TriangleNCT01072175 · OUTCOME
Part D: Number of Participants With the Indicated Worst-case Change From Baseline in Heart Rate and Blood Pressure
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From Baseline (Day 1) until Follow-up visit (up to approximately 7 years)
What was measured
Blood pressure were summarized according to National Cancer Institutes (NCI) 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 G3 or G4 occurred.lood pressure measurement included systolic blood pressure (BP, milimeter of mercury \[mmHg\]) and diastolic BP (DBP). Worst case change from Baseline was calculated as the post-Baseline value minus the Baseline value. Heart Rate is the measure of heartbeats per minute (bpm). Changes in heart rate, either decrease to \<60 bpm, change to normal or no change, or increase to \>100 bpm are presented
Analysis population: ATP Population
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 | 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 | 40 |
| Part D: Dabrafenib 150 mg + Trametinib 2 mg | 39 |
Reported measurements
Heart rate, Decrease to <60 bpm
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg | 2 | 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 | 12 | Not reported | Not reported | Not reported | Not reported |
| Part D: Dabrafenib 150 mg + Trametinib 2 mg | 14 | Not reported | Not reported | Not reported | Not reported |
Heart rate, Change to normal or no change
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg | 9 | Not reported | Not reported | Not reported | Not reported |
| Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg | 8 | Not reported | Not reported | Not reported | Not reported |
| Part D: Dabrafenib 75 mg + Trametinib 2 mg | 18 | Not reported | Not reported | Not reported | Not reported |
| Part D: Dabrafenib 150 mg + Trametinib 2 mg | 17 | Not reported | Not reported | Not reported | Not reported |
Heart rate, Increase to >100 bpm
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg | 5 | Not reported | Not reported | Not reported | Not reported |
| Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg | 5 | Not reported | Not reported | Not reported | Not reported |
| Part D: Dabrafenib 75 mg + Trametinib 2 mg | 12 | Not reported | Not reported | Not reported | Not reported |
| Part D: Dabrafenib 150 mg + Trametinib 2 mg | 12 | Not reported | Not reported | Not reported | Not reported |
Systolic BP (mmHg) , increase to G3 or G4
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg | 3 | 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 | 5 | Not reported | Not reported | Not reported | Not reported |
| Part D: Dabrafenib 150 mg + Trametinib 2 mg | 6 | Not reported | Not reported | Not reported | Not reported |
Diastolic BP (mmHg), increase to G3 or G4
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg | 4 | 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 | 2 | 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 |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 14
- title
- Heart rate, Decrease to <60 bpm
- categories
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 18
- group Id
- OG003
- value
- 17
- title
- Heart rate, Change to normal or no change
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 12
- title
- Heart rate, Increase to >100 bpm
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 6
- title
- Systolic BP (mmHg) , increase to G3 or G4
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 3
- title
- Diastolic BP (mmHg), increase to G3 or G4
- denoms
- counts
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 15
- group Id
- OG002
- value
- 40
- group Id
- OG003
- value
- 39
- units
- Participants
- description
- Blood pressure were summarized according to National Cancer Institutes (NCI) 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 G3 or G4 occurred.lood pressure measurement included systolic blood pressure (BP, milimeter of mercury \[mmHg\]) and diastolic BP (DBP). Worst case change from Baseline was calculated as the post-Baseline value minus the Baseline value. Heart Rate is the measure of heartbeats per minute (bpm). Changes in heart rate, either decrease to \<60 bpm, change to normal or no change, or increase to \>100 bpm are presented
- 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
- NUMBER
- population Description
- ATP Population
- 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 the Indicated Worst-case Change From Baseline in Heart Rate and Blood Pressure
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice