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NCT01587703 · OUTCOME

Number of Participants With Changes in Pulse Rate 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

Pulse rate was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. The clinical concern range for pulse rate is \<60 beats per minute and \>100 beats per minute. 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. Participants were counted twice if the participant "Decreased to \<60" and "Increased to \>100" post-baseline.

Analysis population: All Treated Population. Only those participants with data available at Baseline and the specified time points were analyzed.

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

GroupSource count
Participants With NMC11
Participants With SCLC14
Participants With CRPC22
Participants With TNBC19
Participants With ER+BC20
Participants With GIST12

Reported measurements

Pulse rate; decrease to <60
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Participants With NMC0Not reportedNot reportedNot reportedNot reported
Participants With SCLC1Not reportedNot reportedNot reportedNot reported
Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Participants With ER+BC1Not reportedNot reportedNot reportedNot reported
Participants With GIST1Not reportedNot reportedNot reportedNot reported
Pulse rate; Change to normal/no change
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Participants With NMC7Not reportedNot reportedNot reportedNot reported
Participants With SCLC10Not reportedNot reportedNot reportedNot reported
Participants With CRPC13Not reportedNot reportedNot reportedNot reported
Participants With TNBC11Not reportedNot reportedNot reportedNot reported
Participants With ER+BC9Not reportedNot reportedNot reportedNot reported
Participants With GIST8Not reportedNot reportedNot reportedNot reported
Pulse rate; increase to >100
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Participants With NMC5Not reportedNot reportedNot reportedNot reported
Participants With SCLC4Not reportedNot reportedNot reportedNot reported
Participants With CRPC9Not reportedNot reportedNot reportedNot reported
Participants With TNBC9Not reportedNot reportedNot reportedNot reported
Participants With ER+BC10Not reportedNot reportedNot reportedNot reported
Participants With GIST3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        1
    title
    Pulse rate; decrease to <60
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        10
      3. group Id
        OG002
        value
        13
      4. group Id
        OG003
        value
        11
      5. group Id
        OG004
        value
        9
      6. group Id
        OG005
        value
        8
    title
    Pulse rate; Change to normal/no change
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        9
      4. group Id
        OG003
        value
        9
      5. group Id
        OG004
        value
        10
      6. group Id
        OG005
        value
        3
    title
    Pulse rate; increase to >100
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    2. group Id
      OG001
      value
      14
    3. group Id
      OG002
      value
      22
    4. group Id
      OG003
      value
      19
    5. group Id
      OG004
      value
      20
    6. group Id
      OG005
      value
      12
    units
    Participants
description
Pulse rate was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. The clinical concern range for pulse rate is \<60 beats per minute and \>100 beats per minute. 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. Participants were counted twice if the participant "Decreased to \<60" and "Increased to \>100" post-baseline.
groups
  1. description
    Participants with NUT Midline Carcinoma (NMC) were administered continuous once daily oral dose of 75 mg GSK525762
    id
    OG000
    title
    Participants With NMC
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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.
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 Pulse Rate From Baseline-Part 2
type
PRIMARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice