Trial Outcomes & Findings for Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer (NCT NCT03155997)

Last Updated: 2025-04-20

Results Overview

IDFS, as defined by the STEEP System, was measured from the date of randomization to the date of first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, second primary non-breast invasive cancer, death attributable to any cause.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

5637 participants

Primary outcome timeframe

Baseline to Recurrence or Death from Any Cause (Up to 32 Months)

Results posted on

2025-04-20

Participant Flow

Completers included participants who had recurrence disease, death due to any cause, and participants off treatment but on study follow-up.

Participant milestones

Participant milestones
Measure	150 mg Abemaciclib + Endocrine Therapy Participants received Abemaciclib orally at 150 milligrams (mg) twice daily with at least 6 hours between doses for up to 2 years or until evidence of disease recurrence or other discontinuation criteria were met, whichever occurs first. Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met.	Endocrine Therapy Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met.
Overall Study STARTED	2808	2829
Overall Study Received at Least One Dose of Study Drug	2791	2800
Overall Study COMPLETED	650	607
Overall Study NOT COMPLETED	2158	2222

Reasons for withdrawal

Reasons for withdrawal
Measure	150 mg Abemaciclib + Endocrine Therapy Participants received Abemaciclib orally at 150 milligrams (mg) twice daily with at least 6 hours between doses for up to 2 years or until evidence of disease recurrence or other discontinuation criteria were met, whichever occurs first. Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met.	Endocrine Therapy Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met.
Overall Study Withdrawal by Subject	119	134
Overall Study Lost to Follow-up	12	13
Overall Study Missing disposition data	0	1
Overall Study On study treatment	2027	2074

Baseline Characteristics

Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	150 mg Abemaciclib + Endocrine Therapy n=2808 Participants Participants received Abemaciclib orally at 150 milligrams (mg) twice daily with at least 6 hours between doses for up to for up to 2 years or until evidence of disease recurrence or other discontinuation criteria were met, whichever occurs first. Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met.	Endocrine Therapy n=2829 Participants Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met.	Total n=5637 Participants Total of all reporting groups
Age, Continuous	52.20 years STANDARD_DEVIATION 11.26 • n=93 Participants	52.10 years STANDARD_DEVIATION 11.20 • n=4 Participants	52.10 years STANDARD_DEVIATION 11.23 • n=27 Participants
Sex: Female, Male Female	2787 Participants n=93 Participants	2814 Participants n=4 Participants	5601 Participants n=27 Participants
Sex: Female, Male Male	21 Participants n=93 Participants	15 Participants n=4 Participants	36 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	355 Participants n=93 Participants	378 Participants n=4 Participants	733 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1734 Participants n=93 Participants	1738 Participants n=4 Participants	3472 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	719 Participants n=93 Participants	713 Participants n=4 Participants	1432 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	64 Participants n=93 Participants	58 Participants n=4 Participants	122 Participants n=27 Participants
Race (NIH/OMB) Asian	675 Participants n=93 Participants	669 Participants n=4 Participants	1344 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=93 Participants	4 Participants n=4 Participants	7 Participants n=27 Participants
Race (NIH/OMB) Black or African American	57 Participants n=93 Participants	53 Participants n=4 Participants	110 Participants n=27 Participants
Race (NIH/OMB) White	1947 Participants n=93 Participants	1978 Participants n=4 Participants	3925 Participants n=27 Participants
Race (NIH/OMB) More than one race	22 Participants n=93 Participants	25 Participants n=4 Participants	47 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	40 Participants n=93 Participants	42 Participants n=4 Participants	82 Participants n=27 Participants
Region of Enrollment Argentina	77 Participants n=93 Participants	68 Participants n=4 Participants	145 Participants n=27 Participants
Region of Enrollment Australia	108 Participants n=93 Participants	109 Participants n=4 Participants	217 Participants n=27 Participants
Region of Enrollment Austria	22 Participants n=93 Participants	20 Participants n=4 Participants	42 Participants n=27 Participants
Region of Enrollment Belgium	65 Participants n=93 Participants	51 Participants n=4 Participants	116 Participants n=27 Participants
Region of Enrollment Brazil	144 Participants n=93 Participants	153 Participants n=4 Participants	297 Participants n=27 Participants
Region of Enrollment Canada	28 Participants n=93 Participants	16 Participants n=4 Participants	44 Participants n=27 Participants
Region of Enrollment China	187 Participants n=93 Participants	170 Participants n=4 Participants	357 Participants n=27 Participants
Region of Enrollment Czechia	15 Participants n=93 Participants	12 Participants n=4 Participants	27 Participants n=27 Participants
Region of Enrollment Denmark	54 Participants n=93 Participants	58 Participants n=4 Participants	112 Participants n=27 Participants
Region of Enrollment Finland	45 Participants n=93 Participants	49 Participants n=4 Participants	94 Participants n=27 Participants
Region of Enrollment France	86 Participants n=93 Participants	101 Participants n=4 Participants	187 Participants n=27 Participants
Region of Enrollment Germany	148 Participants n=93 Participants	152 Participants n=4 Participants	300 Participants n=27 Participants
Region of Enrollment Greece	74 Participants n=93 Participants	64 Participants n=4 Participants	138 Participants n=27 Participants
Region of Enrollment Hong Kong	8 Participants n=93 Participants	12 Participants n=4 Participants	20 Participants n=27 Participants
Region of Enrollment Hungary	24 Participants n=93 Participants	28 Participants n=4 Participants	52 Participants n=27 Participants
Region of Enrollment India	59 Participants n=93 Participants	53 Participants n=4 Participants	112 Participants n=27 Participants
Region of Enrollment Israel	39 Participants n=93 Participants	38 Participants n=4 Participants	77 Participants n=27 Participants
Region of Enrollment Italy	72 Participants n=93 Participants	59 Participants n=4 Participants	131 Participants n=27 Participants
Region of Enrollment Japan	181 Participants n=93 Participants	196 Participants n=4 Participants	377 Participants n=27 Participants
Region of Enrollment Mexico	104 Participants n=93 Participants	121 Participants n=4 Participants	225 Participants n=27 Participants
Region of Enrollment Netherlands	5 Participants n=93 Participants	14 Participants n=4 Participants	19 Participants n=27 Participants
Region of Enrollment New Zealand	21 Participants n=93 Participants	22 Participants n=4 Participants	43 Participants n=27 Participants
Region of Enrollment Poland	65 Participants n=93 Participants	60 Participants n=4 Participants	125 Participants n=27 Participants
Region of Enrollment Portugal	21 Participants n=93 Participants	16 Participants n=4 Participants	37 Participants n=27 Participants
Region of Enrollment Puerto Rico	1 Participants n=93 Participants	3 Participants n=4 Participants	4 Participants n=27 Participants
Region of Enrollment Romania	53 Participants n=93 Participants	60 Participants n=4 Participants	113 Participants n=27 Participants
Region of Enrollment Russia	66 Participants n=93 Participants	73 Participants n=4 Participants	139 Participants n=27 Participants
Region of Enrollment Saudi Arabia	5 Participants n=93 Participants	9 Participants n=4 Participants	14 Participants n=27 Participants
Region of Enrollment Singapore	11 Participants n=93 Participants	21 Participants n=4 Participants	32 Participants n=27 Participants
Region of Enrollment South Africa	3 Participants n=93 Participants	6 Participants n=4 Participants	9 Participants n=27 Participants
Region of Enrollment South Korea	122 Participants n=93 Participants	123 Participants n=4 Participants	245 Participants n=27 Participants
Region of Enrollment Spain	144 Participants n=93 Participants	148 Participants n=4 Participants	292 Participants n=27 Participants
Region of Enrollment Sweden	7 Participants n=93 Participants	5 Participants n=4 Participants	12 Participants n=27 Participants
Region of Enrollment Taiwan	64 Participants n=93 Participants	60 Participants n=4 Participants	124 Participants n=27 Participants
Region of Enrollment Turkey	125 Participants n=93 Participants	110 Participants n=4 Participants	235 Participants n=27 Participants
Region of Enrollment Ukraine	54 Participants n=93 Participants	51 Participants n=4 Participants	105 Participants n=27 Participants
Region of Enrollment United Kingdom	99 Participants n=93 Participants	100 Participants n=4 Participants	199 Participants n=27 Participants
Region of Enrollment United States	402 Participants n=93 Participants	418 Participants n=4 Participants	820 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline to Recurrence or Death from Any Cause (Up to 32 Months)

Population: All randomized participants (including the censored participants). 2672 participants were censored in "150 mg Abemaciclib + Endocrine Therapy," 2642 participants were censored in "Endocrine Therapy."

Outcome measures

Outcome measures
Measure	150 mg Abemaciclib + Endocrine Therapy n=2808 Participants Participants received Abemaciclib orally at 150 milligrams (mg) twice daily with at least 6 hours between doses for up to 2 years or until evidence of disease recurrence or other discontinuation criteria were met, whichever occurs first. Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met.	Endocrine Therapy n=2829 Participants Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met.
Invasive Disease Free Survival (IDFS)	NA Months There were not enough events to compute a median or 95% confidence interval.	NA Months There were not enough events to compute a median or 95% confidence interval.

SECONDARY outcome

Timeframe: Baseline to Recurrence or Death from Any Cause (Approximately 10 Years)

Outcome data will be provided after the study is completed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to Distant Recurrence or Death from Any Cause (Up to 32 Months)

Population: All randomized participants (including the censored participants). 2702 participants were censored in "150 mg Abemaciclib + Endocrine Therapy," 2677 participants were censored in "Endocrine Therapy."

Distant relapse-free survival is defined as the time from randomization to distant recurrence or death from any cause, whichever occurs first.

Outcome measures

Outcome measures
Measure	150 mg Abemaciclib + Endocrine Therapy n=2808 Participants Participants received Abemaciclib orally at 150 milligrams (mg) twice daily with at least 6 hours between doses for up to 2 years or until evidence of disease recurrence or other discontinuation criteria were met, whichever occurs first. Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met.	Endocrine Therapy n=2829 Participants Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met.
Distant Relapse-Free Survival (DRFS)	NA Months There were not enough events to compute a median or 95% confidence interval.	NA Months There were not enough events to compute a median or 95% confidence interval.

SECONDARY outcome

Timeframe: Baseline to Death from Any Cause (Approximately 10 Years)

Outcome data will be provided after the study is completed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 (2 hours post-dose), Days 30, 60, 90 post-dose

Population: All randomized participants who received at least one dose of Abemaciclib and had evaluable PK data.

Pharmacokinetics (PK): Minimum Steady State Concentration (Cmin,ss) of Abemaciclib

Outcome measures

Outcome measures
Measure	150 mg Abemaciclib + Endocrine Therapy n=483 Participants Participants received Abemaciclib orally at 150 milligrams (mg) twice daily with at least 6 hours between doses for up to 2 years or until evidence of disease recurrence or other discontinuation criteria were met, whichever occurs first. Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met.	Endocrine Therapy Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met.
Pharmacokinetics (PK): Minimum Steady State Concentration (Cmin,ss) of Abemaciclib	143 Nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 110	—

SECONDARY outcome

Timeframe: Baseline, Follow Up (Approximately 3 Years)

Other events: 2318 other events

Deaths: 36 deaths

Serious adverse events

Other adverse events

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Serious adverse events
Measure	150 mg Abemaciclib + Endocrine Therapy n=2791 participants at risk Participants received Abemaciclib orally at 150 milligrams (mg) twice daily with at least 6 hours between doses for up to 2 years or until evidence of disease recurrence or other discontinuation criteria were met, whichever occurs first. Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met.	Endocrine Therapy n=2800 participants at risk Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met.
Infections and infestations Implant site infection	0.04% 1/2791 • Number of events 1 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/2800 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Infection	0.00% 0/2791 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	0.04% 1/2800 • Number of events 1 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Infective pulmonary exacerbation of cystic fibrosis	0.00% 0/2791 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	0.04% 1/2800 • Number of events 1 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Influenza	0.25% 7/2791 • Number of events 7 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	0.11% 3/2800 • Number of events 3 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Intervertebral discitis	0.00% 0/2791 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	0.04% 1/2800 • Number of events 1 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Laryngitis	0.04% 1/2791 • Number of events 1 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/2800 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Lower respiratory tract infection	0.04% 1/2791 • Number of events 1 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	0.04% 1/2800 • Number of events 1 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Lymphangitis	0.07% 2/2791 • Number of events 2 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/2800 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Mastitis	0.11% 3/2791 • Number of events 4 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	0.18% 5/2800 • Number of events 5 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Mastoiditis	0.04% 1/2791 • Number of events 1 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/2800 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Blood and lymphatic system disorders Anaemia	0.29% 8/2791 • Number of events 8 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	0.07% 2/2800 • Number of events 2 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Blood and lymphatic system disorders Bone marrow oedema	0.04% 1/2791 • Number of events 1 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/2800 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.04% 1/2791 • Number of events 1 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/2800 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Blood and lymphatic system disorders Febrile neutropenia	0.14% 4/2791 • Number of events 4 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/2800 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Blood and lymphatic system disorders Leukopenia	0.14% 4/2791 • Number of events 4 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/2800 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Blood and lymphatic system disorders Lymphadenopathy mediastinal	0.00% 0/2791 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	0.04% 1/2800 • Number of events 1 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Blood and lymphatic system disorders Neutropenia	0.11% 3/2791 • Number of events 3 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	0.04% 1/2800 • Number of events 1 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Blood and lymphatic system disorders Pancytopenia	0.04% 1/2791 • Number of events 1 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/2800 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Blood and lymphatic system disorders Thrombocytopenia	0.14% 4/2791 • Number of events 5 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	0.04% 1/2800 • Number of events 1 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Cardiac disorders Acute left ventricular failure	0.04% 1/2791 • Number of events 1 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/2800 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Cardiac disorders Angina pectoris	0.04% 1/2791 • Number of events 1 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/2800 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Cardiac disorders Atrial fibrillation	0.21% 6/2791 • Number of events 6 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	0.04% 1/2800 • Number of events 1 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Cardiac disorders Atrioventricular block complete	0.00% 0/2791 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	0.04% 1/2800 • Number of events 1 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Cardiac disorders Cardiac arrest	0.07% 2/2791 • Number of events 2 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/2800 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Cardiac disorders Cardiac failure	0.14% 4/2791 • Number of events 5 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	0.04% 1/2800 • Number of events 1 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Cardiac disorders Cardiotoxicity	0.00% 0/2791 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	0.04% 1/2800 • Number of events 1 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Cardiac disorders Coronary artery disease	0.04% 1/2791 • Number of events 1 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	0.04% 1/2800 • Number of events 1 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Cardiac disorders Myocardial infarction	0.14% 4/2791 • Number of events 4 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	0.04% 1/2800 • Number of events 1 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Cardiac disorders Myocardial ischaemia	0.04% 1/2791 • Number of events 1 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/2800 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Cardiac disorders Pericarditis	0.00% 0/2791 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	0.04% 1/2800 • Number of events 1 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Cardiac disorders Sinus tachycardia	0.04% 1/2791 • Number of events 1 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	0.04% 1/2800 • Number of events 1 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Cardiac disorders Stress cardiomyopathy	0.00% 0/2791 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	0.07% 2/2800 • Number of events 2 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Cardiac disorders Supraventricular tachycardia	0.04% 1/2791 • Number of events 1 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	0.04% 1/2800 • Number of events 1 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Cardiac disorders Ventricular fibrillation	0.04% 1/2791 • Number of events 1 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/2800 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Ear and labyrinth disorders Tympanic membrane perforation	0.00% 0/2791 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	0.04% 1/2800 • Number of events 1 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Ear and labyrinth disorders Vertigo	0.00% 0/2791 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	0.04% 1/2800 • Number of events 1 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Eye disorders Angle closure glaucoma	0.04% 1/2791 • Number of events 1 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/2800 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Eye disorders Cataract	0.00% 0/2791 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	0.04% 1/2800 • Number of events 1 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Eye disorders Eyelid ptosis	0.04% 1/2791 • Number of events 1 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/2800 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Eye disorders Macular hole	0.04% 1/2791 • Number of events 1 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/2800 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.

Other adverse events
Measure	150 mg Abemaciclib + Endocrine Therapy n=2791 participants at risk Participants received Abemaciclib orally at 150 milligrams (mg) twice daily with at least 6 hours between doses for up to 2 years or until evidence of disease recurrence or other discontinuation criteria were met, whichever occurs first. Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met.	Endocrine Therapy n=2800 participants at risk Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met.
Blood and lymphatic system disorders Anaemia	22.7% 634/2791 • Number of events 862 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	3.1% 88/2800 • Number of events 113 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Blood and lymphatic system disorders Leukopenia	36.8% 1026/2791 • Number of events 1706 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	6.1% 171/2800 • Number of events 244 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Blood and lymphatic system disorders Lymphopenia	13.3% 372/2791 • Number of events 527 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	3.4% 94/2800 • Number of events 118 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Blood and lymphatic system disorders Neutropenia	44.6% 1246/2791 • Number of events 2316 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	5.0% 140/2800 • Number of events 214 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Blood and lymphatic system disorders Thrombocytopenia	12.2% 341/2791 • Number of events 528 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	1.4% 39/2800 • Number of events 48 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Cardiac disorders Palpitations	1.9% 54/2791 • Number of events 62 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	0.71% 20/2800 • Number of events 22 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Ear and labyrinth disorders Vertigo	2.5% 70/2791 • Number of events 93 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	1.7% 47/2800 • Number of events 55 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Endocrine disorders Hypothyroidism	1.0% 28/2791 • Number of events 29 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	1.2% 34/2800 • Number of events 34 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Eye disorders Dry eye	2.5% 71/2791 • Number of events 76 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	1.0% 28/2800 • Number of events 31 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Eye disorders Lacrimation increased	4.9% 137/2791 • Number of events 158 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	0.36% 10/2800 • Number of events 10 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Eye disorders Vision blurred	1.6% 46/2791 • Number of events 52 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	0.86% 24/2800 • Number of events 25 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Abdominal distension	2.7% 75/2791 • Number of events 90 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	0.96% 27/2800 • Number of events 28 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Abdominal pain	33.9% 945/2791 • Number of events 1974 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	8.1% 226/2800 • Number of events 275 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Constipation	10.3% 288/2791 • Number of events 377 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	5.1% 142/2800 • Number of events 161 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Diarrhoea	82.2% 2294/2791 • Number of events 11663 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	7.1% 199/2800 • Number of events 288 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Dry mouth	3.4% 94/2791 • Number of events 103 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	0.89% 25/2800 • Number of events 27 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Dyspepsia	7.3% 205/2791 • Number of events 264 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	2.2% 61/2800 • Number of events 66 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Flatulence	3.0% 84/2791 • Number of events 95 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	0.39% 11/2800 • Number of events 12 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Gastritis	2.1% 58/2791 • Number of events 65 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	1.1% 31/2800 • Number of events 34 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Gastrooesophageal reflux disease	2.7% 74/2791 • Number of events 76 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	1.6% 45/2800 • Number of events 47 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Haemorrhoids	2.4% 68/2791 • Number of events 82 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	1.0% 28/2800 • Number of events 28 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Mouth ulceration	1.4% 39/2791 • Number of events 48 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	0.11% 3/2800 • Number of events 3 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Nausea	27.9% 779/2791 • Number of events 1203 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	7.9% 222/2800 • Number of events 274 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Stomatitis	5.5% 154/2791 • Number of events 212 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	1.1% 30/2800 • Number of events 39 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Toothache	1.8% 49/2791 • Number of events 55 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	1.5% 42/2800 • Number of events 50 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Vomiting	16.3% 454/2791 • Number of events 744 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	4.2% 117/2800 • Number of events 144 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
General disorders Axillary pain	1.0% 28/2791 • Number of events 28 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	1.4% 39/2800 • Number of events 41 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
General disorders Chest pain	1.3% 35/2791 • Number of events 40 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	1.2% 35/2800 • Number of events 36 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
General disorders Chills	1.8% 49/2791 • Number of events 55 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	0.64% 18/2800 • Number of events 18 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
General disorders Fatigue	38.4% 1073/2791 • Number of events 1434 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	15.5% 433/2800 • Number of events 522 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
General disorders Influenza like illness	5.1% 141/2791 • Number of events 180 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	4.0% 112/2800 • Number of events 152 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
General disorders Malaise	3.2% 88/2791 • Number of events 109 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	1.0% 29/2800 • Number of events 29 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
General disorders Mucosal inflammation	2.6% 72/2791 • Number of events 90 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	0.75% 21/2800 • Number of events 32 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
General disorders Oedema peripheral	6.1% 169/2791 • Number of events 200 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	3.7% 103/2800 • Number of events 119 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
General disorders Pain	2.1% 60/2791 • Number of events 64 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	1.9% 53/2800 • Number of events 58 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
General disorders Peripheral swelling	1.8% 51/2791 • Number of events 58 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	1.9% 53/2800 • Number of events 61 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
General disorders Pyrexia	8.1% 227/2791 • Number of events 299 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	4.1% 114/2800 • Number of events 130 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Hepatobiliary disorders Hepatic steatosis	1.5% 41/2791 • Number of events 42 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	1.2% 35/2800 • Number of events 35 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Bronchitis	1.5% 42/2791 • Number of events 50 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	1.4% 40/2800 • Number of events 44 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Cellulitis	1.3% 37/2791 • Number of events 43 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.	1.0% 28/2800 • Number of events 31 • Baseline to 32 Months All randomized participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.