NCT01587703 · OUTCOME
Number of Participants With Grade Change From Baseline in Hematology Data-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 Blood samples were collected for the analysis of hematology parameters: aPTT, platelet count, RBC, WBC, INR, PT, Fib, hemoglobin, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death. Baseline is the most recent, non-missing value 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 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 12 Participants With SCLC 14 Participants With CRPC 23 Participants With TNBC 19 Participants With ER+BC 21 Participants With GIST 13
Reported measurements Basophils; Any grade increase; n=11,13,23,19,21,13 Analysis denominator · Participants
Group Source count Participants With NMC 11 Participants With SCLC 13 Participants With CRPC 23 Participants With TNBC 19 Participants With ER+BC 21 Participants With GIST 13
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 0 Not reported Not reported Not reported Not reported Participants With TNBC 0 Not reported Not reported Not reported Not reported Participants With ER+BC 0 Not reported Not reported Not reported Not reported Participants With GIST 0 Not reported Not reported Not reported Not reported
Basophils; Increase to Grade3; n=11,13,23,19,21,13 Analysis denominator · Participants
Group Source count Participants With NMC 11 Participants With SCLC 13 Participants With CRPC 23 Participants With TNBC 19 Participants With ER+BC 21 Participants With GIST 13
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 0 Not reported Not reported Not reported Not reported Participants With TNBC 0 Not reported Not reported Not reported Not reported Participants With ER+BC 0 Not reported Not reported Not reported Not reported Participants With GIST 0 Not reported Not reported Not reported Not reported
Basophils; Increase to Grade4; n=11,13,23,19,21,13 Analysis denominator · Participants
Group Source count Participants With NMC 11 Participants With SCLC 13 Participants With CRPC 23 Participants With TNBC 19 Participants With ER+BC 21 Participants With GIST 13
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 0 Not reported Not reported Not reported Not reported Participants With TNBC 0 Not reported Not reported Not reported Not reported Participants With ER+BC 0 Not reported Not reported Not reported Not reported Participants With GIST 0 Not reported Not reported Not reported Not reported
Eosinophils;Any grade increase;n=11,13,23,19,21,13 Analysis denominator · Participants
Group Source count Participants With NMC 11 Participants With SCLC 13 Participants With CRPC 23 Participants With TNBC 19 Participants With ER+BC 21 Participants With GIST 13
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 0 Not reported Not reported Not reported Not reported Participants With TNBC 0 Not reported Not reported Not reported Not reported Participants With ER+BC 0 Not reported Not reported Not reported Not reported Participants With GIST 0 Not reported Not reported Not reported Not reported
Eosinophils;Increase to Grade3;n=11,13,23,19,21,13 Analysis denominator · Participants
Group Source count Participants With NMC 11 Participants With SCLC 13 Participants With CRPC 23 Participants With TNBC 19 Participants With ER+BC 21 Participants With GIST 13
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 0 Not reported Not reported Not reported Not reported Participants With TNBC 0 Not reported Not reported Not reported Not reported Participants With ER+BC 0 Not reported Not reported Not reported Not reported Participants With GIST 0 Not reported Not reported Not reported Not reported
Eosinophils;Increase to Grade4;n=11,13,23,19,21,13 Analysis denominator · Participants
Group Source count Participants With NMC 11 Participants With SCLC 13 Participants With CRPC 23 Participants With TNBC 19 Participants With ER+BC 21 Participants With GIST 13
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 0 Not reported Not reported Not reported Not reported Participants With TNBC 0 Not reported Not reported Not reported Not reported Participants With ER+BC 0 Not reported Not reported Not reported Not reported Participants With GIST 0 Not reported Not reported Not reported Not reported
Hemoglobin;Any grade increase;n=11,14,23,19,21,13 Analysis denominator · Participants
Group Source count Participants With NMC 11 Participants With SCLC 14 Participants With CRPC 23 Participants With TNBC 19 Participants With ER+BC 21 Participants With GIST 13
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Participants With NMC 6 Not reported Not reported Not reported Not reported Participants With SCLC 10 Not reported Not reported Not reported Not reported Participants With CRPC 18 Not reported Not reported Not reported Not reported Participants With TNBC 10 Not reported Not reported Not reported Not reported Participants With ER+BC 18 Not reported Not reported Not reported Not reported Participants With GIST 6 Not reported Not reported Not reported Not reported
Hemoglobin;Increase to Grade3;n=11,14,23,19,21,13 Analysis denominator · Participants
Group Source count Participants With NMC 11 Participants With SCLC 14 Participants With CRPC 23 Participants With TNBC 19 Participants With ER+BC 21 Participants With GIST 13
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Participants With NMC 3 Not reported Not reported Not reported Not reported Participants With SCLC 2 Not reported Not reported Not reported Not reported Participants With CRPC 9 Not reported Not reported Not reported Not reported Participants With TNBC 4 Not reported Not reported Not reported Not reported Participants With ER+BC 5 Not reported Not reported Not reported Not reported Participants With GIST 3 Not reported Not reported Not reported Not reported
Hemoglobin;Increase to Grade4;n=11,14, 23,19,21,13 Analysis denominator · Participants
Group Source count Participants With NMC 11 Participants With SCLC 14 Participants With CRPC 23 Participants With TNBC 19 Participants With ER+BC 21 Participants With GIST 13
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 0 Not reported Not reported Not reported Not reported Participants With TNBC 0 Not reported Not reported Not reported Not reported Participants With ER+BC 0 Not reported Not reported Not reported Not reported Participants With GIST 0 Not reported Not reported Not reported Not reported
INR; Any grade increase; n=11,12,21,17,18,12 Analysis denominator · Participants
Group Source count Participants With NMC 11 Participants With SCLC 12 Participants With CRPC 21 Participants With TNBC 17 Participants With ER+BC 18 Participants With GIST 12
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Participants With NMC 8 Not reported Not reported Not reported Not reported Participants With SCLC 6 Not reported Not reported Not reported Not reported Participants With CRPC 13 Not reported Not reported Not reported Not reported Participants With TNBC 8 Not reported Not reported Not reported Not reported Participants With ER+BC 11 Not reported Not reported Not reported Not reported Participants With GIST 7 Not reported Not reported Not reported Not reported
INR; Increase to Grade3; n=11,12,21,17,18,12 Analysis denominator · Participants
Group Source count Participants With NMC 11 Participants With SCLC 12 Participants With CRPC 21 Participants With TNBC 17 Participants With ER+BC 18 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 0 Not reported Not reported Not reported Not reported Participants With TNBC 0 Not reported Not reported Not reported Not reported Participants With ER+BC 0 Not reported Not reported Not reported Not reported Participants With GIST 0 Not reported Not reported Not reported Not reported
INR; Increase to Grade4; n=11,12,21,17,18,12 Analysis denominator · Participants
Group Source count Participants With NMC 11 Participants With SCLC 12 Participants With CRPC 21 Participants With TNBC 17 Participants With ER+BC 18 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 0 Not reported Not reported Not reported Not reported Participants With TNBC 0 Not reported Not reported Not reported Not reported Participants With ER+BC 0 Not reported Not reported Not reported Not reported Participants With GIST 0 Not reported Not reported Not reported Not reported
Lymphocytes;Any grade increase;n=11,13,23,19,21,13 Analysis denominator · Participants
Group Source count Participants With NMC 11 Participants With SCLC 13 Participants With CRPC 23 Participants With TNBC 19 Participants With ER+BC 21 Participants With GIST 13
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Participants With NMC 8 Not reported Not reported Not reported Not reported Participants With SCLC 7 Not reported Not reported Not reported Not reported Participants With CRPC 14 Not reported Not reported Not reported Not reported Participants With TNBC 9 Not reported Not reported Not reported Not reported Participants With ER+BC 13 Not reported Not reported Not reported Not reported Participants With GIST 6 Not reported Not reported Not reported Not reported
Lymphocytes;Increase to Grade3;n=11,13,23,19,21,13 Analysis denominator · Participants
Group Source count Participants With NMC 11 Participants With SCLC 13 Participants With CRPC 23 Participants With TNBC 19 Participants With ER+BC 21 Participants With GIST 13
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 2 Not reported Not reported Not reported Not reported Participants With CRPC 6 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 0 Not reported Not reported Not reported Not reported
Lymphocytes;Increase to Grade4;n=11,13,23,19,21,13 Analysis denominator · Participants
Group Source count Participants With NMC 11 Participants With SCLC 13 Participants With CRPC 23 Participants With TNBC 19 Participants With ER+BC 21 Participants With GIST 13
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 0 Not reported Not reported Not reported Not reported Participants With TNBC 0 Not reported Not reported Not reported Not reported Participants With ER+BC 0 Not reported Not reported Not reported Not reported Participants With GIST 0 Not reported Not reported Not reported Not reported
Monocytes; Any grade increase; n=11,13,23,19,21,13 Analysis denominator · Participants
Group Source count Participants With NMC 11 Participants With SCLC 13 Participants With CRPC 23 Participants With TNBC 19 Participants With ER+BC 21 Participants With GIST 13
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 0 Not reported Not reported Not reported Not reported Participants With TNBC 0 Not reported Not reported Not reported Not reported Participants With ER+BC 0 Not reported Not reported Not reported Not reported Participants With GIST 0 Not reported Not reported Not reported Not reported
Monocytes;Increase to Grade3; n=11,13,23,19,21,13 Analysis denominator · Participants
Group Source count Participants With NMC 11 Participants With SCLC 13 Participants With CRPC 23 Participants With TNBC 19 Participants With ER+BC 21 Participants With GIST 13
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 00 Not reported Not reported Not reported Not reported Participants With TNBC 0 Not reported Not reported Not reported Not reported Participants With ER+BC 0 Not reported Not reported Not reported Not reported Participants With GIST 0 Not reported Not reported Not reported Not reported
Monocytes; Increase to Grade4; n=11,13,23,19,21,13 Analysis denominator · Participants
Group Source count Participants With NMC 11 Participants With SCLC 13 Participants With CRPC 23 Participants With TNBC 19 Participants With ER+BC 21 Participants With GIST 13
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 0 Not reported Not reported Not reported Not reported Participants With TNBC 0 Not reported Not reported Not reported Not reported Participants With ER+BC 0 Not reported Not reported Not reported Not reported Participants With GIST 0 Not reported Not reported Not reported Not reported
Neutrophils;Any grade increase;n=11,14,23,19,21,13 Analysis denominator · Participants
Group Source count Participants With NMC 11 Participants With SCLC 14 Participants With CRPC 23 Participants With TNBC 19 Participants With ER+BC 21 Participants With GIST 13
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 8 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
Neutrophils;Increase to Grade3;n=11,14,23,19,21,13 Analysis denominator · Participants
Group Source count Participants With NMC 11 Participants With SCLC 14 Participants With CRPC 23 Participants With TNBC 19 Participants With ER+BC 21 Participants With GIST 13
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Participants With NMC 1 Not reported Not reported Not reported Not reported Participants With SCLC 1 Not reported Not reported Not reported Not reported Participants With CRPC 0 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 0 Not reported Not reported Not reported Not reported
Neutrophils;Increase to Grade4;n=11,14,23,19,21,13 Analysis denominator · Participants
Group Source count Participants With NMC 11 Participants With SCLC 14 Participants With CRPC 23 Participants With TNBC 19 Participants With ER+BC 21 Participants With GIST 13
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 0 Not reported Not reported Not reported Not reported Participants With TNBC 0 Not reported Not reported Not reported Not reported Participants With ER+BC 0 Not reported Not reported Not reported Not reported Participants With GIST 0 Not reported Not reported Not reported Not reported
Platelets; Any grade increase; n=11,14,23,19,21,13 Analysis denominator · Participants
Group Source count Participants With NMC 11 Participants With SCLC 14 Participants With CRPC 23 Participants With TNBC 19 Participants With ER+BC 21 Participants With GIST 13
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Participants With NMC 7 Not reported Not reported Not reported Not reported Participants With SCLC 12 Not reported Not reported Not reported Not reported Participants With CRPC 20 Not reported Not reported Not reported Not reported Participants With TNBC 17 Not reported Not reported Not reported Not reported Participants With ER+BC 18 Not reported Not reported Not reported Not reported Participants With GIST 7 Not reported Not reported Not reported Not reported
Platelets; Increase to Grade3; n=11,14,23,19,21,13 Analysis denominator · Participants
Group Source count Participants With NMC 11 Participants With SCLC 14 Participants With CRPC 23 Participants With TNBC 19 Participants With ER+BC 21 Participants With GIST 13
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 5 Not reported Not reported Not reported Not reported Participants With TNBC 6 Not reported Not reported Not reported Not reported Participants With ER+BC 6 Not reported Not reported Not reported Not reported Participants With GIST 0 Not reported Not reported Not reported Not reported
Platelets; Increase to Grade4; n=11,14,23,19,21,13 Analysis denominator · Participants
Group Source count Participants With NMC 11 Participants With SCLC 14 Participants With CRPC 23 Participants With TNBC 19 Participants With ER+BC 21 Participants With GIST 13
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 4 Not reported Not reported Not reported Not reported Participants With ER+BC 2 Not reported Not reported Not reported Not reported Participants With GIST 0 Not reported Not reported Not reported Not reported
PT; Any grade increase;n=10,10, 18, 17, 18, 12 Analysis denominator · Participants
Group Source count Participants With NMC 10 Participants With SCLC 10 Participants With CRPC 18 Participants With TNBC 17 Participants With ER+BC 18 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 0 Not reported Not reported Not reported Not reported Participants With TNBC 0 Not reported Not reported Not reported Not reported Participants With ER+BC 0 Not reported Not reported Not reported Not reported Participants With GIST 0 Not reported Not reported Not reported Not reported
PT; Increase to Grade 3; n=10,10, 18, 17, 18, 12 Analysis denominator · Participants
Group Source count Participants With NMC 10 Participants With SCLC 10 Participants With CRPC 18 Participants With TNBC 17 Participants With ER+BC 18 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 0 Not reported Not reported Not reported Not reported Participants With TNBC 0 Not reported Not reported Not reported Not reported Participants With ER+BC 0 Not reported Not reported Not reported Not reported Participants With GIST 0 Not reported Not reported Not reported Not reported
PT; Increase to Grade 4; n=10,10, 18, 17, 18, 12 Analysis denominator · Participants
Group Source count Participants With NMC 10 Participants With SCLC 10 Participants With CRPC 18 Participants With TNBC 17 Participants With ER+BC 18 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 0 Not reported Not reported Not reported Not reported Participants With TNBC 0 Not reported Not reported Not reported Not reported Participants With ER+BC 0 Not reported Not reported Not reported Not reported Participants With GIST 0 Not reported Not reported Not reported Not reported
RBC; Any grade increase; n=11, 13, 23, 19, 21, 13 Analysis denominator · Participants
Group Source count Participants With NMC 11 Participants With SCLC 13 Participants With CRPC 23 Participants With TNBC 19 Participants With ER+BC 21 Participants With GIST 13
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 0 Not reported Not reported Not reported Not reported Participants With TNBC 0 Not reported Not reported Not reported Not reported Participants With ER+BC 0 Not reported Not reported Not reported Not reported Participants With GIST 0 Not reported Not reported Not reported Not reported
RBC; Increase to Grade 3; n=11, 13, 23, 19, 21, 13 Analysis denominator · Participants
Group Source count Participants With NMC 11 Participants With SCLC 13 Participants With CRPC 23 Participants With TNBC 19 Participants With ER+BC 21 Participants With GIST 13
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 0 Not reported Not reported Not reported Not reported Participants With TNBC 0 Not reported Not reported Not reported Not reported Participants With ER+BC 0 Not reported Not reported Not reported Not reported Participants With GIST 0 Not reported Not reported Not reported Not reported
RBC; Increase to Grade 4; n=11, 13, 23, 19, 21, 13 Analysis denominator · Participants
Group Source count Participants With NMC 11 Participants With SCLC 13 Participants With CRPC 23 Participants With TNBC 19 Participants With ER+BC 21 Participants With GIST 13
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 0 Not reported Not reported Not reported Not reported Participants With TNBC 0 Not reported Not reported Not reported Not reported Participants With ER+BC 0 Not reported Not reported Not reported Not reported Participants With GIST 0 Not reported Not reported Not reported Not reported
WBC; Any grade increase; n=11, 14, 23, 19, 21, 13 Analysis denominator · Participants
Group Source count Participants With NMC 11 Participants With SCLC 14 Participants With CRPC 23 Participants With TNBC 19 Participants With ER+BC 21 Participants With GIST 13
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Participants With NMC 7 Not reported Not reported Not reported Not reported Participants With SCLC 5 Not reported Not reported Not reported Not reported Participants With CRPC 9 Not reported Not reported Not reported Not reported Participants With TNBC 5 Not reported Not reported Not reported Not reported Participants With ER+BC 6 Not reported Not reported Not reported Not reported Participants With GIST 3 Not reported Not reported Not reported Not reported
WBC; Increase to Grade 3; n=11, 14, 23, 19, 21, 13 Analysis denominator · Participants
Group Source count Participants With NMC 11 Participants With SCLC 14 Participants With CRPC 23 Participants With TNBC 19 Participants With ER+BC 21 Participants With GIST 13
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Participants With NMC 1 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 1 Not reported Not reported Not reported Not reported Participants With ER+BC 0 Not reported Not reported Not reported Not reported Participants With GIST 0 Not reported Not reported Not reported Not reported
WBC; Increase to Grade 4; n=11, 14, 23, 19, 21, 13 Analysis denominator · Participants
Group Source count Participants With NMC 11 Participants With SCLC 14 Participants With CRPC 23 Participants With TNBC 19 Participants With ER+BC 21 Participants With GIST 13
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 0 Not reported Not reported Not reported Not reported Participants With TNBC 0 Not reported Not reported Not reported Not reported Participants With ER+BC 0 Not reported Not reported Not reported Not reported Participants With GIST 0 Not reported Not reported Not reported Not reported
Fib; Any grade increase; n=11, 11, 21, 17, 18, 12 Analysis denominator · Participants
Group Source count Participants With NMC 11 Participants With SCLC 11 Participants With CRPC 21 Participants With TNBC 17 Participants With ER+BC 18 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 0 Not reported Not reported Not reported Not reported Participants With CRPC 1 Not reported Not reported Not reported Not reported Participants With TNBC 0 Not reported Not reported Not reported Not reported Participants With ER+BC 0 Not reported Not reported Not reported Not reported Participants With GIST 1 Not reported Not reported Not reported Not reported
Fib; Increase to Grade 3; n=11, 11, 21, 17, 18, 12 Analysis denominator · Participants
Group Source count Participants With NMC 11 Participants With SCLC 11 Participants With CRPC 21 Participants With TNBC 17 Participants With ER+BC 18 Participants With GIST 12
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Participants With NMC 1 Not reported Not reported Not reported Not reported Participants With SCLC 0 Not reported Not reported Not reported Not reported Participants With CRPC 0 Not reported Not reported Not reported Not reported Participants With TNBC 0 Not reported Not reported Not reported Not reported Participants With ER+BC 0 Not reported Not reported Not reported Not reported Participants With GIST 0 Not reported Not reported Not reported Not reported
Fib; Increase to Grade 4; n=11, 11, 21, 17, 18, 12 Analysis denominator · Participants
Group Source count Participants With NMC 11 Participants With SCLC 11 Participants With CRPC 21 Participants With TNBC 17 Participants With ER+BC 18 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 0 Not reported Not reported Not reported Not reported Participants With TNBC 0 Not reported Not reported Not reported Not reported Participants With ER+BC 0 Not reported Not reported Not reported Not reported Participants With GIST 0 Not reported Not reported Not reported Not reported
aPTT; Any grade increase; n=11,12,21,17,18,12 Analysis denominator · Participants
Group Source count Participants With NMC 11 Participants With SCLC 12 Participants With CRPC 21 Participants With TNBC 17 Participants With ER+BC 18 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 1 Not reported Not reported Not reported Not reported Participants With TNBC 3 Not reported Not reported Not reported Not reported Participants With ER+BC 5 Not reported Not reported Not reported Not reported Participants With GIST 4 Not reported Not reported Not reported Not reported
aPTT; Increase to Grade3; n=11,12,21, 17, 18, 12 Analysis denominator · Participants
Group Source count Participants With NMC 11 Participants With SCLC 12 Participants With CRPC 21 Participants With TNBC 17 Participants With ER+BC 18 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 0 Not reported Not reported Not reported Not reported Participants With TNBC 1 Not reported Not reported Not reported Not reported Participants With ER+BC 0 Not reported Not reported Not reported Not reported Participants With GIST 0 Not reported Not reported Not reported Not reported
aPTT; Increase to Grade4; n=11,12,21,17,18,12 Analysis denominator · Participants
Group Source count Participants With NMC 11 Participants With SCLC 12 Participants With CRPC 21 Participants With TNBC 17 Participants With ER+BC 18 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 0 Not reported Not reported Not reported Not reported Participants With TNBC 0 Not reported Not reported Not reported Not reported Participants With ER+BC 0 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 0
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 0
group Id OG004
value 0
group Id OG005
value 0 denoms counts
group Id OG000
value 11
group Id OG001
value 13
group Id OG002
value 23
group Id OG003
value 19
group Id OG004
value 21
group Id OG005
value 13
units Participants
title Basophils; Any grade increase; n=11,13,23,19,21,13 categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 0
group Id OG004
value 0
group Id OG005
value 0 denoms counts
group Id OG000
value 11
group Id OG001
value 13
group Id OG002
value 23
group Id OG003
value 19
group Id OG004
value 21
group Id OG005
value 13
units Participants
title Basophils; Increase to Grade3; n=11,13,23,19,21,13 categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 0
group Id OG004
value 0
group Id OG005
value 0 denoms counts
group Id OG000
value 11
group Id OG001
value 13
group Id OG002
value 23
group Id OG003
value 19
group Id OG004
value 21
group Id OG005
value 13
units Participants
title Basophils; Increase to Grade4; n=11,13,23,19,21,13 categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 0
group Id OG004
value 0
group Id OG005
value 0 denoms counts
group Id OG000
value 11
group Id OG001
value 13
group Id OG002
value 23
group Id OG003
value 19
group Id OG004
value 21
group Id OG005
value 13
units Participants
title Eosinophils;Any grade increase;n=11,13,23,19,21,13 categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 0
group Id OG004
value 0
group Id OG005
value 0 denoms counts
group Id OG000
value 11
group Id OG001
value 13
group Id OG002
value 23
group Id OG003
value 19
group Id OG004
value 21
group Id OG005
value 13
units Participants
title Eosinophils;Increase to Grade3;n=11,13,23,19,21,13 categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 0
group Id OG004
value 0
group Id OG005
value 0 denoms counts
group Id OG000
value 11
group Id OG001
value 13
group Id OG002
value 23
group Id OG003
value 19
group Id OG004
value 21
group Id OG005
value 13
units Participants
title Eosinophils;Increase to Grade4;n=11,13,23,19,21,13 categories measurements
group Id OG000
value 6
group Id OG001
value 10
group Id OG002
value 18
group Id OG003
value 10
group Id OG004
value 18
group Id OG005
value 6 denoms counts
group Id OG000
value 11
group Id OG001
value 14
group Id OG002
value 23
group Id OG003
value 19
group Id OG004
value 21
group Id OG005
value 13
units Participants
title Hemoglobin;Any grade increase;n=11,14,23,19,21,13 categories measurements
group Id OG000
value 3
group Id OG001
value 2
group Id OG002
value 9
group Id OG003
value 4
group Id OG004
value 5
group Id OG005
value 3 denoms counts
group Id OG000
value 11
group Id OG001
value 14
group Id OG002
value 23
group Id OG003
value 19
group Id OG004
value 21
group Id OG005
value 13
units Participants
title Hemoglobin;Increase to Grade3;n=11,14,23,19,21,13 categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 0
group Id OG004
value 0
group Id OG005
value 0 denoms counts
group Id OG000
value 11
group Id OG001
value 14
group Id OG002
value 23
group Id OG003
value 19
group Id OG004
value 21
group Id OG005
value 13
units Participants
title Hemoglobin;Increase to Grade4;n=11,14, 23,19,21,13 categories measurements
group Id OG000
value 8
group Id OG001
value 6
group Id OG002
value 13
group Id OG003
value 8
group Id OG004
value 11
group Id OG005
value 7 denoms counts
group Id OG000
value 11
group Id OG001
value 12
group Id OG002
value 21
group Id OG003
value 17
group Id OG004
value 18
group Id OG005
value 12
units Participants
title INR; Any grade increase; n=11,12,21,17,18,12 categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 0
group Id OG004
value 0
group Id OG005
value 0 denoms counts
group Id OG000
value 11
group Id OG001
value 12
group Id OG002
value 21
group Id OG003
value 17
group Id OG004
value 18
group Id OG005
value 12
units Participants
title INR; Increase to Grade3; n=11,12,21,17,18,12 categories measurements
group Id OG000
value 0
group Id OG001
value 0
group Id OG002
value 0
group Id OG003
value 0
group Id OG004
value 0
group Id OG005
value 0 denoms counts
group Id OG000
value 11
group Id OG001
value 12
group Id OG002
value 21
group Id OG003
value 17
group Id OG004
value 18
group Id OG005
value 12
units Participants
title INR; Increase to Grade4; n=11,12,21,17,18,12 Show more (12 of 39) denoms counts
group Id OG000
value 12
group Id OG001
value 14
group Id OG002
value 23
group Id OG003
value 19
group Id OG004
value 21
group Id OG005
value 13
units Participants
description Blood samples were collected for the analysis of hematology parameters: aPTT, platelet count, RBC, WBC, INR, PT, Fib, hemoglobin, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death. Baseline is the most recent, non-missing value 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 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 Grade Change From Baseline in Hematology Data-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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