally QD for 2 weeks.
All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.
Total treatment duration was 16 weeks.
|
|---|---|---|---|
|
Percent Change From Baseline to 2 Weeks in Ki67 Expression
|
-92.86 Percent Change
Interval -94.82 to -90.16
|
-90.52 Percent Change
Interval -93.12 to -86.93
|
-62.78 Percent Change
Interval -72.99 to -48.71
|
SECONDARY outcome
Timeframe: From Start of Treatment Up to 16 WeeksPopulation: All participants who received combination treatment post cycle 1 and had evaluable pCR data. Radiological/surgery assessments occurred at the start of treatment and at the end of the treatment.
pCR is defined as absence of invasive cancer in the breast and sampled regional lymph nodes.
Outcome measures
| Measure |
Abemaciclib + Anastrozole
n=190 Participants
Participants were given 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for 2 weeks.
All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.
Total treatment duration was 16 weeks.
|
Abemaciclib
Participants received 150 mg of abemaciclib orally Q12H for 2 weeks.
All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole QD for an additional 14 weeks.
Total treatment duration was 16 weeks.
|
Anastrozole
Participants received 1 mg of anastrozole orally QD for 2 weeks.
All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.
Total treatment duration was 16 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Pathologic Complete Response (pCR)
|
3.7 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From Start of Treatment to Objective Progression or Start of New Anticancer Therapy (Up to 16 Weeks)Population: All participants who received combination treatment post cycle 1. Radiological/surgery assessments occurred at the start of treatment and at the end of the treatment.
Clinical objective response is defined as the percentage of participants with the best overall response rate (ORR) with a best OR of CR or PR, according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST) v1.1. ORR is recorded from the start of the study treatment until the earliest of objective progression or start of new anticancer therapy. A responder depends on target and non-target disease and the appearance of new lesions. CR is defined as the disappearance of all non-target lesions. PR is at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. All lymph nodes are non-pathological or normal in size (\<10mm short axis). Progressive disease (PD) is a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, a relative increase of 20%, the sum must also demonstrate an absolute increase of 5 mm.
Outcome measures
| Measure |
Abemaciclib + Anastrozole
n=224 Participants
Participants were given 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for 2 weeks.
All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.
Total treatment duration was 16 weeks.
|
Abemaciclib
Participants received 150 mg of abemaciclib orally Q12H for 2 weeks.
All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole QD for an additional 14 weeks.
Total treatment duration was 16 weeks.
|
Anastrozole
Participants received 1 mg of anastrozole orally QD for 2 weeks.
All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.
Total treatment duration was 16 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Complete Response (CR) or Partial Response (PR): Clinical Objective Response
|
53.6 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From Start of Treatment to Objective Progression or Start of New Anticancer Therapy (Up to 16 Weeks)Population: All participants who received combination treatment post cycle 1. Radiological/surgery assessments occurred at the start of treatment and at the end of the treatment.
Radiological response is the percentage of participants with CR or, PR according to RECIST v.1.1. A responder is defined as any participant who exhibits a CR or PR. CR is the disappearance of all target lesions. PR is a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. PD is 20% increase in the sum of diameters of target lesions taking as reference the smallest sum and the appearance of 1 or more new lesions.
Outcome measures
| Measure |
Abemaciclib + Anastrozole
n=224 Participants
Participants were given 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for 2 weeks.
All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.
Total treatment duration was 16 weeks.
|
Abemaciclib
Participants received 150 mg of abemaciclib orally Q12H for 2 weeks.
All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole QD for an additional 14 weeks.
Total treatment duration was 16 weeks.
|
Anastrozole
Participants received 1 mg of anastrozole orally QD for 2 weeks.
All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.
Total treatment duration was 16 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Complete Radiologic Response or Partial Radiological Response: Radiological Response
|
46.4 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 2 WeeksPopulation: All randomized participants who received at least one dose of study drug and had evaluable data for EORTC QLQ.
EORTC QLQ-C30 v3.0 was a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, emotional, cognitive, or social functioning), global health status and symptom scales of fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, or financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms.
Outcome measures
| Measure |
Abemaciclib + Anastrozole
n=74 Participants
Participants were given 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for 2 weeks.
All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.
Total treatment duration was 16 weeks.
|
Abemaciclib
n=76 Participants
Participants received 150 mg of abemaciclib orally Q12H for 2 weeks.
All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole QD for an additional 14 weeks.
Total treatment duration was 16 weeks.
|
Anastrozole
n=74 Participants
Participants received 1 mg of anastrozole orally QD for 2 weeks.
All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.
Total treatment duration was 16 weeks.
|
|---|---|---|---|
|
Change From Baseline to Week 2 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Emotional
|
5.4 units on a scale
Standard Deviation 17.1
|
3.5 units on a scale
Standard Deviation 21.4
|
1.3 units on a scale
Standard Deviation 14.0
|
|
Change From Baseline to Week 2 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Social Functioning
|
-8.3 units on a scale
Standard Deviation 18.8
|
-3.5 units on a scale
Standard Deviation 16.7
|
-0.7 units on a scale
Standard Deviation 12.6
|
|
Change From Baseline to Week 2 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Fatigue
|
13.6 units on a scale
Standard Deviation 23.2
|
13.9 units on a scale
Standard Deviation 22.6
|
4.0 units on a scale
Standard Deviation 12.8
|
|
Change From Baseline to Week 2 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Constipation
|
22.4 units on a scale
Standard Deviation 31.5
|
16.9 units on a scale
Standard Deviation 31.2
|
1.9 units on a scale
Standard Deviation 15.0
|
|
Change From Baseline to Week 2 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Diarrhea
|
18.3 units on a scale
Standard Deviation 29.4
|
27.8 units on a scale
Standard Deviation 25.9
|
0.0 units on a scale
Standard Deviation 15.1
|
|
Change From Baseline to Week 2 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Global Health Status
|
-9.5 units on a scale
Standard Deviation 17.9
|
-7.6 units on a scale
Standard Deviation 18.1
|
-2.3 units on a scale
Standard Deviation 13.4
|
|
Change From Baseline to Week 2 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Physical Functioning
|
-3.2 units on a scale
Standard Deviation 10.2
|
-5.5 units on a scale
Standard Deviation 12.6
|
-0.3 units on a scale
Standard Deviation 7.5
|
|
Change From Baseline to Week 2 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Role Functioning
|
-11.3 units on a scale
Standard Deviation 23.7
|
-11.4 units on a scale
Standard Deviation 24.0
|
-2.2 units on a scale
Standard Deviation 17.4
|
|
Change From Baseline to Week 2 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Cognitive
|
0.5 units on a scale
Standard Deviation 12.4
|
-2.0 units on a scale
Standard Deviation 15.6
|
-1.4 units on a scale
Standard Deviation 11.0
|
|
Change From Baseline to Week 2 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Nausea/Vomiting
|
11.8 units on a scale
Standard Deviation 17.7
|
9.6 units on a scale
Standard Deviation 12.4
|
2.7 units on a scale
Standard Deviation 7.4
|
|
Change From Baseline to Week 2 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Pain
|
4.8 units on a scale
Standard Deviation 19.9
|
3.5 units on a scale
Standard Deviation 19.3
|
2.9 units on a scale
Standard Deviation 16.7
|
|
Change From Baseline to Week 2 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Dyspnea
|
1.1 units on a scale
Standard Deviation 19.1
|
0.5 units on a scale
Standard Deviation 19.8
|
-1.0 units on a scale
Standard Deviation 12.7
|
|
Change From Baseline to Week 2 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Insomnia
|
-1.1 units on a scale
Standard Deviation 19.1
|
0.5 units on a scale
Standard Deviation 29.5
|
-1.9 units on a scale
Standard Deviation 22.1
|
|
Change From Baseline to Week 2 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Appetite Loss
|
16.9 units on a scale
Standard Deviation 28.3
|
16.9 units on a scale
Standard Deviation 27.5
|
1.9 units on a scale
Standard Deviation 15.0
|
|
Change From Baseline to Week 2 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Financial Impact
|
-2.8 units on a scale
Standard Deviation 19.7
|
2.0 units on a scale
Standard Deviation 18.4
|
0.0 units on a scale
Standard Deviation 11.4
|
SECONDARY outcome
Timeframe: Cycle(C)1, Day(D)1: 2 to 4 Hours (Hrs) Postdose; C1D14: 4 Hrs Postdose, 7 Hrs Postdose; C3D1: Predose, 3 Hrs Postdose, C4D1 & C5D1, Predose, C5D28: Predose, 3 Hrs PostdosePopulation: All randomized participants who received at least one dose of abemaciclib across cycles 1 and cycles 3-5. The results are summarized by the original randomized arms of cycle 1.
Abemaciclib apparent clearance (CL/F) was calculated by population nonlinear mixed effects modeling (NONMEM) using all available data spanning cycles 1 and cycles 3-5.
Outcome measures
| Measure |
Abemaciclib + Anastrozole
n=74 Participants
Participants were given 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for 2 weeks.
All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.
Total treatment duration was 16 weeks.
|
Abemaciclib
n=75 Participants
Participants received 150 mg of abemaciclib orally Q12H for 2 weeks.
All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole QD for an additional 14 weeks.
Total treatment duration was 16 weeks.
|
Anastrozole
n=74 Participants
Participants received 1 mg of anastrozole orally QD for 2 weeks.
All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.
Total treatment duration was 16 weeks.
|
|---|---|---|---|
|
Pharmacokinetics (PK): Apparent Clearance of Abemaciclib
|
24.0 Liters/hour (L/h)
Geometric Coefficient of Variation 32
|
19.1 Liters/hour (L/h)
Geometric Coefficient of Variation 55
|
24.4 Liters/hour (L/h)
Geometric Coefficient of Variation 61
|
SECONDARY outcome
Timeframe: Cycle(C)1, Day(D)1: 2 to 4 Hours (Hrs) Postdose; C1D14: 4 Hrs Postdose, 7 Hrs Postdose; C3D1: Predose, 3 Hrs Postdose, C4D1 & C5D1, Predose, C5D28: Predose, 3 Hrs PostdosePopulation: All randomized participants who received at least one dose of abemaciclib across cycles 1 and cycles 3-5. The results are summarized by the original randomized arms of cycle 1.
Abemaciclib apparent volume of distribution was calculated by population NONMEM using all available data spanning cycles 1 and cycles 3-5.
Outcome measures
| Measure |
Abemaciclib + Anastrozole
n=74 Participants
Participants were given 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for 2 weeks.
All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.
Total treatment duration was 16 weeks.
|
Abemaciclib
n=75 Participants
Participants received 150 mg of abemaciclib orally Q12H for 2 weeks.
All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole QD for an additional 14 weeks.
Total treatment duration was 16 weeks.
|
Anastrozole
n=74 Participants
Participants received 1 mg of anastrozole orally QD for 2 weeks.
All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.
Total treatment duration was 16 weeks.
|
|---|---|---|---|
|
PK: Apparent Volume of Distribution of Abemaciclib
|
941 Liters (L)
Geometric Coefficient of Variation 53
|
720 Liters (L)
Geometric Coefficient of Variation 58
|
758 Liters (L)
Geometric Coefficient of Variation 49
|
Adverse Events
Abemaciclib + Anastrozole Cycle 1
Serious events: 1 serious events
Other events: 62 other events
Deaths: 0 deaths
Abemaciclib Cycle 1
Serious events: 1 serious events
Other events: 58 other events
Deaths: 0 deaths
Anastrozole Cycle 1
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Abemaciclib + Anastrozole Cycle 2 and Beyond
Serious events: 16 serious events
Other events: 189 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Abemaciclib + Anastrozole Cycle 1
n=74 participants at risk
Participants were given 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for 2 weeks.
All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.
Total treatment duration was 16 weeks.
|
Abemaciclib Cycle 1
n=75 participants at risk
Participants received 150 mg of abemaciclib orally QD for 2 weeks.
All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.
Total treatment duration was 16 weeks.
|
Anastrozole Cycle 1
n=74 participants at risk
Participants received 1 mg of anastrozole orally Q12H for 2 weeks.
All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole QD for an additional 14 weeks.
Total treatment duration was 16 weeks.
.
|
Abemaciclib + Anastrozole Cycle 2 and Beyond
n=217 participants at risk
Combination Therapy: All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.
Total treatment duration was 16 weeks.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.46%
1/217 • Number of events 1 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.46%
1/217 • Number of events 1 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.46%
1/217 • Number of events 1 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.46%
1/217 • Number of events 1 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.4%
1/74 • Number of events 1 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.46%
1/217 • Number of events 1 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.46%
1/217 • Number of events 1 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Mastitis
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.92%
2/217 • Number of events 2 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
1.4%
3/217 • Number of events 3 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
1.4%
1/74 • Number of events 1 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/217 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
1.4%
1/74 • Number of events 1 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/217 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.92%
2/217 • Number of events 2 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
1.3%
1/75 • Number of events 1 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/217 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.46%
1/217 • Number of events 1 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.46%
1/217 • Number of events 1 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Seizure
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.46%
1/217 • Number of events 1 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.46%
1/217 • Number of events 1 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.46%
1/217 • Number of events 1 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.46%
1/217 • Number of events 1 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.46%
1/217 • Number of events 1 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/75 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.46%
1/217 • Number of events 1 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Abemaciclib + Anastrozole Cycle 1
n=74 participants at risk
Participants were given 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for 2 weeks.
All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.
Total treatment duration was 16 weeks.
|
Abemaciclib Cycle 1
n=75 participants at risk
Participants received 150 mg of abemaciclib orally QD for 2 weeks.
All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.
Total treatment duration was 16 weeks.
|
Anastrozole Cycle 1
n=74 participants at risk
Participants received 1 mg of anastrozole orally Q12H for 2 weeks.
All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole QD for an additional 14 weeks.
Total treatment duration was 16 weeks.
.
|
Abemaciclib + Anastrozole Cycle 2 and Beyond
n=217 participants at risk
Combination Therapy: All participants received 150 mg of abemaciclib orally Q12H plus 1 mg of anastrozole orally QD for an additional 14 weeks.
Total treatment duration was 16 weeks.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
4.0%
3/75 • Number of events 3 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
12.4%
27/217 • Number of events 31 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.4%
1/74 • Number of events 1 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
4.0%
3/75 • Number of events 3 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
8.8%
19/217 • Number of events 22 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.7%
2/74 • Number of events 2 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
1.3%
1/75 • Number of events 1 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
20.7%
45/217 • Number of events 58 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
17.6%
13/74 • Number of events 15 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
9.3%
7/75 • Number of events 7 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
2.7%
2/74 • Number of events 2 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
13.8%
30/217 • Number of events 34 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
36.5%
27/74 • Number of events 27 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
34.7%
26/75 • Number of events 30 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
6.8%
5/74 • Number of events 5 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
23.0%
50/217 • Number of events 62 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
41.9%
31/74 • Number of events 34 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
38.7%
29/75 • Number of events 33 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
2.7%
2/74 • Number of events 2 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
46.5%
101/217 • Number of events 162 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
1.4%
1/74 • Number of events 1 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
6.7%
5/75 • Number of events 5 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
3.2%
7/217 • Number of events 8 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.1%
6/74 • Number of events 6 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
1.3%
1/75 • Number of events 1 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
3.2%
7/217 • Number of events 7 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
25.7%
19/74 • Number of events 19 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
20.0%
15/75 • Number of events 15 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
2.7%
2/74 • Number of events 2 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
30.9%
67/217 • Number of events 75 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
2.7%
2/74 • Number of events 2 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
1.3%
1/75 • Number of events 1 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
8.8%
19/217 • Number of events 21 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
6.8%
5/74 • Number of events 6 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
1.3%
1/75 • Number of events 1 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
11.5%
25/217 • Number of events 32 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
25.7%
19/74 • Number of events 20 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
22.7%
17/75 • Number of events 18 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
4.1%
3/74 • Number of events 4 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
28.6%
62/217 • Number of events 70 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
5.4%
4/74 • Number of events 4 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
1.3%
1/75 • Number of events 1 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
12.0%
26/217 • Number of events 27 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
2.7%
2/74 • Number of events 3 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
1.3%
1/75 • Number of events 1 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
10.1%
22/217 • Number of events 23 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Blood creatinine increased
|
2.7%
2/74 • Number of events 2 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
1.3%
1/75 • Number of events 1 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
6.5%
14/217 • Number of events 15 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Weight decreased
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
2.7%
2/75 • Number of events 2 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
6.9%
15/217 • Number of events 17 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.8%
5/74 • Number of events 5 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
17.3%
13/75 • Number of events 13 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
15.2%
33/217 • Number of events 36 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
1.4%
1/74 • Number of events 1 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
6.7%
5/75 • Number of events 5 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
1.4%
1/74 • Number of events 1 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
3.7%
8/217 • Number of events 10 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
5.4%
4/74 • Number of events 4 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
6.7%
5/75 • Number of events 5 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
7.8%
17/217 • Number of events 18 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
4.1%
3/74 • Number of events 3 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
6.7%
5/75 • Number of events 5 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
7.4%
16/217 • Number of events 17 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
1.3%
1/75 • Number of events 1 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
5.5%
12/217 • Number of events 12 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.7%
2/74 • Number of events 2 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
1.3%
1/75 • Number of events 1 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
1.4%
1/74 • Number of events 1 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
9.2%
20/217 • Number of events 21 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
2.7%
2/75 • Number of events 2 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/74 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
10.1%
22/217 • Number of events 24 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Hot flush
|
4.1%
3/74 • Number of events 3 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
2.7%
2/75 • Number of events 2 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
6.8%
5/74 • Number of events 5 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
8.8%
19/217 • Number of events 20 • Up to 24 Weeks
All randomized participants who received at least one dose of study drug.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60