Percentage of Participants With Grade 3-4 Laboratory Parameters
A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Participants With Metastatic Breast Cancer (MARIANNE) · Source last updated 2024-03-04
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
Day 1, 8, and 15 of Cycle 1-3 and on Day 1 of each subsequent cycle up to 50 months from randomization until clinical cutoff of 16-Sept-2014
What was measured
Laboratory results were graded according to NCI CTCAE version 4.0. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activity of daily living with inability to perform bathing, dressing and undressing, feeding self, using the toilet, taking medications but not bedridden. Grade 4: An immediate threat to life. Urgent medical intervention is required in order to maintain survival.
Analysis population: Safety population. Number of participants analyzed=participants with available data for the outcome.
Groups in this outcome
Trastuzumab + Taxane
Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m\^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m\^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
Trastuzumab Emtansine + Placebo
Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
Trastuzumab Emtansine + Pertuzumab
Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
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
Trastuzumab + Taxane
352
Trastuzumab Emtansine + Placebo
361
Trastuzumab Emtansine + Pertuzumab
363
Reported measurements
Hemoglobin-Low: Grade 3
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab + Taxane
4.3
Not reported
Not reported
Not reported
Not reported
Trastuzumab Emtansine + Placebo
5.8
Not reported
Not reported
Not reported
Not reported
Trastuzumab Emtansine + Pertuzumab
6.9
Not reported
Not reported
Not reported
Not reported
Neutrophils-Low: Grade 3
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab + Taxane
20.2
Not reported
Not reported
Not reported
Not reported
Trastuzumab Emtansine + Placebo
5.5
Not reported
Not reported
Not reported
Not reported
Trastuzumab Emtansine + Pertuzumab
5.0
Not reported
Not reported
Not reported
Not reported
Neutrophils-Low: Grade 4
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab + Taxane
43.8
Not reported
Not reported
Not reported
Not reported
Trastuzumab Emtansine + Placebo
1.9
Not reported
Not reported
Not reported
Not reported
Trastuzumab Emtansine + Pertuzumab
0.8
Not reported
Not reported
Not reported
Not reported
Platelets-Low: Grade 3
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab + Taxane
0.9
Not reported
Not reported
Not reported
Not reported
Trastuzumab Emtansine + Placebo
12.7
Not reported
Not reported
Not reported
Not reported
Trastuzumab Emtansine + Pertuzumab
12.9
Not reported
Not reported
Not reported
Not reported
Platelets-Low: Grade 4
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab + Taxane
0.3
Not reported
Not reported
Not reported
Not reported
Trastuzumab Emtansine + Placebo
2.8
Not reported
Not reported
Not reported
Not reported
Trastuzumab Emtansine + Pertuzumab
2.5
Not reported
Not reported
Not reported
Not reported
Alkaline Phosphate-High: Grade 3
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab + Taxane
1.1
Not reported
Not reported
Not reported
Not reported
Trastuzumab Emtansine + Placebo
3.9
Not reported
Not reported
Not reported
Not reported
Trastuzumab Emtansine + Pertuzumab
3.0
Not reported
Not reported
Not reported
Not reported
Alanine Transaminase-High: Grade 3
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab + Taxane
3.4
Not reported
Not reported
Not reported
Not reported
Trastuzumab Emtansine + Placebo
9.1
Not reported
Not reported
Not reported
Not reported
Trastuzumab Emtansine + Pertuzumab
8.0
Not reported
Not reported
Not reported
Not reported
Alanine Transaminase-High: Grade 4
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab + Taxane
0.0
Not reported
Not reported
Not reported
Not reported
Trastuzumab Emtansine + Placebo
0.3
Not reported
Not reported
Not reported
Not reported
Trastuzumab Emtansine + Pertuzumab
0.6
Not reported
Not reported
Not reported
Not reported
Aspartate Aminotransferase-High: Grade 3
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab + Taxane
1.1
Not reported
Not reported
Not reported
Not reported
Trastuzumab Emtansine + Placebo
11.9
Not reported
Not reported
Not reported
Not reported
Trastuzumab Emtansine + Pertuzumab
6.9
Not reported
Not reported
Not reported
Not reported
Aspartate Aminotransferase-High: Grade 4
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab + Taxane
0.0
Not reported
Not reported
Not reported
Not reported
Trastuzumab Emtansine + Placebo
0.3
Not reported
Not reported
Not reported
Not reported
Trastuzumab Emtansine + Pertuzumab
0.3
Not reported
Not reported
Not reported
Not reported
Creatinine-High: Grade 3
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab + Taxane
0.9
Not reported
Not reported
Not reported
Not reported
Trastuzumab Emtansine + Placebo
0.3
Not reported
Not reported
Not reported
Not reported
Trastuzumab Emtansine + Pertuzumab
1.1
Not reported
Not reported
Not reported
Not reported
Creatinine-High: Grade 4
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab + Taxane
0.0
Not reported
Not reported
Not reported
Not reported
Trastuzumab Emtansine + Placebo
0.0
Not reported
Not reported
Not reported
Not reported
Trastuzumab Emtansine + Pertuzumab
0.3
Not reported
Not reported
Not reported
Not reported
Potassium-Low: Grade 3
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab + Taxane
4.3
Not reported
Not reported
Not reported
Not reported
Trastuzumab Emtansine + Placebo
4.7
Not reported
Not reported
Not reported
Not reported
Trastuzumab Emtansine + Pertuzumab
5.2
Not reported
Not reported
Not reported
Not reported
Potassium-Low: Grade 4
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab + Taxane
0.6
Not reported
Not reported
Not reported
Not reported
Trastuzumab Emtansine + Placebo
1.7
Not reported
Not reported
Not reported
Not reported
Trastuzumab Emtansine + Pertuzumab
0.6
Not reported
Not reported
Not reported
Not reported
Total Bilirubin-High: Grade 3
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Trastuzumab + Taxane
0.3
Not reported
Not reported
Not reported
Not reported
Trastuzumab Emtansine + Placebo
0.3
Not reported
Not reported
Not reported
Not reported
Trastuzumab Emtansine + Pertuzumab
0.3
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
4.3
group Id
OG001
value
5.8
group Id
OG002
value
6.9
title
Hemoglobin-Low: Grade 3
categories
measurements
group Id
OG000
value
20.2
group Id
OG001
value
5.5
group Id
OG002
value
5.0
title
Neutrophils-Low: Grade 3
categories
measurements
group Id
OG000
value
43.8
group Id
OG001
value
1.9
group Id
OG002
value
0.8
title
Neutrophils-Low: Grade 4
categories
measurements
group Id
OG000
value
0.9
group Id
OG001
value
12.7
group Id
OG002
value
12.9
title
Platelets-Low: Grade 3
categories
measurements
group Id
OG000
value
0.3
group Id
OG001
value
2.8
group Id
OG002
value
2.5
title
Platelets-Low: Grade 4
categories
measurements
group Id
OG000
value
1.1
group Id
OG001
value
3.9
group Id
OG002
value
3.0
title
Alkaline Phosphate-High: Grade 3
categories
measurements
group Id
OG000
value
3.4
group Id
OG001
value
9.1
group Id
OG002
value
8.0
title
Alanine Transaminase-High: Grade 3
categories
measurements
group Id
OG000
value
0.0
group Id
OG001
value
0.3
group Id
OG002
value
0.6
title
Alanine Transaminase-High: Grade 4
categories
measurements
group Id
OG000
value
1.1
group Id
OG001
value
11.9
group Id
OG002
value
6.9
title
Aspartate Aminotransferase-High: Grade 3
categories
measurements
group Id
OG000
value
0.0
group Id
OG001
value
0.3
group Id
OG002
value
0.3
title
Aspartate Aminotransferase-High: Grade 4
categories
measurements
group Id
OG000
value
0.9
group Id
OG001
value
0.3
group Id
OG002
value
1.1
title
Creatinine-High: Grade 3
categories
measurements
group Id
OG000
value
0.0
group Id
OG001
value
0.0
group Id
OG002
value
0.3
title
Creatinine-High: Grade 4
denoms
counts
group Id
OG000
value
352
group Id
OG001
value
361
group Id
OG002
value
363
units
Participants
description
Laboratory results were graded according to NCI CTCAE version 4.0. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activity of daily living with inability to perform bathing, dressing and undressing, feeding self, using the toilet, taking medications but not bedridden. Grade 4: An immediate threat to life. Urgent medical intervention is required in order to maintain survival.
groups
description
Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m\^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m\^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
id
OG000
title
Trastuzumab + Taxane
description
Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
id
OG001
title
Trastuzumab Emtansine + Placebo
description
Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
id
OG002
title
Trastuzumab Emtansine + Pertuzumab
param Type
NUMBER
population Description
Safety population. Number of participants analyzed=participants with available data for the outcome.
reporting Status
POSTED
time Frame
Day 1, 8, and 15 of Cycle 1-3 and on Day 1 of each subsequent cycle up to 50 months from randomization until clinical cutoff of 16-Sept-2014
title
Percentage of Participants With Grade 3-4 Laboratory Parameters
Triangle