Percentage of Participants With Laboratory Abnormalities
A Study of the Safety, Tolerability, and Effects of Cobimetinib and GDC-0994 in Patients With Locally Advanced or Metastatic Solid Tumors · Source last updated 2018-11-20
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
Up to 15 months
What was measured
Laboratory abnormalities were graded per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v4.0.
SGPT/ALT - serum glutamic-pyruvic transaminase/alanine aminotransferase; SGOT/AST - serum glutamic oxaloacetic transaminase/aspartate aminotransferase
Analysis population: All participants. Data are reported for evaluable participants.
Groups in this outcome
Not Assigned
One participant was assigned to receive intermittent cobimetinib 80 milligrams (mg) + GDC 0994 200 mg) and did receive study drug. However, the participant diary was not returned, and the site was unable to document study dose administration.
COB 20 mg + GDC 200 mg
Concurrent or intermittent dosing of cobimetinib 20 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
COB 40 mg + GDC 200 mg
Concurrent or intermittent dosing of cobimetinib 40 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
COB 80 mg + GDC 200 mg
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
COB 80 mg + GDC 400 mg
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 400 mg for 21 consecutive days, followed by 7 days off.
COB 100 mg + GDC 200 mg
Concurrent or intermittent dosing of cobimetinib 100 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
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
Not Assigned
1
COB 20 mg + GDC 200 mg
5
COB 40 mg + GDC 200 mg
3
COB 80 mg + GDC 200 mg
5
COB 80 mg + GDC 400 mg
4
COB 100 mg + GDC 200 mg
6
Reported measurements
Albumin
Analysis denominator · Participants
Group
Source count
Not Assigned
1
COB 20 mg + GDC 200 mg
5
COB 40 mg + GDC 200 mg
3
COB 80 mg + GDC 200 mg
5
COB 80 mg + GDC 400 mg
4
COB 100 mg + GDC 200 mg
6
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Not Assigned
100.0
Not reported
Not reported
Not reported
Not reported
COB 20 mg + GDC 200 mg
80.0
Not reported
Not reported
Not reported
Not reported
COB 40 mg + GDC 200 mg
66.7
Not reported
Not reported
Not reported
Not reported
COB 80 mg + GDC 200 mg
100.0
Not reported
Not reported
Not reported
Not reported
COB 80 mg + GDC 400 mg
100.0
Not reported
Not reported
Not reported
Not reported
COB 100 mg + GDC 200 mg
83.3
Not reported
Not reported
Not reported
Not reported
Alkaline Phosphatase
Analysis denominator · Participants
Group
Source count
Not Assigned
1
COB 20 mg + GDC 200 mg
5
COB 40 mg + GDC 200 mg
3
COB 80 mg + GDC 200 mg
5
COB 80 mg + GDC 400 mg
4
COB 100 mg + GDC 200 mg
6
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Not Assigned
100.0
Not reported
Not reported
Not reported
Not reported
COB 20 mg + GDC 200 mg
80.0
Not reported
Not reported
Not reported
Not reported
COB 40 mg + GDC 200 mg
66.7
Not reported
Not reported
Not reported
Not reported
COB 80 mg + GDC 200 mg
80.0
Not reported
Not reported
Not reported
Not reported
COB 80 mg + GDC 400 mg
75.0
Not reported
Not reported
Not reported
Not reported
COB 100 mg + GDC 200 mg
50.0
Not reported
Not reported
Not reported
Not reported
SGPT/ALT
Analysis denominator · Participants
Group
Source count
Not Assigned
1
COB 20 mg + GDC 200 mg
5
COB 40 mg + GDC 200 mg
3
COB 80 mg + GDC 200 mg
5
COB 80 mg + GDC 400 mg
4
COB 100 mg + GDC 200 mg
6
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Not Assigned
0.0
Not reported
Not reported
Not reported
Not reported
COB 20 mg + GDC 200 mg
60.0
Not reported
Not reported
Not reported
Not reported
COB 40 mg + GDC 200 mg
0.0
Not reported
Not reported
Not reported
Not reported
COB 80 mg + GDC 200 mg
60.0
Not reported
Not reported
Not reported
Not reported
COB 80 mg + GDC 400 mg
25.0
Not reported
Not reported
Not reported
Not reported
COB 100 mg + GDC 200 mg
33.3
Not reported
Not reported
Not reported
Not reported
SGOT/AST
Analysis denominator · Participants
Group
Source count
Not Assigned
1
COB 20 mg + GDC 200 mg
5
COB 40 mg + GDC 200 mg
3
COB 80 mg + GDC 200 mg
5
COB 80 mg + GDC 400 mg
4
COB 100 mg + GDC 200 mg
6
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Not Assigned
100.0
Not reported
Not reported
Not reported
Not reported
COB 20 mg + GDC 200 mg
100.0
Not reported
Not reported
Not reported
Not reported
COB 40 mg + GDC 200 mg
66.7
Not reported
Not reported
Not reported
Not reported
COB 80 mg + GDC 200 mg
60.0
Not reported
Not reported
Not reported
Not reported
COB 80 mg + GDC 400 mg
75.0
Not reported
Not reported
Not reported
Not reported
COB 100 mg + GDC 200 mg
50.0
Not reported
Not reported
Not reported
Not reported
Calcium
Analysis denominator · Participants
Group
Source count
Not Assigned
1
COB 20 mg + GDC 200 mg
5
COB 40 mg + GDC 200 mg
3
COB 80 mg + GDC 200 mg
5
COB 80 mg + GDC 400 mg
4
COB 100 mg + GDC 200 mg
6
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Not Assigned
100.0
Not reported
Not reported
Not reported
Not reported
COB 20 mg + GDC 200 mg
20.0
Not reported
Not reported
Not reported
Not reported
COB 40 mg + GDC 200 mg
33.3
Not reported
Not reported
Not reported
Not reported
COB 80 mg + GDC 200 mg
80.0
Not reported
Not reported
Not reported
Not reported
COB 80 mg + GDC 400 mg
100.0
Not reported
Not reported
Not reported
Not reported
COB 100 mg + GDC 200 mg
33.3
Not reported
Not reported
Not reported
Not reported
Creatinine
Analysis denominator · Participants
Group
Source count
Not Assigned
1
COB 20 mg + GDC 200 mg
5
COB 40 mg + GDC 200 mg
3
COB 80 mg + GDC 200 mg
5
COB 80 mg + GDC 400 mg
4
COB 100 mg + GDC 200 mg
6
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Not Assigned
100.0
Not reported
Not reported
Not reported
Not reported
COB 20 mg + GDC 200 mg
100.0
Not reported
Not reported
Not reported
Not reported
COB 40 mg + GDC 200 mg
100.0
Not reported
Not reported
Not reported
Not reported
COB 80 mg + GDC 200 mg
100.0
Not reported
Not reported
Not reported
Not reported
COB 80 mg + GDC 400 mg
100.0
Not reported
Not reported
Not reported
Not reported
COB 100 mg + GDC 200 mg
50.0
Not reported
Not reported
Not reported
Not reported
Blood Glucose, Fasting
Analysis denominator · Participants
Group
Source count
Not Assigned
1
COB 20 mg + GDC 200 mg
4
COB 40 mg + GDC 200 mg
2
COB 80 mg + GDC 200 mg
3
COB 80 mg + GDC 400 mg
3
COB 100 mg + GDC 200 mg
1
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Not Assigned
0.0
Not reported
Not reported
Not reported
Not reported
COB 20 mg + GDC 200 mg
100.0
Not reported
Not reported
Not reported
Not reported
COB 40 mg + GDC 200 mg
100.0
Not reported
Not reported
Not reported
Not reported
COB 80 mg + GDC 200 mg
0.0
Not reported
Not reported
Not reported
Not reported
COB 80 mg + GDC 400 mg
66.6
Not reported
Not reported
Not reported
Not reported
COB 100 mg + GDC 200 mg
100.0
Not reported
Not reported
Not reported
Not reported
Gamma Glutamyl Transferase
Analysis denominator · Participants
Group
Source count
Not Assigned
1
COB 20 mg + GDC 200 mg
5
COB 40 mg + GDC 200 mg
3
COB 80 mg + GDC 200 mg
5
COB 80 mg + GDC 400 mg
4
COB 100 mg + GDC 200 mg
6
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Not Assigned
100.0
Not reported
Not reported
Not reported
Not reported
COB 20 mg + GDC 200 mg
60.0
Not reported
Not reported
Not reported
Not reported
COB 40 mg + GDC 200 mg
66.7
Not reported
Not reported
Not reported
Not reported
COB 80 mg + GDC 200 mg
60.0
Not reported
Not reported
Not reported
Not reported
COB 80 mg + GDC 400 mg
75.0
Not reported
Not reported
Not reported
Not reported
COB 100 mg + GDC 200 mg
50.0
Not reported
Not reported
Not reported
Not reported
Glucose
Analysis denominator · Participants
Group
Source count
Not Assigned
1
COB 20 mg + GDC 200 mg
5
COB 40 mg + GDC 200 mg
3
COB 80 mg + GDC 200 mg
5
COB 80 mg + GDC 400 mg
3
COB 100 mg + GDC 200 mg
6
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Not Assigned
0
Not reported
Not reported
Not reported
Not reported
COB 20 mg + GDC 200 mg
20.0
Not reported
Not reported
Not reported
Not reported
COB 40 mg + GDC 200 mg
0.0
Not reported
Not reported
Not reported
Not reported
COB 80 mg + GDC 200 mg
0.0
Not reported
Not reported
Not reported
Not reported
COB 80 mg + GDC 400 mg
0.0
Not reported
Not reported
Not reported
Not reported
COB 100 mg + GDC 200 mg
0.0
Not reported
Not reported
Not reported
Not reported
Hemoglobin
Analysis denominator · Participants
Group
Source count
Not Assigned
1
COB 20 mg + GDC 200 mg
5
COB 40 mg + GDC 200 mg
3
COB 80 mg + GDC 200 mg
5
COB 80 mg + GDC 400 mg
4
COB 100 mg + GDC 200 mg
6
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Not Assigned
100.0
Not reported
Not reported
Not reported
Not reported
COB 20 mg + GDC 200 mg
60.0
Not reported
Not reported
Not reported
Not reported
COB 40 mg + GDC 200 mg
66.7
Not reported
Not reported
Not reported
Not reported
COB 80 mg + GDC 200 mg
100.0
Not reported
Not reported
Not reported
Not reported
COB 80 mg + GDC 400 mg
75.0
Not reported
Not reported
Not reported
Not reported
COB 100 mg + GDC 200 mg
66.7
Not reported
Not reported
Not reported
Not reported
Lymphocytes, Absolute
Analysis denominator · Participants
Group
Source count
Not Assigned
1
COB 20 mg + GDC 200 mg
5
COB 40 mg + GDC 200 mg
3
COB 80 mg + GDC 200 mg
5
COB 80 mg + GDC 400 mg
4
COB 100 mg + GDC 200 mg
6
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Not Assigned
100.0
Not reported
Not reported
Not reported
Not reported
COB 20 mg + GDC 200 mg
40.0
Not reported
Not reported
Not reported
Not reported
COB 40 mg + GDC 200 mg
33.3
Not reported
Not reported
Not reported
Not reported
COB 80 mg + GDC 200 mg
60.0
Not reported
Not reported
Not reported
Not reported
COB 80 mg + GDC 400 mg
50.0
Not reported
Not reported
Not reported
Not reported
COB 100 mg + GDC 200 mg
16.7
Not reported
Not reported
Not reported
Not reported
Magnesium
Analysis denominator · Participants
Group
Source count
Not Assigned
1
COB 20 mg + GDC 200 mg
5
COB 40 mg + GDC 200 mg
3
COB 80 mg + GDC 200 mg
5
COB 80 mg + GDC 400 mg
4
COB 100 mg + GDC 200 mg
6
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Not Assigned
100.0
Not reported
Not reported
Not reported
Not reported
COB 20 mg + GDC 200 mg
40.0
Not reported
Not reported
Not reported
Not reported
COB 40 mg + GDC 200 mg
66.6
Not reported
Not reported
Not reported
Not reported
COB 80 mg + GDC 200 mg
20.0
Not reported
Not reported
Not reported
Not reported
COB 80 mg + GDC 400 mg
50.0
Not reported
Not reported
Not reported
Not reported
COB 100 mg + GDC 200 mg
16.7
Not reported
Not reported
Not reported
Not reported
Phosphorus
Analysis denominator · Participants
Group
Source count
Not Assigned
1
COB 20 mg + GDC 200 mg
5
COB 40 mg + GDC 200 mg
3
COB 80 mg + GDC 200 mg
5
COB 80 mg + GDC 400 mg
4
COB 100 mg + GDC 200 mg
6
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Not Assigned
0.0
Not reported
Not reported
Not reported
Not reported
COB 20 mg + GDC 200 mg
20.0
Not reported
Not reported
Not reported
Not reported
COB 40 mg + GDC 200 mg
0.0
Not reported
Not reported
Not reported
Not reported
COB 80 mg + GDC 200 mg
0.0
Not reported
Not reported
Not reported
Not reported
COB 80 mg + GDC 400 mg
25.0
Not reported
Not reported
Not reported
Not reported
COB 100 mg + GDC 200 mg
0.0
Not reported
Not reported
Not reported
Not reported
Platelets
Analysis denominator · Participants
Group
Source count
Not Assigned
1
COB 20 mg + GDC 200 mg
5
COB 40 mg + GDC 200 mg
3
COB 80 mg + GDC 200 mg
5
COB 80 mg + GDC 400 mg
4
COB 100 mg + GDC 200 mg
6
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Not Assigned
0.0
Not reported
Not reported
Not reported
Not reported
COB 20 mg + GDC 200 mg
20.0
Not reported
Not reported
Not reported
Not reported
COB 40 mg + GDC 200 mg
33.3
Not reported
Not reported
Not reported
Not reported
COB 80 mg + GDC 200 mg
40.0
Not reported
Not reported
Not reported
Not reported
COB 80 mg + GDC 400 mg
50.0
Not reported
Not reported
Not reported
Not reported
COB 100 mg + GDC 200 mg
33.3
Not reported
Not reported
Not reported
Not reported
Potassium
Analysis denominator · Participants
Group
Source count
Not Assigned
1
COB 20 mg + GDC 200 mg
5
COB 40 mg + GDC 200 mg
3
COB 80 mg + GDC 200 mg
5
COB 80 mg + GDC 400 mg
4
COB 100 mg + GDC 200 mg
6
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Not Assigned
0.0
Not reported
Not reported
Not reported
Not reported
COB 20 mg + GDC 200 mg
40.0
Not reported
Not reported
Not reported
Not reported
COB 40 mg + GDC 200 mg
66.7
Not reported
Not reported
Not reported
Not reported
COB 80 mg + GDC 200 mg
40.0
Not reported
Not reported
Not reported
Not reported
COB 80 mg + GDC 400 mg
25.0
Not reported
Not reported
Not reported
Not reported
COB 100 mg + GDC 200 mg
33.3
Not reported
Not reported
Not reported
Not reported
Sodium
Analysis denominator · Participants
Group
Source count
Not Assigned
1
COB 20 mg + GDC 200 mg
5
COB 40 mg + GDC 200 mg
3
COB 80 mg + GDC 200 mg
5
COB 80 mg + GDC 400 mg
4
COB 100 mg + GDC 200 mg
6
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Not Assigned
0.0
Not reported
Not reported
Not reported
Not reported
COB 20 mg + GDC 200 mg
60.0
Not reported
Not reported
Not reported
Not reported
COB 40 mg + GDC 200 mg
33.3
Not reported
Not reported
Not reported
Not reported
COB 80 mg + GDC 200 mg
0.0
Not reported
Not reported
Not reported
Not reported
COB 80 mg + GDC 400 mg
50.0
Not reported
Not reported
Not reported
Not reported
COB 100 mg + GDC 200 mg
16.7
Not reported
Not reported
Not reported
Not reported
Bilirubin
Analysis denominator · Participants
Group
Source count
Not Assigned
1
COB 20 mg + GDC 200 mg
5
COB 40 mg + GDC 200 mg
3
COB 80 mg + GDC 200 mg
5
COB 80 mg + GDC 400 mg
4
COB 100 mg + GDC 200 mg
6
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Not Assigned
100.0
Not reported
Not reported
Not reported
Not reported
COB 20 mg + GDC 200 mg
20.0
Not reported
Not reported
Not reported
Not reported
COB 40 mg + GDC 200 mg
0.0
Not reported
Not reported
Not reported
Not reported
COB 80 mg + GDC 200 mg
0.0
Not reported
Not reported
Not reported
Not reported
COB 80 mg + GDC 400 mg
25.0
Not reported
Not reported
Not reported
Not reported
COB 100 mg + GDC 200 mg
0.0
Not reported
Not reported
Not reported
Not reported
Uric Acid
Analysis denominator · Participants
Group
Source count
Not Assigned
1
COB 20 mg + GDC 200 mg
5
COB 40 mg + GDC 200 mg
3
COB 80 mg + GDC 200 mg
5
COB 80 mg + GDC 400 mg
4
COB 100 mg + GDC 200 mg
6
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Not Assigned
0.0
Not reported
Not reported
Not reported
Not reported
COB 20 mg + GDC 200 mg
20.0
Not reported
Not reported
Not reported
Not reported
COB 40 mg + GDC 200 mg
0.0
Not reported
Not reported
Not reported
Not reported
COB 80 mg + GDC 200 mg
0.0
Not reported
Not reported
Not reported
Not reported
COB 80 mg + GDC 400 mg
25.0
Not reported
Not reported
Not reported
Not reported
COB 100 mg + GDC 200 mg
16.7
Not reported
Not reported
Not reported
Not reported
White Blood Cell Count
Analysis denominator · Participants
Group
Source count
Not Assigned
1
COB 20 mg + GDC 200 mg
5
COB 40 mg + GDC 200 mg
3
COB 80 mg + GDC 200 mg
5
COB 80 mg + GDC 400 mg
4
COB 100 mg + GDC 200 mg
6
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Not Assigned
0.0
Not reported
Not reported
Not reported
Not reported
COB 20 mg + GDC 200 mg
20
Not reported
Not reported
Not reported
Not reported
COB 40 mg + GDC 200 mg
0.0
Not reported
Not reported
Not reported
Not reported
COB 80 mg + GDC 200 mg
20.0
Not reported
Not reported
Not reported
Not reported
COB 80 mg + GDC 400 mg
25.0
Not reported
Not reported
Not reported
Not reported
COB 100 mg + GDC 200 mg
33.3
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
100.0
group Id
OG001
value
80.0
group Id
OG002
value
66.7
group Id
OG003
value
100.0
group Id
OG004
value
100.0
group Id
OG005
value
83.3
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
5
group Id
OG002
value
3
group Id
OG003
value
5
group Id
OG004
value
4
group Id
OG005
value
6
units
Participants
title
Albumin
categories
measurements
group Id
OG000
value
100.0
group Id
OG001
value
80.0
group Id
OG002
value
66.7
group Id
OG003
value
80.0
group Id
OG004
value
75.0
group Id
OG005
value
50.0
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
5
group Id
OG002
value
3
group Id
OG003
value
5
group Id
OG004
value
4
group Id
OG005
value
6
units
Participants
title
Alkaline Phosphatase
categories
measurements
group Id
OG000
value
0.0
group Id
OG001
value
60.0
group Id
OG002
value
0.0
group Id
OG003
value
60.0
group Id
OG004
value
25.0
group Id
OG005
value
33.3
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
5
group Id
OG002
value
3
group Id
OG003
value
5
group Id
OG004
value
4
group Id
OG005
value
6
units
Participants
title
SGPT/ALT
categories
measurements
group Id
OG000
value
100.0
group Id
OG001
value
100.0
group Id
OG002
value
66.7
group Id
OG003
value
60.0
group Id
OG004
value
75.0
group Id
OG005
value
50.0
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
5
group Id
OG002
value
3
group Id
OG003
value
5
group Id
OG004
value
4
group Id
OG005
value
6
units
Participants
title
SGOT/AST
categories
measurements
group Id
OG000
value
100.0
group Id
OG001
value
20.0
group Id
OG002
value
33.3
group Id
OG003
value
80.0
group Id
OG004
value
100.0
group Id
OG005
value
33.3
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
5
group Id
OG002
value
3
group Id
OG003
value
5
group Id
OG004
value
4
group Id
OG005
value
6
units
Participants
title
Calcium
categories
measurements
group Id
OG000
value
100.0
group Id
OG001
value
100.0
group Id
OG002
value
100.0
group Id
OG003
value
100.0
group Id
OG004
value
100.0
group Id
OG005
value
50.0
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
5
group Id
OG002
value
3
group Id
OG003
value
5
group Id
OG004
value
4
group Id
OG005
value
6
units
Participants
title
Creatinine
categories
measurements
group Id
OG000
value
0.0
group Id
OG001
value
100.0
group Id
OG002
value
100.0
group Id
OG003
value
0.0
group Id
OG004
value
66.6
group Id
OG005
value
100.0
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
4
group Id
OG002
value
2
group Id
OG003
value
3
group Id
OG004
value
3
group Id
OG005
value
1
units
Participants
title
Blood Glucose, Fasting
categories
measurements
group Id
OG000
value
100.0
group Id
OG001
value
60.0
group Id
OG002
value
66.7
group Id
OG003
value
60.0
group Id
OG004
value
75.0
group Id
OG005
value
50.0
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
5
group Id
OG002
value
3
group Id
OG003
value
5
group Id
OG004
value
4
group Id
OG005
value
6
units
Participants
title
Gamma Glutamyl Transferase
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
20.0
group Id
OG002
value
0.0
group Id
OG003
value
0.0
group Id
OG004
value
0.0
group Id
OG005
value
0.0
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
5
group Id
OG002
value
3
group Id
OG003
value
5
group Id
OG004
value
3
group Id
OG005
value
6
units
Participants
title
Glucose
categories
measurements
group Id
OG000
value
100.0
group Id
OG001
value
60.0
group Id
OG002
value
66.7
group Id
OG003
value
100.0
group Id
OG004
value
75.0
group Id
OG005
value
66.7
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
5
group Id
OG002
value
3
group Id
OG003
value
5
group Id
OG004
value
4
group Id
OG005
value
6
units
Participants
title
Hemoglobin
categories
measurements
group Id
OG000
value
100.0
group Id
OG001
value
40.0
group Id
OG002
value
33.3
group Id
OG003
value
60.0
group Id
OG004
value
50.0
group Id
OG005
value
16.7
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
5
group Id
OG002
value
3
group Id
OG003
value
5
group Id
OG004
value
4
group Id
OG005
value
6
units
Participants
title
Lymphocytes, Absolute
categories
measurements
group Id
OG000
value
100.0
group Id
OG001
value
40.0
group Id
OG002
value
66.6
group Id
OG003
value
20.0
group Id
OG004
value
50.0
group Id
OG005
value
16.7
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
5
group Id
OG002
value
3
group Id
OG003
value
5
group Id
OG004
value
4
group Id
OG005
value
6
units
Participants
title
Magnesium
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
5
group Id
OG002
value
3
group Id
OG003
value
5
group Id
OG004
value
4
group Id
OG005
value
6
units
Participants
description
Laboratory abnormalities were graded per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v4.0.
SGPT/ALT - serum glutamic-pyruvic transaminase/alanine aminotransferase; SGOT/AST - serum glutamic oxaloacetic transaminase/aspartate aminotransferase
groups
description
One participant was assigned to receive intermittent cobimetinib 80 milligrams (mg) + GDC 0994 200 mg) and did receive study drug. However, the participant diary was not returned, and the site was unable to document study dose administration.
id
OG000
title
Not Assigned
description
Concurrent or intermittent dosing of cobimetinib 20 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
id
OG001
title
COB 20 mg + GDC 200 mg
description
Concurrent or intermittent dosing of cobimetinib 40 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
id
OG002
title
COB 40 mg + GDC 200 mg
description
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
id
OG003
title
COB 80 mg + GDC 200 mg
description
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 400 mg for 21 consecutive days, followed by 7 days off.
id
OG004
title
COB 80 mg + GDC 400 mg
description
Concurrent or intermittent dosing of cobimetinib 100 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
id
OG005
title
COB 100 mg + GDC 200 mg
param Type
NUMBER
population Description
All participants. Data are reported for evaluable participants.
reporting Status
POSTED
time Frame
Up to 15 months
title
Percentage of Participants With Laboratory Abnormalities
Triangle