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
Group
Source count
Part 2: Participants With NMC
12
Part 2: Participants With SCLC
14
Part 2: Participants With CRPC
23
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
21
Part 2: Participants With GIST
13
Reported measurements
Glucose; Any grade increase; n=11,13,23,19,21,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
13
Part 2: Participants With CRPC
23
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
21
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
10
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
10
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
20
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
16
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
18
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
9
Not reported
Not reported
Not reported
Not reported
Glucose; Increase to Grade 3; n=11,13,23,19,21,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
13
Part 2: Participants With CRPC
23
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
21
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
1
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
2
Not reported
Not reported
Not reported
Not reported
Glucose; Increase to Grade 4; n=11,13,23,19,21,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
13
Part 2: Participants With CRPC
23
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
21
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
Albumin; Any grade increase; n=11,13,23,19,21,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
13
Part 2: Participants With CRPC
23
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
21
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
5
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
6
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
9
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
8
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
7
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
5
Not reported
Not reported
Not reported
Not reported
Albumin; Increase to Grade 3; n=11,13,23,19,21,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
13
Part 2: Participants With CRPC
23
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
21
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
1
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
Albumin; Increase to Grade 4; n=11,13,23,19,21,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
13
Part 2: Participants With CRPC
23
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
21
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
ALP; Any grade increase; n=11,13,23,19,21,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
13
Part 2: Participants With CRPC
23
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
21
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
3
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
1
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
6
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
3
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
4
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
4
Not reported
Not reported
Not reported
Not reported
ALP; Increase to Grade 3; n=11,13,23,19,21,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
13
Part 2: Participants With CRPC
23
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
21
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
2
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
ALP; Increase to Grade 4; n=11,13,23,19,21,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
13
Part 2: Participants With CRPC
23
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
21
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
ALT; Any grade increase; n=11,14,23,19,21,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
14
Part 2: Participants With CRPC
23
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
21
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
3
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
6
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
6
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
5
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
12
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
3
Not reported
Not reported
Not reported
Not reported
ALT; Increase to Grade 3; n=11,14,23,19,21,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
14
Part 2: Participants With CRPC
23
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
21
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
1
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
ALT; Increase to Grade 4; n=11,14,23,19,21,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
14
Part 2: Participants With CRPC
23
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
21
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
Amylase; Any grade increase; n=11,12,22,19,20,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
12
Part 2: Participants With CRPC
22
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
20
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
5
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
5
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
9
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
5
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
6
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
1
Not reported
Not reported
Not reported
Not reported
Amylase; Increase to Grade 3; n=11,12,22,19,20,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
12
Part 2: Participants With CRPC
22
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
20
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
1
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
2
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
2
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
2
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
2
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
Amylase; Increase to Grade 4; n=11,12,22,19,20,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
12
Part 2: Participants With CRPC
22
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
20
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
AST; Any grade increase; n=11,13,23,19,21,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
13
Part 2: Participants With CRPC
23
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
21
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
3
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
5
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
10
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
8
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
14
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
6
Not reported
Not reported
Not reported
Not reported
AST; Increase to Grade 3; n=11,13,23,19,21,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
13
Part 2: Participants With CRPC
23
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
21
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
1
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
1
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
3
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
AST; Increase to Grade 4; n=11,13,23,19,21,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
13
Part 2: Participants With CRPC
23
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
21
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
Dir bil; Any grade increase; n=11,13,23,19,20,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
13
Part 2: Participants With CRPC
23
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
20
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
Dir bil; Increase to Grade 3; n=11,13,23,19,20,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
13
Part 2: Participants With CRPC
23
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
20
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
Dir bil; Increase to Grade 4; n=11,13,23,19,20,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
13
Part 2: Participants With CRPC
23
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
20
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
Bilirubin;Any grade increase;n=11,14,23,19,21,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
14
Part 2: Participants With CRPC
23
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
21
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
8
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
10
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
13
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
6
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
13
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
4
Not reported
Not reported
Not reported
Not reported
Bilirubin;Increase to Grade 3; n=11,14,23,19,21,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
14
Part 2: Participants With CRPC
23
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
21
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
1
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
1
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
2
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
3
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
Bilirubin;Increase to Grade 4; n=11,14,23,19,21,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
14
Part 2: Participants With CRPC
23
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
21
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
NT-BNP; Any grade increase; n=11,12,22,17,15,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
12
Part 2: Participants With CRPC
22
Part 2: Participants With TNBC
17
Part 2: Participants With ER+BC
15
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
NT-BNP; Increase to Grade 3; n=11,12,22,17,15,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
12
Part 2: Participants With CRPC
22
Part 2: Participants With TNBC
17
Part 2: Participants With ER+BC
15
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
NT-BNP; Increase to Grade 4; n=11,12,22,17,15,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
12
Part 2: Participants With CRPC
22
Part 2: Participants With TNBC
17
Part 2: Participants With ER+BC
15
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
Calcium; Any grade increase; n=11,13,23,19,21,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
13
Part 2: Participants With CRPC
23
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
21
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
6
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
3
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
8
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
4
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
3
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
3
Not reported
Not reported
Not reported
Not reported
Calcium; Increase to Grade 3; n=11,13,23,19,21,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
13
Part 2: Participants With CRPC
23
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
21
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
1
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
2
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
1
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
Calcium; Increase to Grade 4; n=11,13,23,19,21,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
13
Part 2: Participants With CRPC
23
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
21
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
5
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
2
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
2
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
2
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
9
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
5
Not reported
Not reported
Not reported
Not reported
Cholesterol;Increase to Grade3;n=10,12,22,19,20,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
10
Part 2: Participants With SCLC
12
Part 2: Participants With CRPC
22
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
20
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
Cholesterol;Increase to Grade4;n=10,12,22,19,20,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
10
Part 2: Participants With SCLC
12
Part 2: Participants With CRPC
22
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
20
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
CK; Any grade increase; n=9,9,21,17,18,11
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
9
Part 2: Participants With SCLC
9
Part 2: Participants With CRPC
21
Part 2: Participants With TNBC
17
Part 2: Participants With ER+BC
18
Part 2: Participants With GIST
11
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
3
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
2
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
4
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
7
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
5
Not reported
Not reported
Not reported
Not reported
CK; Increase to Grade 3; n=9,9,21,17,18,11
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
9
Part 2: Participants With SCLC
9
Part 2: Participants With CRPC
21
Part 2: Participants With TNBC
17
Part 2: Participants With ER+BC
18
Part 2: Participants With GIST
11
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
CK; Increase to Grade 4; n=9,9,21,17,18,11
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
9
Part 2: Participants With SCLC
9
Part 2: Participants With CRPC
21
Part 2: Participants With TNBC
17
Part 2: Participants With ER+BC
18
Part 2: Participants With GIST
11
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
Chloride; Any grade increase; n=11,13,23,19,21,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
13
Part 2: Participants With CRPC
23
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
21
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
Chloride; Increase to Grade 3; n=11,13,23,19,21,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
13
Part 2: Participants With CRPC
23
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
21
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
Chloride; Increase to Grade 4; n=11,13,23,19,21,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
13
Part 2: Participants With CRPC
23
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
21
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
CO2; Any grade increase; n=11,12,23,19,21,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
12
Part 2: Participants With CRPC
23
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
21
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
CO2; Increase to Grade 3; n=11,12,23,19,21,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
12
Part 2: Participants With CRPC
23
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
21
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
CO2; Increase to Grade 4; n=11,12,23,19,21,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
12
Part 2: Participants With CRPC
23
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
21
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
Creatinine;Any grade increase;n=11,14,23,19,21,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
14
Part 2: Participants With CRPC
23
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
21
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
3
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
4
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
9
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
2
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
6
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
3
Not reported
Not reported
Not reported
Not reported
Creatinine;Increase to Grade3;n=11,14,23,19,21,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
14
Part 2: Participants With CRPC
23
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
21
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
2
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
Creatinine;Increase to Grade4;n=11,14,23,19,21,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
14
Part 2: Participants With CRPC
23
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
21
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
1
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
GGT; Any grade increase; n=11,13,22,19,20,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
13
Part 2: Participants With CRPC
22
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
20
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
3
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
7
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
5
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
6
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
1
Not reported
Not reported
Not reported
Not reported
GGT; Increase to Grade 3; n=11,13,22,19,20,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
13
Part 2: Participants With CRPC
22
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
20
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
2
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
2
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
3
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
GGT; Increase to Grade 4; n=11,13,22,19,20,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
13
Part 2: Participants With CRPC
22
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
20
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
1
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
HDL; Any grade increase; n=10,10,22,19,19,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
10
Part 2: Participants With SCLC
10
Part 2: Participants With CRPC
22
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
19
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
HDL; Increase to Grade 3; n=10,10,22,19,19,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
10
Part 2: Participants With SCLC
10
Part 2: Participants With CRPC
22
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
19
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
HDL; Increase to Grade 4;n=10,10,22,19,19,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
10
Part 2: Participants With SCLC
10
Part 2: Participants With CRPC
22
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
19
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
Insulin; Any grade increase; n=11,12,22,19,20,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
12
Part 2: Participants With CRPC
22
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
20
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
Insulin; Increase to Grade 3; n=11,12,22,19,20,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
12
Part 2: Participants With CRPC
22
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
20
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
Insulin; Increase to Grade 4; n=11,12,22,19,20,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
12
Part 2: Participants With CRPC
22
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
20
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
Potassium; Any grade increase; n=11,14,23,19,21,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
14
Part 2: Participants With CRPC
23
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
21
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
6
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
4
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
10
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
5
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
7
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
7
Not reported
Not reported
Not reported
Not reported
Potassium;Increase to Grade3;n=11,14,23,19,21,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
14
Part 2: Participants With CRPC
23
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
21
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
1
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
1
Not reported
Not reported
Not reported
Not reported
Potassium;Increase to Grade4;n=11,14,23,19,21,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
14
Part 2: Participants With CRPC
23
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
21
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
LDL; Any grade increase; n=10,10,22,19,19,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
10
Part 2: Participants With SCLC
10
Part 2: Participants With CRPC
22
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
19
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
LDL; Increase to Grade 3; n=10,10,22,19,19,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
10
Part 2: Participants With SCLC
10
Part 2: Participants With CRPC
22
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
19
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
LDL; Increase to Grade 4;n=10,10,22,19,19,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
10
Part 2: Participants With SCLC
10
Part 2: Participants With CRPC
22
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
19
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
Lipase; Any grade increase; n=11,12,22,19,20,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
12
Part 2: Participants With CRPC
22
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
20
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
3
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
5
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
7
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
5
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
4
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
2
Not reported
Not reported
Not reported
Not reported
Lipase; Increase to Grade 3;n=11,12,22,19,20,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
12
Part 2: Participants With CRPC
22
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
20
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
2
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
3
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
1
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
Lipase; Increase to Grade 4;n=11,12,22,19,20,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
12
Part 2: Participants With CRPC
22
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
20
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
1
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
1
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
Magnesium; Any grade increase; n=11,12,22,19,21,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
12
Part 2: Participants With CRPC
22
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
21
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
2
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
2
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
5
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
1
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
4
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
1
Not reported
Not reported
Not reported
Not reported
Magnesium; Increase to Grade 3;n=11,12,22,19,21,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
12
Part 2: Participants With CRPC
22
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
21
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
Magnesium; Increase to Grade4;n=11,12,22,19,21,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
12
Part 2: Participants With CRPC
22
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
21
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
Protein; Any grade increase; n=11,13,23,19,21,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
13
Part 2: Participants With CRPC
23
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
21
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
Protein; Increase to Grade 3;n=11,13,23,19,21,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
13
Part 2: Participants With CRPC
23
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
21
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
Protein; Increase to Grade 4;n=11,13,23,19,21,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
13
Part 2: Participants With CRPC
23
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
21
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
Sodium; Any grade increase; n=11, 14,23,19,21,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
14
Part 2: Participants With CRPC
23
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
21
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
5
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
5
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
8
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
5
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
4
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
5
Not reported
Not reported
Not reported
Not reported
Sodium; Increase to Grade 3; n=11, 14,23,19,21,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
14
Part 2: Participants With CRPC
23
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
21
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
1
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
1
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
2
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
2
Not reported
Not reported
Not reported
Not reported
Sodium; Increase to Grade 4; n=11, 14,23,19,21,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
14
Part 2: Participants With CRPC
23
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
21
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
1
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
Thyroxine; Any grade increase;n=7,7,20,15,18,8
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
7
Part 2: Participants With SCLC
7
Part 2: Participants With CRPC
20
Part 2: Participants With TNBC
15
Part 2: Participants With ER+BC
18
Part 2: Participants With GIST
8
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
Thyroxine; Increase to Grade3;n=7,7,20,15,18,8
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
7
Part 2: Participants With SCLC
7
Part 2: Participants With CRPC
20
Part 2: Participants With TNBC
15
Part 2: Participants With ER+BC
18
Part 2: Participants With GIST
8
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
Thyroxine; Increase to Grade4;n=7,7,20,15,18,8
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
7
Part 2: Participants With SCLC
7
Part 2: Participants With CRPC
20
Part 2: Participants With TNBC
15
Part 2: Participants With ER+BC
18
Part 2: Participants With GIST
8
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
Testosterone; Any grade increase; n=4,3,18,0,1,5
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
4
Part 2: Participants With SCLC
3
Part 2: Participants With CRPC
18
Part 2: Participants With TNBC
0
Part 2: Participants With ER+BC
1
Part 2: Participants With GIST
5
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
Testosterone; Increase to Grade3; n=4,3,18,0,1,5
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
4
Part 2: Participants With SCLC
3
Part 2: Participants With CRPC
18
Part 2: Participants With TNBC
0
Part 2: Participants With ER+BC
1
Part 2: Participants With GIST
5
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
Testosterone; Increase to Grade4; n=4,3,18,0,1,5
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
4
Part 2: Participants With SCLC
3
Part 2: Participants With CRPC
18
Part 2: Participants With TNBC
0
Part 2: Participants With ER+BC
1
Part 2: Participants With GIST
5
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
Triglyc;Any grade increase;n=10,12,22,19,20,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
10
Part 2: Participants With SCLC
12
Part 2: Participants With CRPC
22
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
20
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
7
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
7
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
15
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
10
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
11
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
8
Not reported
Not reported
Not reported
Not reported
Triglyc;Increase to Grade3;n=10,12,22,19,20,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
10
Part 2: Participants With SCLC
12
Part 2: Participants With CRPC
22
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
20
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
1
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
4
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
1
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
Triglyc;Increase to Grade4;n=10,12,22,19,20,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
10
Part 2: Participants With SCLC
12
Part 2: Participants With CRPC
22
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
20
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
Troponin I; Any grade increase; n=7,6,15,15,14,7
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
7
Part 2: Participants With SCLC
6
Part 2: Participants With CRPC
15
Part 2: Participants With TNBC
15
Part 2: Participants With ER+BC
14
Part 2: Participants With GIST
7
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
Troponin I; Increase to Grade 3; n=7,6,15,15,14,7
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
7
Part 2: Participants With SCLC
6
Part 2: Participants With CRPC
15
Part 2: Participants With TNBC
15
Part 2: Participants With ER+BC
14
Part 2: Participants With GIST
7
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
Troponin I; Increase to Grade 4; n=7,6,15,15,14,7
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
7
Part 2: Participants With SCLC
6
Part 2: Participants With CRPC
15
Part 2: Participants With TNBC
15
Part 2: Participants With ER+BC
14
Part 2: Participants With GIST
7
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
Troponin T;Any grade increase;n=11,12,22,19,20,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
12
Part 2: Participants With CRPC
22
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
20
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
Troponin T;Increase to Grade3;n=11,12,22,19,20,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
12
Part 2: Participants With CRPC
22
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
20
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
Troponin T;Increase to Grade4;n=11,12,22,19,20,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
12
Part 2: Participants With CRPC
22
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
20
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
Urate; Any grade increase; n=11,12,22,19,20,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
12
Part 2: Participants With CRPC
22
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
20
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
2
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
2
Not reported
Not reported
Not reported
Not reported
Urate; Increase to Grade 3; n=11,12,22,19,20,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
12
Part 2: Participants With CRPC
22
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
20
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
Urate; Increase to Grade 4; n=11,12,22,19,20,12
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
12
Part 2: Participants With CRPC
22
Part 2: Participants With TNBC
19
Part 2: Participants With ER+BC
20
Part 2: Participants With GIST
12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
2
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
2
Not reported
Not reported
Not reported
Not reported
Urea; Any grade increase; n=11,14,23,17,17,11
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
14
Part 2: Participants With CRPC
23
Part 2: Participants With TNBC
17
Part 2: Participants With ER+BC
17
Part 2: Participants With GIST
11
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
Urea; Increase to Grade 3; n=11,14,23,17,17,11
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
14
Part 2: Participants With CRPC
23
Part 2: Participants With TNBC
17
Part 2: Participants With ER+BC
17
Part 2: Participants With GIST
11
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
Urea; Increase to Grade 4;n=11,14,23,17,17,11
Analysis denominator · Participants
Group
Source count
Part 2: Participants With NMC
11
Part 2: Participants With SCLC
14
Part 2: Participants With CRPC
23
Part 2: Participants With TNBC
17
Part 2: Participants With ER+BC
17
Part 2: Participants With GIST
11
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: Participants With NMC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With SCLC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With CRPC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With TNBC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With ER+BC
0
Not reported
Not reported
Not reported
Not reported
Part 2: Participants With GIST
0
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
10
group Id
OG001
value
10
group Id
OG002
value
20
group Id
OG003
value
16
group Id
OG004
value
18
group Id
OG005
value
9
denoms
counts
group Id
OG000
value
11
group Id
OG001
value
13
group Id
OG002
value
23
group Id
OG003
value
19
group Id
OG004
value
21
group Id
OG005
value
12
units
Participants
title
Glucose; Any grade increase; n=11,13,23,19,21,12
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
1
group Id
OG005
value
2
denoms
counts
group Id
OG000
value
11
group Id
OG001
value
13
group Id
OG002
value
23
group Id
OG003
value
19
group Id
OG004
value
21
group Id
OG005
value
12
units
Participants
title
Glucose; Increase to Grade 3; n=11,13,23,19,21,12
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
denoms
counts
group Id
OG000
value
11
group Id
OG001
value
13
group Id
OG002
value
23
group Id
OG003
value
19
group Id
OG004
value
21
group Id
OG005
value
12
units
Participants
title
Glucose; Increase to Grade 4; n=11,13,23,19,21,12
categories
measurements
group Id
OG000
value
5
group Id
OG001
value
6
group Id
OG002
value
9
group Id
OG003
value
8
group Id
OG004
value
7
group Id
OG005
value
5
denoms
counts
group Id
OG000
value
11
group Id
OG001
value
13
group Id
OG002
value
23
group Id
OG003
value
19
group Id
OG004
value
21
group Id
OG005
value
12
units
Participants
title
Albumin; Any grade increase; n=11,13,23,19,21,12
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
1
group Id
OG005
value
0
denoms
counts
group Id
OG000
value
11
group Id
OG001
value
13
group Id
OG002
value
23
group Id
OG003
value
19
group Id
OG004
value
21
group Id
OG005
value
12
units
Participants
title
Albumin; Increase to Grade 3; n=11,13,23,19,21,12
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
denoms
counts
group Id
OG000
value
11
group Id
OG001
value
13
group Id
OG002
value
23
group Id
OG003
value
19
group Id
OG004
value
21
group Id
OG005
value
12
units
Participants
title
Albumin; Increase to Grade 4; n=11,13,23,19,21,12
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
1
group Id
OG002
value
6
group Id
OG003
value
3
group Id
OG004
value
4
group Id
OG005
value
4
denoms
counts
group Id
OG000
value
11
group Id
OG001
value
13
group Id
OG002
value
23
group Id
OG003
value
19
group Id
OG004
value
21
group Id
OG005
value
12
units
Participants
title
ALP; Any grade increase; n=11,13,23,19,21,12
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
2
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
denoms
counts
group Id
OG000
value
11
group Id
OG001
value
13
group Id
OG002
value
23
group Id
OG003
value
19
group Id
OG004
value
21
group Id
OG005
value
12
units
Participants
title
ALP; Increase to Grade 3; n=11,13,23,19,21,12
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
denoms
counts
group Id
OG000
value
11
group Id
OG001
value
13
group Id
OG002
value
23
group Id
OG003
value
19
group Id
OG004
value
21
group Id
OG005
value
12
units
Participants
title
ALP; Increase to Grade 4; n=11,13,23,19,21,12
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
6
group Id
OG002
value
6
group Id
OG003
value
5
group Id
OG004
value
12
group Id
OG005
value
3
denoms
counts
group Id
OG000
value
11
group Id
OG001
value
14
group Id
OG002
value
23
group Id
OG003
value
19
group Id
OG004
value
21
group Id
OG005
value
12
units
Participants
title
ALT; Any grade increase; n=11,14,23,19,21,12
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
denoms
counts
group Id
OG000
value
11
group Id
OG001
value
14
group Id
OG002
value
23
group Id
OG003
value
19
group Id
OG004
value
21
group Id
OG005
value
12
units
Participants
title
ALT; Increase to Grade 3; n=11,14,23,19,21,12
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
denoms
counts
group Id
OG000
value
11
group Id
OG001
value
14
group Id
OG002
value
23
group Id
OG003
value
19
group Id
OG004
value
21
group Id
OG005
value
12
units
Participants
title
ALT; Increase to Grade 4; n=11,14,23,19,21,12
denoms
counts
group Id
OG000
value
12
group Id
OG001
value
14
group Id
OG002
value
23
group Id
OG003
value
19
group Id
OG004
value
21
group Id
OG005
value
13
units
Participants
description
Blood samples were collected for the analysis of 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
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
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
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
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
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
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