NCT01587703 · OUTCOME
Number of Participants With Changes in Blood Pressure From Baseline-Part 2
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 points were analyzed (indicated by n=X in category titles).
Groups in this outcome
Participants With NMC
Participants with NUT Midline Carcinoma (NMC) were administered continuous once daily oral dose of 75 mg GSK525762
Participants With SCLC
Participants with small cell lung cancer(SCLC) were administered continuous once daily oral dose of 75 mg GSK525762
Participants With CRPC
Participants with Castrate-Resistant Prostate Cancer (CRPC) were administered continuous once daily oral dose of 75 mg GSK525762
Participants With TNBC
Participants with Triple Negative Breast Cancer (TNBC) were administered continuous once daily oral dose of 75 mg GSK525762
Participants With ER+BC
Participants with estrogen receptor positive breast cancer (ER+BC) were administered continuous once daily oral dose of 75 mg GSK525762
Participants With GIST
Participants with Gastrointestinal Stromal Tumor (GIST) were administered continuous once daily oral dose of 75 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 |
|---|
| Participants With NMC | 11 |
|---|
| Participants With SCLC | 14 |
|---|
| Participants With CRPC | 22 |
|---|
| Participants With TNBC | 19 |
|---|
| Participants With ER+BC | 19 |
|---|
| Participants With GIST | 12 |
|---|
Reported measurements
DBP; Increase to Grade 1;n=11,14,22,19,19,12
Analysis denominator · Participants
| Group | Source count |
|---|
| Participants With NMC | 11 |
|---|
| Participants With SCLC | 14 |
|---|
| Participants With CRPC | 22 |
|---|
| Participants With TNBC | 19 |
|---|
| Participants With ER+BC | 19 |
|---|
| Participants With GIST | 12 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Participants With NMC | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Participants With SCLC | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Participants With CRPC | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Participants With TNBC | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Participants With ER+BC | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Participants With GIST | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
DBP; Increase to Grade 2;n=11,14,22,19,19,12
Analysis denominator · Participants
| Group | Source count |
|---|
| Participants With NMC | 11 |
|---|
| Participants With SCLC | 14 |
|---|
| Participants With CRPC | 22 |
|---|
| Participants With TNBC | 19 |
|---|
| Participants With ER+BC | 19 |
|---|
| Participants With GIST | 12 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Participants With NMC | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Participants With SCLC | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Participants With CRPC | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Participants With TNBC | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Participants With ER+BC | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Participants With GIST | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
DBP; Increase to Grade 3/4;n=11,14,22,19,19,12
Analysis denominator · Participants
| Group | Source count |
|---|
| Participants With NMC | 11 |
|---|
| Participants With SCLC | 14 |
|---|
| Participants With CRPC | 22 |
|---|
| Participants With TNBC | 19 |
|---|
| Participants With ER+BC | 19 |
|---|
| Participants With GIST | 12 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Participants With NMC | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Participants With SCLC | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Participants With CRPC | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Participants With TNBC | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Participants With ER+BC | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Participants With GIST | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
SBP; Increase to Grade 1;n=11,14,21,19,19,12
Analysis denominator · Participants
| Group | Source count |
|---|
| Participants With NMC | 11 |
|---|
| Participants With SCLC | 14 |
|---|
| Participants With CRPC | 21 |
|---|
| Participants With TNBC | 19 |
|---|
| Participants With ER+BC | 19 |
|---|
| Participants With GIST | 12 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Participants With NMC | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Participants With SCLC | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Participants With CRPC | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Participants With TNBC | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Participants With ER+BC | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Participants With GIST | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
SBP; Increase to Grade 2;n=11,14,21,19,19,12
Analysis denominator · Participants
| Group | Source count |
|---|
| Participants With NMC | 11 |
|---|
| Participants With SCLC | 14 |
|---|
| Participants With CRPC | 21 |
|---|
| Participants With TNBC | 19 |
|---|
| Participants With ER+BC | 19 |
|---|
| Participants With GIST | 12 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Participants With NMC | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Participants With SCLC | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Participants With CRPC | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
| Participants With TNBC | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Participants With ER+BC | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Participants With GIST | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
SBP; Increase to Grade 3/4;n=11,14,21,19,19,12
Analysis denominator · Participants
| Group | Source count |
|---|
| Participants With NMC | 11 |
|---|
| Participants With SCLC | 14 |
|---|
| Participants With CRPC | 21 |
|---|
| Participants With TNBC | 19 |
|---|
| Participants With ER+BC | 19 |
|---|
| Participants With GIST | 12 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Participants With NMC | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Participants With SCLC | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Participants With CRPC | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Participants With TNBC | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Participants With ER+BC | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Participants With GIST | 0 | 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
- 8
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 3
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 14
- group Id
- OG002
- value
- 22
- group Id
- OG003
- value
- 19
- group Id
- OG004
- value
- 19
- group Id
- OG005
- value
- 12
- units
- Participants
- title
- DBP; Increase to Grade 1;n=11,14,22,19,19,12
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 14
- group Id
- OG002
- value
- 22
- group Id
- OG003
- value
- 19
- group Id
- OG004
- value
- 19
- group Id
- OG005
- value
- 12
- units
- Participants
- title
- DBP; Increase to Grade 2;n=11,14,22,19,19,12
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 14
- group Id
- OG002
- value
- 22
- group Id
- OG003
- value
- 19
- group Id
- OG004
- value
- 19
- group Id
- OG005
- value
- 12
- units
- Participants
- title
- DBP; Increase to Grade 3/4;n=11,14,22,19,19,12
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 9
- group Id
- OG004
- value
- 7
- group Id
- OG005
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 14
- group Id
- OG002
- value
- 21
- group Id
- OG003
- value
- 19
- group Id
- OG004
- value
- 19
- group Id
- OG005
- value
- 12
- units
- Participants
- title
- SBP; Increase to Grade 1;n=11,14,21,19,19,12
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 11
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 7
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 14
- group Id
- OG002
- value
- 21
- group Id
- OG003
- value
- 19
- group Id
- OG004
- value
- 19
- group Id
- OG005
- value
- 12
- units
- Participants
- title
- SBP; Increase to Grade 2;n=11,14,21,19,19,12
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 14
- group Id
- OG002
- value
- 21
- group Id
- OG003
- value
- 19
- group Id
- OG004
- value
- 19
- group Id
- OG005
- value
- 12
- units
- Participants
- title
- SBP; Increase to Grade 3/4;n=11,14,21,19,19,12
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 14
- group Id
- OG002
- value
- 22
- group Id
- OG003
- value
- 19
- group Id
- OG004
- value
- 19
- group Id
- OG005
- value
- 12
- 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 with NUT Midline Carcinoma (NMC) were administered continuous once daily oral dose of 75 mg GSK525762
- id
- OG000
- title
- Participants With NMC
- description
- Participants with small cell lung cancer(SCLC) were administered continuous once daily oral dose of 75 mg GSK525762
- id
- OG001
- title
- Participants With SCLC
- description
- Participants with Castrate-Resistant Prostate Cancer (CRPC) were administered continuous once daily oral dose of 75 mg GSK525762
- id
- OG002
- title
- Participants With CRPC
- description
- Participants with Triple Negative Breast Cancer (TNBC) were administered continuous once daily oral dose of 75 mg GSK525762
- id
- OG003
- title
- Participants With TNBC
- description
- Participants with estrogen receptor positive breast cancer (ER+BC) were administered continuous once daily oral dose of 75 mg GSK525762
- id
- OG004
- title
- Participants With ER+BC
- description
- Participants with Gastrointestinal Stromal Tumor (GIST) were administered continuous once daily oral dose of 75 mg GSK525762
- id
- OG005
- title
- Participants With GIST
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All Treated Population. Only those participants with data available at Baseline and the specified time points 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 Changes in Blood Pressure From Baseline-Part 2
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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