TriangleNCT01266967 · OUTCOME
Number of Participants With a Worst-case On-therapy Increase From Baseline in Bazett's QTc Reading in the 12-lead Electrocardiogram (ECG)
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
- Baseline; Weeks 4, 12, 20, 28, 40, 52, and 64
What was measured
An increase in the QTc interval corrected using Bazett's formula (Bazett's QTc) was recorded for all treated participants. Grade 1 (450-480 milliseconds \[msec\]), Grade 2 (481-500 msec), Grade 3/4 (\>=501 msec). An increase is defined as an increase in CTCAE grade relative to Baseline grade.
Analysis population: ATS Population. Only those participants with data available at the indicated time points were analyzed.
Groups in this outcome
GSK2118436 150 mg: No Prior Local Therapy
Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
GSK2118436 150 mg: Prior Local Therapy
Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
| Group | Source count |
|---|---|
| GSK2118436 150 mg: No Prior Local Therapy | 75 |
| GSK2118436 150 mg: Prior Local Therapy | 74 |
Reported measurements
Increase from Baseline to any grade
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| GSK2118436 150 mg: No Prior Local Therapy | 11 | Not reported | Not reported | Not reported | Not reported |
| GSK2118436 150 mg: Prior Local Therapy | 17 | Not reported | Not reported | Not reported | Not reported |
Increase from Baseline to Grade 2
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| GSK2118436 150 mg: No Prior Local Therapy | 1 | Not reported | Not reported | Not reported | Not reported |
| GSK2118436 150 mg: Prior Local Therapy | 2 | Not reported | Not reported | Not reported | Not reported |
Increase from Baseline to Grade 3/4
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| GSK2118436 150 mg: No Prior Local Therapy | 0 | Not reported | Not reported | Not reported | Not reported |
| GSK2118436 150 mg: Prior Local Therapy | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 17
- title
- Increase from Baseline to any grade
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- title
- Increase from Baseline to Grade 2
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Increase from Baseline to Grade 3/4
- denoms
- counts
- group Id
- OG000
- value
- 75
- group Id
- OG001
- value
- 74
- units
- Participants
- description
- An increase in the QTc interval corrected using Bazett's formula (Bazett's QTc) was recorded for all treated participants. Grade 1 (450-480 milliseconds \[msec\]), Grade 2 (481-500 msec), Grade 3/4 (\>=501 msec). An increase is defined as an increase in CTCAE grade relative to Baseline grade.
- groups
- description
- Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
- id
- OG000
- title
- GSK2118436 150 mg: No Prior Local Therapy
- description
- Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
- id
- OG001
- title
- GSK2118436 150 mg: Prior Local Therapy
- param Type
- NUMBER
- population Description
- ATS Population. Only those participants with data available at the indicated time points were analyzed.
- reporting Status
- POSTED
- time Frame
- Baseline; Weeks 4, 12, 20, 28, 40, 52, and 64
- title
- Number of Participants With a Worst-case On-therapy Increase From Baseline in Bazett's QTc Reading in the 12-lead Electrocardiogram (ECG)
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice