NCT01072175 · OUTCOME
Part C (Randomized): 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) CTCAE grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe; Grade 4, Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase 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 C: Dabrafenib 150 mg
Participants received dabrafenib 150 mg gelatin capsules BID.
Part C: Dabrafenib 150 mg + Trametinib 1 mg
Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
Part C: Dabrafenib 150 mg + Trametinib 2 mg
Participants received dabrafenib 150 mg gelatin 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 C: Dabrafenib 150 mg | 53 |
|---|
| Part C: Dabrafenib 150 mg + Trametinib 1 mg | 54 |
|---|
| Part C: Dabrafenib 150 mg + Trametinib 2 mg | 55 |
|---|
Reported measurements
Hemoglobin (Increased)
Analysis denominator · Participants
| Group | Source count |
|---|
| Part C: Dabrafenib 150 mg | 0 |
|---|
| Part C: Dabrafenib 150 mg + Trametinib 1 mg | 0 |
|---|
| Part C: 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 C: Dabrafenib 150 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part C: Dabrafenib 150 mg + Trametinib 1 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part C: 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 C: Dabrafenib 150 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part C: Dabrafenib 150 mg + Trametinib 1 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part C: Dabrafenib 150 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Hemoglobin (Anemia)
Analysis denominator · Participants
| Group | Source count |
|---|
| Part C: Dabrafenib 150 mg | 0 |
|---|
| Part C: Dabrafenib 150 mg + Trametinib 1 mg | 4 |
|---|
| Part C: Dabrafenib 150 mg + Trametinib 2 mg | 2 |
|---|
Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part C: Dabrafenib 150 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part C: Dabrafenib 150 mg + Trametinib 1 mg | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part C: Dabrafenib 150 mg + Trametinib 2 mg | 2 | 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 C: Dabrafenib 150 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part C: Dabrafenib 150 mg + Trametinib 1 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part C: Dabrafenib 150 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Lymphocytes (Increased)
Analysis denominator · Participants
| Group | Source count |
|---|
| Part C: Dabrafenib 150 mg | 0 |
|---|
| Part C: Dabrafenib 150 mg + Trametinib 1 mg | 0 |
|---|
| Part C: 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 C: Dabrafenib 150 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part C: Dabrafenib 150 mg + Trametinib 1 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part C: 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 C: Dabrafenib 150 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part C: Dabrafenib 150 mg + Trametinib 1 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part C: Dabrafenib 150 mg + Trametinib 2 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Lymphocytes (Decreased)
Analysis denominator · Participants
| Group | Source count |
|---|
| Part C: Dabrafenib 150 mg | 3 |
|---|
| Part C: Dabrafenib 150 mg + Trametinib 1 mg | 11 |
|---|
| Part C: Dabrafenib 150 mg + Trametinib 2 mg | 15 |
|---|
Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part C: Dabrafenib 150 mg | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part C: Dabrafenib 150 mg + Trametinib 1 mg | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part C: Dabrafenib 150 mg + Trametinib 2 mg | 12 | 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 C: Dabrafenib 150 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part C: Dabrafenib 150 mg + Trametinib 1 mg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part C: Dabrafenib 150 mg + Trametinib 2 mg | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Total Neutrophils
Analysis denominator · Participants
| Group | Source count |
|---|
| Part C: Dabrafenib 150 mg | 1 |
|---|
| Part C: Dabrafenib 150 mg + Trametinib 1 mg | 2 |
|---|
| Part C: Dabrafenib 150 mg + Trametinib 2 mg | 8 |
|---|
Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part C: Dabrafenib 150 mg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part C: Dabrafenib 150 mg + Trametinib 1 mg | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part C: 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 C: Dabrafenib 150 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part C: Dabrafenib 150 mg + Trametinib 1 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part C: Dabrafenib 150 mg + Trametinib 2 mg | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
Platelet Count
Analysis denominator · Participants
| Group | Source count |
|---|
| Part C: Dabrafenib 150 mg | 0 |
|---|
| Part C: Dabrafenib 150 mg + Trametinib 1 mg | 2 |
|---|
| Part C: 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 C: Dabrafenib 150 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part C: Dabrafenib 150 mg + Trametinib 1 mg | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part C: 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 C: Dabrafenib 150 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part C: Dabrafenib 150 mg + Trametinib 1 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part C: Dabrafenib 150 mg + Trametinib 2 mg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
White Blood Cell count
Analysis denominator · Participants
| Group | Source count |
|---|
| Part C: Dabrafenib 150 mg | 0 |
|---|
| Part C: Dabrafenib 150 mg + Trametinib 1 mg | 3 |
|---|
| Part C: Dabrafenib 150 mg + Trametinib 2 mg | 5 |
|---|
Increase to Grade 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part C: Dabrafenib 150 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part C: Dabrafenib 150 mg + Trametinib 1 mg | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part C: Dabrafenib 150 mg + Trametinib 2 mg | 5 | 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 C: Dabrafenib 150 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part C: Dabrafenib 150 mg + Trametinib 1 mg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part C: 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
- title
- Increase to Grade 3
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Increase to Grade 4
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- units
- Participants
- title
- Hemoglobin (Increased)
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 2
- title
- Increase to Grade 3
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Increase to Grade 4
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 2
- units
- Participants
- title
- Hemoglobin (Anemia)
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Increase to Grade 3
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Increase to Grade 4
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- units
- Participants
- title
- Lymphocytes (Increased)
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 12
- title
- Increase to Grade 3
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 3
- title
- Increase to Grade 4
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 11
- group Id
- OG002
- value
- 15
- units
- Participants
- title
- Lymphocytes (Decreased)
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 4
- title
- Increase to Grade 3
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 4
- title
- Increase to Grade 4
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 8
- units
- Participants
- title
- Total Neutrophils
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 3
- title
- Increase to Grade 3
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- title
- Increase to Grade 4
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 4
- units
- Participants
- title
- Platelet Count
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 5
- title
- Increase to Grade 3
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Increase to Grade 4
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 5
- units
- Participants
- title
- White Blood Cell count
- denoms
- counts
- group Id
- OG000
- value
- 53
- group Id
- OG001
- value
- 54
- group Id
- OG002
- value
- 55
- units
- Participants
- description
- Hematology parameters were summarized according to National Cancer Institutes (NCI) CTCAE grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe; Grade 4, Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase 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 dabrafenib 150 mg gelatin capsules BID.
- id
- OG000
- title
- Part C: Dabrafenib 150 mg
- description
- Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
- id
- OG001
- title
- Part C: Dabrafenib 150 mg + Trametinib 1 mg
- description
- Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
- id
- OG002
- title
- Part C: 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 C (Randomized): 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
Triangle