NCT01587703 · OUTCOME
Number of Participants With Increase in Blood Pressure From Baseline-Part 1 BID
A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GSK525762 in Subjects With NUT Midline Carcinoma (NMC) and Other Cancers · Source last updated 2020-03-16
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
- Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposure
What was measured
SBP and DBP were measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. Grading of SBP and DBP were done using NCI-CTCAE version 4.0 where, SBP (millimeters of mercury): Grade 0 (\<120), Grade 1 (120-139), Grade 2 (140-159), Grade 3/4 (\>=160) and DBP: Grade 0 (\<80), Grade 1 (80-89), Grade 2 (90-99), Grade 3/4 (\>=100). An increase is defined as an increase in CTCAE grade relative to baseline grade. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented
Analysis population: All Treated Population. Only those participants with data available at Baseline and the specified time point were analyzed (indicated by n=X in category titles).
Groups in this outcome
Part 1: GSK525762 20 mg BID
Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
Part 1: GSK525762 30 mg BID
Participants were administered twice daily oral dose of 30 mg GSK525762.
Part 1: GSK525762 40 mg BID
Participants were administered twice daily oral dose of 40 mg GSK525762.
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 1: GSK525762 20 mg BID | 4 |
|---|
| Part 1: GSK525762 30 mg BID | 10 |
|---|
| Part 1: GSK525762 40 mg BID | 5 |
|---|
Reported measurements
DBP; Increase to Grade 1;n=4,10,4
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1: GSK525762 20 mg BID | 4 |
|---|
| Part 1: GSK525762 30 mg BID | 10 |
|---|
| Part 1: GSK525762 40 mg BID | 4 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: GSK525762 20 mg BID | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: GSK525762 30 mg BID | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: GSK525762 40 mg BID | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
DBP; Increase to Grade 2;n=4,10,4
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1: GSK525762 20 mg BID | 4 |
|---|
| Part 1: GSK525762 30 mg BID | 10 |
|---|
| Part 1: GSK525762 40 mg BID | 4 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: GSK525762 20 mg BID | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: GSK525762 30 mg BID | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: GSK525762 40 mg BID | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
DBP; Increase to Grade 3/4;n=4,10,4
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1: GSK525762 20 mg BID | 4 |
|---|
| Part 1: GSK525762 30 mg BID | 10 |
|---|
| Part 1: GSK525762 40 mg BID | 4 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: GSK525762 20 mg BID | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: GSK525762 30 mg BID | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: GSK525762 40 mg BID | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
SBP; Increase to Grade 1;n=4,9,5
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1: GSK525762 20 mg BID | 4 |
|---|
| Part 1: GSK525762 30 mg BID | 9 |
|---|
| Part 1: GSK525762 40 mg BID | 5 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: GSK525762 20 mg BID | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: GSK525762 30 mg BID | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: GSK525762 40 mg BID | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
SBP; Increase to Grade 2;n=4,9,5
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1: GSK525762 20 mg BID | 4 |
|---|
| Part 1: GSK525762 30 mg BID | 9 |
|---|
| Part 1: GSK525762 40 mg BID | 5 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: GSK525762 20 mg BID | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: GSK525762 30 mg BID | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: GSK525762 40 mg BID | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
SBP; Increase to Grade 3/4;n=4,9,5
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1: GSK525762 20 mg BID | 4 |
|---|
| Part 1: GSK525762 30 mg BID | 9 |
|---|
| Part 1: GSK525762 40 mg BID | 5 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: GSK525762 20 mg BID | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: GSK525762 30 mg BID | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: GSK525762 40 mg BID | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 4
- units
- Participants
- title
- DBP; Increase to Grade 1;n=4,10,4
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 4
- units
- Participants
- title
- DBP; Increase to Grade 2;n=4,10,4
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 4
- units
- Participants
- title
- DBP; Increase to Grade 3/4;n=4,10,4
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 5
- units
- Participants
- title
- SBP; Increase to Grade 1;n=4,9,5
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 5
- units
- Participants
- title
- SBP; Increase to Grade 2;n=4,9,5
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 5
- units
- Participants
- title
- SBP; Increase to Grade 3/4;n=4,9,5
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 5
- units
- Participants
- description
- SBP and DBP were measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. Grading of SBP and DBP were done using NCI-CTCAE version 4.0 where, SBP (millimeters of mercury): Grade 0 (\<120), Grade 1 (120-139), Grade 2 (140-159), Grade 3/4 (\>=160) and DBP: Grade 0 (\<80), Grade 1 (80-89), Grade 2 (90-99), Grade 3/4 (\>=100). An increase is defined as an increase in CTCAE grade relative to baseline grade. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented
- groups
- description
- Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
- id
- OG000
- title
- Part 1: GSK525762 20 mg BID
- description
- Participants were administered twice daily oral dose of 30 mg GSK525762.
- id
- OG001
- title
- Part 1: GSK525762 30 mg BID
- description
- Participants were administered twice daily oral dose of 40 mg GSK525762.
- id
- OG002
- title
- Part 1: GSK525762 40 mg BID
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All Treated Population. Only those participants with data available at Baseline and the specified time point were analyzed (indicated by n=X in category titles).
- reporting Status
- POSTED
- time Frame
- Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposure
- title
- Number of Participants With Increase in Blood Pressure From Baseline-Part 1 BID
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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