NCT03915951 · OUTCOME
Number of Participants With Shifts From Grade ≤2 at Baseline to Grade 3 or 4 at Post-baseline in Hematology 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, End of Treatment (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 anemia, hemoglobin increased, leukocytosis and lymphocyte count increased as Grade 4 was not defined for these 4 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
Anemia - Grade 3
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment-Naive | 55 |
|---|
| Previously Treated | 38 |
|---|
| Total | 93 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment-Naive | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Previously Treated | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Total | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
Hemoglobin increased - Grade 3
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment-Naive | 55 |
|---|
| Previously Treated | 38 |
|---|
| Total | 93 |
|---|
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 |
|---|
Leukocytosis - Grade 3
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment-Naive | 55 |
|---|
| Previously Treated | 38 |
|---|
| Total | 93 |
|---|
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 |
|---|
Lymphocyte count decreased - Grade 3
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment-Naive | 54 |
|---|
| Previously Treated | 37 |
|---|
| 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 | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Total | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
Lymphocyte count decreased - Grade 4
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment-Naive | 54 |
|---|
| Previously Treated | 37 |
|---|
| 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 |
|---|
Lymphocyte count increased - Grade 3
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment-Naive | 54 |
|---|
| Previously Treated | 37 |
|---|
| 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 |
|---|
Neutrophil count decreased - Grade 3
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment-Naive | 54 |
|---|
| Previously Treated | 37 |
|---|
| 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 |
|---|
Neutrophil count decreased - Grade 4
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment-Naive | 54 |
|---|
| Previously Treated | 37 |
|---|
| 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 |
|---|
Platelet count decreased - Grade 3
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment-Naive | 55 |
|---|
| Previously Treated | 38 |
|---|
| Total | 93 |
|---|
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 |
|---|
Platelet count decreased - Grade 4
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment-Naive | 55 |
|---|
| Previously Treated | 38 |
|---|
| Total | 93 |
|---|
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 |
|---|
White blood cell decreased - Grade 3
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment-Naive | 55 |
|---|
| Previously Treated | 38 |
|---|
| Total | 93 |
|---|
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 |
|---|
White blood cell decreased - Grade 4
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment-Naive | 55 |
|---|
| Previously Treated | 38 |
|---|
| Total | 93 |
|---|
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
- 9
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 10
- denoms
- counts
- group Id
- OG000
- value
- 55
- group Id
- OG001
- value
- 38
- group Id
- OG002
- value
- 93
- units
- Participants
- title
- Anemia - 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
- 38
- group Id
- OG002
- value
- 93
- units
- Participants
- title
- Hemoglobin 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
- 38
- group Id
- OG002
- value
- 93
- units
- Participants
- title
- Leukocytosis - Grade 3
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 5
- denoms
- counts
- group Id
- OG000
- value
- 54
- group Id
- OG001
- value
- 37
- group Id
- OG002
- value
- 91
- units
- Participants
- title
- Lymphocyte count decreased - 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
- 54
- group Id
- OG001
- value
- 37
- group Id
- OG002
- value
- 91
- units
- Participants
- title
- Lymphocyte count decreased - 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
- 54
- group Id
- OG001
- value
- 37
- group Id
- OG002
- value
- 91
- units
- Participants
- title
- Lymphocyte count increased - Grade 3
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 54
- group Id
- OG001
- value
- 37
- group Id
- OG002
- value
- 91
- units
- Participants
- title
- Neutrophil count decreased - 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
- 54
- group Id
- OG001
- value
- 37
- group Id
- OG002
- value
- 91
- units
- Participants
- title
- Neutrophil count decreased - Grade 4
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 55
- group Id
- OG001
- value
- 38
- group Id
- OG002
- value
- 93
- units
- Participants
- title
- Platelet count decreased - 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
- 38
- group Id
- OG002
- value
- 93
- units
- Participants
- title
- Platelet count decreased - 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
- 55
- group Id
- OG001
- value
- 38
- group Id
- OG002
- value
- 93
- units
- Participants
- title
- White blood cell decreased - 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
- 38
- group Id
- OG002
- value
- 93
- units
- Participants
- title
- White blood cell decreased - 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 anemia, hemoglobin increased, leukocytosis and lymphocyte count increased as Grade 4 was not defined for these 4 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, End of Treatment (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 Hematology Laboratory Test Values Based on CTCAE Grade
- type
- SECONDARY
- unit Of Measure
- Participants
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