Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology): Interim Analysis
Tucatinib Plus Trastuzumab in Patients With HER2+ Colorectal Cancer · Source last updated 2024-11-26
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
Up to 49.3 months
What was measured
The following hematology laboratory parameters were assessed: Hemoglobin decreased; leukocytes decreased; neutrophils decreased and Platelets decreased. Treatment emergent laboratory abnormalities were defined as abnormalities that were new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment. NCI CTCAE v4.03 was used for the lab parameters. Grade 1: mild; Grade 2: moderate; Grade 3: severe or clinically significant; Grade 4: life-threatening.
Analysis population: The safety analysis set included all participants who received any amount of study treatment. Data for cohorts A and B was combined as prespecified in SAP. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Groups in this outcome
Tucatinib+Trastuzumab (Cohorts A+B)
Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Trastuzumab 8 mg/kg by IV infusion on Day 1 of Cycle 1 and 6 mg/kg on Day 1 of each subsequent cycle until PD, death, withdrawal of consent, study closure, or alternative therapy.
Tucatinib Pre-Crossover (Cohort C)
Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Participants who did not respond to monotherapy were given the option to receive tucatinib and trastuzumab based on radiographic progression (as determined by investigator assessment using RECIST v1.1), or if they had not achieved a PR or CR by the week 12 assessment.
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
Tucatinib+Trastuzumab (Cohorts A+B)
85
Tucatinib Pre-Crossover (Cohort C)
29
Reported measurements
Hemoglobin decreased, Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tucatinib+Trastuzumab (Cohorts A+B)
28
Not reported
Not reported
Not reported
Not reported
Tucatinib Pre-Crossover (Cohort C)
6
Not reported
Not reported
Not reported
Not reported
Hemoglobin decreased, Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tucatinib+Trastuzumab (Cohorts A+B)
8
Not reported
Not reported
Not reported
Not reported
Tucatinib Pre-Crossover (Cohort C)
2
Not reported
Not reported
Not reported
Not reported
Hemoglobin decreased, Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tucatinib+Trastuzumab (Cohorts A+B)
3
Not reported
Not reported
Not reported
Not reported
Tucatinib Pre-Crossover (Cohort C)
0
Not reported
Not reported
Not reported
Not reported
Hemoglobin decreased, Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tucatinib+Trastuzumab (Cohorts A+B)
0
Not reported
Not reported
Not reported
Not reported
Tucatinib Pre-Crossover (Cohort C)
0
Not reported
Not reported
Not reported
Not reported
Leukocytes decreased, Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tucatinib+Trastuzumab (Cohorts A+B)
14
Not reported
Not reported
Not reported
Not reported
Tucatinib Pre-Crossover (Cohort C)
3
Not reported
Not reported
Not reported
Not reported
Leukocytes decreased, Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tucatinib+Trastuzumab (Cohorts A+B)
5
Not reported
Not reported
Not reported
Not reported
Tucatinib Pre-Crossover (Cohort C)
0
Not reported
Not reported
Not reported
Not reported
Leukocytes decreased, Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tucatinib+Trastuzumab (Cohorts A+B)
0
Not reported
Not reported
Not reported
Not reported
Tucatinib Pre-Crossover (Cohort C)
0
Not reported
Not reported
Not reported
Not reported
Leukocytes decreased, Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tucatinib+Trastuzumab (Cohorts A+B)
0
Not reported
Not reported
Not reported
Not reported
Tucatinib Pre-Crossover (Cohort C)
0
Not reported
Not reported
Not reported
Not reported
Neutrophils decreased, Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tucatinib+Trastuzumab (Cohorts A+B)
6
Not reported
Not reported
Not reported
Not reported
Tucatinib Pre-Crossover (Cohort C)
1
Not reported
Not reported
Not reported
Not reported
Neutrophils decreased, Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tucatinib+Trastuzumab (Cohorts A+B)
2
Not reported
Not reported
Not reported
Not reported
Tucatinib Pre-Crossover (Cohort C)
1
Not reported
Not reported
Not reported
Not reported
Neutrophils decreased, Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tucatinib+Trastuzumab (Cohorts A+B)
0
Not reported
Not reported
Not reported
Not reported
Tucatinib Pre-Crossover (Cohort C)
0
Not reported
Not reported
Not reported
Not reported
Neutrophils decreased, Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tucatinib+Trastuzumab (Cohorts A+B)
0
Not reported
Not reported
Not reported
Not reported
Tucatinib Pre-Crossover (Cohort C)
0
Not reported
Not reported
Not reported
Not reported
Platelets decreased, Grade 1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tucatinib+Trastuzumab (Cohorts A+B)
11
Not reported
Not reported
Not reported
Not reported
Tucatinib Pre-Crossover (Cohort C)
1
Not reported
Not reported
Not reported
Not reported
Platelets decreased, Grade 2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tucatinib+Trastuzumab (Cohorts A+B)
2
Not reported
Not reported
Not reported
Not reported
Tucatinib Pre-Crossover (Cohort C)
2
Not reported
Not reported
Not reported
Not reported
Platelets decreased, Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tucatinib+Trastuzumab (Cohorts A+B)
0
Not reported
Not reported
Not reported
Not reported
Tucatinib Pre-Crossover (Cohort C)
0
Not reported
Not reported
Not reported
Not reported
Platelets decreased, Grade 4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tucatinib+Trastuzumab (Cohorts A+B)
0
Not reported
Not reported
Not reported
Not reported
Tucatinib Pre-Crossover (Cohort C)
0
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
28
group Id
OG001
value
6
title
Hemoglobin decreased, Grade 1
categories
measurements
group Id
OG000
value
8
group Id
OG001
value
2
title
Hemoglobin decreased, Grade 2
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
0
title
Hemoglobin decreased, Grade 3
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
Hemoglobin decreased, Grade 4
categories
measurements
group Id
OG000
value
14
group Id
OG001
value
3
title
Leukocytes decreased, Grade 1
categories
measurements
group Id
OG000
value
5
group Id
OG001
value
0
title
Leukocytes decreased, Grade 2
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
Leukocytes decreased, Grade 3
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
Leukocytes decreased, Grade 4
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
1
title
Neutrophils decreased, Grade 1
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
1
title
Neutrophils decreased, Grade 2
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
Neutrophils decreased, Grade 3
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
Neutrophils decreased, Grade 4
denoms
counts
group Id
OG000
value
85
group Id
OG001
value
29
units
Participants
description
The following hematology laboratory parameters were assessed: Hemoglobin decreased; leukocytes decreased; neutrophils decreased and Platelets decreased. Treatment emergent laboratory abnormalities were defined as abnormalities that were new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment. NCI CTCAE v4.03 was used for the lab parameters. Grade 1: mild; Grade 2: moderate; Grade 3: severe or clinically significant; Grade 4: life-threatening.
groups
description
Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Trastuzumab 8 mg/kg by IV infusion on Day 1 of Cycle 1 and 6 mg/kg on Day 1 of each subsequent cycle until PD, death, withdrawal of consent, study closure, or alternative therapy.
id
OG000
title
Tucatinib+Trastuzumab (Cohorts A+B)
description
Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Participants who did not respond to monotherapy were given the option to receive tucatinib and trastuzumab based on radiographic progression (as determined by investigator assessment using RECIST v1.1), or if they had not achieved a PR or CR by the week 12 assessment.
id
OG001
title
Tucatinib Pre-Crossover (Cohort C)
param Type
COUNT_OF_PARTICIPANTS
population Description
The safety analysis set included all participants who received any amount of study treatment. Data for cohorts A and B was combined as prespecified in SAP. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
reporting Status
POSTED
time Frame
Up to 49.3 months
title
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology): Interim Analysis
Triangle