NCT01740427 · ADVERSE EVENTS

Adverse events

A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2) · Source last updated 2024-11-14

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: From the date of randomization up to 28 days after last dose of study medication (final analysis till study completion, approximately up to 10.51 years)
Other-event reporting threshold: 5%

Same event may appear as non-SAE and SAE but are distinct events. Event may be an SAE in 1 participant and non-SAE in other, or participant may have both non-SAE and SAE. AT population included all participants who received at least 1 dose of study medication, with treatment assignments designated according to actual study treatment received.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Palbociclib Plus Letrozole Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.	125 / 444	435 / 444	16 / 444
Placebo Plus Letrozole Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.	38 / 222	209 / 222	6 / 222

Group identifiers: EG000: Palbociclib Plus Letrozole · EG001: Placebo Plus Letrozole

Serious adverse events

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

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
5
num At Risk
444
group Id
EG001
num Affected
0
num At Risk
222
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
8
num At Risk
444
group Id
EG001
num Affected
0
num At Risk
222
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
444
group Id
EG001
num Affected
0
num At Risk
222
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
444
group Id
EG001
num Affected
0
num At Risk
222
term
Acute myocardial infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
2
num At Risk
444
group Id
EG001
num Affected
0
num At Risk
222
term
Angina pectoris
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
444
group Id
EG001
num Affected
0
num At Risk
222
term
Angina unstable
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
444
group Id
EG001
num Affected
0
num At Risk
222
term
Aortic valve stenosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
2
num At Risk
444
group Id
EG001
num Affected
0
num At Risk
222
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
444
group Id
EG001
num Affected
0
num At Risk
222
term
Atrioventricular block
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
444
group Id
EG001
num Affected
0
num At Risk
222
term
Bradycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
444
group Id
EG001
num Affected
1
num At Risk
222
term
Cardiac arrest
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
444
group Id
EG001
num Affected
1
num At Risk
222
term
Cardiac failure

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
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
125
num At Risk
444
group Id
EG001
num Affected
23
num At Risk
222
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
115
num At Risk
444
group Id
EG001
num Affected
2
num At Risk
222
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
308
num At Risk
444
group Id
EG001
num Affected
8
num At Risk
222
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
64
num At Risk
444
group Id
EG001
num Affected
4
num At Risk
222
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
28
num At Risk
444
group Id
EG001
num Affected
7
num At Risk
222
term
Cataract
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
28
num At Risk
444
group Id
EG001
num Affected
10
num At Risk
222
term
Dry eye
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
33
num At Risk
444
group Id
EG001
num Affected
2
num At Risk
222
term
Lacrimation increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
23
num At Risk
444
group Id
EG001
num Affected
7
num At Risk
222
term
Vision blurred
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
21
num At Risk
444
group Id
EG001
num Affected
14
num At Risk
222
term
Abdominal distension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
67
num At Risk
444
group Id
EG001
num Affected
15
num At Risk
222
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
41
num At Risk
444
group Id
EG001
num Affected
20
num At Risk
222
term
Abdominal pain upper
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
105
num At Risk
444
group Id
EG001
num Affected
36
num At Risk
222
term
Constipation

Complete source fields

description

event Groups

deaths Num Affected
16
deaths Num At Risk
444
description
Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
id
EG000
other Num Affected
435
other Num At Risk
444
serious Num Affected
125
serious Num At Risk
444
title
Palbociclib Plus Letrozole
deaths Num Affected
6
deaths Num At Risk
222
description
Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
id
EG001
other Num Affected
209
other Num At Risk
222
serious Num Affected
38
serious Num At Risk
222
title
Placebo Plus Letrozole

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
125
num At Risk
444
group Id
EG001
num Affected
23
num At Risk
222
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
115
num At Risk
444
group Id
EG001
num Affected
2
num At Risk
222
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
308
num At Risk
444
group Id
EG001
num Affected
8
num At Risk
222
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
64
num At Risk
444
group Id
EG001
num Affected
4
num At Risk
222
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
28
num At Risk
444
group Id
EG001
num Affected
7
num At Risk
222
term
Cataract
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
28
num At Risk
444
group Id
EG001
num Affected
10
num At Risk
222
term
Dry eye
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
33
num At Risk
444
group Id
EG001
num Affected
2
num At Risk
222
term
Lacrimation increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
23
num At Risk
444
group Id
EG001
num Affected
7
num At Risk
222
term
Vision blurred
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
21
num At Risk
444
group Id
EG001
num Affected
14
num At Risk
222
term
Abdominal distension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
67
num At Risk
444
group Id
EG001
num Affected
15
num At Risk
222
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
41
num At Risk
444
group Id
EG001
num Affected
20
num At Risk
222
term
Abdominal pain upper
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
105
num At Risk
444
group Id
EG001
num Affected
36
num At Risk
222
term
Constipation

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
5
num At Risk
444
group Id
EG001
num Affected
0
num At Risk
222
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
8
num At Risk
444
group Id
EG001
num Affected
0
num At Risk
222
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
444
group Id
EG001
num Affected
0
num At Risk
222
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
444
group Id
EG001
num Affected
0
num At Risk
222
term
Acute myocardial infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
2
num At Risk
444
group Id
EG001
num Affected
0
num At Risk
222
term
Angina pectoris
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
444
group Id
EG001
num Affected
0
num At Risk
222
term
Angina unstable
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
444
group Id
EG001
num Affected
0
num At Risk
222
term
Aortic valve stenosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
2
num At Risk
444
group Id
EG001
num Affected
0
num At Risk
222
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
444
group Id
EG001
num Affected
0
num At Risk
222
term
Atrioventricular block
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
1
num At Risk
444
group Id
EG001
num Affected
0
num At Risk
222
term
Bradycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
444
group Id
EG001
num Affected
1
num At Risk
222
term
Cardiac arrest
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 26.1
stats
group Id
EG000
num Affected
0
num At Risk
444
group Id
EG001
num Affected
1
num At Risk
222
term
Cardiac failure

time Frame

From the date of randomization up to 28 days after last dose of study medication (final analysis till study completion, approximately up to 10.51 years)

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