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NCT03915951 · OUTCOME

Number of Participants With Shifts From Grade ≤2 at Baseline to Grade 3 or 4 at Post-baseline in Chemistry Laboratory Test Values Based on CTCAE Grade

An Open-label Study of Encorafenib + Binimetinib in Patients With BRAFV600-mutant Non-small Cell Lung Cancer · Source last updated 2026-03-24

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: Screening, Cycle 1 Day 1, Cycle 2 Day 1 ±3 Days, Day 1 ±3 Days in Subsequent Cycles, EOT ±3 Days and Safety Follow-up Visit (30 Days [±7 Days] After the EOT Visit) (Up to 36 Months)

What was measured

Blood and urine samples for the laboratory tests. A central laboratory will perform all clinical laboratory assessments. Baseline was the last available assessment performed prior to the study intervention start date/time. Grade 4 was not applicable for the parameters of hyperglycemia and hypoalbuminemia as Grade 4 was not defined for these 2 parameters per CTCAE version 4.03.

Analysis population: Safety Analysis Set included all participants who received at least 1 dose of study intervention. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.

Groups in this outcome

Treatment-Naive

Treatment-naïve participants with BRAF V600E-mutant metastatic NSCLC were enrolled to receive encorafenib 450 mg QD and binimetinib 45 mg BID in 28-day (±3 days) cycles and continued until the participants met the protocol-defined criteria for treatment withdrawal.

Previously Treated

Patients who had received 1) first-line treatment with standard platinum-based chemotherapy, or 2) first-line treatment with an anti-PD-1/PD-L1 inhibitor given alone, or in combination with platinum-based chemotherapy, or in combination with immunotherapy (eg, ipilimumab) with or without platinum-based chemotherapy were enrolled to receive encorafenib 450 mg QD and binimetinib 45 mg BID was to be administered in 28-day (±3 days) cycles and continued until the participants met the protocol-defined criteria for treatment withdrawal.

Total

Sum of all participants in the Study C4221008 (ARRAY-818-202)

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
Treatment-Naive	59
Previously Treated	39
Total	98

Reported measurements

Alanine aminotransferase increased - Grade 3

Analysis denominator · Participants

Group	Source count
Treatment-Naive	56
Previously Treated	38
Total	94

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment-Naive	6	Not reported	Not reported	Not reported	Not reported
Previously Treated	2	Not reported	Not reported	Not reported	Not reported
Total	8	Not reported	Not reported	Not reported	Not reported

Alanine aminotransferase increased - Grade 4

Analysis denominator · Participants

Group	Source count
Treatment-Naive	56
Previously Treated	38
Total	94

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment-Naive	0	Not reported	Not reported	Not reported	Not reported
Previously Treated	0	Not reported	Not reported	Not reported	Not reported
Total	0	Not reported	Not reported	Not reported	Not reported

Alkaline phosphatase increased - Grade 3

Analysis denominator · Participants

Group	Source count
Treatment-Naive	56
Previously Treated	38
Total	94

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment-Naive	2	Not reported	Not reported	Not reported	Not reported
Previously Treated	1	Not reported	Not reported	Not reported	Not reported
Total	3	Not reported	Not reported	Not reported	Not reported

Alkaline phosphatase increased - Grade 4

Analysis denominator · Participants

Group	Source count
Treatment-Naive	56
Previously Treated	38
Total	94

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment-Naive	0	Not reported	Not reported	Not reported	Not reported
Previously Treated	0	Not reported	Not reported	Not reported	Not reported
Total	0	Not reported	Not reported	Not reported	Not reported

Aspartate aminotransferase increased - Grade 3

Analysis denominator · Participants

Group	Source count
Treatment-Naive	56
Previously Treated	38
Total	94

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment-Naive	7	Not reported	Not reported	Not reported	Not reported
Previously Treated	2	Not reported	Not reported	Not reported	Not reported
Total	9	Not reported	Not reported	Not reported	Not reported

Aspartate aminotransferase increased - Grade 4

Analysis denominator · Participants

Group	Source count
Treatment-Naive	56
Previously Treated	38
Total	94

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment-Naive	0	Not reported	Not reported	Not reported	Not reported
Previously Treated	0	Not reported	Not reported	Not reported	Not reported
Total	0	Not reported	Not reported	Not reported	Not reported

Blood bilirubin increased - Grade 3

Analysis denominator · Participants

Group	Source count
Treatment-Naive	56
Previously Treated	38
Total	94

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment-Naive	0	Not reported	Not reported	Not reported	Not reported
Previously Treated	0	Not reported	Not reported	Not reported	Not reported
Total	0	Not reported	Not reported	Not reported	Not reported

Blood bilirubin increased - Grade 4

Analysis denominator · Participants

Group	Source count
Treatment-Naive	56
Previously Treated	38
Total	94

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment-Naive	0	Not reported	Not reported	Not reported	Not reported
Previously Treated	0	Not reported	Not reported	Not reported	Not reported
Total	0	Not reported	Not reported	Not reported	Not reported

Creatine kinase increased - Grade 3

Analysis denominator · Participants

Group	Source count
Treatment-Naive	55
Previously Treated	36
Total	91

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment-Naive	2	Not reported	Not reported	Not reported	Not reported
Previously Treated	1	Not reported	Not reported	Not reported	Not reported
Total	3	Not reported	Not reported	Not reported	Not reported

Creatine kinase increased - Grade 4

Analysis denominator · Participants

Group	Source count
Treatment-Naive	55
Previously Treated	36
Total	91

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment-Naive	0	Not reported	Not reported	Not reported	Not reported
Previously Treated	0	Not reported	Not reported	Not reported	Not reported
Total	0	Not reported	Not reported	Not reported	Not reported

Creatinine increased - Grade 3

Analysis denominator · Participants

Group	Source count
Treatment-Naive	57
Previously Treated	38
Total	95

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment-Naive	3	Not reported	Not reported	Not reported	Not reported
Previously Treated	0	Not reported	Not reported	Not reported	Not reported
Total	3	Not reported	Not reported	Not reported	Not reported

Creatinine increased - Grade 4

Analysis denominator · Participants

Group	Source count
Treatment-Naive	57
Previously Treated	38
Total	95

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment-Naive	0	Not reported	Not reported	Not reported	Not reported
Previously Treated	0	Not reported	Not reported	Not reported	Not reported
Total	0	Not reported	Not reported	Not reported	Not reported

Hypercalcemia - Grade 3

Analysis denominator · Participants

Group	Source count
Treatment-Naive	56
Previously Treated	38
Total	94

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment-Naive	1	Not reported	Not reported	Not reported	Not reported
Previously Treated	1	Not reported	Not reported	Not reported	Not reported
Total	2	Not reported	Not reported	Not reported	Not reported

Hypercalcemia - Grade 4

Analysis denominator · Participants

Group	Source count
Treatment-Naive	56
Previously Treated	38
Total	94

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment-Naive	0	Not reported	Not reported	Not reported	Not reported
Previously Treated	0	Not reported	Not reported	Not reported	Not reported
Total	0	Not reported	Not reported	Not reported	Not reported

Hyperglycemia - Grade 3

Analysis denominator · Participants

Group	Source count
Treatment-Naive	56
Previously Treated	38
Total	94

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment-Naive	5	Not reported	Not reported	Not reported	Not reported
Previously Treated	1	Not reported	Not reported	Not reported	Not reported
Total	6	Not reported	Not reported	Not reported	Not reported

Hyperkalemia - Grade 3

Analysis denominator · Participants

Group	Source count
Treatment-Naive	56
Previously Treated	38
Total	94

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment-Naive	2	Not reported	Not reported	Not reported	Not reported
Previously Treated	0	Not reported	Not reported	Not reported	Not reported
Total	2	Not reported	Not reported	Not reported	Not reported

Hyperkalemia - Grade 4

Analysis denominator · Participants

Group	Source count
Treatment-Naive	56
Previously Treated	38
Total	94

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment-Naive	0	Not reported	Not reported	Not reported	Not reported
Previously Treated	0	Not reported	Not reported	Not reported	Not reported
Total	0	Not reported	Not reported	Not reported	Not reported

Hypermagnesemia - Grade 3

Analysis denominator · Participants

Group	Source count
Treatment-Naive	55
Previously Treated	36
Total	91

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment-Naive	0	Not reported	Not reported	Not reported	Not reported
Previously Treated	1	Not reported	Not reported	Not reported	Not reported
Total	1	Not reported	Not reported	Not reported	Not reported

Hypermagnesemia - Grade 4

Analysis denominator · Participants

Group	Source count
Treatment-Naive	55
Previously Treated	36
Total	91

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment-Naive	0	Not reported	Not reported	Not reported	Not reported
Previously Treated	0	Not reported	Not reported	Not reported	Not reported
Total	0	Not reported	Not reported	Not reported	Not reported

Hypernatremia - Grade 3

Analysis denominator · Participants

Group	Source count
Treatment-Naive	56
Previously Treated	38
Total	94

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment-Naive	0	Not reported	Not reported	Not reported	Not reported
Previously Treated	0	Not reported	Not reported	Not reported	Not reported
Total	0	Not reported	Not reported	Not reported	Not reported

Hypernatremia - Grade 4

Analysis denominator · Participants

Group	Source count
Treatment-Naive	56
Previously Treated	38
Total	94

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment-Naive	0	Not reported	Not reported	Not reported	Not reported
Previously Treated	0	Not reported	Not reported	Not reported	Not reported
Total	0	Not reported	Not reported	Not reported	Not reported

Hypoalbuminemia - Grade 3

Analysis denominator · Participants

Group	Source count
Treatment-Naive	56
Previously Treated	38
Total	94

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment-Naive	0	Not reported	Not reported	Not reported	Not reported
Previously Treated	0	Not reported	Not reported	Not reported	Not reported
Total	0	Not reported	Not reported	Not reported	Not reported

Hypocalcemia - Grade 3

Analysis denominator · Participants

Group	Source count
Treatment-Naive	56
Previously Treated	38
Total	94

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment-Naive	0	Not reported	Not reported	Not reported	Not reported
Previously Treated	0	Not reported	Not reported	Not reported	Not reported
Total	0	Not reported	Not reported	Not reported	Not reported

Hypocalcemia - Grade 4

Analysis denominator · Participants

Group	Source count
Treatment-Naive	56
Previously Treated	38
Total	94

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment-Naive	2	Not reported	Not reported	Not reported	Not reported
Previously Treated	0	Not reported	Not reported	Not reported	Not reported
Total	2	Not reported	Not reported	Not reported	Not reported

Hypoglycemia - Grade 3

Analysis denominator · Participants

Group	Source count
Treatment-Naive	56
Previously Treated	38
Total	94

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment-Naive	0	Not reported	Not reported	Not reported	Not reported
Previously Treated	0	Not reported	Not reported	Not reported	Not reported
Total	0	Not reported	Not reported	Not reported	Not reported

Hypoglycemia - Grade 4

Analysis denominator · Participants

Group	Source count
Treatment-Naive	56
Previously Treated	38
Total	94

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment-Naive	0	Not reported	Not reported	Not reported	Not reported
Previously Treated	0	Not reported	Not reported	Not reported	Not reported
Total	0	Not reported	Not reported	Not reported	Not reported

Hypokalemia - Grade 3

Analysis denominator · Participants

Group	Source count
Treatment-Naive	56
Previously Treated	38
Total	94

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment-Naive	0	Not reported	Not reported	Not reported	Not reported
Previously Treated	1	Not reported	Not reported	Not reported	Not reported
Total	1	Not reported	Not reported	Not reported	Not reported

Hypokalemia - Grade 4

Analysis denominator · Participants

Group	Source count
Treatment-Naive	56
Previously Treated	38
Total	94

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment-Naive	0	Not reported	Not reported	Not reported	Not reported
Previously Treated	0	Not reported	Not reported	Not reported	Not reported
Total	0	Not reported	Not reported	Not reported	Not reported

Hypomagnesemia - Grade 3

Analysis denominator · Participants

Group	Source count
Treatment-Naive	55
Previously Treated	36
Total	91

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment-Naive	0	Not reported	Not reported	Not reported	Not reported
Previously Treated	0	Not reported	Not reported	Not reported	Not reported
Total	0	Not reported	Not reported	Not reported	Not reported

Hypomagnesemia - Grade 4

Analysis denominator · Participants

Group	Source count
Treatment-Naive	55
Previously Treated	36
Total	91

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment-Naive	0	Not reported	Not reported	Not reported	Not reported
Previously Treated	0	Not reported	Not reported	Not reported	Not reported
Total	0	Not reported	Not reported	Not reported	Not reported

Hyponatremia - Grade 3

Analysis denominator · Participants

Group	Source count
Treatment-Naive	56
Previously Treated	38
Total	94

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment-Naive	7	Not reported	Not reported	Not reported	Not reported
Previously Treated	2	Not reported	Not reported	Not reported	Not reported
Total	9	Not reported	Not reported	Not reported	Not reported

Hyponatremia - Grade 4

Analysis denominator · Participants

Group	Source count
Treatment-Naive	56
Previously Treated	38
Total	94

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment-Naive	0	Not reported	Not reported	Not reported	Not reported
Previously Treated	0	Not reported	Not reported	Not reported	Not reported
Total	0	Not reported	Not reported	Not reported	Not reported

Hypophosphatemia - Grade 3

Analysis denominator · Participants

Group	Source count
Treatment-Naive	55
Previously Treated	36
Total	91

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment-Naive	1	Not reported	Not reported	Not reported	Not reported
Previously Treated	0	Not reported	Not reported	Not reported	Not reported
Total	1	Not reported	Not reported	Not reported	Not reported

Hypophosphatemia - Grade 4

Analysis denominator · Participants

Group	Source count
Treatment-Naive	55
Previously Treated	36
Total	91

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment-Naive	0	Not reported	Not reported	Not reported	Not reported
Previously Treated	0	Not reported	Not reported	Not reported	Not reported
Total	0	Not reported	Not reported	Not reported	Not reported

Lipase increased - Grade 3

Analysis denominator · Participants

Group	Source count
Treatment-Naive	56
Previously Treated	36
Total	92

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment-Naive	8	Not reported	Not reported	Not reported	Not reported
Previously Treated	3	Not reported	Not reported	Not reported	Not reported
Total	11	Not reported	Not reported	Not reported	Not reported

Lipase increased - Grade 4

Analysis denominator · Participants

Group	Source count
Treatment-Naive	56
Previously Treated	36
Total	92

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment-Naive	2	Not reported	Not reported	Not reported	Not reported
Previously Treated	0	Not reported	Not reported	Not reported	Not reported
Total	2	Not reported	Not reported	Not reported	Not reported

Serum amylase increased - Grade 3

Analysis denominator · Participants

Group	Source count
Treatment-Naive	56
Previously Treated	36
Total	92

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment-Naive	1	Not reported	Not reported	Not reported	Not reported
Previously Treated	0	Not reported	Not reported	Not reported	Not reported
Total	1	Not reported	Not reported	Not reported	Not reported

Serum amylase increased - Grade 4

Analysis denominator · Participants

Group	Source count
Treatment-Naive	56
Previously Treated	36
Total	92

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment-Naive	0	Not reported	Not reported	Not reported	Not reported
Previously Treated	0	Not reported	Not reported	Not reported	Not reported
Total	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
6
group Id
OG001
value
2
group Id
OG002
value
8
denoms
counts
group Id
OG000
value
56
group Id
OG001
value
38
group Id
OG002
value
94
units
Participants
title
Alanine aminotransferase increased - Grade 3
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
56
group Id
OG001
value
38
group Id
OG002
value
94
units
Participants
title
Alanine aminotransferase increased - Grade 4
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
1
group Id
OG002
value
3
denoms
counts
group Id
OG000
value
56
group Id
OG001
value
38
group Id
OG002
value
94
units
Participants
title
Alkaline phosphatase increased - Grade 3
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
56
group Id
OG001
value
38
group Id
OG002
value
94
units
Participants
title
Alkaline phosphatase increased - Grade 4
categories
measurements
group Id
OG000
value
7
group Id
OG001
value
2
group Id
OG002
value
9
denoms
counts
group Id
OG000
value
56
group Id
OG001
value
38
group Id
OG002
value
94
units
Participants
title
Aspartate aminotransferase increased - Grade 3
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
56
group Id
OG001
value
38
group Id
OG002
value
94
units
Participants
title
Aspartate aminotransferase increased - Grade 4
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
56
group Id
OG001
value
38
group Id
OG002
value
94
units
Participants
title
Blood bilirubin increased - Grade 3
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
56
group Id
OG001
value
38
group Id
OG002
value
94
units
Participants
title
Blood bilirubin increased - Grade 4
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
1
group Id
OG002
value
3
denoms
counts
group Id
OG000
value
55
group Id
OG001
value
36
group Id
OG002
value
91
units
Participants
title
Creatine kinase increased - Grade 3
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
55
group Id
OG001
value
36
group Id
OG002
value
91
units
Participants
title
Creatine kinase increased - Grade 4
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
0
group Id
OG002
value
3
denoms
counts
group Id
OG000
value
57
group Id
OG001
value
38
group Id
OG002
value
95
units
Participants
title
Creatinine increased - Grade 3
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
57
group Id
OG001
value
38
group Id
OG002
value
95
units
Participants
title
Creatinine increased - Grade 4

denoms

counts
group Id
OG000
value
59
group Id
OG001
value
39
group Id
OG002
value
98
units
Participants

description

Blood and urine samples for the laboratory tests. A central laboratory will perform all clinical laboratory assessments. Baseline was the last available assessment performed prior to the study intervention start date/time. Grade 4 was not applicable for the parameters of hyperglycemia and hypoalbuminemia as Grade 4 was not defined for these 2 parameters per CTCAE version 4.03.

groups

description
Treatment-naïve participants with BRAF V600E-mutant metastatic NSCLC were enrolled to receive encorafenib 450 mg QD and binimetinib 45 mg BID in 28-day (±3 days) cycles and continued until the participants met the protocol-defined criteria for treatment withdrawal.
id
OG000
title
Treatment-Naive
description
Patients who had received 1) first-line treatment with standard platinum-based chemotherapy, or 2) first-line treatment with an anti-PD-1/PD-L1 inhibitor given alone, or in combination with platinum-based chemotherapy, or in combination with immunotherapy (eg, ipilimumab) with or without platinum-based chemotherapy were enrolled to receive encorafenib 450 mg QD and binimetinib 45 mg BID was to be administered in 28-day (±3 days) cycles and continued until the participants met the protocol-defined criteria for treatment withdrawal.
id
OG001
title
Previously Treated
description
Sum of all participants in the Study C4221008 (ARRAY-818-202)
id
OG002
title
Total

param Type

COUNT_OF_PARTICIPANTS

population Description

Safety Analysis Set included all participants who received at least 1 dose of study intervention. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.

reporting Status

POSTED

time Frame

Screening, Cycle 1 Day 1, Cycle 2 Day 1 ±3 Days, Day 1 ±3 Days in Subsequent Cycles, EOT ±3 Days and Safety Follow-up Visit (30 Days [±7 Days] After the EOT Visit) (Up to 36 Months)

title

Number of Participants With Shifts From Grade ≤2 at Baseline to Grade 3 or 4 at Post-baseline in Chemistry Laboratory Test Values Based on CTCAE Grade

type

SECONDARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice