NCT02107703 · ADVERSE EVENTS

Adverse events

A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer · Source last updated 2025-10-21

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: Up To 7 years 7.7 Months
Other-event reporting threshold: 5%

Adverse Events: All randomized participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants. Analyses presented in this report are based on a database lock for the pre-planned final OS analysis of 22 April 2022.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Abemaciclib + Fulvestrant 150 mg Abemaciclib given orally once every 12 hours in 28 day cycles. 500 mg fulvestrant administered as two 250-mg injections intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants may continue to receive treatment until discontinuation criteria are met.	129 / 441	432 / 441	283 / 446
Placebo + Fulvestrant Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.	33 / 223	194 / 223	157 / 223

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

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 25.0
stats
group Id
EG000
num Affected
3
num At Risk
441
num Events
3
group Id
EG001
num Affected
0
num At Risk
223
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
441
num Events
1
group Id
EG001
num Affected
0
num At Risk
223
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
3
num At Risk
441
num Events
3
group Id
EG001
num Affected
0
num At Risk
223
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
441
num Events
1
group Id
EG001
num Affected
1
num At Risk
223
num Events
1
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
441
num Events
1
group Id
EG001
num Affected
0
num At Risk
223
num Events
0
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
2
num At Risk
441
num Events
2
group Id
EG001
num Affected
0
num At Risk
223
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
441
num Events
1
group Id
EG001
num Affected
0
num At Risk
223
num Events
0
term
Atrioventricular block first degree
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
441
num Events
0
group Id
EG001
num Affected
1
num At Risk
223
num Events
2
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
2
num At Risk
441
num Events
2
group Id
EG001
num Affected
0
num At Risk
223
num Events
0
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
441
num Events
1
group Id
EG001
num Affected
0
num At Risk
223
num Events
0
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
441
num Events
1
group Id
EG001
num Affected
0
num At Risk
223
num Events
0
term
Restrictive cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
441
num Events
1
group Id
EG001
num Affected
0
num At Risk
223
num Events
0
term
Sinus 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 25.0
stats
group Id
EG000
num Affected
155
num At Risk
441
num Events
313
group Id
EG001
num Affected
11
num At Risk
223
num Events
15
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
148
num At Risk
441
num Events
500
group Id
EG001
num Affected
4
num At Risk
223
num Events
10
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
45
num At Risk
441
num Events
113
group Id
EG001
num Affected
2
num At Risk
223
num Events
9
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
219
num At Risk
441
num Events
760
group Id
EG001
num Affected
8
num At Risk
223
num Events
15
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
79
num At Risk
441
num Events
135
group Id
EG001
num Affected
6
num At Risk
223
num Events
7
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
34
num At Risk
441
num Events
44
group Id
EG001
num Affected
3
num At Risk
223
num Events
3
term
Lacrimation increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
24
num At Risk
441
num Events
28
group Id
EG001
num Affected
5
num At Risk
223
num Events
6
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
166
num At Risk
441
num Events
320
group Id
EG001
num Affected
36
num At Risk
223
num Events
65
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
73
num At Risk
441
num Events
96
group Id
EG001
num Affected
36
num At Risk
223
num Events
47
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
384
num At Risk
441
num Events
1205
group Id
EG001
num Affected
62
num At Risk
223
num Events
104
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
35
num At Risk
441
num Events
40
group Id
EG001
num Affected
15
num At Risk
223
num Events
15
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
33
num At Risk
441
num Events
43
group Id
EG001
num Affected
12
num At Risk
223
num Events
15
term
Dyspepsia

Complete source fields

description

event Groups

deaths Num Affected
283
deaths Num At Risk
446
description
150 mg Abemaciclib given orally once every 12 hours in 28 day cycles. 500 mg fulvestrant administered as two 250-mg injections intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants may continue to receive treatment until discontinuation criteria are met.
id
EG000
other Num Affected
432
other Num At Risk
441
serious Num Affected
129
serious Num At Risk
441
title
Abemaciclib + Fulvestrant
deaths Num Affected
157
deaths Num At Risk
223
description
Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.
id
EG001
other Num Affected
194
other Num At Risk
223
serious Num Affected
33
serious Num At Risk
223
title
Placebo + Fulvestrant

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
155
num At Risk
441
num Events
313
group Id
EG001
num Affected
11
num At Risk
223
num Events
15
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
148
num At Risk
441
num Events
500
group Id
EG001
num Affected
4
num At Risk
223
num Events
10
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
45
num At Risk
441
num Events
113
group Id
EG001
num Affected
2
num At Risk
223
num Events
9
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
219
num At Risk
441
num Events
760
group Id
EG001
num Affected
8
num At Risk
223
num Events
15
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
79
num At Risk
441
num Events
135
group Id
EG001
num Affected
6
num At Risk
223
num Events
7
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
34
num At Risk
441
num Events
44
group Id
EG001
num Affected
3
num At Risk
223
num Events
3
term
Lacrimation increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
24
num At Risk
441
num Events
28
group Id
EG001
num Affected
5
num At Risk
223
num Events
6
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
166
num At Risk
441
num Events
320
group Id
EG001
num Affected
36
num At Risk
223
num Events
65
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
73
num At Risk
441
num Events
96
group Id
EG001
num Affected
36
num At Risk
223
num Events
47
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
384
num At Risk
441
num Events
1205
group Id
EG001
num Affected
62
num At Risk
223
num Events
104
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
35
num At Risk
441
num Events
40
group Id
EG001
num Affected
15
num At Risk
223
num Events
15
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
33
num At Risk
441
num Events
43
group Id
EG001
num Affected
12
num At Risk
223
num Events
15
term
Dyspepsia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
3
num At Risk
441
num Events
3
group Id
EG001
num Affected
0
num At Risk
223
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
441
num Events
1
group Id
EG001
num Affected
0
num At Risk
223
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
3
num At Risk
441
num Events
3
group Id
EG001
num Affected
0
num At Risk
223
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
441
num Events
1
group Id
EG001
num Affected
1
num At Risk
223
num Events
1
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
441
num Events
1
group Id
EG001
num Affected
0
num At Risk
223
num Events
0
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
2
num At Risk
441
num Events
2
group Id
EG001
num Affected
0
num At Risk
223
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
441
num Events
1
group Id
EG001
num Affected
0
num At Risk
223
num Events
0
term
Atrioventricular block first degree
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
441
num Events
0
group Id
EG001
num Affected
1
num At Risk
223
num Events
2
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
2
num At Risk
441
num Events
2
group Id
EG001
num Affected
0
num At Risk
223
num Events
0
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
441
num Events
1
group Id
EG001
num Affected
0
num At Risk
223
num Events
0
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
441
num Events
1
group Id
EG001
num Affected
0
num At Risk
223
num Events
0
term
Restrictive cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
441
num Events
1
group Id
EG001
num Affected
0
num At Risk
223
num Events
0
term
Sinus tachycardia

time Frame

Up To 7 years 7.7 Months

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Preserved source evidence · Not medical advice