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NCT01587703 · OUTCOME

Number of Participants With Grade Change From Baseline in Clinical Chemistry 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 clinical chemistry parameters: glucose, albumin, ALP, ALT, amylase, AST, Dir bil, bilirubin, NT-BNP, calcium, cholesterol, CK, chloride, CO2, creatinine, GGT, HDL and LDL cholesterol, insulin, potassium, LDH, lipase, magnesium, protein, sodium, thyroxine, testosterone, triglycerides (triglyc), troponin I and T, urate and urea. 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

Part 2: Participants With NMC

Participants with NUT Midline Carcinoma (NMC) were administered continuous once daily oral dose of 75 mg GSK525762.

Part 2: Participants With SCLC

Participants with small cell lung cancer(SCLC) were administered continuous once daily oral dose of 75 mg GSK525762.

Part 2: Participants With CRPC

Participants with Castrate-Resistant Prostate Cancer (CRPC) were administered continuous once daily oral dose of 75 mg GSK525762.

Part 2: Participants With TNBC

Participants with Triple Negative Breast Cancer (TNBC) were administered continuous once daily oral dose of 75 mg GSK525762.

Part 2: Participants With ER+BC

Participants with estrogen receptor positive breast cancer (ER+BC) were administered continuous once daily oral dose of 75 mg GSK525762.

Part 2: 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
Part 2: Participants With NMC12
Part 2: Participants With SCLC14
Part 2: Participants With CRPC23
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC21
Part 2: Participants With GIST13

Reported measurements

Glucose; Any grade increase; n=11,13,23,19,21,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC13
Part 2: Participants With CRPC23
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC21
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC10Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC10Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC20Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC16Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC18Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST9Not reportedNot reportedNot reportedNot reported
Glucose; Increase to Grade 3; n=11,13,23,19,21,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC13
Part 2: Participants With CRPC23
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC21
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC1Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST2Not reportedNot reportedNot reportedNot reported
Glucose; Increase to Grade 4; n=11,13,23,19,21,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC13
Part 2: Participants With CRPC23
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC21
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
Albumin; Any grade increase; n=11,13,23,19,21,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC13
Part 2: Participants With CRPC23
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC21
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC5Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC6Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC9Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC8Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC7Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST5Not reportedNot reportedNot reportedNot reported
Albumin; Increase to Grade 3; n=11,13,23,19,21,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC13
Part 2: Participants With CRPC23
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC21
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC1Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
Albumin; Increase to Grade 4; n=11,13,23,19,21,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC13
Part 2: Participants With CRPC23
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC21
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
ALP; Any grade increase; n=11,13,23,19,21,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC13
Part 2: Participants With CRPC23
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC21
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC3Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC1Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC6Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC3Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC4Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST4Not reportedNot reportedNot reportedNot reported
ALP; Increase to Grade 3; n=11,13,23,19,21,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC13
Part 2: Participants With CRPC23
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC21
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC2Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
ALP; Increase to Grade 4; n=11,13,23,19,21,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC13
Part 2: Participants With CRPC23
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC21
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
ALT; Any grade increase; n=11,14,23,19,21,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC14
Part 2: Participants With CRPC23
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC21
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC3Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC6Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC6Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC5Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC12Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST3Not reportedNot reportedNot reportedNot reported
ALT; Increase to Grade 3; n=11,14,23,19,21,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC14
Part 2: Participants With CRPC23
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC21
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC1Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
ALT; Increase to Grade 4; n=11,14,23,19,21,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC14
Part 2: Participants With CRPC23
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC21
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
Amylase; Any grade increase; n=11,12,22,19,20,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC12
Part 2: Participants With CRPC22
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC20
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC5Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC5Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC9Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC5Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC6Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST1Not reportedNot reportedNot reportedNot reported
Amylase; Increase to Grade 3; n=11,12,22,19,20,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC12
Part 2: Participants With CRPC22
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC20
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC1Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC2Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC2Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC2Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC2Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
Amylase; Increase to Grade 4; n=11,12,22,19,20,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC12
Part 2: Participants With CRPC22
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC20
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
AST; Any grade increase; n=11,13,23,19,21,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC13
Part 2: Participants With CRPC23
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC21
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC3Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC5Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC10Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC8Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC14Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST6Not reportedNot reportedNot reportedNot reported
AST; Increase to Grade 3; n=11,13,23,19,21,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC13
Part 2: Participants With CRPC23
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC21
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC1Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC1Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC3Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
AST; Increase to Grade 4; n=11,13,23,19,21,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC13
Part 2: Participants With CRPC23
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC21
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
Dir bil; Any grade increase; n=11,13,23,19,20,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC13
Part 2: Participants With CRPC23
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC20
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
Dir bil; Increase to Grade 3; n=11,13,23,19,20,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC13
Part 2: Participants With CRPC23
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC20
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
Dir bil; Increase to Grade 4; n=11,13,23,19,20,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC13
Part 2: Participants With CRPC23
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC20
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
Bilirubin;Any grade increase;n=11,14,23,19,21,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC14
Part 2: Participants With CRPC23
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC21
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC8Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC10Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC13Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC6Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC13Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST4Not reportedNot reportedNot reportedNot reported
Bilirubin;Increase to Grade 3; n=11,14,23,19,21,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC14
Part 2: Participants With CRPC23
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC21
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC1Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC1Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC2Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC3Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
Bilirubin;Increase to Grade 4; n=11,14,23,19,21,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC14
Part 2: Participants With CRPC23
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC21
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
NT-BNP; Any grade increase; n=11,12,22,17,15,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC12
Part 2: Participants With CRPC22
Part 2: Participants With TNBC17
Part 2: Participants With ER+BC15
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
NT-BNP; Increase to Grade 3; n=11,12,22,17,15,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC12
Part 2: Participants With CRPC22
Part 2: Participants With TNBC17
Part 2: Participants With ER+BC15
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
NT-BNP; Increase to Grade 4; n=11,12,22,17,15,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC12
Part 2: Participants With CRPC22
Part 2: Participants With TNBC17
Part 2: Participants With ER+BC15
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
Calcium; Any grade increase; n=11,13,23,19,21,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC13
Part 2: Participants With CRPC23
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC21
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC6Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC3Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC8Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC4Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC3Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST3Not reportedNot reportedNot reportedNot reported
Calcium; Increase to Grade 3; n=11,13,23,19,21,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC13
Part 2: Participants With CRPC23
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC21
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC1Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC2Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC1Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
Calcium; Increase to Grade 4; n=11,13,23,19,21,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC13
Part 2: Participants With CRPC23
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC21
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
Cholesterol;Any grade increase;n=10,12,22,19,20,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC10
Part 2: Participants With SCLC12
Part 2: Participants With CRPC22
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC20
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC5Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC2Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC2Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC2Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC9Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST5Not reportedNot reportedNot reportedNot reported
Cholesterol;Increase to Grade3;n=10,12,22,19,20,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC10
Part 2: Participants With SCLC12
Part 2: Participants With CRPC22
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC20
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
Cholesterol;Increase to Grade4;n=10,12,22,19,20,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC10
Part 2: Participants With SCLC12
Part 2: Participants With CRPC22
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC20
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
CK; Any grade increase; n=9,9,21,17,18,11

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC9
Part 2: Participants With SCLC9
Part 2: Participants With CRPC21
Part 2: Participants With TNBC17
Part 2: Participants With ER+BC18
Part 2: Participants With GIST11
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC3Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC2Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC4Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC7Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST5Not reportedNot reportedNot reportedNot reported
CK; Increase to Grade 3; n=9,9,21,17,18,11

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC9
Part 2: Participants With SCLC9
Part 2: Participants With CRPC21
Part 2: Participants With TNBC17
Part 2: Participants With ER+BC18
Part 2: Participants With GIST11
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
CK; Increase to Grade 4; n=9,9,21,17,18,11

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC9
Part 2: Participants With SCLC9
Part 2: Participants With CRPC21
Part 2: Participants With TNBC17
Part 2: Participants With ER+BC18
Part 2: Participants With GIST11
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
Chloride; Any grade increase; n=11,13,23,19,21,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC13
Part 2: Participants With CRPC23
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC21
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
Chloride; Increase to Grade 3; n=11,13,23,19,21,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC13
Part 2: Participants With CRPC23
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC21
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
Chloride; Increase to Grade 4; n=11,13,23,19,21,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC13
Part 2: Participants With CRPC23
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC21
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
CO2; Any grade increase; n=11,12,23,19,21,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC12
Part 2: Participants With CRPC23
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC21
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
CO2; Increase to Grade 3; n=11,12,23,19,21,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC12
Part 2: Participants With CRPC23
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC21
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
CO2; Increase to Grade 4; n=11,12,23,19,21,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC12
Part 2: Participants With CRPC23
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC21
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
Creatinine;Any grade increase;n=11,14,23,19,21,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC14
Part 2: Participants With CRPC23
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC21
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC3Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC4Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC9Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC2Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC6Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST3Not reportedNot reportedNot reportedNot reported
Creatinine;Increase to Grade3;n=11,14,23,19,21,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC14
Part 2: Participants With CRPC23
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC21
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC2Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
Creatinine;Increase to Grade4;n=11,14,23,19,21,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC14
Part 2: Participants With CRPC23
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC21
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC1Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
GGT; Any grade increase; n=11,13,22,19,20,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC13
Part 2: Participants With CRPC22
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC20
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC3Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC7Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC5Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC6Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST1Not reportedNot reportedNot reportedNot reported
GGT; Increase to Grade 3; n=11,13,22,19,20,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC13
Part 2: Participants With CRPC22
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC20
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC2Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC2Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC3Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
GGT; Increase to Grade 4; n=11,13,22,19,20,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC13
Part 2: Participants With CRPC22
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC20
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC1Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
HDL; Any grade increase; n=10,10,22,19,19,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC10
Part 2: Participants With SCLC10
Part 2: Participants With CRPC22
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC19
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
HDL; Increase to Grade 3; n=10,10,22,19,19,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC10
Part 2: Participants With SCLC10
Part 2: Participants With CRPC22
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC19
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
HDL; Increase to Grade 4;n=10,10,22,19,19,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC10
Part 2: Participants With SCLC10
Part 2: Participants With CRPC22
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC19
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
Insulin; Any grade increase; n=11,12,22,19,20,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC12
Part 2: Participants With CRPC22
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC20
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
Insulin; Increase to Grade 3; n=11,12,22,19,20,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC12
Part 2: Participants With CRPC22
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC20
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
Insulin; Increase to Grade 4; n=11,12,22,19,20,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC12
Part 2: Participants With CRPC22
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC20
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
Potassium; Any grade increase; n=11,14,23,19,21,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC14
Part 2: Participants With CRPC23
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC21
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC6Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC4Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC10Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC5Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC7Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST7Not reportedNot reportedNot reportedNot reported
Potassium;Increase to Grade3;n=11,14,23,19,21,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC14
Part 2: Participants With CRPC23
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC21
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC1Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST1Not reportedNot reportedNot reportedNot reported
Potassium;Increase to Grade4;n=11,14,23,19,21,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC14
Part 2: Participants With CRPC23
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC21
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
LDL; Any grade increase; n=10,10,22,19,19,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC10
Part 2: Participants With SCLC10
Part 2: Participants With CRPC22
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC19
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
LDL; Increase to Grade 3; n=10,10,22,19,19,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC10
Part 2: Participants With SCLC10
Part 2: Participants With CRPC22
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC19
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
LDL; Increase to Grade 4;n=10,10,22,19,19,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC10
Part 2: Participants With SCLC10
Part 2: Participants With CRPC22
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC19
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
Lipase; Any grade increase; n=11,12,22,19,20,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC12
Part 2: Participants With CRPC22
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC20
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC3Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC5Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC7Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC5Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC4Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST2Not reportedNot reportedNot reportedNot reported
Lipase; Increase to Grade 3;n=11,12,22,19,20,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC12
Part 2: Participants With CRPC22
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC20
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC2Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC3Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC1Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
Lipase; Increase to Grade 4;n=11,12,22,19,20,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC12
Part 2: Participants With CRPC22
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC20
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC1Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC1Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
Magnesium; Any grade increase; n=11,12,22,19,21,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC12
Part 2: Participants With CRPC22
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC21
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC2Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC2Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC5Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC1Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC4Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST1Not reportedNot reportedNot reportedNot reported
Magnesium; Increase to Grade 3;n=11,12,22,19,21,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC12
Part 2: Participants With CRPC22
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC21
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
Magnesium; Increase to Grade4;n=11,12,22,19,21,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC12
Part 2: Participants With CRPC22
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC21
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
Protein; Any grade increase; n=11,13,23,19,21,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC13
Part 2: Participants With CRPC23
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC21
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
Protein; Increase to Grade 3;n=11,13,23,19,21,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC13
Part 2: Participants With CRPC23
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC21
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
Protein; Increase to Grade 4;n=11,13,23,19,21,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC13
Part 2: Participants With CRPC23
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC21
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
Sodium; Any grade increase; n=11, 14,23,19,21,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC14
Part 2: Participants With CRPC23
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC21
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC5Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC5Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC8Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC5Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC4Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST5Not reportedNot reportedNot reportedNot reported
Sodium; Increase to Grade 3; n=11, 14,23,19,21,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC14
Part 2: Participants With CRPC23
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC21
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC1Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC1Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC2Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST2Not reportedNot reportedNot reportedNot reported
Sodium; Increase to Grade 4; n=11, 14,23,19,21,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC14
Part 2: Participants With CRPC23
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC21
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC1Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
Thyroxine; Any grade increase;n=7,7,20,15,18,8

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC7
Part 2: Participants With SCLC7
Part 2: Participants With CRPC20
Part 2: Participants With TNBC15
Part 2: Participants With ER+BC18
Part 2: Participants With GIST8
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
Thyroxine; Increase to Grade3;n=7,7,20,15,18,8

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC7
Part 2: Participants With SCLC7
Part 2: Participants With CRPC20
Part 2: Participants With TNBC15
Part 2: Participants With ER+BC18
Part 2: Participants With GIST8
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
Thyroxine; Increase to Grade4;n=7,7,20,15,18,8

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC7
Part 2: Participants With SCLC7
Part 2: Participants With CRPC20
Part 2: Participants With TNBC15
Part 2: Participants With ER+BC18
Part 2: Participants With GIST8
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
Testosterone; Any grade increase; n=4,3,18,0,1,5

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC4
Part 2: Participants With SCLC3
Part 2: Participants With CRPC18
Part 2: Participants With TNBC0
Part 2: Participants With ER+BC1
Part 2: Participants With GIST5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
Testosterone; Increase to Grade3; n=4,3,18,0,1,5

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC4
Part 2: Participants With SCLC3
Part 2: Participants With CRPC18
Part 2: Participants With TNBC0
Part 2: Participants With ER+BC1
Part 2: Participants With GIST5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
Testosterone; Increase to Grade4; n=4,3,18,0,1,5

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC4
Part 2: Participants With SCLC3
Part 2: Participants With CRPC18
Part 2: Participants With TNBC0
Part 2: Participants With ER+BC1
Part 2: Participants With GIST5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
Triglyc;Any grade increase;n=10,12,22,19,20,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC10
Part 2: Participants With SCLC12
Part 2: Participants With CRPC22
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC20
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC7Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC7Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC15Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC10Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC11Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST8Not reportedNot reportedNot reportedNot reported
Triglyc;Increase to Grade3;n=10,12,22,19,20,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC10
Part 2: Participants With SCLC12
Part 2: Participants With CRPC22
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC20
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC1Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC4Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC1Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
Triglyc;Increase to Grade4;n=10,12,22,19,20,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC10
Part 2: Participants With SCLC12
Part 2: Participants With CRPC22
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC20
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
Troponin I; Any grade increase; n=7,6,15,15,14,7

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC7
Part 2: Participants With SCLC6
Part 2: Participants With CRPC15
Part 2: Participants With TNBC15
Part 2: Participants With ER+BC14
Part 2: Participants With GIST7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
Troponin I; Increase to Grade 3; n=7,6,15,15,14,7

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC7
Part 2: Participants With SCLC6
Part 2: Participants With CRPC15
Part 2: Participants With TNBC15
Part 2: Participants With ER+BC14
Part 2: Participants With GIST7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
Troponin I; Increase to Grade 4; n=7,6,15,15,14,7

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC7
Part 2: Participants With SCLC6
Part 2: Participants With CRPC15
Part 2: Participants With TNBC15
Part 2: Participants With ER+BC14
Part 2: Participants With GIST7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
Troponin T;Any grade increase;n=11,12,22,19,20,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC12
Part 2: Participants With CRPC22
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC20
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
Troponin T;Increase to Grade3;n=11,12,22,19,20,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC12
Part 2: Participants With CRPC22
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC20
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
Troponin T;Increase to Grade4;n=11,12,22,19,20,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC12
Part 2: Participants With CRPC22
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC20
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
Urate; Any grade increase; n=11,12,22,19,20,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC12
Part 2: Participants With CRPC22
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC20
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC2Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST2Not reportedNot reportedNot reportedNot reported
Urate; Increase to Grade 3; n=11,12,22,19,20,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC12
Part 2: Participants With CRPC22
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC20
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
Urate; Increase to Grade 4; n=11,12,22,19,20,12

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC12
Part 2: Participants With CRPC22
Part 2: Participants With TNBC19
Part 2: Participants With ER+BC20
Part 2: Participants With GIST12
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC2Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST2Not reportedNot reportedNot reportedNot reported
Urea; Any grade increase; n=11,14,23,17,17,11

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC14
Part 2: Participants With CRPC23
Part 2: Participants With TNBC17
Part 2: Participants With ER+BC17
Part 2: Participants With GIST11
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
Urea; Increase to Grade 3; n=11,14,23,17,17,11

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC14
Part 2: Participants With CRPC23
Part 2: Participants With TNBC17
Part 2: Participants With ER+BC17
Part 2: Participants With GIST11
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
Urea; Increase to Grade 4;n=11,14,23,17,17,11

Analysis denominator · Participants

GroupSource count
Part 2: Participants With NMC11
Part 2: Participants With SCLC14
Part 2: Participants With CRPC23
Part 2: Participants With TNBC17
Part 2: Participants With ER+BC17
Part 2: Participants With GIST11
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Participants With NMC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With SCLC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With CRPC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With TNBC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With ER+BC0Not reportedNot reportedNot reportedNot reported
Part 2: Participants With GIST0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        10
      3. group Id
        OG002
        value
        20
      4. group Id
        OG003
        value
        16
      5. group Id
        OG004
        value
        18
      6. group Id
        OG005
        value
        9
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        13
      3. group Id
        OG002
        value
        23
      4. group Id
        OG003
        value
        19
      5. group Id
        OG004
        value
        21
      6. group Id
        OG005
        value
        12
      units
      Participants
    title
    Glucose; Any grade increase; n=11,13,23,19,21,12
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        2
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        13
      3. group Id
        OG002
        value
        23
      4. group Id
        OG003
        value
        19
      5. group Id
        OG004
        value
        21
      6. group Id
        OG005
        value
        12
      units
      Participants
    title
    Glucose; Increase to Grade 3; n=11,13,23,19,21,12
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        13
      3. group Id
        OG002
        value
        23
      4. group Id
        OG003
        value
        19
      5. group Id
        OG004
        value
        21
      6. group Id
        OG005
        value
        12
      units
      Participants
    title
    Glucose; Increase to Grade 4; n=11,13,23,19,21,12
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        9
      4. group Id
        OG003
        value
        8
      5. group Id
        OG004
        value
        7
      6. group Id
        OG005
        value
        5
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        13
      3. group Id
        OG002
        value
        23
      4. group Id
        OG003
        value
        19
      5. group Id
        OG004
        value
        21
      6. group Id
        OG005
        value
        12
      units
      Participants
    title
    Albumin; Any grade increase; n=11,13,23,19,21,12
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        13
      3. group Id
        OG002
        value
        23
      4. group Id
        OG003
        value
        19
      5. group Id
        OG004
        value
        21
      6. group Id
        OG005
        value
        12
      units
      Participants
    title
    Albumin; Increase to Grade 3; n=11,13,23,19,21,12
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        13
      3. group Id
        OG002
        value
        23
      4. group Id
        OG003
        value
        19
      5. group Id
        OG004
        value
        21
      6. group Id
        OG005
        value
        12
      units
      Participants
    title
    Albumin; Increase to Grade 4; n=11,13,23,19,21,12
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        4
      6. group Id
        OG005
        value
        4
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        13
      3. group Id
        OG002
        value
        23
      4. group Id
        OG003
        value
        19
      5. group Id
        OG004
        value
        21
      6. group Id
        OG005
        value
        12
      units
      Participants
    title
    ALP; Any grade increase; n=11,13,23,19,21,12
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        13
      3. group Id
        OG002
        value
        23
      4. group Id
        OG003
        value
        19
      5. group Id
        OG004
        value
        21
      6. group Id
        OG005
        value
        12
      units
      Participants
    title
    ALP; Increase to Grade 3; n=11,13,23,19,21,12
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        13
      3. group Id
        OG002
        value
        23
      4. group Id
        OG003
        value
        19
      5. group Id
        OG004
        value
        21
      6. group Id
        OG005
        value
        12
      units
      Participants
    title
    ALP; Increase to Grade 4; n=11,13,23,19,21,12
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        5
      5. group Id
        OG004
        value
        12
      6. group Id
        OG005
        value
        3
    denoms
    1. counts
      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
        12
      units
      Participants
    title
    ALT; Any grade increase; n=11,14,23,19,21,12
  11. 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
        0
      6. group Id
        OG005
        value
        0
    denoms
    1. counts
      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
        12
      units
      Participants
    title
    ALT; Increase to Grade 3; n=11,14,23,19,21,12
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    denoms
    1. counts
      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
        12
      units
      Participants
    title
    ALT; Increase to Grade 4; n=11,14,23,19,21,12
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
Blood samples were collected for the analysis of clinical chemistry parameters: glucose, albumin, ALP, ALT, amylase, AST, Dir bil, bilirubin, NT-BNP, calcium, cholesterol, CK, chloride, CO2, creatinine, GGT, HDL and LDL cholesterol, insulin, potassium, LDH, lipase, magnesium, protein, sodium, thyroxine, testosterone, triglycerides (triglyc), troponin I and T, urate and urea. 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
  1. description
    Participants with NUT Midline Carcinoma (NMC) were administered continuous once daily oral dose of 75 mg GSK525762.
    id
    OG000
    title
    Part 2: 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
    Part 2: 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
    Part 2: 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
    Part 2: 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
    Part 2: 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
    Part 2: 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 Clinical Chemistry Data-Part 2
type
PRIMARY
unit Of Measure
Participants

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