NCT01740427 · OUTCOME

Number of Participants With Laboratory Abnormalities by Maximum Common Terminology Criteria for Adverse Events (CTCAE) Grade

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.

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: From randomization up to 28 days after last dose of study drug (assessed up to analysis date of 15-Nov-2021, approximately 8.7 years)

What was measured

Laboratory abnormalities included anemia, hemoglobin increased, neutrophils (absolute), platelets, white blood cells, alanine aminotransferase (ALT), alkaline phosphatase, aspartate aminotransferase (AST), bilirubin (total), creatinine, hypercalcemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypokalemia, hypomagnesemia and hyponatremia. Laboratory abnormalities were graded by CTCAE version (v) 4.0 as Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = life-threatening. Categories with at least 1 non-zero data values are reported.

Analysis population: AT population included all participants who received at least 1 dose of study medication, with treatment assignments designated according to actual study treatment received. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Groups in this outcome

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.

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Palbociclib Plus Letrozole	444
Placebo Plus Letrozole	221

Reported measurements

Anemia: Grade 1-2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib Plus Letrozole	328	Not reported	Not reported	Not reported	Not reported
Placebo Plus Letrozole	90	Not reported	Not reported	Not reported	Not reported

Anemia: Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib Plus Letrozole	30	Not reported	Not reported	Not reported	Not reported
Placebo Plus Letrozole	6	Not reported	Not reported	Not reported	Not reported

Hemoglobin Increased: Grade 1-2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib Plus Letrozole	14	Not reported	Not reported	Not reported	Not reported
Placebo Plus Letrozole	25	Not reported	Not reported	Not reported	Not reported

Hemoglobin Increased: Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib Plus Letrozole	1	Not reported	Not reported	Not reported	Not reported
Placebo Plus Letrozole	0	Not reported	Not reported	Not reported	Not reported

Neutrophils (Absolute): Grade 1-2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib Plus Letrozole	109	Not reported	Not reported	Not reported	Not reported
Placebo Plus Letrozole	42	Not reported	Not reported	Not reported	Not reported

Neutrophils (Absolute): Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib Plus Letrozole	254	Not reported	Not reported	Not reported	Not reported
Placebo Plus Letrozole	2	Not reported	Not reported	Not reported	Not reported

Neutrophils (Absolute): Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib Plus Letrozole	60	Not reported	Not reported	Not reported	Not reported
Placebo Plus Letrozole	1	Not reported	Not reported	Not reported	Not reported

Platelets: Grade 1-2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib Plus Letrozole	289	Not reported	Not reported	Not reported	Not reported
Placebo Plus Letrozole	32	Not reported	Not reported	Not reported	Not reported

Platelets: Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib Plus Letrozole	6	Not reported	Not reported	Not reported	Not reported
Placebo Plus Letrozole	0	Not reported	Not reported	Not reported	Not reported

Platelets: Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib Plus Letrozole	1	Not reported	Not reported	Not reported	Not reported
Placebo Plus Letrozole	0	Not reported	Not reported	Not reported	Not reported

White Blood Cells: Grade 1-2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib Plus Letrozole	248	Not reported	Not reported	Not reported	Not reported
Placebo Plus Letrozole	57	Not reported	Not reported	Not reported	Not reported

White Blood Cells: Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib Plus Letrozole	177	Not reported	Not reported	Not reported	Not reported
Placebo Plus Letrozole	0	Not reported	Not reported	Not reported	Not reported

White Blood Cells: Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib Plus Letrozole	6	Not reported	Not reported	Not reported	Not reported
Placebo Plus Letrozole	0	Not reported	Not reported	Not reported	Not reported

ALT: Grade 1-2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib Plus Letrozole	222	Not reported	Not reported	Not reported	Not reported
Placebo Plus Letrozole	76	Not reported	Not reported	Not reported	Not reported

ALT: Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib Plus Letrozole	16	Not reported	Not reported	Not reported	Not reported
Placebo Plus Letrozole	0	Not reported	Not reported	Not reported	Not reported

ALT: Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib Plus Letrozole	1	Not reported	Not reported	Not reported	Not reported
Placebo Plus Letrozole	0	Not reported	Not reported	Not reported	Not reported

Alkaline Phosphatase: Grade 1-2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib Plus Letrozole	174	Not reported	Not reported	Not reported	Not reported
Placebo Plus Letrozole	95	Not reported	Not reported	Not reported	Not reported

Alkaline Phosphatase: Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib Plus Letrozole	7	Not reported	Not reported	Not reported	Not reported
Placebo Plus Letrozole	0	Not reported	Not reported	Not reported	Not reported

AST: Grade 1-2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib Plus Letrozole	260	Not reported	Not reported	Not reported	Not reported
Placebo Plus Letrozole	82	Not reported	Not reported	Not reported	Not reported

AST: Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib Plus Letrozole	23	Not reported	Not reported	Not reported	Not reported
Placebo Plus Letrozole	2	Not reported	Not reported	Not reported	Not reported

Bilirubin (Total): Grade 1-2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib Plus Letrozole	33	Not reported	Not reported	Not reported	Not reported
Placebo Plus Letrozole	11	Not reported	Not reported	Not reported	Not reported

Bilirubin (Total): Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib Plus Letrozole	3	Not reported	Not reported	Not reported	Not reported
Placebo Plus Letrozole	0	Not reported	Not reported	Not reported	Not reported

Creatinine: Grade 1-2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib Plus Letrozole	418	Not reported	Not reported	Not reported	Not reported
Placebo Plus Letrozole	201	Not reported	Not reported	Not reported	Not reported

Creatinine: Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib Plus Letrozole	8	Not reported	Not reported	Not reported	Not reported
Placebo Plus Letrozole	0	Not reported	Not reported	Not reported	Not reported

Creatinine: Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib Plus Letrozole	2	Not reported	Not reported	Not reported	Not reported
Placebo Plus Letrozole	0	Not reported	Not reported	Not reported	Not reported

Hypercalcemia: Grade 1-2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib Plus Letrozole	111	Not reported	Not reported	Not reported	Not reported
Placebo Plus Letrozole	54	Not reported	Not reported	Not reported	Not reported

Hypercalcemia: Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib Plus Letrozole	1	Not reported	Not reported	Not reported	Not reported
Placebo Plus Letrozole	2	Not reported	Not reported	Not reported	Not reported

Hyperkalemia: Grade 1-2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib Plus Letrozole	118	Not reported	Not reported	Not reported	Not reported
Placebo Plus Letrozole	51	Not reported	Not reported	Not reported	Not reported

Hyperkalemia: Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib Plus Letrozole	6	Not reported	Not reported	Not reported	Not reported
Placebo Plus Letrozole	1	Not reported	Not reported	Not reported	Not reported

Hyperkalemia: Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib Plus Letrozole	2	Not reported	Not reported	Not reported	Not reported
Placebo Plus Letrozole	0	Not reported	Not reported	Not reported	Not reported

Hypermagnesemia: Grade 1-2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib Plus Letrozole	71	Not reported	Not reported	Not reported	Not reported
Placebo Plus Letrozole	26	Not reported	Not reported	Not reported	Not reported

Hypermagnesemia: Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib Plus Letrozole	9	Not reported	Not reported	Not reported	Not reported
Placebo Plus Letrozole	6	Not reported	Not reported	Not reported	Not reported

Hypermagnesemia: Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib Plus Letrozole	2	Not reported	Not reported	Not reported	Not reported
Placebo Plus Letrozole	0	Not reported	Not reported	Not reported	Not reported

Hypernatremia: Grade 1-2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib Plus Letrozole	94	Not reported	Not reported	Not reported	Not reported
Placebo Plus Letrozole	35	Not reported	Not reported	Not reported	Not reported

Hypernatremia: Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib Plus Letrozole	8	Not reported	Not reported	Not reported	Not reported
Placebo Plus Letrozole	1	Not reported	Not reported	Not reported	Not reported

Hypoalbuminemia: Grade 1-2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib Plus Letrozole	118	Not reported	Not reported	Not reported	Not reported
Placebo Plus Letrozole	42	Not reported	Not reported	Not reported	Not reported

Hypoalbuminemia: Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib Plus Letrozole	2	Not reported	Not reported	Not reported	Not reported
Placebo Plus Letrozole	0	Not reported	Not reported	Not reported	Not reported

Hypocalcemia: Grade 1-2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib Plus Letrozole	158	Not reported	Not reported	Not reported	Not reported
Placebo Plus Letrozole	48	Not reported	Not reported	Not reported	Not reported

Hypocalcemia: Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib Plus Letrozole	4	Not reported	Not reported	Not reported	Not reported
Placebo Plus Letrozole	1	Not reported	Not reported	Not reported	Not reported

Hypocalcemia: Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib Plus Letrozole	3	Not reported	Not reported	Not reported	Not reported
Placebo Plus Letrozole	0	Not reported	Not reported	Not reported	Not reported

Hypokalemia: Grade 1-2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib Plus Letrozole	105	Not reported	Not reported	Not reported	Not reported
Placebo Plus Letrozole	32	Not reported	Not reported	Not reported	Not reported

Hypokalemia: Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib Plus Letrozole	11	Not reported	Not reported	Not reported	Not reported
Placebo Plus Letrozole	2	Not reported	Not reported	Not reported	Not reported

Hypomagnesemia: Grade 1-2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib Plus Letrozole	127	Not reported	Not reported	Not reported	Not reported
Placebo Plus Letrozole	41	Not reported	Not reported	Not reported	Not reported

Hypomagnesemia: Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib Plus Letrozole	1	Not reported	Not reported	Not reported	Not reported
Placebo Plus Letrozole	0	Not reported	Not reported	Not reported	Not reported

Hypomagnesemia: Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib Plus Letrozole	2	Not reported	Not reported	Not reported	Not reported
Placebo Plus Letrozole	0	Not reported	Not reported	Not reported	Not reported

Hyponatremia: Grade 1-2

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib Plus Letrozole	107	Not reported	Not reported	Not reported	Not reported
Placebo Plus Letrozole	44	Not reported	Not reported	Not reported	Not reported

Hyponatremia: Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib Plus Letrozole	11	Not reported	Not reported	Not reported	Not reported
Placebo Plus Letrozole	4	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
328
group Id
OG001
value
90
title
Anemia: Grade 1-2
categories
measurements
group Id
OG000
value
30
group Id
OG001
value
6
title
Anemia: Grade 3
categories
measurements
group Id
OG000
value
14
group Id
OG001
value
25
title
Hemoglobin Increased: Grade 1-2
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
title
Hemoglobin Increased: Grade 3
categories
measurements
group Id
OG000
value
109
group Id
OG001
value
42
title
Neutrophils (Absolute): Grade 1-2
categories
measurements
group Id
OG000
value
254
group Id
OG001
value
2
title
Neutrophils (Absolute): Grade 3
categories
measurements
group Id
OG000
value
60
group Id
OG001
value
1
title
Neutrophils (Absolute): Grade 4
categories
measurements
group Id
OG000
value
289
group Id
OG001
value
32
title
Platelets: Grade 1-2
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
0
title
Platelets: Grade 3
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
title
Platelets: Grade 4
categories
measurements
group Id
OG000
value
248
group Id
OG001
value
57
title
White Blood Cells: Grade 1-2
categories
measurements
group Id
OG000
value
177
group Id
OG001
value
0
title
White Blood Cells: Grade 3

denoms

counts
group Id
OG000
value
444
group Id
OG001
value
221
units
Participants

description

groups

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
OG000
title
Palbociclib Plus Letrozole
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
OG001
title
Placebo Plus Letrozole

param Type

COUNT_OF_PARTICIPANTS

population Description

AT population included all participants who received at least 1 dose of study medication, with treatment assignments designated according to actual study treatment received. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

reporting Status

POSTED

time Frame

From randomization up to 28 days after last dose of study drug (assessed up to analysis date of 15-Nov-2021, approximately 8.7 years)

title

Number of Participants With Laboratory Abnormalities by Maximum Common Terminology Criteria for Adverse Events (CTCAE) Grade

type

SECONDARY

unit Of Measure

Participants

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Preserved source evidence · Not medical advice