TriangleNCT01943851 · OUTCOME
Part 2: Number of Participants With Worst Case Vital Signs Results Relative to Baseline: Pulse Rate and Body Temperature
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
- Up to 36.4 weeks
What was measured
Vital signs (pulse rate and temperature) were measured after resting for at least 5 minutes in a supine or semi-recumbent position. The clinical concern ranges were: For pulse rate (low \<60 beats per minute \[bpm\] and high \>100 bpm); For body temperature (\<=35 degrees Celsius or \>=38 degrees Celsius). Participants were counted in the worst case category that their value changed to (low, normal or high), unless there was no change in their category. Participants whose value category was unchanged, or whose value became normal, were recorded in the "To Normal or No Change" category. Participants were counted twice if the participant had values that changed "To Low" and "To High", so the percentages may not add to 100%. Baseline was the most recent, non-missing value prior to or on the first study treatment dose date.
Analysis population: All Treated Population.
Groups in this outcome
Part 2: GSK525762 60 mg QD CTCL
Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.
Part 2: GSK525762 75 mg QD MDS
Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762
Part 2: GSK525762 80 mg QD CTCL
Participants CTCL were administered once daily oral dose of 80 mg GSK525762
| Group | Source count |
|---|---|
| Part 2: GSK525762 60 mg QD CTCL | 7 |
| Part 2: GSK525762 75 mg QD MDS | 16 |
| Part 2: GSK525762 80 mg QD CTCL | 1 |
Reported measurements
Pulse rate, To Low
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2: GSK525762 60 mg QD CTCL | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 2: GSK525762 75 mg QD MDS | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2: GSK525762 80 mg QD CTCL | 0 | Not reported | Not reported | Not reported | Not reported |
Pulse rate, To Normal or No change
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2: GSK525762 60 mg QD CTCL | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 2: GSK525762 75 mg QD MDS | 9 | Not reported | Not reported | Not reported | Not reported |
| Part 2: GSK525762 80 mg QD CTCL | 0 | Not reported | Not reported | Not reported | Not reported |
Pulse Rate, To High
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2: GSK525762 60 mg QD CTCL | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 2: GSK525762 75 mg QD MDS | 7 | Not reported | Not reported | Not reported | Not reported |
| Part 2: GSK525762 80 mg QD CTCL | 1 | Not reported | Not reported | Not reported | Not reported |
Temperature, To Low
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2: GSK525762 60 mg QD CTCL | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 2: GSK525762 75 mg QD MDS | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2: GSK525762 80 mg QD CTCL | 0 | Not reported | Not reported | Not reported | Not reported |
Temperature, To Normal or No Change
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2: GSK525762 60 mg QD CTCL | 5 | Not reported | Not reported | Not reported | Not reported |
| Part 2: GSK525762 75 mg QD MDS | 13 | Not reported | Not reported | Not reported | Not reported |
| Part 2: GSK525762 80 mg QD CTCL | 1 | Not reported | Not reported | Not reported | Not reported |
Temperature, To High
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2: GSK525762 60 mg QD CTCL | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 2: GSK525762 75 mg QD MDS | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 2: GSK525762 80 mg QD CTCL | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Pulse rate, To Low
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 0
- title
- Pulse rate, To Normal or No change
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 1
- title
- Pulse Rate, To High
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Temperature, To Low
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 13
- group Id
- OG002
- value
- 1
- title
- Temperature, To Normal or No Change
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 0
- title
- Temperature, To High
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 16
- group Id
- OG002
- value
- 1
- units
- Participants
- description
- Vital signs (pulse rate and temperature) were measured after resting for at least 5 minutes in a supine or semi-recumbent position. The clinical concern ranges were: For pulse rate (low \<60 beats per minute \[bpm\] and high \>100 bpm); For body temperature (\<=35 degrees Celsius or \>=38 degrees Celsius). Participants were counted in the worst case category that their value changed to (low, normal or high), unless there was no change in their category. Participants whose value category was unchanged, or whose value became normal, were recorded in the "To Normal or No Change" category. Participants were counted twice if the participant had values that changed "To Low" and "To High", so the percentages may not add to 100%. Baseline was the most recent, non-missing value prior to or on the first study treatment dose date.
- groups
- description
- Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.
- id
- OG000
- title
- Part 2: GSK525762 60 mg QD CTCL
- description
- Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762
- id
- OG001
- title
- Part 2: GSK525762 75 mg QD MDS
- description
- Participants CTCL were administered once daily oral dose of 80 mg GSK525762
- id
- OG002
- title
- Part 2: GSK525762 80 mg QD CTCL
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All Treated Population.
- reporting Status
- POSTED
- time Frame
- Up to 36.4 weeks
- title
- Part 2: Number of Participants With Worst Case Vital Signs Results Relative to Baseline: Pulse Rate and Body Temperature
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice