NCT01072175 · OUTCOME
Part D: Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline
Investigate Safety, Pharmacokinetics and Pharmacodynamics of GSK2118436 & GSK1120212 · Source last updated 2019-07-05
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
- From Baseline (Day 1) until Follow-up visit (up to approximately 7 years)
What was measured
Hematology parameters were summarized according to National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. Participants with missing Baseline Grade were assumed to have Baseline Grade of 0. All increases were an increase in grade from Baseline. Only descriptive analysis.
Analysis population: All Treated Participants (ATP) Population. Only participants with lab values at the specified planned time were considered.
Groups in this outcome
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
Part D: Dabrafenib 75 mg + Trametinib 2 mg
Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
Part D: Dabrafenib 150 mg + Trametinib 2 mg
Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
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 |
|---|
| Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg | 15 |
|---|
| Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg | 15 |
|---|
| Part D: Dabrafenib 75 mg + Trametinib 2 mg | 41 |
|---|
| Part D: Dabrafenib 150 mg + Trametinib 2 mg | 39 |
|---|
Reported measurements
Hemoglobin (Increased)
Analysis denominator · Participants
| Group | Source count |
|---|
| Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg | 0 |
|---|
| Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg | 0 |
|---|
| Part D: Dabrafenib 75 mg + Trametinib 2 mg | 0 |
|---|
| Part D: Dabrafenib 150 mg + Trametinib 2 mg | 0 |
|---|
Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part D: Dabrafenib 75 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part D: Dabrafenib 150 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part D: Dabrafenib 75 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part D: Dabrafenib 150 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Hemoglobin (Anemia)
Analysis denominator · Participants
| Group | Source count |
|---|
| Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg | 1 |
|---|
| Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg | 1 |
|---|
| Part D: Dabrafenib 75 mg + Trametinib 2 mg | 3 |
|---|
| Part D: Dabrafenib 150 mg + Trametinib 2 mg | 1 |
|---|
Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part D: Dabrafenib 75 mg + Trametinib 2 mg | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part D: Dabrafenib 150 mg + Trametinib 2 mg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part D: Dabrafenib 75 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part D: Dabrafenib 150 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Lymphocytes (Increased)
Analysis denominator · Participants
| Group | Source count |
|---|
| Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg | 0 |
|---|
| Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg | 0 |
|---|
| Part D: Dabrafenib 75 mg + Trametinib 2 mg | 0 |
|---|
| Part D: Dabrafenib 150 mg + Trametinib 2 mg | 0 |
|---|
Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part D: Dabrafenib 75 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part D: Dabrafenib 150 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part D: Dabrafenib 75 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part D: Dabrafenib 150 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Lymphocytes (Decreased)
Analysis denominator · Participants
| Group | Source count |
|---|
| Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg | 1 |
|---|
| Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg | 4 |
|---|
| Part D: Dabrafenib 75 mg + Trametinib 2 mg | 12 |
|---|
| Part D: Dabrafenib 150 mg + Trametinib 2 mg | 12 |
|---|
Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part D: Dabrafenib 75 mg + Trametinib 2 mg | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part D: Dabrafenib 150 mg + Trametinib 2 mg | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part D: Dabrafenib 75 mg + Trametinib 2 mg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part D: Dabrafenib 150 mg + Trametinib 2 mg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Total Neutrophils
Analysis denominator · Participants
| Group | Source count |
|---|
| Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg | 0 |
|---|
| Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg | 1 |
|---|
| Part D: Dabrafenib 75 mg + Trametinib 2 mg | 3 |
|---|
| Part D: Dabrafenib 150 mg + Trametinib 2 mg | 4 |
|---|
Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part D: Dabrafenib 75 mg + Trametinib 2 mg | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part D: Dabrafenib 150 mg + Trametinib 2 mg | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part D: Dabrafenib 75 mg + Trametinib 2 mg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part D: Dabrafenib 150 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Platelet count
Analysis denominator · Participants
| Group | Source count |
|---|
| Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg | 1 |
|---|
| Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg | 0 |
|---|
| Part D: Dabrafenib 75 mg + Trametinib 2 mg | 1 |
|---|
| Part D: Dabrafenib 150 mg + Trametinib 2 mg | 0 |
|---|
Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part D: Dabrafenib 75 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part D: Dabrafenib 150 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part D: Dabrafenib 75 mg + Trametinib 2 mg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part D: Dabrafenib 150 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
White Blood Cell count
Analysis denominator · Participants
| Group | Source count |
|---|
| Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg | 0 |
|---|
| Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg | 0 |
|---|
| Part D: Dabrafenib 75 mg + Trametinib 2 mg | 2 |
|---|
| Part D: Dabrafenib 150 mg + Trametinib 2 mg | 3 |
|---|
Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part D: Dabrafenib 75 mg + Trametinib 2 mg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part D: Dabrafenib 150 mg + Trametinib 2 mg | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Increase to Grade 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part D: Dabrafenib 75 mg + Trametinib 2 mg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part D: Dabrafenib 150 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Increase to Grade 3
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Increase to Grade 4
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- units
- Participants
- title
- Hemoglobin (Increased)
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 1
- title
- Increase to Grade 3
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Increase to Grade 4
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 1
- units
- Participants
- title
- Hemoglobin (Anemia)
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Increase to Grade 3
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Increase to Grade 4
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- units
- Participants
- title
- Lymphocytes (Increased)
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 11
- group Id
- OG003
- value
- 11
- title
- Increase to Grade 3
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- title
- Increase to Grade 4
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 12
- units
- Participants
- title
- Lymphocytes (Decreased)
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 4
- title
- Increase to Grade 3
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- title
- Increase to Grade 4
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 4
- units
- Participants
- title
- Total Neutrophils
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Increase to Grade 3
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- title
- Increase to Grade 4
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- units
- Participants
- title
- Platelet count
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 3
- title
- Increase to Grade 3
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- title
- Increase to Grade 4
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 3
- units
- Participants
- title
- White Blood Cell count
- denoms
- counts
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 15
- group Id
- OG002
- value
- 41
- group Id
- OG003
- value
- 39
- units
- Participants
- description
- Hematology parameters were summarized according to National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. Participants with missing Baseline Grade were assumed to have Baseline Grade of 0. All increases were an increase in grade from Baseline. Only descriptive analysis.
- groups
- description
- Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
- id
- OG000
- title
- Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
- description
- Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
- id
- OG001
- title
- Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
- description
- Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
- id
- OG002
- title
- Part D: Dabrafenib 75 mg + Trametinib 2 mg
- description
- Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
- id
- OG003
- title
- Part D: Dabrafenib 150 mg + Trametinib 2 mg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All Treated Participants (ATP) Population. Only participants with lab values at the specified planned time were considered.
- reporting Status
- POSTED
- time Frame
- From Baseline (Day 1) until Follow-up visit (up to approximately 7 years)
- title
- Part D: Number of Participants With Worst-case Hematology Toxicity Grade Change From Baseline
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice
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