Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final 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 65.1 months
What was measured
The following chemistry laboratory parameters were assessed: Potassium increased; potassium decreased; aspartate aminotransferase increased; creatinine increased; alkaline phosphatase increased; total bilirubin increased; albumin decreased; calcium corrected for albumin decreased; calcium corrected for albumin increased; glomerular filtration rate (GFR), estimated decreased; glucose decreased; glucose increased; sodium decreased; sodium increased; calcium and ionized increased. Treatment emergent laboratory abnormalities: 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 v5.0 used for creatinine increased. NCI CTCAE v4.03 used for the other laboratory 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 and "Number Analyzed" signifies number evaluable for specified rows.
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 Post-Crossover (Cohort C)
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.
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 Post-Crossover (Cohort C)
28
Reported measurements
Potassium increased, All grades
Analysis denominator · Participants
Group
Source count
Tucatinib+Trastuzumab (Cohorts A+B)
85
Tucatinib Post-Crossover (Cohort C)
28
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 Post-Crossover (Cohort C)
4
Not reported
Not reported
Not reported
Not reported
Potassium increased, Grade 3
Analysis denominator · Participants
Group
Source count
Tucatinib+Trastuzumab (Cohorts A+B)
85
Tucatinib Post-Crossover (Cohort C)
28
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 Post-Crossover (Cohort C)
0
Not reported
Not reported
Not reported
Not reported
Potassium increased, Grade 4
Analysis denominator · Participants
Group
Source count
Tucatinib+Trastuzumab (Cohorts A+B)
85
Tucatinib Post-Crossover (Cohort C)
28
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 Post-Crossover (Cohort C)
0
Not reported
Not reported
Not reported
Not reported
Potassium decreased, All grades
Analysis denominator · Participants
Group
Source count
Tucatinib+Trastuzumab (Cohorts A+B)
85
Tucatinib Post-Crossover (Cohort C)
28
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tucatinib+Trastuzumab (Cohorts A+B)
15
Not reported
Not reported
Not reported
Not reported
Tucatinib Post-Crossover (Cohort C)
4
Not reported
Not reported
Not reported
Not reported
Potassium decreased, Grade 3
Analysis denominator · Participants
Group
Source count
Tucatinib+Trastuzumab (Cohorts A+B)
85
Tucatinib Post-Crossover (Cohort C)
28
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tucatinib+Trastuzumab (Cohorts A+B)
1
Not reported
Not reported
Not reported
Not reported
Tucatinib Post-Crossover (Cohort C)
0
Not reported
Not reported
Not reported
Not reported
Potassium decreased, Grade 4
Analysis denominator · Participants
Group
Source count
Tucatinib+Trastuzumab (Cohorts A+B)
85
Tucatinib Post-Crossover (Cohort C)
28
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 Post-Crossover (Cohort C)
0
Not reported
Not reported
Not reported
Not reported
Aspartate Aminotransferase increased, All grades
Analysis denominator · Participants
Group
Source count
Tucatinib+Trastuzumab (Cohorts A+B)
85
Tucatinib Post-Crossover (Cohort C)
28
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tucatinib+Trastuzumab (Cohorts A+B)
29
Not reported
Not reported
Not reported
Not reported
Tucatinib Post-Crossover (Cohort C)
9
Not reported
Not reported
Not reported
Not reported
Aspartate Aminotransferase increased, Grade 3
Analysis denominator · Participants
Group
Source count
Tucatinib+Trastuzumab (Cohorts A+B)
85
Tucatinib Post-Crossover (Cohort C)
28
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 Post-Crossover (Cohort C)
3
Not reported
Not reported
Not reported
Not reported
Aspartate Aminotransferase increased, Grade 4
Analysis denominator · Participants
Group
Source count
Tucatinib+Trastuzumab (Cohorts A+B)
85
Tucatinib Post-Crossover (Cohort C)
28
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 Post-Crossover (Cohort C)
0
Not reported
Not reported
Not reported
Not reported
Alanine Aminotransferase increased, All grades
Analysis denominator · Participants
Group
Source count
Tucatinib+Trastuzumab (Cohorts A+B)
85
Tucatinib Post-Crossover (Cohort C)
28
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tucatinib+Trastuzumab (Cohorts A+B)
39
Not reported
Not reported
Not reported
Not reported
Tucatinib Post-Crossover (Cohort C)
7
Not reported
Not reported
Not reported
Not reported
Alanine Aminotransferase increased, Grade 3
Analysis denominator · Participants
Group
Source count
Tucatinib+Trastuzumab (Cohorts A+B)
85
Tucatinib Post-Crossover (Cohort C)
28
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 Post-Crossover (Cohort C)
2
Not reported
Not reported
Not reported
Not reported
Alanine Aminotransferase increased, Grade 4
Analysis denominator · Participants
Group
Source count
Tucatinib+Trastuzumab (Cohorts A+B)
85
Tucatinib Post-Crossover (Cohort C)
28
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 Post-Crossover (Cohort C)
0
Not reported
Not reported
Not reported
Not reported
Creatinine increased, All grades
Analysis denominator · Participants
Group
Source count
Tucatinib+Trastuzumab (Cohorts A+B)
85
Tucatinib Post-Crossover (Cohort C)
28
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tucatinib+Trastuzumab (Cohorts A+B)
50
Not reported
Not reported
Not reported
Not reported
Tucatinib Post-Crossover (Cohort C)
10
Not reported
Not reported
Not reported
Not reported
Creatinine increased, Grade 3
Analysis denominator · Participants
Group
Source count
Tucatinib+Trastuzumab (Cohorts A+B)
85
Tucatinib Post-Crossover (Cohort C)
28
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 Post-Crossover (Cohort C)
0
Not reported
Not reported
Not reported
Not reported
Creatinine increased, Grade 4
Analysis denominator · Participants
Group
Source count
Tucatinib+Trastuzumab (Cohorts A+B)
85
Tucatinib Post-Crossover (Cohort C)
28
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 Post-Crossover (Cohort C)
0
Not reported
Not reported
Not reported
Not reported
Alkaline Phosphatase increased, All grades
Analysis denominator · Participants
Group
Source count
Tucatinib+Trastuzumab (Cohorts A+B)
85
Tucatinib Post-Crossover (Cohort C)
28
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tucatinib+Trastuzumab (Cohorts A+B)
21
Not reported
Not reported
Not reported
Not reported
Tucatinib Post-Crossover (Cohort C)
3
Not reported
Not reported
Not reported
Not reported
Alkaline Phosphatase increased, Grade 3
Analysis denominator · Participants
Group
Source count
Tucatinib+Trastuzumab (Cohorts A+B)
85
Tucatinib Post-Crossover (Cohort C)
28
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tucatinib+Trastuzumab (Cohorts A+B)
1
Not reported
Not reported
Not reported
Not reported
Tucatinib Post-Crossover (Cohort C)
0
Not reported
Not reported
Not reported
Not reported
Alkaline Phosphatase increased, Grade 4
Analysis denominator · Participants
Group
Source count
Tucatinib+Trastuzumab (Cohorts A+B)
85
Tucatinib Post-Crossover (Cohort C)
28
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 Post-Crossover (Cohort C)
0
Not reported
Not reported
Not reported
Not reported
Total Bilirubin increased, All grades
Analysis denominator · Participants
Group
Source count
Tucatinib+Trastuzumab (Cohorts A+B)
85
Tucatinib Post-Crossover (Cohort C)
28
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tucatinib+Trastuzumab (Cohorts A+B)
25
Not reported
Not reported
Not reported
Not reported
Tucatinib Post-Crossover (Cohort C)
4
Not reported
Not reported
Not reported
Not reported
Total Bilirubin increased, Grade 3
Analysis denominator · Participants
Group
Source count
Tucatinib+Trastuzumab (Cohorts A+B)
85
Tucatinib Post-Crossover (Cohort C)
28
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 Post-Crossover (Cohort C)
0
Not reported
Not reported
Not reported
Not reported
Total Bilirubin increased, Grade 4
Analysis denominator · Participants
Group
Source count
Tucatinib+Trastuzumab (Cohorts A+B)
85
Tucatinib Post-Crossover (Cohort C)
28
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 Post-Crossover (Cohort C)
0
Not reported
Not reported
Not reported
Not reported
Albumin decreased, All grades
Analysis denominator · Participants
Group
Source count
Tucatinib+Trastuzumab (Cohorts A+B)
85
Tucatinib Post-Crossover (Cohort C)
28
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tucatinib+Trastuzumab (Cohorts A+B)
23
Not reported
Not reported
Not reported
Not reported
Tucatinib Post-Crossover (Cohort C)
8
Not reported
Not reported
Not reported
Not reported
Albumin decreased, Grade 3
Analysis denominator · Participants
Group
Source count
Tucatinib+Trastuzumab (Cohorts A+B)
85
Tucatinib Post-Crossover (Cohort C)
28
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tucatinib+Trastuzumab (Cohorts A+B)
1
Not reported
Not reported
Not reported
Not reported
Tucatinib Post-Crossover (Cohort C)
0
Not reported
Not reported
Not reported
Not reported
Albumin decreased, Grade 4
Analysis denominator · Participants
Group
Source count
Tucatinib+Trastuzumab (Cohorts A+B)
85
Tucatinib Post-Crossover (Cohort C)
28
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 Post-Crossover (Cohort C)
0
Not reported
Not reported
Not reported
Not reported
Calcium Corrected for Albumin decreased, All grades
Analysis denominator · Participants
Group
Source count
Tucatinib+Trastuzumab (Cohorts A+B)
84
Tucatinib Post-Crossover (Cohort C)
28
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 Post-Crossover (Cohort C)
5
Not reported
Not reported
Not reported
Not reported
Calcium Corrected for Albumin decreased, Grade 3
Analysis denominator · Participants
Group
Source count
Tucatinib+Trastuzumab (Cohorts A+B)
84
Tucatinib Post-Crossover (Cohort C)
28
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 Post-Crossover (Cohort C)
0
Not reported
Not reported
Not reported
Not reported
Calcium Corrected for Albumin decreased, Grade 4
Analysis denominator · Participants
Group
Source count
Tucatinib+Trastuzumab (Cohorts A+B)
84
Tucatinib Post-Crossover (Cohort C)
28
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 Post-Crossover (Cohort C)
0
Not reported
Not reported
Not reported
Not reported
Calcium Corrected for Albumin increased, All grades
Analysis denominator · Participants
Group
Source count
Tucatinib+Trastuzumab (Cohorts A+B)
84
Tucatinib Post-Crossover (Cohort C)
28
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 Post-Crossover (Cohort C)
5
Not reported
Not reported
Not reported
Not reported
Calcium Corrected for Albumin increased, Grade 3
Analysis denominator · Participants
Group
Source count
Tucatinib+Trastuzumab (Cohorts A+B)
84
Tucatinib Post-Crossover (Cohort C)
28
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 Post-Crossover (Cohort C)
0
Not reported
Not reported
Not reported
Not reported
Calcium Corrected for Albumin increased, Grade 4
Analysis denominator · Participants
Group
Source count
Tucatinib+Trastuzumab (Cohorts A+B)
84
Tucatinib Post-Crossover (Cohort C)
28
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 Post-Crossover (Cohort C)
0
Not reported
Not reported
Not reported
Not reported
Glomerular Filtration Rate, Estimated decreased, All grades
Analysis denominator · Participants
Group
Source count
Tucatinib+Trastuzumab (Cohorts A+B)
77
Tucatinib Post-Crossover (Cohort C)
21
Values in Participants · Interval/dispersion: Not reported
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 Post-Crossover (Cohort C)
0
Not reported
Not reported
Not reported
Not reported
Glucose decreased, All grades
Analysis denominator · Participants
Group
Source count
Tucatinib+Trastuzumab (Cohorts A+B)
85
Tucatinib Post-Crossover (Cohort C)
28
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tucatinib+Trastuzumab (Cohorts A+B)
10
Not reported
Not reported
Not reported
Not reported
Tucatinib Post-Crossover (Cohort C)
1
Not reported
Not reported
Not reported
Not reported
Glucose decreased, Grade 3
Analysis denominator · Participants
Group
Source count
Tucatinib+Trastuzumab (Cohorts A+B)
85
Tucatinib Post-Crossover (Cohort C)
28
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 Post-Crossover (Cohort C)
0
Not reported
Not reported
Not reported
Not reported
Glucose decreased, Grade 4
Analysis denominator · Participants
Group
Source count
Tucatinib+Trastuzumab (Cohorts A+B)
85
Tucatinib Post-Crossover (Cohort C)
28
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 Post-Crossover (Cohort C)
0
Not reported
Not reported
Not reported
Not reported
Glucose increased, All grades
Analysis denominator · Participants
Group
Source count
Tucatinib+Trastuzumab (Cohorts A+B)
85
Tucatinib Post-Crossover (Cohort C)
28
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tucatinib+Trastuzumab (Cohorts A+B)
48
Not reported
Not reported
Not reported
Not reported
Tucatinib Post-Crossover (Cohort C)
9
Not reported
Not reported
Not reported
Not reported
Glucose increased, Grade 3
Analysis denominator · Participants
Group
Source count
Tucatinib+Trastuzumab (Cohorts A+B)
85
Tucatinib Post-Crossover (Cohort C)
28
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 Post-Crossover (Cohort C)
0
Not reported
Not reported
Not reported
Not reported
Glucose increased, Grade 4
Analysis denominator · Participants
Group
Source count
Tucatinib+Trastuzumab (Cohorts A+B)
85
Tucatinib Post-Crossover (Cohort C)
28
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 Post-Crossover (Cohort C)
0
Not reported
Not reported
Not reported
Not reported
Sodium decreased, All grades
Analysis denominator · Participants
Group
Source count
Tucatinib+Trastuzumab (Cohorts A+B)
85
Tucatinib Post-Crossover (Cohort C)
28
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tucatinib+Trastuzumab (Cohorts A+B)
18
Not reported
Not reported
Not reported
Not reported
Tucatinib Post-Crossover (Cohort C)
1
Not reported
Not reported
Not reported
Not reported
Sodium decreased, Grade 3
Analysis denominator · Participants
Group
Source count
Tucatinib+Trastuzumab (Cohorts A+B)
85
Tucatinib Post-Crossover (Cohort C)
28
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 Post-Crossover (Cohort C)
0
Not reported
Not reported
Not reported
Not reported
Sodium decreased, Grade 4
Analysis denominator · Participants
Group
Source count
Tucatinib+Trastuzumab (Cohorts A+B)
85
Tucatinib Post-Crossover (Cohort C)
28
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 Post-Crossover (Cohort C)
0
Not reported
Not reported
Not reported
Not reported
Sodium increased, All grades
Analysis denominator · Participants
Group
Source count
Tucatinib+Trastuzumab (Cohorts A+B)
85
Tucatinib Post-Crossover (Cohort C)
28
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Tucatinib+Trastuzumab (Cohorts A+B)
7
Not reported
Not reported
Not reported
Not reported
Tucatinib Post-Crossover (Cohort C)
4
Not reported
Not reported
Not reported
Not reported
Sodium increased, Grade 3
Analysis denominator · Participants
Group
Source count
Tucatinib+Trastuzumab (Cohorts A+B)
85
Tucatinib Post-Crossover (Cohort C)
28
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 Post-Crossover (Cohort C)
0
Not reported
Not reported
Not reported
Not reported
Sodium increased, Grade 4
Analysis denominator · Participants
Group
Source count
Tucatinib+Trastuzumab (Cohorts A+B)
85
Tucatinib Post-Crossover (Cohort C)
28
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 Post-Crossover (Cohort C)
0
Not reported
Not reported
Not reported
Not reported
Calcium, Ionized increased: All grades
Analysis denominator · Participants
Group
Source count
Tucatinib+Trastuzumab (Cohorts A+B)
3
Tucatinib Post-Crossover (Cohort C)
28
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 Post-Crossover (Cohort C)
0
Not reported
Not reported
Not reported
Not reported
Calcium, Ionized increased: Grade 3
Analysis denominator · Participants
Group
Source count
Tucatinib+Trastuzumab (Cohorts A+B)
3
Tucatinib Post-Crossover (Cohort C)
28
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 Post-Crossover (Cohort C)
0
Not reported
Not reported
Not reported
Not reported
Calcium, Ionized increased: Grade 4
Analysis denominator · Participants
Group
Source count
Tucatinib+Trastuzumab (Cohorts A+B)
3
Tucatinib Post-Crossover (Cohort C)
28
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 Post-Crossover (Cohort C)
0
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
4
denoms
counts
group Id
OG000
value
85
group Id
OG001
value
28
units
Participants
title
Potassium increased, All grades
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
85
group Id
OG001
value
28
units
Participants
title
Potassium increased, Grade 3
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
85
group Id
OG001
value
28
units
Participants
title
Potassium increased, Grade 4
categories
measurements
group Id
OG000
value
15
group Id
OG001
value
4
denoms
counts
group Id
OG000
value
85
group Id
OG001
value
28
units
Participants
title
Potassium decreased, All grades
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
85
group Id
OG001
value
28
units
Participants
title
Potassium decreased, Grade 3
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
85
group Id
OG001
value
28
units
Participants
title
Potassium decreased, Grade 4
categories
measurements
group Id
OG000
value
29
group Id
OG001
value
9
denoms
counts
group Id
OG000
value
85
group Id
OG001
value
28
units
Participants
title
Aspartate Aminotransferase increased, All grades
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
3
denoms
counts
group Id
OG000
value
85
group Id
OG001
value
28
units
Participants
title
Aspartate Aminotransferase increased, Grade 3
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
85
group Id
OG001
value
28
units
Participants
title
Aspartate Aminotransferase increased, Grade 4
categories
measurements
group Id
OG000
value
39
group Id
OG001
value
7
denoms
counts
group Id
OG000
value
85
group Id
OG001
value
28
units
Participants
title
Alanine Aminotransferase increased, All grades
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
2
denoms
counts
group Id
OG000
value
85
group Id
OG001
value
28
units
Participants
title
Alanine Aminotransferase increased, Grade 3
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
0
denoms
counts
group Id
OG000
value
85
group Id
OG001
value
28
units
Participants
title
Alanine Aminotransferase increased, Grade 4
denoms
counts
group Id
OG000
value
85
group Id
OG001
value
28
units
Participants
description
The following chemistry laboratory parameters were assessed: Potassium increased; potassium decreased; aspartate aminotransferase increased; creatinine increased; alkaline phosphatase increased; total bilirubin increased; albumin decreased; calcium corrected for albumin decreased; calcium corrected for albumin increased; glomerular filtration rate (GFR), estimated decreased; glucose decreased; glucose increased; sodium decreased; sodium increased; calcium and ionized increased. Treatment emergent laboratory abnormalities: 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 v5.0 used for creatinine increased. NCI CTCAE v4.03 used for the other laboratory 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. 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
OG001
title
Tucatinib Post-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 and "Number Analyzed" signifies number evaluable for specified rows.
reporting Status
POSTED
time Frame
Up to 65.1 months
title
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis
Triangle