NCT04607421 · OUTCOME
Phase 3: Number of Participants According to Response to Patient Global Impression of Severity (PGIS) Assessment at Baseline and at Week 30
A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer · Source last updated 2026-06-11
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
- Baseline and Week 30
What was measured
PGIS is a single-item scale where participants rated the severity of colorectal cancer as follows: none, mild, moderate, severe and very severe.
Analysis population: The FAS for Phase 3 included all participants who were randomized in the Phase 3 portion of the study, respectively. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.
Groups in this outcome
Phase 3: Arm A [EC]
Participants received encorafenib 300 mg QD orally and cetuximab 500 mg/m\^2 IV infusion for 120 minutes Q2W. Participants received treatment in 28-day cycles.
Phase 3: Arm B [EC + mFOLFOX6]
Participants received encorafenib 300 mg QD orally and cetuximab 500 mg/m\^2 IV infusion for 120 minutes Q2W along with fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W. Participants received treatment in 28-day cycles.
Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm]
Participants received standard of care (SOC) chemotherapy per Investigator's choice: mFOLFOX6 with or without bevacizumab or FOLFOXIRI with or without bevacizumab or CAPOX with or without bevacizumab. Bevacizumab was optional and it was given per prescribing instructions of treating physician. mFOLFOX6 (28-day Cycle): fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W; FOLFOXIRI (28-day Cycle): fluorouracil 2400 or 3200 mg/m\^2 continuous IV infusion over 46-48 hours Q2W (per local standard of care); leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W and irinotecan 165 mg/m\^2 as IV infusion for 90 minutes Q2W; CAPOX (21-day Cycle): capecitabine 1000 mg/m\^2 oral tablet twice daily on Days 1-14 and oxaliplatin 130 mg/m\^2 IV infusion for 120 minutes Q3W.
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 |
|---|
| Phase 3: Arm A [EC] | 134 |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 201 |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 182 |
|---|
Reported measurements
Baseline
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 3: Arm A [EC] | 134 |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 201 |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 182 |
|---|
None
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 27 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 50 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 48 | Not reported | Not reported | Not reported | Not reported |
|---|
Mild
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 44 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 67 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 64 | Not reported | Not reported | Not reported | Not reported |
|---|
Moderate
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 37 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 56 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 47 | Not reported | Not reported | Not reported | Not reported |
|---|
Severe
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 26 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 28 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 23 | Not reported | Not reported | Not reported | Not reported |
|---|
Very Severe
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 30
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 3: Arm A [EC] | 68 |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 140 |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 89 |
|---|
None
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 27 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 48 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 34 | Not reported | Not reported | Not reported | Not reported |
|---|
Mild
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 25 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 53 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 35 | Not reported | Not reported | Not reported | Not reported |
|---|
Moderate
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 30 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 14 | Not reported | Not reported | Not reported | Not reported |
|---|
Severe
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
Very Severe
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 27
- group Id
- OG001
- value
- 50
- group Id
- OG002
- value
- 48
- title
- None
- measurements
- group Id
- OG000
- value
- 44
- group Id
- OG001
- value
- 67
- group Id
- OG002
- value
- 64
- title
- Mild
- measurements
- group Id
- OG000
- value
- 37
- group Id
- OG001
- value
- 56
- group Id
- OG002
- value
- 47
- title
- Moderate
- measurements
- group Id
- OG000
- value
- 26
- group Id
- OG001
- value
- 28
- group Id
- OG002
- value
- 23
- title
- Severe
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Very Severe
- denoms
- counts
- group Id
- OG000
- value
- 134
- group Id
- OG001
- value
- 201
- group Id
- OG002
- value
- 182
- units
- Participants
- title
- Baseline
- categories
- measurements
- group Id
- OG000
- value
- 27
- group Id
- OG001
- value
- 48
- group Id
- OG002
- value
- 34
- title
- None
- measurements
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 53
- group Id
- OG002
- value
- 35
- title
- Mild
- measurements
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 30
- group Id
- OG002
- value
- 14
- title
- Moderate
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 6
- title
- Severe
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Very Severe
- denoms
- counts
- group Id
- OG000
- value
- 68
- group Id
- OG001
- value
- 140
- group Id
- OG002
- value
- 89
- units
- Participants
- title
- Week 30
- denoms
- counts
- group Id
- OG000
- value
- 134
- group Id
- OG001
- value
- 201
- group Id
- OG002
- value
- 182
- units
- Participants
- description
- PGIS is a single-item scale where participants rated the severity of colorectal cancer as follows: none, mild, moderate, severe and very severe.
- groups
- description
- Participants received encorafenib 300 mg QD orally and cetuximab 500 mg/m\^2 IV infusion for 120 minutes Q2W. Participants received treatment in 28-day cycles.
- id
- OG000
- title
- Phase 3: Arm A [EC]
- description
- Participants received encorafenib 300 mg QD orally and cetuximab 500 mg/m\^2 IV infusion for 120 minutes Q2W along with fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W. Participants received treatment in 28-day cycles.
- id
- OG001
- title
- Phase 3: Arm B [EC + mFOLFOX6]
- description
- Participants received standard of care (SOC) chemotherapy per Investigator's choice: mFOLFOX6 with or without bevacizumab or FOLFOXIRI with or without bevacizumab or CAPOX with or without bevacizumab. Bevacizumab was optional and it was given per prescribing instructions of treating physician. mFOLFOX6 (28-day Cycle): fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W; FOLFOXIRI (28-day Cycle): fluorouracil 2400 or 3200 mg/m\^2 continuous IV infusion over 46-48 hours Q2W (per local standard of care); leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W and irinotecan 165 mg/m\^2 as IV infusion for 90 minutes Q2W; CAPOX (21-day Cycle): capecitabine 1000 mg/m\^2 oral tablet twice daily on Days 1-14 and oxaliplatin 130 mg/m\^2 IV infusion for 120 minutes Q3W.
- id
- OG002
- title
- Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm]
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The FAS for Phase 3 included all participants who were randomized in the Phase 3 portion of the study, respectively. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.
- reporting Status
- POSTED
- time Frame
- Baseline and Week 30
- title
- Phase 3: Number of Participants According to Response to Patient Global Impression of Severity (PGIS) Assessment at Baseline and at Week 30
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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