NCT03155997 · ADVERSE EVENTS

Adverse events

Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer · Source last updated 2026-04-24

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Baseline to 32 Months
Other-event reporting threshold: 1%

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.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
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.	344 / 2791	2723 / 2791	38 / 2791
Endocrine Therapy Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met.	202 / 2800	2318 / 2800	36 / 2800

Group identifiers: EG000: 150 mg Abemaciclib + Endocrine Therapy · EG001: Endocrine Therapy

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
8
num At Risk
2791
num Events
8
group Id
EG001
num Affected
2
num At Risk
2800
num Events
2
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
2791
num Events
1
group Id
EG001
num Affected
0
num At Risk
2800
num Events
0
term
Bone marrow oedema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
2791
num Events
1
group Id
EG001
num Affected
0
num At Risk
2800
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
4
num At Risk
2791
num Events
4
group Id
EG001
num Affected
0
num At Risk
2800
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
4
num At Risk
2791
num Events
4
group Id
EG001
num Affected
0
num At Risk
2800
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
2791
num Events
0
group Id
EG001
num Affected
1
num At Risk
2800
num Events
1
term
Lymphadenopathy mediastinal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
3
num At Risk
2791
num Events
3
group Id
EG001
num Affected
1
num At Risk
2800
num Events
1
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
2791
num Events
1
group Id
EG001
num Affected
0
num At Risk
2800
num Events
0
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
4
num At Risk
2791
num Events
5
group Id
EG001
num Affected
1
num At Risk
2800
num Events
1
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
2791
num Events
1
group Id
EG001
num Affected
0
num At Risk
2800
num Events
0
term
Acute left ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
2791
num Events
1
group Id
EG001
num Affected
0
num At Risk
2800
num Events
0
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
6
num At Risk
2791
num Events
6
group Id
EG001
num Affected
1
num At Risk
2800
num Events
1
term
Atrial fibrillation

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
634
num At Risk
2791
num Events
862
group Id
EG001
num Affected
88
num At Risk
2800
num Events
113
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1026
num At Risk
2791
num Events
1706
group Id
EG001
num Affected
171
num At Risk
2800
num Events
244
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
372
num At Risk
2791
num Events
527
group Id
EG001
num Affected
94
num At Risk
2800
num Events
118
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1246
num At Risk
2791
num Events
2316
group Id
EG001
num Affected
140
num At Risk
2800
num Events
214
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
341
num At Risk
2791
num Events
528
group Id
EG001
num Affected
39
num At Risk
2800
num Events
48
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
54
num At Risk
2791
num Events
62
group Id
EG001
num Affected
20
num At Risk
2800
num Events
22
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
70
num At Risk
2791
num Events
93
group Id
EG001
num Affected
47
num At Risk
2800
num Events
55
term
Vertigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
28
num At Risk
2791
num Events
29
group Id
EG001
num Affected
34
num At Risk
2800
num Events
34
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
71
num At Risk
2791
num Events
76
group Id
EG001
num Affected
28
num At Risk
2800
num Events
31
term
Dry eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
137
num At Risk
2791
num Events
158
group Id
EG001
num Affected
10
num At Risk
2800
num Events
10
term
Lacrimation increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
46
num At Risk
2791
num Events
52
group Id
EG001
num Affected
24
num At Risk
2800
num Events
25
term
Vision blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
75
num At Risk
2791
num Events
90
group Id
EG001
num Affected
27
num At Risk
2800
num Events
28
term
Abdominal distension

Complete source fields

description

event Groups

deaths Num Affected
38
deaths Num At Risk
2791
description
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.
id
EG000
other Num Affected
2723
other Num At Risk
2791
serious Num Affected
344
serious Num At Risk
2791
title
150 mg Abemaciclib + Endocrine Therapy
deaths Num Affected
36
deaths Num At Risk
2800
description
Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met.
id
EG001
other Num Affected
2318
other Num At Risk
2800
serious Num Affected
202
serious Num At Risk
2800
title
Endocrine Therapy

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
634
num At Risk
2791
num Events
862
group Id
EG001
num Affected
88
num At Risk
2800
num Events
113
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1026
num At Risk
2791
num Events
1706
group Id
EG001
num Affected
171
num At Risk
2800
num Events
244
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
372
num At Risk
2791
num Events
527
group Id
EG001
num Affected
94
num At Risk
2800
num Events
118
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1246
num At Risk
2791
num Events
2316
group Id
EG001
num Affected
140
num At Risk
2800
num Events
214
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
341
num At Risk
2791
num Events
528
group Id
EG001
num Affected
39
num At Risk
2800
num Events
48
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
54
num At Risk
2791
num Events
62
group Id
EG001
num Affected
20
num At Risk
2800
num Events
22
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
70
num At Risk
2791
num Events
93
group Id
EG001
num Affected
47
num At Risk
2800
num Events
55
term
Vertigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
28
num At Risk
2791
num Events
29
group Id
EG001
num Affected
34
num At Risk
2800
num Events
34
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
71
num At Risk
2791
num Events
76
group Id
EG001
num Affected
28
num At Risk
2800
num Events
31
term
Dry eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
137
num At Risk
2791
num Events
158
group Id
EG001
num Affected
10
num At Risk
2800
num Events
10
term
Lacrimation increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
46
num At Risk
2791
num Events
52
group Id
EG001
num Affected
24
num At Risk
2800
num Events
25
term
Vision blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
75
num At Risk
2791
num Events
90
group Id
EG001
num Affected
27
num At Risk
2800
num Events
28
term
Abdominal distension

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
8
num At Risk
2791
num Events
8
group Id
EG001
num Affected
2
num At Risk
2800
num Events
2
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
2791
num Events
1
group Id
EG001
num Affected
0
num At Risk
2800
num Events
0
term
Bone marrow oedema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
2791
num Events
1
group Id
EG001
num Affected
0
num At Risk
2800
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
4
num At Risk
2791
num Events
4
group Id
EG001
num Affected
0
num At Risk
2800
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
4
num At Risk
2791
num Events
4
group Id
EG001
num Affected
0
num At Risk
2800
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
2791
num Events
0
group Id
EG001
num Affected
1
num At Risk
2800
num Events
1
term
Lymphadenopathy mediastinal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
3
num At Risk
2791
num Events
3
group Id
EG001
num Affected
1
num At Risk
2800
num Events
1
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
2791
num Events
1
group Id
EG001
num Affected
0
num At Risk
2800
num Events
0
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
4
num At Risk
2791
num Events
5
group Id
EG001
num Affected
1
num At Risk
2800
num Events
1
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
2791
num Events
1
group Id
EG001
num Affected
0
num At Risk
2800
num Events
0
term
Acute left ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
2791
num Events
1
group Id
EG001
num Affected
0
num At Risk
2800
num Events
0
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
6
num At Risk
2791
num Events
6
group Id
EG001
num Affected
1
num At Risk
2800
num Events
1
term
Atrial fibrillation

time Frame

Baseline to 32 Months

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Preserved source evidence · Not medical advice