NCT02246621 · ADVERSE EVENTS

Adverse events

A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer · Source last updated 2026-02-03

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 Up to 32 Months
Other-event reporting threshold: 5%

Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Abemaciclib + NSAI 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).	102 / 327	322 / 327	63 / 328
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).	27 / 161	141 / 161	30 / 165

Group identifiers: EG000: Abemaciclib + NSAI · EG001: Placebo + NSAI

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 20.1
stats
group Id
EG000
num Affected
6
num At Risk
327
num Events
6
group Id
EG001
num Affected
0
num At Risk
161
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
327
num Events
1
group Id
EG001
num Affected
0
num At Risk
161
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
2
num At Risk
327
num Events
2
group Id
EG001
num Affected
0
num At Risk
161
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
327
num Events
0
group Id
EG001
num Affected
1
num At Risk
161
num Events
1
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
327
num Events
1
group Id
EG001
num Affected
0
num At Risk
161
num Events
0
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
2
num At Risk
327
num Events
3
group Id
EG001
num Affected
0
num At Risk
161
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
327
num Events
2
group Id
EG001
num Affected
0
num At Risk
161
num Events
0
term
Atrial tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
2
num At Risk
327
num Events
2
group Id
EG001
num Affected
0
num At Risk
161
num Events
0
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
327
num Events
0
group Id
EG001
num Affected
1
num At Risk
161
num Events
1
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
327
num Events
1
group Id
EG001
num Affected
0
num At Risk
161
num Events
0
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
327
num Events
0
group Id
EG001
num Affected
1
num At Risk
161
num Events
1
term
Stress cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
2
num At Risk
327
num Events
2
group Id
EG001
num Affected
0
num At Risk
161
num Events
0
term
Supraventricular tachycardia

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 20.1
stats
group Id
EG000
num Affected
102
num At Risk
327
num Events
328
group Id
EG001
num Affected
13
num At Risk
161
num Events
21
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
72
num At Risk
327
num Events
293
group Id
EG001
num Affected
4
num At Risk
161
num Events
6
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
24
num At Risk
327
num Events
67
group Id
EG001
num Affected
6
num At Risk
161
num Events
6
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
143
num At Risk
327
num Events
625
group Id
EG001
num Affected
3
num At Risk
161
num Events
20
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
41
num At Risk
327
num Events
91
group Id
EG001
num Affected
5
num At Risk
161
num Events
12
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
17
num At Risk
327
num Events
19
group Id
EG001
num Affected
1
num At Risk
161
num Events
1
term
Dry eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
23
num At Risk
327
num Events
30
group Id
EG001
num Affected
1
num At Risk
161
num Events
1
term
Lacrimation increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
102
num At Risk
327
num Events
158
group Id
EG001
num Affected
20
num At Risk
161
num Events
24
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
57
num At Risk
327
num Events
81
group Id
EG001
num Affected
23
num At Risk
161
num Events
29
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
267
num At Risk
327
num Events
984
group Id
EG001
num Affected
52
num At Risk
161
num Events
97
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
26
num At Risk
327
num Events
33
group Id
EG001
num Affected
5
num At Risk
161
num Events
5
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
135
num At Risk
327
num Events
239
group Id
EG001
num Affected
33
num At Risk
161
num Events
44
term
Nausea

Complete source fields

description

Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.

event Groups

deaths Num Affected
63
deaths Num At Risk
328
description
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).
id
EG000
other Num Affected
322
other Num At Risk
327
serious Num Affected
102
serious Num At Risk
327
title
Abemaciclib + NSAI
deaths Num Affected
30
deaths Num At Risk
165
description
Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
id
EG001
other Num Affected
141
other Num At Risk
161
serious Num Affected
27
serious Num At Risk
161
title
Placebo + NSAI

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
102
num At Risk
327
num Events
328
group Id
EG001
num Affected
13
num At Risk
161
num Events
21
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
72
num At Risk
327
num Events
293
group Id
EG001
num Affected
4
num At Risk
161
num Events
6
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
24
num At Risk
327
num Events
67
group Id
EG001
num Affected
6
num At Risk
161
num Events
6
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
143
num At Risk
327
num Events
625
group Id
EG001
num Affected
3
num At Risk
161
num Events
20
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
41
num At Risk
327
num Events
91
group Id
EG001
num Affected
5
num At Risk
161
num Events
12
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
17
num At Risk
327
num Events
19
group Id
EG001
num Affected
1
num At Risk
161
num Events
1
term
Dry eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
23
num At Risk
327
num Events
30
group Id
EG001
num Affected
1
num At Risk
161
num Events
1
term
Lacrimation increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
102
num At Risk
327
num Events
158
group Id
EG001
num Affected
20
num At Risk
161
num Events
24
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
57
num At Risk
327
num Events
81
group Id
EG001
num Affected
23
num At Risk
161
num Events
29
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
267
num At Risk
327
num Events
984
group Id
EG001
num Affected
52
num At Risk
161
num Events
97
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
26
num At Risk
327
num Events
33
group Id
EG001
num Affected
5
num At Risk
161
num Events
5
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
135
num At Risk
327
num Events
239
group Id
EG001
num Affected
33
num At Risk
161
num Events
44
term
Nausea

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
6
num At Risk
327
num Events
6
group Id
EG001
num Affected
0
num At Risk
161
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
327
num Events
1
group Id
EG001
num Affected
0
num At Risk
161
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
2
num At Risk
327
num Events
2
group Id
EG001
num Affected
0
num At Risk
161
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
327
num Events
0
group Id
EG001
num Affected
1
num At Risk
161
num Events
1
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
327
num Events
1
group Id
EG001
num Affected
0
num At Risk
161
num Events
0
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
2
num At Risk
327
num Events
3
group Id
EG001
num Affected
0
num At Risk
161
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
327
num Events
2
group Id
EG001
num Affected
0
num At Risk
161
num Events
0
term
Atrial tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
2
num At Risk
327
num Events
2
group Id
EG001
num Affected
0
num At Risk
161
num Events
0
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
327
num Events
0
group Id
EG001
num Affected
1
num At Risk
161
num Events
1
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
327
num Events
1
group Id
EG001
num Affected
0
num At Risk
161
num Events
0
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
327
num Events
0
group Id
EG001
num Affected
1
num At Risk
161
num Events
1
term
Stress cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
2
num At Risk
327
num Events
2
group Id
EG001
num Affected
0
num At Risk
161
num Events
0
term
Supraventricular tachycardia

time Frame

Baseline Up to 32 Months

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Preserved source evidence · Not medical advice