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NCT01587703 · OUTCOME

Number of Participants With AEs and SAEs-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
Median of 1.41 months of drug exposure

What was measured

An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; important medical events that may require medical or surgical intervention to prevent one of the outcomes mentioned; events of possible study treatment-induced liver injury with hyperbilirubinemia; any new primary cancers; significant cardiac dysfunction; Grade 4 laboratory abnormalities; and drug related hepatobiliary event leading to permanent discontinuation of study treatment.

Analysis population: All Treated Population

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 NMC12
Participants With SCLC14
Participants With CRPC23
Participants With TNBC19
Participants With ER+BC21
Participants With GIST13

Reported measurements

Any AE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Participants With NMC11Not reportedNot reportedNot reportedNot reported
Participants With SCLC14Not reportedNot reportedNot reportedNot reported
Participants With CRPC23Not reportedNot reportedNot reportedNot reported
Participants With TNBC19Not reportedNot reportedNot reportedNot reported
Participants With ER+BC21Not reportedNot reportedNot reportedNot reported
Participants With GIST13Not reportedNot reportedNot reportedNot reported
Any SAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Participants With NMC6Not reportedNot reportedNot reportedNot reported
Participants With SCLC9Not reportedNot reportedNot reportedNot reported
Participants With CRPC16Not reportedNot reportedNot reportedNot reported
Participants With TNBC11Not reportedNot reportedNot reportedNot reported
Participants With ER+BC15Not reportedNot reportedNot reportedNot reported
Participants With GIST8Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        14
      3. group Id
        OG002
        value
        23
      4. group Id
        OG003
        value
        19
      5. group Id
        OG004
        value
        21
      6. group Id
        OG005
        value
        13
    title
    Any AE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        16
      4. group Id
        OG003
        value
        11
      5. group Id
        OG004
        value
        15
      6. group Id
        OG005
        value
        8
    title
    Any SAE
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    2. group Id
      OG001
      value
      14
    3. group Id
      OG002
      value
      23
    4. group Id
      OG003
      value
      19
    5. group Id
      OG004
      value
      21
    6. group Id
      OG005
      value
      13
    units
    Participants
description
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; important medical events that may require medical or surgical intervention to prevent one of the outcomes mentioned; events of possible study treatment-induced liver injury with hyperbilirubinemia; any new primary cancers; significant cardiac dysfunction; Grade 4 laboratory abnormalities; and drug related hepatobiliary event leading to permanent discontinuation of study treatment.
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
reporting Status
POSTED
time Frame
Median of 1.41 months of drug exposure
title
Number of Participants With AEs and SAEs-Part 2
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice