Trial Outcomes & Findings for A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer (NCT NCT02246621)
NCT ID: NCT02246621
Last Updated: 2026-02-03
Results Overview
PFS defined as the time from the first day of therapy to the first evidence of disease progression as defined by RECIST v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
493 participants
Primary outcome timeframe
Randomization to Progressive Disease or Death Due to Any Cause (Up to 32 Months)
Results posted on
2026-02-03
Participant Flow
Completers are participants who died.
Participant milestones
| Measure |
Abemaciclib + NSAI (Nonsteroidal Aromatase Inhibitors)
150 milligrams (mg) Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
|
Placebo + NSAI
Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
|
|---|---|---|
|
Overall Study
STARTED
|
328
|
165
|
|
Overall Study
Received At Least One Dose of Study Drug
|
327
|
161
|
|
Overall Study
COMPLETED
|
63
|
30
|
|
Overall Study
NOT COMPLETED
|
265
|
135
|
Reasons for withdrawal
| Measure |
Abemaciclib + NSAI (Nonsteroidal Aromatase Inhibitors)
150 milligrams (mg) Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
|
Placebo + NSAI
Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
28
|
16
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
On Study Treatment/ Follow Up
|
236
|
119
|
Baseline Characteristics
A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer
Baseline characteristics by cohort
| Measure |
Placebo + NSAI
n=165 Participants
Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
|
Total
n=493 Participants
Total of all reporting groups
|
Abemaciclib + NSAI
n=328 Participants
150 milligrams (mg) Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
|
|---|---|---|---|
|
Age, Continuous
|
62.92 years
STANDARD_DEVIATION 9.96 • n=1581 Participants
|
63.05 years
STANDARD_DEVIATION 9.92 • n=4626 Participants
|
63.13 years
STANDARD_DEVIATION 9.92 • n=41 Participants
|
|
Sex: Female, Male
Female
|
165 Participants
n=1581 Participants
|
493 Participants
n=4626 Participants
|
328 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=1581 Participants
|
44 Participants
n=4626 Participants
|
32 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
125 Participants
n=1581 Participants
|
355 Participants
n=4626 Participants
|
230 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
28 Participants
n=1581 Participants
|
94 Participants
n=4626 Participants
|
66 Participants
n=41 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=1581 Participants
|
7 Participants
n=4626 Participants
|
4 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Asian
|
45 Participants
n=1581 Participants
|
148 Participants
n=4626 Participants
|
103 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=1581 Participants
|
8 Participants
n=4626 Participants
|
5 Participants
n=41 Participants
|
|
Race (NIH/OMB)
White
|
102 Participants
n=1581 Participants
|
288 Participants
n=4626 Participants
|
186 Participants
n=41 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1581 Participants
|
2 Participants
n=4626 Participants
|
2 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=1581 Participants
|
39 Participants
n=4626 Participants
|
28 Participants
n=41 Participants
|
|
Region of Enrollment
Australia
|
6 Participants
n=1581 Participants
|
15 Participants
n=4626 Participants
|
9 Participants
n=41 Participants
|
|
Region of Enrollment
Austria
|
3 Participants
n=1581 Participants
|
13 Participants
n=4626 Participants
|
10 Participants
n=41 Participants
|
|
Region of Enrollment
Belgium
|
7 Participants
n=1581 Participants
|
21 Participants
n=4626 Participants
|
14 Participants
n=41 Participants
|
|
Region of Enrollment
Canada
|
11 Participants
n=1581 Participants
|
25 Participants
n=4626 Participants
|
14 Participants
n=41 Participants
|
|
Region of Enrollment
Germany
|
5 Participants
n=1581 Participants
|
16 Participants
n=4626 Participants
|
11 Participants
n=41 Participants
|
|
Region of Enrollment
Spain
|
14 Participants
n=1581 Participants
|
30 Participants
n=4626 Participants
|
16 Participants
n=41 Participants
|
|
Region of Enrollment
France
|
11 Participants
n=1581 Participants
|
41 Participants
n=4626 Participants
|
30 Participants
n=41 Participants
|
|
Region of Enrollment
United Kingdom
|
2 Participants
n=1581 Participants
|
9 Participants
n=4626 Participants
|
7 Participants
n=41 Participants
|
|
Region of Enrollment
Greece
|
1 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
0 Participants
n=41 Participants
|
|
Region of Enrollment
Israel
|
19 Participants
n=1581 Participants
|
47 Participants
n=4626 Participants
|
28 Participants
n=41 Participants
|
|
Region of Enrollment
Italy
|
11 Participants
n=1581 Participants
|
22 Participants
n=4626 Participants
|
11 Participants
n=41 Participants
|
|
Region of Enrollment
Japan
|
15 Participants
n=1581 Participants
|
53 Participants
n=4626 Participants
|
38 Participants
n=41 Participants
|
|
Region of Enrollment
South Korea
|
18 Participants
n=1581 Participants
|
59 Participants
n=4626 Participants
|
41 Participants
n=41 Participants
|
|
Region of Enrollment
Mexico
|
7 Participants
n=1581 Participants
|
29 Participants
n=4626 Participants
|
22 Participants
n=41 Participants
|
|
Region of Enrollment
Netherlands
|
4 Participants
n=1581 Participants
|
6 Participants
n=4626 Participants
|
2 Participants
n=41 Participants
|
|
Region of Enrollment
New Zealand
|
0 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
1 Participants
n=41 Participants
|
|
Region of Enrollment
Russia
|
6 Participants
n=1581 Participants
|
19 Participants
n=4626 Participants
|
13 Participants
n=41 Participants
|
|
Region of Enrollment
Slovakia
|
0 Participants
n=1581 Participants
|
2 Participants
n=4626 Participants
|
2 Participants
n=41 Participants
|
|
Region of Enrollment
Sweden
|
1 Participants
n=1581 Participants
|
4 Participants
n=4626 Participants
|
3 Participants
n=41 Participants
|
|
Region of Enrollment
Turkey
|
3 Participants
n=1581 Participants
|
12 Participants
n=4626 Participants
|
9 Participants
n=41 Participants
|
|
Region of Enrollment
Taiwan
|
9 Participants
n=1581 Participants
|
32 Participants
n=4626 Participants
|
23 Participants
n=41 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=1581 Participants
|
36 Participants
n=4626 Participants
|
24 Participants
n=41 Participants
|
PRIMARY outcome
Timeframe: Randomization to Progressive Disease or Death Due to Any Cause (Up to 32 Months)Population: All randomized participants who had evaluable data. Censored participants: Abemaciclib + NSAI = 190 and Placebo + NSAI =57.
PFS defined as the time from the first day of therapy to the first evidence of disease progression as defined by RECIST v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.
Outcome measures
| Measure |
Abemaciclib + NSAI
n=328 Participants
150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
|
Placebo + NSAI
n=165 Participants
Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
|
|---|---|---|
|
Progression Free Survival (PFS)
|
28.18 Months
Interval 23.51 to
The upper limit of the 95% CI was not evaluable due to the high censoring rate.
|
14.76 Months
Interval 11.24 to 19.2
|
SECONDARY outcome
Timeframe: Randomization to Progressive Disease or Death Due to Any Cause (Estimated Up to 82 Months)OS defined as the time from first dose date to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Randomization to Progressive Disease or Death Due to Any Cause (Up to 32 Months)Population: All randomized participants.
ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.
Outcome measures
| Measure |
Abemaciclib + NSAI
n=328 Participants
150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
|
Placebo + NSAI
n=165 Participants
Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
|
|---|---|---|
|
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
|
49.7 Percentage of Participants
Interval 44.3 to 55.1
|
37 Percentage of Participants
Interval 29.6 to 44.3
|
SECONDARY outcome
Timeframe: CR or PR to Disease Progression or Death Due to Any Cause (Up to 32 Months)Population: All randomized participants who had evaluable data. Censored participants: Abemaciclib + NSAI = 112 and Placebo + NSAI =28.
DOR was the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR were defined using the RECIST v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date.
Outcome measures
| Measure |
Abemaciclib + NSAI
n=163 Participants
150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
|
Placebo + NSAI
n=61 Participants
Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
|
|---|---|---|
|
Duration of Response (DoR)
|
27.39 Months
Interval 25.74 to
The upper limit of the 95% CI was not evaluable due to the high censoring rate.
|
17.46 Months
Interval 11.21 to 22.19
|
SECONDARY outcome
Timeframe: Randomization to Progressive Disease or Death Due to Any Cause (Up to 32 Months)Population: All randomized participants.
DCR was the percentage of participants with a best overall response of CR, PR, or SD as per response using RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions.
Outcome measures
| Measure |
Abemaciclib + NSAI
n=328 Participants
150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
|
Placebo + NSAI
n=165 Participants
Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
|
|---|---|---|
|
Percentage of Participants With CR, PR or Stable Disease (SD) (Disease Control Rate [DCR])
|
88.7 Percentage of Participants
Interval 85.3 to 92.1
|
86.7 Percentage of Participants
Interval 81.5 to 91.9
|
SECONDARY outcome
Timeframe: Randomization to Progressive Disease or Death Due to Any Cause (Up to 32 Months)Population: All randomized participants.
CBR defined as percentage of participants with best overall response of CR, PR, or SD with a duration of at least 6 months. CR, PR, or SD were defined using RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. Percentage of participants = (participants with CR+PR+SD with a duration of at least 6 months / number of participants enrolled) \* 100.
Outcome measures
| Measure |
Abemaciclib + NSAI
n=328 Participants
150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
|
Placebo + NSAI
n=165 Participants
Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
|
|---|---|---|
|
Percentage of Participants With Tumor Response of SD for at Least 6 Months, PR, or CR (Clinical Benefit Rate [CBR])
|
78.0 Percentage of Participants
Interval 73.6 to 82.5
|
71.5 Percentage of Participants
Interval 64.6 to 78.4
|
SECONDARY outcome
Timeframe: Baseline, End of Study (Up to 32 Months)Population: All randomized participants.
EORTC QLQ-C30 v3.0 is a self-administered questionnaire with multidimensional scales that measures 5 functional domains(physical,role,cognitive,emotional, and social),global health status, and symptom scales of fatigue, pain, nausea and vomiting,dyspnea,loss of appetite,insomnia,constipation and diarrhea, and financial difficulties.Functional scale options are defined on a 7-point scale ranging from 1, "Very poor" to 7, "Excellent". A linear transformation is applied to standardize the raw scores to range between 0 and 100 with higher score indicating better functioning. For functional domains and global health status, higher scores represent a better level of functioning. Least Square(LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, Visit, Treatment\*Visit and Baseline.
Outcome measures
| Measure |
Abemaciclib + NSAI
n=328 Participants
150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
|
Placebo + NSAI
n=165 Participants
Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
|
|---|---|---|
|
Change From Baseline to End of Study in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Functional Scale Scores
Physical
|
-1.0 score on a scale
Standard Error 0.9
|
1.7 score on a scale
Standard Error 1.2
|
|
Change From Baseline to End of Study in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Functional Scale Scores
Role
|
-1.4 score on a scale
Standard Error 1.1
|
2.9 score on a scale
Standard Error 1.6
|
|
Change From Baseline to End of Study in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Functional Scale Scores
Emotional
|
4.7 score on a scale
Standard Error 0.9
|
4.0 score on a scale
Standard Error 1.3
|
|
Change From Baseline to End of Study in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Functional Scale Scores
Cognitive
|
-4.0 score on a scale
Standard Error 0.9
|
-4.0 score on a scale
Standard Error 1.3
|
|
Change From Baseline to End of Study in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Functional Scale Scores
Social
|
-0.1 score on a scale
Standard Error 1.0
|
3.3 score on a scale
Standard Error 1.4
|
SECONDARY outcome
Timeframe: Baseline, End of Study (Up to 32 Months)Population: All randomized participants.
EORTC QLQ-C30 v3.0 is a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. Symptom scale ranges from: 1, "Not at all"; 2, "A little"; 3, "Quite a bit"; to 4, "Very much." A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For symptoms scales, higher scores indicated greater symptom burden. Least Square(LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, Visit, Treatment\*Visit and Baseline. Small changes are generally defined as at least a 3, 4 or 5 point change from baseline.
Outcome measures
| Measure |
Abemaciclib + NSAI
n=328 Participants
150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
|
Placebo + NSAI
n=165 Participants
Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
|
|---|---|---|
|
Change From Baseline to End of Study in Symptom Burden on the EORTC QLQ-C30 Symptom Scale Scores
Fatigue
|
2.4 score on a scale
Standard Error 1.0
|
-2.6 score on a scale
Standard Error 1.4
|
|
Change From Baseline to End of Study in Symptom Burden on the EORTC QLQ-C30 Symptom Scale Scores
Nausea and Vomiting
|
2.4 score on a scale
Standard Error 0.6
|
-0.4 score on a scale
Standard Error 0.9
|
|
Change From Baseline to End of Study in Symptom Burden on the EORTC QLQ-C30 Symptom Scale Scores
Pain
|
-4.8 score on a scale
Standard Error 1.0
|
-5.7 score on a scale
Standard Error 1.5
|
|
Change From Baseline to End of Study in Symptom Burden on the EORTC QLQ-C30 Symptom Scale Scores
Dyspnea
|
0.9 score on a scale
Standard Error 1.0
|
-1.6 score on a scale
Standard Error 1.4
|
|
Change From Baseline to End of Study in Symptom Burden on the EORTC QLQ-C30 Symptom Scale Scores
Insomnia
|
-1.7 score on a scale
Standard Error 1.2
|
-4.1 score on a scale
Standard Error 1.7
|
|
Change From Baseline to End of Study in Symptom Burden on the EORTC QLQ-C30 Symptom Scale Scores
Appetite loss
|
0.2 score on a scale
Standard Error 1.1
|
-3.9 score on a scale
Standard Error 1.6
|
|
Change From Baseline to End of Study in Symptom Burden on the EORTC QLQ-C30 Symptom Scale Scores
Constipation
|
-0.8 score on a scale
Standard Error 0.9
|
1.6 score on a scale
Standard Error 1.3
|
|
Change From Baseline to End of Study in Symptom Burden on the EORTC QLQ-C30 Symptom Scale Scores
Diarrhea
|
18.2 score on a scale
Standard Error 1.0
|
-0.5 score on a scale
Standard Error 1.5
|
|
Change From Baseline to End of Study in Symptom Burden on the EORTC QLQ-C30 Symptom Scale Scores
Financial difficulties
|
-0.7 score on a scale
Standard Error 1.1
|
-1.2 score on a scale
Standard Error 1.6
|
SECONDARY outcome
Timeframe: Baseline, End of Study (Up to 32 Months)Population: All randomized participants.
The EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual functioning, sexual enjoyment, future perspective) and four symptom scales (systemic side effects, breast symptoms, arm symptoms, upset by hair loss). QLQ-BR23 questionnaire employs 4-point scales with responses from: 1, "Not at all"; 2, "A little"; 3, "Quite a bit"; to 4, "Very much". All scores are converted to a 0 to 100 scale. A higher score representing a higher ("better") level of functioning (BR23: body image, sexual functioning, future perspective), or a higher ("worse") level of symptoms. Least Square (LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, Visit, Treatment\*Visit and Baseline.
Outcome measures
| Measure |
Abemaciclib + NSAI
n=328 Participants
150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
|
Placebo + NSAI
n=165 Participants
Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
|
|---|---|---|
|
Change From Baseline to End of Study in Symptom Burden on the EORTC QLQ-Breast23 Questionnaire
Body image
|
-4.5 score on a scale
Standard Error 1.1
|
0.6 score on a scale
Standard Error 1.6
|
|
Change From Baseline to End of Study in Symptom Burden on the EORTC QLQ-Breast23 Questionnaire
Sexual functioning
|
-0.2 score on a scale
Standard Error 0.7
|
-0.1 score on a scale
Standard Error 1.0
|
|
Change From Baseline to End of Study in Symptom Burden on the EORTC QLQ-Breast23 Questionnaire
Future perspective
|
12.7 score on a scale
Standard Error 1.3
|
11.9 score on a scale
Standard Error 1.9
|
|
Change From Baseline to End of Study in Symptom Burden on the EORTC QLQ-Breast23 Questionnaire
Systemic therapy side effects
|
8.15 score on a scale
Standard Error 0.68
|
3.68 score on a scale
Standard Error 0.98
|
|
Change From Baseline to End of Study in Symptom Burden on the EORTC QLQ-Breast23 Questionnaire
Breast symptoms
|
-6.12 score on a scale
Standard Error 0.64
|
-6.23 score on a scale
Standard Error 0.93
|
|
Change From Baseline to End of Study in Symptom Burden on the EORTC QLQ-Breast23 Questionnaire
Arm symptoms
|
-1.14 score on a scale
Standard Error 0.87
|
-2.23 score on a scale
Standard Error 1.27
|
SECONDARY outcome
Timeframe: Baseline, End of Study (Up to 32 Months)Population: All randomized participants.
The EuroQol-5D (version 5L) is a brief self-administered, validated instrument consisting of 2 parts.The first part consists of 5 descriptors of current health state (mobility, self care, usual activities, pain/discomfort, and anxiety/ depression); a participant is asked to rate each state on a five level scale (no problem, slight problem, moderate problem, severe problem and extreme problem) with higher levels indicating greater severity/ impairment. Published weights are available that allow for the creation of a single summary score called the EQ-5D index that ranges from 0 to 1, with low scores representing a higher level of dysfunction and 1 as perfect health. Minimally important differences in the EQ-5D index score are 0.06 or greater in cancer patients. Least Square(LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, Visit, Treatment\*Visit and Baseline.
Outcome measures
| Measure |
Abemaciclib + NSAI
n=328 Participants
150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
|
Placebo + NSAI
n=165 Participants
Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
|
|---|---|---|
|
Change From Baseline to End of Study in Health Status on the EuroQuol 5-Dimension 5 Level (EuroQol-5D 5L) Index Value
|
0.01 units on a scale
Standard Error 0.01
|
0.01 units on a scale
Standard Error 0.01
|
SECONDARY outcome
Timeframe: Baseline, End of Study (Up to 32 Months)Population: All randomized participants.
The EuroQol-5D (version 5L) is a brief self-administered, validated instrument consisting of 2 parts. The second part consists of the EQ-5D general health status as measured by a visual analog scale (EQ-5D VAS). EQ-5D VAS measures the participant's self-rated health status on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state). Minimally important differences in the EQ-5D VAS score are 7 or greater in cancer patients. Least Square(LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, Visit, Treatment\*Visit and Baseline.
Outcome measures
| Measure |
Abemaciclib + NSAI
n=328 Participants
150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
|
Placebo + NSAI
n=165 Participants
Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
|
|---|---|---|
|
Change From Baseline to End of Study in Health Status on the EuroQol-5D 5L Visual Analog Scale (VAS) Scores Scale
|
0.49 millimeter (mm)
Standard Error 0.78
|
1.51 millimeter (mm)
Standard Error 1.15
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1; 2 to 4 hours (h) post dose, Cycle 2 Day 1; 3 h post dose; 7 h post dose, Cycle 3 Day 1; pre dose, 3 h post dosePopulation: All randomized participants who received at least one dose of study drug with evaluable PK data.
Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity \[AUC(0-∞)\] of Abemaciclib and Its Metabolites M2 and M20
Outcome measures
| Measure |
Abemaciclib + NSAI
n=322 Participants
150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
|
Placebo + NSAI
Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
|
|---|---|---|
|
Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity [AUC(0-∞)] of Abemaciclib and Its Metabolites M2 and M20
M20
|
2300 nanogram*hours/milliliter (ng*h/mL)
Geometric Coefficient of Variation 74.4
|
—
|
|
Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity [AUC(0-∞)] of Abemaciclib and Its Metabolites M2 and M20
M2
|
1290 nanogram*hours/milliliter (ng*h/mL)
Geometric Coefficient of Variation 75.8
|
—
|
|
Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity [AUC(0-∞)] of Abemaciclib and Its Metabolites M2 and M20
Abemaciclib
|
3360 nanogram*hours/milliliter (ng*h/mL)
Geometric Coefficient of Variation 36.6
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1; 2 to 4 hours (h) post dose, Cycle 2 Day 1; 3 h post dose; 7 h post dose, Cycle 3 Day 1; pre dose, 3 h post dosePopulation: All randomized participants who received at least one dose of study drug with evaluable PK data.
PK: Hepatic Clearance of Abemaciclib, and apparent hepatic clearance of its Metabolites M2 and M20
Outcome measures
| Measure |
Abemaciclib + NSAI
n=322 Participants
150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
|
Placebo + NSAI
Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
|
|---|---|---|
|
PK: Hepatic Clearance of Abemaciclib, and Apparent Hepatic Clearance of Its Metabolites M2 and M20
Abemaciclib
|
23.0 liters/hour (L/h)
Geometric Coefficient of Variation 26.7
|
—
|
|
PK: Hepatic Clearance of Abemaciclib, and Apparent Hepatic Clearance of Its Metabolites M2 and M20
M2
|
21.6 liters/hour (L/h)
Geometric Coefficient of Variation 50.4
|
—
|
|
PK: Hepatic Clearance of Abemaciclib, and Apparent Hepatic Clearance of Its Metabolites M2 and M20
M20
|
26.0 liters/hour (L/h)
Geometric Coefficient of Variation 46.4
|
—
|
Adverse Events
Abemaciclib + NSAI
Serious events: 102 serious events
Other events: 322 other events
Deaths: 63 deaths
Placebo + NSAI
Serious events: 27 serious events
Other events: 141 other events
Deaths: 30 deaths
Serious adverse events
| Measure |
Abemaciclib + NSAI
n=327 participants at risk
150 milligrams (mg) Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
|
Placebo + NSAI
n=161 participants at risk
Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.8%
6/327 • Number of events 6 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.61%
2/327 • Number of events 2 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/327 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.62%
1/161 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Cardiac disorders
Angina pectoris
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Cardiac disorders
Atrial fibrillation
|
0.61%
2/327 • Number of events 3 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Cardiac disorders
Atrial tachycardia
|
0.31%
1/327 • Number of events 2 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Cardiac disorders
Cardiac failure
|
0.61%
2/327 • Number of events 2 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/327 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.62%
1/161 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Cardiac disorders
Pericardial effusion
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/327 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.62%
1/161 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.61%
2/327 • Number of events 2 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/327 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.62%
1/161 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
1.2%
2/161 • Number of events 2 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Gastrointestinal disorders
Colitis
|
0.31%
1/327 • Number of events 2 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Gastrointestinal disorders
Constipation
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.5%
5/327 • Number of events 7 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.61%
2/327 • Number of events 2 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Gastrointestinal disorders
Food poisoning
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Gastrointestinal disorders
Gastritis
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Gastrointestinal disorders
Ileus
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.62%
1/161 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Gastrointestinal disorders
Nausea
|
0.31%
1/327 • Number of events 2 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.62%
1/161 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Gastrointestinal disorders
Vomiting
|
0.61%
2/327 • Number of events 3 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
1.2%
2/161 • Number of events 2 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
General disorders
General physical health deterioration
|
0.61%
2/327 • Number of events 2 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.62%
1/161 • Number of events 2 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
General disorders
Inflammation
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/327 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.62%
1/161 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
General disorders
Pyrexia
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.62%
1/161 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
General disorders
Sudden death
|
0.00%
0/327 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.62%
1/161 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
General disorders
Ulcer haemorrhage
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.61%
2/327 • Number of events 2 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.62%
1/161 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.31%
1/327 • Number of events 2 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Immune system disorders
Anaphylactic reaction
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.62%
1/161 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Infections and infestations
Appendicitis
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Infections and infestations
Bacteraemia
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Infections and infestations
Cellulitis
|
0.61%
2/327 • Number of events 2 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Infections and infestations
Diverticulitis
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Infections and infestations
Erysipelas
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/327 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.62%
1/161 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Infections and infestations
Kidney infection
|
0.61%
2/327 • Number of events 2 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Infections and infestations
Lung infection
|
4.0%
13/327 • Number of events 17 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Infections and infestations
Mastitis
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Infections and infestations
Sepsis
|
0.61%
2/327 • Number of events 2 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.62%
1/161 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Infections and infestations
Skin infection
|
0.31%
1/327 • Number of events 2 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.62%
1/161 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Infections and infestations
Urinary tract infection
|
1.2%
4/327 • Number of events 4 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.62%
1/161 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Infections and infestations
Wound infection
|
0.00%
0/327 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.62%
1/161 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Injury, poisoning and procedural complications
Fall
|
0.61%
2/327 • Number of events 3 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.62%
1/161 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.92%
3/327 • Number of events 3 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.62%
1/161 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.92%
3/327 • Number of events 3 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/327 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.62%
1/161 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Investigations
Alanine aminotransferase increased
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Investigations
Aspartate aminotransferase increased
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Investigations
Blood bilirubin increased
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Investigations
Blood creatinine increased
|
0.92%
3/327 • Number of events 3 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/327 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.62%
1/161 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/327 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.62%
1/161 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/327 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.62%
1/161 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.62%
1/161 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.2%
4/327 • Number of events 5 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
1.2%
2/161 • Number of events 2 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.61%
2/327 • Number of events 2 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.92%
3/327 • Number of events 4 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.61%
2/327 • Number of events 2 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/327 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.62%
1/161 • Number of events 2 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/327 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.62%
1/161 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/327 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.62%
1/161 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.31%
1/327 • Number of events 2 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.92%
3/327 • Number of events 3 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.62%
1/161 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Nervous system disorders
Headache
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Nervous system disorders
Presyncope
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/327 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.62%
1/161 • Number of events 2 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Nervous system disorders
Syncope
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.5%
5/327 • Number of events 6 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.31%
1/327 • Number of events 2 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.92%
3/327 • Number of events 5 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/327 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.62%
1/161 • Number of events 2 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.2%
4/327 • Number of events 5 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.61%
2/327 • Number of events 3 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/327 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.62%
1/161 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Vascular disorders
Embolism
|
2.4%
8/327 • Number of events 10 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.62%
1/161 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Vascular disorders
Haematoma
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Vascular disorders
Hypertension
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.31%
1/327 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Vascular disorders
Peripheral ischaemia
|
0.31%
1/327 • Number of events 2 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.00%
0/161 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
Other adverse events
| Measure |
Abemaciclib + NSAI
n=327 participants at risk
150 milligrams (mg) Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
|
Placebo + NSAI
n=161 participants at risk
Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
|
|---|---|---|
|
Eye disorders
Lacrimation increased
|
7.0%
23/327 • Number of events 30 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.62%
1/161 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Gastrointestinal disorders
Constipation
|
17.4%
57/327 • Number of events 81 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
14.3%
23/161 • Number of events 29 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Gastrointestinal disorders
Abdominal pain
|
31.2%
102/327 • Number of events 158 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
12.4%
20/161 • Number of events 24 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Blood and lymphatic system disorders
Anaemia
|
31.2%
102/327 • Number of events 328 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
8.1%
13/161 • Number of events 21 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Blood and lymphatic system disorders
Leukopenia
|
22.0%
72/327 • Number of events 293 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
2.5%
4/161 • Number of events 6 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
7.3%
24/327 • Number of events 67 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
3.7%
6/161 • Number of events 6 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Blood and lymphatic system disorders
Neutropenia
|
43.7%
143/327 • Number of events 625 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
1.9%
3/161 • Number of events 20 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.5%
41/327 • Number of events 91 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
3.1%
5/161 • Number of events 12 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Eye disorders
Dry eye
|
5.2%
17/327 • Number of events 19 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
0.62%
1/161 • Number of events 1 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Gastrointestinal disorders
Diarrhoea
|
81.7%
267/327 • Number of events 984 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
32.3%
52/161 • Number of events 97 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.0%
26/327 • Number of events 33 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
3.1%
5/161 • Number of events 5 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Gastrointestinal disorders
Nausea
|
41.3%
135/327 • Number of events 239 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
20.5%
33/161 • Number of events 44 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Gastrointestinal disorders
Stomatitis
|
12.5%
41/327 • Number of events 55 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
10.6%
17/161 • Number of events 25 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Gastrointestinal disorders
Vomiting
|
30.0%
98/327 • Number of events 146 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
12.4%
20/161 • Number of events 31 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
General disorders
Fatigue
|
41.3%
135/327 • Number of events 255 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
33.5%
54/161 • Number of events 79 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
General disorders
Influenza like illness
|
11.9%
39/327 • Number of events 54 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
9.3%
15/161 • Number of events 19 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
General disorders
Oedema peripheral
|
10.1%
33/327 • Number of events 41 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
6.2%
10/161 • Number of events 11 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
General disorders
Pain
|
8.3%
27/327 • Number of events 35 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
6.8%
11/161 • Number of events 14 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
General disorders
Pyrexia
|
10.1%
33/327 • Number of events 40 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
9.9%
16/161 • Number of events 19 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.1%
33/327 • Number of events 48 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
5.6%
9/161 • Number of events 15 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Infections and infestations
Urinary tract infection
|
10.4%
34/327 • Number of events 46 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
9.9%
16/161 • Number of events 31 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Injury, poisoning and procedural complications
Fall
|
5.2%
17/327 • Number of events 24 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
1.9%
3/161 • Number of events 3 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Investigations
Alanine aminotransferase increased
|
17.4%
57/327 • Number of events 143 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
7.5%
12/161 • Number of events 17 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Investigations
Aspartate aminotransferase increased
|
16.8%
55/327 • Number of events 119 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
7.5%
12/161 • Number of events 14 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Investigations
Blood alkaline phosphatase increased
|
5.8%
19/327 • Number of events 25 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
3.7%
6/161 • Number of events 7 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Investigations
Blood creatinine increased
|
20.5%
67/327 • Number of events 174 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
4.3%
7/161 • Number of events 8 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Investigations
Weight decreased
|
11.0%
36/327 • Number of events 65 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
3.1%
5/161 • Number of events 8 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
26.3%
86/327 • Number of events 140 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
10.6%
17/161 • Number of events 23 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.6%
28/327 • Number of events 48 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
1.2%
2/161 • Number of events 2 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.1%
56/327 • Number of events 91 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
20.5%
33/161 • Number of events 50 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.9%
52/327 • Number of events 67 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
16.1%
26/161 • Number of events 33 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.1%
33/327 • Number of events 42 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
8.7%
14/161 • Number of events 20 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.2%
17/327 • Number of events 27 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
3.7%
6/161 • Number of events 10 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.4%
34/327 • Number of events 38 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
7.5%
12/161 • Number of events 15 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.7%
35/327 • Number of events 50 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
11.8%
19/161 • Number of events 26 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Nervous system disorders
Dizziness
|
13.5%
44/327 • Number of events 57 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
11.2%
18/161 • Number of events 20 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Nervous system disorders
Dysgeusia
|
9.5%
31/327 • Number of events 37 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
3.1%
5/161 • Number of events 5 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Nervous system disorders
Headache
|
19.6%
64/327 • Number of events 102 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
16.1%
26/161 • Number of events 37 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Nervous system disorders
Neuropathy
|
10.7%
35/327 • Number of events 42 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
9.9%
16/161 • Number of events 17 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Psychiatric disorders
Anxiety
|
3.4%
11/327 • Number of events 16 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
5.6%
9/161 • Number of events 11 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Psychiatric disorders
Insomnia
|
7.3%
24/327 • Number of events 28 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
9.9%
16/161 • Number of events 17 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Reproductive system and breast disorders
Breast pain
|
4.3%
14/327 • Number of events 20 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
6.2%
10/161 • Number of events 13 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.7%
48/327 • Number of events 69 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
12.4%
20/161 • Number of events 27 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.2%
40/327 • Number of events 56 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
6.8%
11/161 • Number of events 15 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
27.5%
90/327 • Number of events 95 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
11.2%
18/161 • Number of events 19 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.5%
31/327 • Number of events 39 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
2.5%
4/161 • Number of events 4 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
5.2%
17/327 • Number of events 20 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
1.2%
2/161 • Number of events 2 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.4%
47/327 • Number of events 68 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
9.3%
15/161 • Number of events 19 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.3%
50/327 • Number of events 72 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
5.0%
8/161 • Number of events 14 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Vascular disorders
Hot flush
|
10.1%
33/327 • Number of events 34 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
17.4%
28/161 • Number of events 35 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
|
Vascular disorders
Hypertension
|
7.3%
24/327 • Number of events 46 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
6.2%
10/161 • Number of events 24 • Baseline Up to 32 Months
Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60