Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
A Study Of PF-06463922 An ALK/ROS1 Inhibitor In Patients With Advanced Non Small Cell Lung Cancer With Specific Molecular Alterations · Source last updated 2024-08-12
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
MEAN
Unit
Units on a scale
Interval / dispersion
Standard Deviation
Time frame
Baseline, Day 1 of Cycle 1-52, and end of treatment (up to 3 years)
What was measured
In Phase 1, the MMSE was collected to assess mental status. The MMSE is a 30 item questionnaire that tests 5 areas of cognitive function: orientation, registration, attention and calculation, recall and language. The maximum score is 30 and minimum score is 0. Highest score indicates no cognitive impairment, lowest score indicates severe cognitive impairment. The MMSE was removed under Amendment 6 of the study protocol, and not required for Phase 2, as the tool was not considered meaningful for assessment of cognitive function.
Analysis population: MMSE assessment evaluable analysis set included all participants in the safety analysis set (all participants who received at least 1 dose of PF-06463922) who completed a baseline and at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, "Number Analyzed" signifies participants evaluable for specified rows.
Groups in this outcome
10 mg QD (Phase 1)
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
25 mg QD (Phase 1)
PF-06463922 25 mg was orally given QD in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
50 mg QD (Phase 1)
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
75 mg QD (Phase 1)
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
100 mg QD (Phase 1)
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
150 mg QD (Phase 1)
PF-06463922 150 mg was orally given QD in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
200 mg QD (Phase 1)
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
35 mg BID (Phase 1)
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
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
10 mg QD (Phase 1)
2
25 mg QD (Phase 1)
3
50 mg QD (Phase 1)
3
75 mg QD (Phase 1)
9
100 mg QD (Phase 1)
16
150 mg QD (Phase 1)
3
200 mg QD (Phase 1)
2
35 mg BID (Phase 1)
2
75 mg BID (Phase 1)
3
100 mg BID (Phase 1)
4
Reported measurements
Cycle 1 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
2
25 mg QD (Phase 1)
0
50 mg QD (Phase 1)
2
75 mg QD (Phase 1)
7
100 mg QD (Phase 1)
9
150 mg QD (Phase 1)
0
200 mg QD (Phase 1)
0
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
1
100 mg BID (Phase 1)
1
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
10 mg QD (Phase 1)
1.0
1.41
Not reported
Not reported
Not reported
50 mg QD (Phase 1)
-0.5
0.71
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
-0.9
2.27
Not reported
Not reported
Not reported
100 mg QD (Phase 1)
0.8
1.39
Not reported
Not reported
Not reported
75 mg BID (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
100 mg BID (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
Cycle 2 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
1
25 mg QD (Phase 1)
3
50 mg QD (Phase 1)
1
75 mg QD (Phase 1)
9
100 mg QD (Phase 1)
16
150 mg QD (Phase 1)
3
200 mg QD (Phase 1)
2
35 mg BID (Phase 1)
2
75 mg BID (Phase 1)
2
100 mg BID (Phase 1)
3
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
10 mg QD (Phase 1)
2.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
25 mg QD (Phase 1)
-0.3
0.58
Not reported
Not reported
Not reported
50 mg QD (Phase 1)
2.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
75 mg QD (Phase 1)
0.3
1.41
Not reported
Not reported
Not reported
100 mg QD (Phase 1)
0.0
1.79
Not reported
Not reported
Not reported
150 mg QD (Phase 1)
4.7
8.08
Not reported
Not reported
Not reported
200 mg QD (Phase 1)
4.0
4.24
Not reported
Not reported
Not reported
35 mg BID (Phase 1)
0.0
0.00
Not reported
Not reported
Not reported
75 mg BID (Phase 1)
0.0
0.00
Not reported
Not reported
Not reported
100 mg BID (Phase 1)
-0.3
1.15
Not reported
Not reported
Not reported
Cycle 3 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
2
25 mg QD (Phase 1)
3
50 mg QD (Phase 1)
2
75 mg QD (Phase 1)
8
100 mg QD (Phase 1)
15
150 mg QD (Phase 1)
2
200 mg QD (Phase 1)
2
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
1
100 mg BID (Phase 1)
3
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
10 mg QD (Phase 1)
2.0
0.00
Not reported
Not reported
Not reported
25 mg QD (Phase 1)
0.3
0.58
Not reported
Not reported
Not reported
50 mg QD (Phase 1)
-0.5
0.71
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
-0.6
1.85
Not reported
Not reported
Not reported
100 mg QD (Phase 1)
0.2
1.52
Not reported
Not reported
Not reported
150 mg QD (Phase 1)
5.0
8.49
Not reported
Not reported
Not reported
200 mg QD (Phase 1)
3.0
2.83
Not reported
Not reported
Not reported
75 mg BID (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
100 mg BID (Phase 1)
-1.0
1.00
Not reported
Not reported
Not reported
Cycle 4 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
1
25 mg QD (Phase 1)
2
50 mg QD (Phase 1)
2
75 mg QD (Phase 1)
8
100 mg QD (Phase 1)
14
150 mg QD (Phase 1)
3
200 mg QD (Phase 1)
2
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
1
100 mg BID (Phase 1)
3
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
10 mg QD (Phase 1)
5.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
25 mg QD (Phase 1)
0.5
0.71
Not reported
Not reported
Not reported
50 mg QD (Phase 1)
1.5
2.12
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
-1.1
1.81
Not reported
Not reported
Not reported
100 mg QD (Phase 1)
0.0
1.47
Not reported
Not reported
Not reported
150 mg QD (Phase 1)
2.0
6.24
Not reported
Not reported
Not reported
200 mg QD (Phase 1)
-0.5
3.54
Not reported
Not reported
Not reported
75 mg BID (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
100 mg BID (Phase 1)
-0.7
1.15
Not reported
Not reported
Not reported
Cycle 5 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
2
25 mg QD (Phase 1)
2
50 mg QD (Phase 1)
2
75 mg QD (Phase 1)
7
100 mg QD (Phase 1)
11
150 mg QD (Phase 1)
3
200 mg QD (Phase 1)
2
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
1
100 mg BID (Phase 1)
2
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
10 mg QD (Phase 1)
0.5
3.54
Not reported
Not reported
Not reported
25 mg QD (Phase 1)
0.5
0.71
Not reported
Not reported
Not reported
50 mg QD (Phase 1)
1.5
2.12
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
0.3
1.25
Not reported
Not reported
Not reported
100 mg QD (Phase 1)
-0.2
1.72
Not reported
Not reported
Not reported
150 mg QD (Phase 1)
4.7
8.14
Not reported
Not reported
Not reported
200 mg QD (Phase 1)
0.5
6.36
Not reported
Not reported
Not reported
75 mg BID (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
100 mg BID (Phase 1)
-0.5
0.71
Not reported
Not reported
Not reported
Cycle 6 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
2
25 mg QD (Phase 1)
2
50 mg QD (Phase 1)
2
75 mg QD (Phase 1)
7
100 mg QD (Phase 1)
11
150 mg QD (Phase 1)
3
200 mg QD (Phase 1)
2
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
1
100 mg BID (Phase 1)
3
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
10 mg QD (Phase 1)
2.5
2.12
Not reported
Not reported
Not reported
25 mg QD (Phase 1)
0.5
0.71
Not reported
Not reported
Not reported
50 mg QD (Phase 1)
1.0
1.41
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
-0.4
2.70
Not reported
Not reported
Not reported
100 mg QD (Phase 1)
0.3
0.90
Not reported
Not reported
Not reported
150 mg QD (Phase 1)
4.3
5.86
Not reported
Not reported
Not reported
200 mg QD (Phase 1)
2.0
4.24
Not reported
Not reported
Not reported
75 mg BID (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
100 mg BID (Phase 1)
-1.3
2.31
Not reported
Not reported
Not reported
Cycle 7 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
1
25 mg QD (Phase 1)
2
50 mg QD (Phase 1)
2
75 mg QD (Phase 1)
7
100 mg QD (Phase 1)
12
150 mg QD (Phase 1)
3
200 mg QD (Phase 1)
2
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
1
100 mg BID (Phase 1)
3
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
10 mg QD (Phase 1)
2.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
25 mg QD (Phase 1)
0.5
0.71
Not reported
Not reported
Not reported
50 mg QD (Phase 1)
1.5
2.12
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
-0.1
1.21
Not reported
Not reported
Not reported
100 mg QD (Phase 1)
0.4
0.90
Not reported
Not reported
Not reported
150 mg QD (Phase 1)
4.7
8.33
Not reported
Not reported
Not reported
200 mg QD (Phase 1)
3.0
4.24
Not reported
Not reported
Not reported
75 mg BID (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
100 mg BID (Phase 1)
-0.7
1.15
Not reported
Not reported
Not reported
Cycle 8 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
1
25 mg QD (Phase 1)
2
50 mg QD (Phase 1)
2
75 mg QD (Phase 1)
7
100 mg QD (Phase 1)
12
150 mg QD (Phase 1)
3
200 mg QD (Phase 1)
2
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
1
100 mg BID (Phase 1)
3
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
10 mg QD (Phase 1)
-4.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
25 mg QD (Phase 1)
0.5
0.71
Not reported
Not reported
Not reported
50 mg QD (Phase 1)
1.5
2.12
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
-0.1
2.34
Not reported
Not reported
Not reported
100 mg QD (Phase 1)
0.2
1.34
Not reported
Not reported
Not reported
150 mg QD (Phase 1)
3.0
7.81
Not reported
Not reported
Not reported
200 mg QD (Phase 1)
4.0
4.24
Not reported
Not reported
Not reported
75 mg BID (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
100 mg BID (Phase 1)
0.0
0.00
Not reported
Not reported
Not reported
Cycle 9 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
0
25 mg QD (Phase 1)
2
50 mg QD (Phase 1)
1
75 mg QD (Phase 1)
7
100 mg QD (Phase 1)
11
150 mg QD (Phase 1)
2
200 mg QD (Phase 1)
1
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
0
100 mg BID (Phase 1)
3
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
25 mg QD (Phase 1)
0.0
0.00
Not reported
Not reported
Not reported
50 mg QD (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
75 mg QD (Phase 1)
-1.0
2.31
Not reported
Not reported
Not reported
100 mg QD (Phase 1)
0.3
2.10
Not reported
Not reported
Not reported
150 mg QD (Phase 1)
6.0
8.49
Not reported
Not reported
Not reported
200 mg QD (Phase 1)
6.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
100 mg BID (Phase 1)
-0.3
0.58
Not reported
Not reported
Not reported
Cycle 10 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
1
25 mg QD (Phase 1)
2
50 mg QD (Phase 1)
1
75 mg QD (Phase 1)
5
100 mg QD (Phase 1)
10
150 mg QD (Phase 1)
2
200 mg QD (Phase 1)
1
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
1
100 mg BID (Phase 1)
3
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
10 mg QD (Phase 1)
-5.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
25 mg QD (Phase 1)
0.5
0.71
Not reported
Not reported
Not reported
50 mg QD (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
75 mg QD (Phase 1)
0.0
0.00
Not reported
Not reported
Not reported
100 mg QD (Phase 1)
-0.1
0.88
Not reported
Not reported
Not reported
150 mg QD (Phase 1)
6.5
9.19
Not reported
Not reported
Not reported
200 mg QD (Phase 1)
6.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
75 mg BID (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
100 mg BID (Phase 1)
-1.7
1.53
Not reported
Not reported
Not reported
Cycle 11 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
0
25 mg QD (Phase 1)
2
50 mg QD (Phase 1)
1
75 mg QD (Phase 1)
7
100 mg QD (Phase 1)
12
150 mg QD (Phase 1)
2
200 mg QD (Phase 1)
2
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
1
100 mg BID (Phase 1)
3
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
25 mg QD (Phase 1)
-0.5
0.71
Not reported
Not reported
Not reported
50 mg QD (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
75 mg QD (Phase 1)
0.3
1.70
Not reported
Not reported
Not reported
100 mg QD (Phase 1)
-0.2
1.53
Not reported
Not reported
Not reported
150 mg QD (Phase 1)
7.0
8.49
Not reported
Not reported
Not reported
200 mg QD (Phase 1)
3.5
3.54
Not reported
Not reported
Not reported
75 mg BID (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
100 mg BID (Phase 1)
0.0
0.00
Not reported
Not reported
Not reported
Cycle 12 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
0
25 mg QD (Phase 1)
2
50 mg QD (Phase 1)
0
75 mg QD (Phase 1)
5
100 mg QD (Phase 1)
12
150 mg QD (Phase 1)
2
200 mg QD (Phase 1)
2
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
1
100 mg BID (Phase 1)
3
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
25 mg QD (Phase 1)
0.5
0.71
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
-0.6
2.19
Not reported
Not reported
Not reported
100 mg QD (Phase 1)
-0.2
2.33
Not reported
Not reported
Not reported
150 mg QD (Phase 1)
6.5
9.19
Not reported
Not reported
Not reported
200 mg QD (Phase 1)
3.5
3.54
Not reported
Not reported
Not reported
75 mg BID (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
100 mg BID (Phase 1)
-0.7
0.58
Not reported
Not reported
Not reported
Cycle 13 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
0
25 mg QD (Phase 1)
2
50 mg QD (Phase 1)
0
75 mg QD (Phase 1)
5
100 mg QD (Phase 1)
10
150 mg QD (Phase 1)
2
200 mg QD (Phase 1)
2
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
1
100 mg BID (Phase 1)
2
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
25 mg QD (Phase 1)
0.5
0.71
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
0.8
1.79
Not reported
Not reported
Not reported
100 mg QD (Phase 1)
0.5
2.22
Not reported
Not reported
Not reported
150 mg QD (Phase 1)
5.5
7.78
Not reported
Not reported
Not reported
200 mg QD (Phase 1)
3.0
4.24
Not reported
Not reported
Not reported
75 mg BID (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
100 mg BID (Phase 1)
-0.5
0.71
Not reported
Not reported
Not reported
Cycle 14 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
0
25 mg QD (Phase 1)
2
50 mg QD (Phase 1)
0
75 mg QD (Phase 1)
6
100 mg QD (Phase 1)
11
150 mg QD (Phase 1)
2
200 mg QD (Phase 1)
2
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
1
100 mg BID (Phase 1)
3
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
25 mg QD (Phase 1)
0.5
0.71
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
-0.3
3.20
Not reported
Not reported
Not reported
100 mg QD (Phase 1)
0.3
0.79
Not reported
Not reported
Not reported
150 mg QD (Phase 1)
6.0
8.49
Not reported
Not reported
Not reported
200 mg QD (Phase 1)
2.5
3.54
Not reported
Not reported
Not reported
75 mg BID (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
100 mg BID (Phase 1)
0.0
0.00
Not reported
Not reported
Not reported
Cycle 15 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
0
25 mg QD (Phase 1)
2
50 mg QD (Phase 1)
0
75 mg QD (Phase 1)
6
100 mg QD (Phase 1)
9
150 mg QD (Phase 1)
0
200 mg QD (Phase 1)
2
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
1
100 mg BID (Phase 1)
3
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
25 mg QD (Phase 1)
0.5
0.71
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
-1.7
5.43
Not reported
Not reported
Not reported
100 mg QD (Phase 1)
0.1
1.36
Not reported
Not reported
Not reported
200 mg QD (Phase 1)
4.0
4.24
Not reported
Not reported
Not reported
75 mg BID (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
100 mg BID (Phase 1)
-0.3
0.58
Not reported
Not reported
Not reported
Cycle 16 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
0
25 mg QD (Phase 1)
2
50 mg QD (Phase 1)
0
75 mg QD (Phase 1)
5
100 mg QD (Phase 1)
9
150 mg QD (Phase 1)
1
200 mg QD (Phase 1)
2
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
1
100 mg BID (Phase 1)
2
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
25 mg QD (Phase 1)
0.0
1.41
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
-0.2
2.49
Not reported
Not reported
Not reported
100 mg QD (Phase 1)
-0.2
1.99
Not reported
Not reported
Not reported
150 mg QD (Phase 1)
1.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
200 mg QD (Phase 1)
1.5
6.36
Not reported
Not reported
Not reported
75 mg BID (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
100 mg BID (Phase 1)
0.0
0.00
Not reported
Not reported
Not reported
Cycle 17 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
0
25 mg QD (Phase 1)
2
50 mg QD (Phase 1)
0
75 mg QD (Phase 1)
5
100 mg QD (Phase 1)
9
150 mg QD (Phase 1)
1
200 mg QD (Phase 1)
2
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
1
100 mg BID (Phase 1)
3
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
25 mg QD (Phase 1)
-2.0
2.83
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
0.6
1.95
Not reported
Not reported
Not reported
100 mg QD (Phase 1)
0.1
1.17
Not reported
Not reported
Not reported
150 mg QD (Phase 1)
-3.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
200 mg QD (Phase 1)
4.0
4.24
Not reported
Not reported
Not reported
75 mg BID (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
100 mg BID (Phase 1)
-1.3
1.53
Not reported
Not reported
Not reported
Cycle 18 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
0
25 mg QD (Phase 1)
2
50 mg QD (Phase 1)
0
75 mg QD (Phase 1)
5
100 mg QD (Phase 1)
9
150 mg QD (Phase 1)
1
200 mg QD (Phase 1)
2
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
0
100 mg BID (Phase 1)
2
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
25 mg QD (Phase 1)
-0.5
0.71
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
0.8
1.79
Not reported
Not reported
Not reported
100 mg QD (Phase 1)
0.0
1.73
Not reported
Not reported
Not reported
150 mg QD (Phase 1)
-2.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
200 mg QD (Phase 1)
3.0
4.24
Not reported
Not reported
Not reported
100 mg BID (Phase 1)
0.0
0.00
Not reported
Not reported
Not reported
Cycle 19 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
0
25 mg QD (Phase 1)
2
50 mg QD (Phase 1)
0
75 mg QD (Phase 1)
5
100 mg QD (Phase 1)
9
150 mg QD (Phase 1)
1
200 mg QD (Phase 1)
2
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
1
100 mg BID (Phase 1)
2
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
25 mg QD (Phase 1)
-0.5
0.71
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
0.8
1.79
Not reported
Not reported
Not reported
100 mg QD (Phase 1)
-0.6
2.65
Not reported
Not reported
Not reported
150 mg QD (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
200 mg QD (Phase 1)
3.5
4.95
Not reported
Not reported
Not reported
75 mg BID (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
100 mg BID (Phase 1)
-0.5
0.71
Not reported
Not reported
Not reported
Cycle 20 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
0
25 mg QD (Phase 1)
2
50 mg QD (Phase 1)
0
75 mg QD (Phase 1)
5
100 mg QD (Phase 1)
9
150 mg QD (Phase 1)
1
200 mg QD (Phase 1)
2
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
1
100 mg BID (Phase 1)
2
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
25 mg QD (Phase 1)
0.0
0.00
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
0.0
1.41
Not reported
Not reported
Not reported
100 mg QD (Phase 1)
0.7
2.12
Not reported
Not reported
Not reported
150 mg QD (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
200 mg QD (Phase 1)
3.5
3.54
Not reported
Not reported
Not reported
75 mg BID (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
100 mg BID (Phase 1)
-0.5
0.71
Not reported
Not reported
Not reported
Cycle 21 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
0
25 mg QD (Phase 1)
2
50 mg QD (Phase 1)
0
75 mg QD (Phase 1)
5
100 mg QD (Phase 1)
9
150 mg QD (Phase 1)
0
200 mg QD (Phase 1)
2
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
1
100 mg BID (Phase 1)
2
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
25 mg QD (Phase 1)
-0.5
0.71
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
0.0
1.41
Not reported
Not reported
Not reported
100 mg QD (Phase 1)
0.1
2.09
Not reported
Not reported
Not reported
200 mg QD (Phase 1)
4.0
4.24
Not reported
Not reported
Not reported
75 mg BID (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
100 mg BID (Phase 1)
-0.5
0.71
Not reported
Not reported
Not reported
Cycle 22 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
0
25 mg QD (Phase 1)
2
50 mg QD (Phase 1)
0
75 mg QD (Phase 1)
5
100 mg QD (Phase 1)
9
150 mg QD (Phase 1)
1
200 mg QD (Phase 1)
2
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
1
100 mg BID (Phase 1)
3
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
25 mg QD (Phase 1)
0.0
0.00
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
0.4
1.52
Not reported
Not reported
Not reported
100 mg QD (Phase 1)
0.1
1.45
Not reported
Not reported
Not reported
150 mg QD (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
200 mg QD (Phase 1)
3.5
3.54
Not reported
Not reported
Not reported
75 mg BID (Phase 1)
-1.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
100 mg BID (Phase 1)
-0.3
0.58
Not reported
Not reported
Not reported
Cycle 23 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
0
25 mg QD (Phase 1)
2
50 mg QD (Phase 1)
0
75 mg QD (Phase 1)
5
100 mg QD (Phase 1)
8
150 mg QD (Phase 1)
1
200 mg QD (Phase 1)
2
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
1
100 mg BID (Phase 1)
3
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
25 mg QD (Phase 1)
0.5
0.71
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
0.0
1.41
Not reported
Not reported
Not reported
100 mg QD (Phase 1)
0.1
1.81
Not reported
Not reported
Not reported
150 mg QD (Phase 1)
-1.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
200 mg QD (Phase 1)
1.5
3.54
Not reported
Not reported
Not reported
75 mg BID (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
100 mg BID (Phase 1)
-2.3
4.04
Not reported
Not reported
Not reported
Cycle 24 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
0
25 mg QD (Phase 1)
2
50 mg QD (Phase 1)
0
75 mg QD (Phase 1)
5
100 mg QD (Phase 1)
8
150 mg QD (Phase 1)
1
200 mg QD (Phase 1)
2
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
1
100 mg BID (Phase 1)
2
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
25 mg QD (Phase 1)
0.5
0.71
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
-0.4
0.89
Not reported
Not reported
Not reported
100 mg QD (Phase 1)
0.6
0.74
Not reported
Not reported
Not reported
150 mg QD (Phase 1)
1.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
200 mg QD (Phase 1)
1.5
4.95
Not reported
Not reported
Not reported
75 mg BID (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
100 mg BID (Phase 1)
0.0
0.00
Not reported
Not reported
Not reported
Cycle 25 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
0
25 mg QD (Phase 1)
2
50 mg QD (Phase 1)
0
75 mg QD (Phase 1)
5
100 mg QD (Phase 1)
7
150 mg QD (Phase 1)
1
200 mg QD (Phase 1)
2
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
1
100 mg BID (Phase 1)
2
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
25 mg QD (Phase 1)
0.0
0.00
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
0.8
1.79
Not reported
Not reported
Not reported
100 mg QD (Phase 1)
-0.9
2.27
Not reported
Not reported
Not reported
150 mg QD (Phase 1)
-2.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
200 mg QD (Phase 1)
2.5
4.95
Not reported
Not reported
Not reported
75 mg BID (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
100 mg BID (Phase 1)
0.0
0.00
Not reported
Not reported
Not reported
Cycle 26 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
0
25 mg QD (Phase 1)
2
50 mg QD (Phase 1)
0
75 mg QD (Phase 1)
5
100 mg QD (Phase 1)
8
150 mg QD (Phase 1)
1
200 mg QD (Phase 1)
2
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
1
100 mg BID (Phase 1)
3
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
25 mg QD (Phase 1)
0.5
0.71
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
0.8
1.79
Not reported
Not reported
Not reported
100 mg QD (Phase 1)
-0.4
2.77
Not reported
Not reported
Not reported
150 mg QD (Phase 1)
-1.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
200 mg QD (Phase 1)
2.0
4.24
Not reported
Not reported
Not reported
75 mg BID (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
100 mg BID (Phase 1)
-0.3
0.58
Not reported
Not reported
Not reported
Cycle 27 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
0
25 mg QD (Phase 1)
2
50 mg QD (Phase 1)
0
75 mg QD (Phase 1)
5
100 mg QD (Phase 1)
7
150 mg QD (Phase 1)
1
200 mg QD (Phase 1)
2
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
1
100 mg BID (Phase 1)
2
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
25 mg QD (Phase 1)
0.5
0.71
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
0.8
1.79
Not reported
Not reported
Not reported
100 mg QD (Phase 1)
-0.1
2.67
Not reported
Not reported
Not reported
150 mg QD (Phase 1)
-1.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
200 mg QD (Phase 1)
3.5
3.54
Not reported
Not reported
Not reported
75 mg BID (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
100 mg BID (Phase 1)
-1.0
1.41
Not reported
Not reported
Not reported
Cycle 28 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
0
25 mg QD (Phase 1)
2
50 mg QD (Phase 1)
0
75 mg QD (Phase 1)
4
100 mg QD (Phase 1)
7
150 mg QD (Phase 1)
1
200 mg QD (Phase 1)
2
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
1
100 mg BID (Phase 1)
3
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
25 mg QD (Phase 1)
0.5
0.71
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
1.0
2.00
Not reported
Not reported
Not reported
100 mg QD (Phase 1)
0.7
0.76
Not reported
Not reported
Not reported
150 mg QD (Phase 1)
-2.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
200 mg QD (Phase 1)
3.0
2.83
Not reported
Not reported
Not reported
75 mg BID (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
100 mg BID (Phase 1)
0.0
0.00
Not reported
Not reported
Not reported
Cycle 29 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
0
25 mg QD (Phase 1)
2
50 mg QD (Phase 1)
0
75 mg QD (Phase 1)
4
100 mg QD (Phase 1)
8
150 mg QD (Phase 1)
1
200 mg QD (Phase 1)
2
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
1
100 mg BID (Phase 1)
3
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
25 mg QD (Phase 1)
-1.5
2.12
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
0.5
1.73
Not reported
Not reported
Not reported
100 mg QD (Phase 1)
0.1
1.81
Not reported
Not reported
Not reported
150 mg QD (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
200 mg QD (Phase 1)
3.5
3.54
Not reported
Not reported
Not reported
75 mg BID (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
100 mg BID (Phase 1)
0.0
0.00
Not reported
Not reported
Not reported
Cycle 30 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
0
25 mg QD (Phase 1)
2
50 mg QD (Phase 1)
0
75 mg QD (Phase 1)
4
100 mg QD (Phase 1)
5
150 mg QD (Phase 1)
1
200 mg QD (Phase 1)
2
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
1
100 mg BID (Phase 1)
3
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
25 mg QD (Phase 1)
0.0
0.00
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
0.8
1.50
Not reported
Not reported
Not reported
100 mg QD (Phase 1)
0.4
0.55
Not reported
Not reported
Not reported
150 mg QD (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
200 mg QD (Phase 1)
3.0
2.83
Not reported
Not reported
Not reported
75 mg BID (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
100 mg BID (Phase 1)
-1.0
1.00
Not reported
Not reported
Not reported
Cycle 31 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
0
25 mg QD (Phase 1)
2
50 mg QD (Phase 1)
0
75 mg QD (Phase 1)
3
100 mg QD (Phase 1)
6
150 mg QD (Phase 1)
1
200 mg QD (Phase 1)
2
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
0
100 mg BID (Phase 1)
3
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
25 mg QD (Phase 1)
0.5
0.71
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
1.0
2.65
Not reported
Not reported
Not reported
100 mg QD (Phase 1)
0.7
0.82
Not reported
Not reported
Not reported
150 mg QD (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
200 mg QD (Phase 1)
3.0
4.24
Not reported
Not reported
Not reported
100 mg BID (Phase 1)
0.0
0.00
Not reported
Not reported
Not reported
Cycle 32 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
0
25 mg QD (Phase 1)
2
50 mg QD (Phase 1)
0
75 mg QD (Phase 1)
3
100 mg QD (Phase 1)
5
150 mg QD (Phase 1)
0
200 mg QD (Phase 1)
2
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
1
100 mg BID (Phase 1)
2
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
25 mg QD (Phase 1)
0.0
0.00
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
1.3
2.31
Not reported
Not reported
Not reported
100 mg QD (Phase 1)
0.4
0.55
Not reported
Not reported
Not reported
200 mg QD (Phase 1)
3.5
3.54
Not reported
Not reported
Not reported
75 mg BID (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
100 mg BID (Phase 1)
0.0
0.00
Not reported
Not reported
Not reported
Cycle 33 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
0
25 mg QD (Phase 1)
2
50 mg QD (Phase 1)
0
75 mg QD (Phase 1)
3
100 mg QD (Phase 1)
4
150 mg QD (Phase 1)
0
200 mg QD (Phase 1)
2
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
1
100 mg BID (Phase 1)
2
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
25 mg QD (Phase 1)
0.0
0.00
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
1.3
2.31
Not reported
Not reported
Not reported
100 mg QD (Phase 1)
0.5
0.58
Not reported
Not reported
Not reported
200 mg QD (Phase 1)
3.5
3.54
Not reported
Not reported
Not reported
75 mg BID (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
100 mg BID (Phase 1)
0.0
0.00
Not reported
Not reported
Not reported
Cycle 34 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
0
25 mg QD (Phase 1)
2
50 mg QD (Phase 1)
0
75 mg QD (Phase 1)
2
100 mg QD (Phase 1)
4
150 mg QD (Phase 1)
0
200 mg QD (Phase 1)
2
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
1
100 mg BID (Phase 1)
2
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
25 mg QD (Phase 1)
0.0
0.00
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
0.0
0.00
Not reported
Not reported
Not reported
100 mg QD (Phase 1)
0.3
0.50
Not reported
Not reported
Not reported
200 mg QD (Phase 1)
4.0
4.24
Not reported
Not reported
Not reported
75 mg BID (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
100 mg BID (Phase 1)
0.0
0.00
Not reported
Not reported
Not reported
Cycle 35 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
0
25 mg QD (Phase 1)
2
50 mg QD (Phase 1)
0
75 mg QD (Phase 1)
1
100 mg QD (Phase 1)
4
150 mg QD (Phase 1)
0
200 mg QD (Phase 1)
2
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
1
100 mg BID (Phase 1)
1
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
25 mg QD (Phase 1)
0.5
0.71
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
100 mg QD (Phase 1)
0.3
0.50
Not reported
Not reported
Not reported
200 mg QD (Phase 1)
4.0
4.24
Not reported
Not reported
Not reported
75 mg BID (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
100 mg BID (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
Cycle 36 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
0
25 mg QD (Phase 1)
2
50 mg QD (Phase 1)
0
75 mg QD (Phase 1)
1
100 mg QD (Phase 1)
3
150 mg QD (Phase 1)
0
200 mg QD (Phase 1)
2
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
1
100 mg BID (Phase 1)
1
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
25 mg QD (Phase 1)
-0.5
0.71
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
100 mg QD (Phase 1)
0.0
0.00
Not reported
Not reported
Not reported
200 mg QD (Phase 1)
4.0
4.24
Not reported
Not reported
Not reported
75 mg BID (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
100 mg BID (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
Cycle 37 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
0
25 mg QD (Phase 1)
2
50 mg QD (Phase 1)
0
75 mg QD (Phase 1)
1
100 mg QD (Phase 1)
2
150 mg QD (Phase 1)
0
200 mg QD (Phase 1)
2
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
0
100 mg BID (Phase 1)
0
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
25 mg QD (Phase 1)
0.0
0.00
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
-1.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
100 mg QD (Phase 1)
0.0
0.00
Not reported
Not reported
Not reported
200 mg QD (Phase 1)
3.5
4.95
Not reported
Not reported
Not reported
Cycle 38 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
0
25 mg QD (Phase 1)
2
50 mg QD (Phase 1)
0
75 mg QD (Phase 1)
1
100 mg QD (Phase 1)
2
150 mg QD (Phase 1)
0
200 mg QD (Phase 1)
2
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
1
100 mg BID (Phase 1)
0
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
25 mg QD (Phase 1)
0.0
0.00
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
100 mg QD (Phase 1)
0.0
0.00
Not reported
Not reported
Not reported
200 mg QD (Phase 1)
3.0
2.83
Not reported
Not reported
Not reported
75 mg BID (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
Cycle 39 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
0
25 mg QD (Phase 1)
1
50 mg QD (Phase 1)
0
75 mg QD (Phase 1)
1
100 mg QD (Phase 1)
2
150 mg QD (Phase 1)
0
200 mg QD (Phase 1)
2
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
0
100 mg BID (Phase 1)
0
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
25 mg QD (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
75 mg QD (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
100 mg QD (Phase 1)
-0.5
0.71
Not reported
Not reported
Not reported
200 mg QD (Phase 1)
3.5
4.95
Not reported
Not reported
Not reported
Cycle 40 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
0
25 mg QD (Phase 1)
2
50 mg QD (Phase 1)
0
75 mg QD (Phase 1)
1
100 mg QD (Phase 1)
1
150 mg QD (Phase 1)
0
200 mg QD (Phase 1)
2
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
0
100 mg BID (Phase 1)
0
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
25 mg QD (Phase 1)
0.5
0.71
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
-1.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
100 mg QD (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
200 mg QD (Phase 1)
4.0
4.24
Not reported
Not reported
Not reported
Cycle 41 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
0
25 mg QD (Phase 1)
2
50 mg QD (Phase 1)
0
75 mg QD (Phase 1)
1
100 mg QD (Phase 1)
1
150 mg QD (Phase 1)
0
200 mg QD (Phase 1)
2
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
0
100 mg BID (Phase 1)
0
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
25 mg QD (Phase 1)
0.5
0.71
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
100 mg QD (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
200 mg QD (Phase 1)
1.5
6.36
Not reported
Not reported
Not reported
Cycle 42 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
0
25 mg QD (Phase 1)
2
50 mg QD (Phase 1)
0
75 mg QD (Phase 1)
1
100 mg QD (Phase 1)
1
150 mg QD (Phase 1)
0
200 mg QD (Phase 1)
2
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
0
100 mg BID (Phase 1)
0
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
25 mg QD (Phase 1)
-0.5
0.71
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
100 mg QD (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
200 mg QD (Phase 1)
4.0
4.24
Not reported
Not reported
Not reported
Cycle 43 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
0
25 mg QD (Phase 1)
2
50 mg QD (Phase 1)
0
75 mg QD (Phase 1)
1
100 mg QD (Phase 1)
0
150 mg QD (Phase 1)
0
200 mg QD (Phase 1)
2
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
0
100 mg BID (Phase 1)
0
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
25 mg QD (Phase 1)
0.0
0.00
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
200 mg QD (Phase 1)
4.0
4.24
Not reported
Not reported
Not reported
Cycle 44 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
0
25 mg QD (Phase 1)
1
50 mg QD (Phase 1)
0
75 mg QD (Phase 1)
1
100 mg QD (Phase 1)
0
150 mg QD (Phase 1)
0
200 mg QD (Phase 1)
2
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
0
100 mg BID (Phase 1)
0
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
25 mg QD (Phase 1)
1.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
75 mg QD (Phase 1)
-1.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
200 mg QD (Phase 1)
3.0
4.24
Not reported
Not reported
Not reported
Cycle 45 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
0
25 mg QD (Phase 1)
1
50 mg QD (Phase 1)
0
75 mg QD (Phase 1)
1
100 mg QD (Phase 1)
0
150 mg QD (Phase 1)
0
200 mg QD (Phase 1)
1
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
0
100 mg BID (Phase 1)
0
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
25 mg QD (Phase 1)
1.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
75 mg QD (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
200 mg QD (Phase 1)
1.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
Cycle 46 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
0
25 mg QD (Phase 1)
1
50 mg QD (Phase 1)
0
75 mg QD (Phase 1)
1
100 mg QD (Phase 1)
0
150 mg QD (Phase 1)
0
200 mg QD (Phase 1)
0
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
0
100 mg BID (Phase 1)
0
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
25 mg QD (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
75 mg QD (Phase 1)
-1.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
Cycle 47 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
0
25 mg QD (Phase 1)
1
50 mg QD (Phase 1)
0
75 mg QD (Phase 1)
1
100 mg QD (Phase 1)
0
150 mg QD (Phase 1)
0
200 mg QD (Phase 1)
0
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
0
100 mg BID (Phase 1)
0
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
25 mg QD (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
75 mg QD (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
Cycle 48 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
0
25 mg QD (Phase 1)
1
50 mg QD (Phase 1)
0
75 mg QD (Phase 1)
1
100 mg QD (Phase 1)
0
150 mg QD (Phase 1)
0
200 mg QD (Phase 1)
0
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
0
100 mg BID (Phase 1)
0
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
25 mg QD (Phase 1)
-3.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
75 mg QD (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
Cycle 49 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
0
25 mg QD (Phase 1)
2
50 mg QD (Phase 1)
0
75 mg QD (Phase 1)
0
100 mg QD (Phase 1)
0
150 mg QD (Phase 1)
0
200 mg QD (Phase 1)
0
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
0
100 mg BID (Phase 1)
0
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
25 mg QD (Phase 1)
0.5
0.71
Not reported
Not reported
Not reported
Cycle 50 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
0
25 mg QD (Phase 1)
1
50 mg QD (Phase 1)
0
75 mg QD (Phase 1)
0
100 mg QD (Phase 1)
0
150 mg QD (Phase 1)
0
200 mg QD (Phase 1)
0
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
0
100 mg BID (Phase 1)
0
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
25 mg QD (Phase 1)
-3.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
Cycle 51 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
0
25 mg QD (Phase 1)
2
50 mg QD (Phase 1)
0
75 mg QD (Phase 1)
0
100 mg QD (Phase 1)
0
150 mg QD (Phase 1)
0
200 mg QD (Phase 1)
0
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
0
100 mg BID (Phase 1)
0
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
25 mg QD (Phase 1)
-0.5
0.71
Not reported
Not reported
Not reported
Cycle 52 Day 1
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
0
25 mg QD (Phase 1)
1
50 mg QD (Phase 1)
0
75 mg QD (Phase 1)
0
100 mg QD (Phase 1)
0
150 mg QD (Phase 1)
0
200 mg QD (Phase 1)
0
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
0
100 mg BID (Phase 1)
0
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
25 mg QD (Phase 1)
1.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
End of treatment
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
1
25 mg QD (Phase 1)
0
50 mg QD (Phase 1)
3
75 mg QD (Phase 1)
1
100 mg QD (Phase 1)
4
150 mg QD (Phase 1)
0
200 mg QD (Phase 1)
0
35 mg BID (Phase 1)
0
75 mg BID (Phase 1)
1
100 mg BID (Phase 1)
1
Values in Units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
10 mg QD (Phase 1)
-8.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
50 mg QD (Phase 1)
0.7
1.15
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
-2.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
100 mg QD (Phase 1)
-2.3
5.19
Not reported
Not reported
Not reported
75 mg BID (Phase 1)
-15.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
100 mg BID (Phase 1)
0.0
NA
Not reported
Not reported
Standard deviation could not be calculated as only 1 participant was analyzed.
Complete source fields
classes
categories
measurements
group Id
OG000
spread
1.41
value
1.0
group Id
OG002
spread
0.71
value
-0.5
group Id
OG003
spread
2.27
value
-0.9
group Id
OG004
spread
1.39
value
0.8
comment
Standard deviation could not be calculated as only 1 participant was analyzed.
group Id
OG008
spread
NA
value
0.0
comment
Standard deviation could not be calculated as only 1 participant was analyzed.
group Id
OG009
spread
NA
value
0.0
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
0
group Id
OG002
value
2
group Id
OG003
value
7
group Id
OG004
value
9
group Id
OG005
value
0
group Id
OG006
value
0
group Id
OG007
value
0
group Id
OG008
value
1
group Id
OG009
value
1
units
Participants
title
Cycle 1 Day 1
categories
measurements
comment
Standard deviation could not be calculated as only 1 participant was analyzed.
group Id
OG000
spread
NA
value
2.0
group Id
OG001
spread
0.58
value
-0.3
comment
Standard deviation could not be calculated as only 1 participant was analyzed.
group Id
OG002
spread
NA
value
2.0
group Id
OG003
spread
1.41
value
0.3
group Id
OG004
spread
1.79
value
0.0
group Id
OG005
spread
8.08
value
4.7
group Id
OG006
spread
4.24
value
4.0
group Id
OG007
spread
0.00
value
0.0
group Id
OG008
spread
0.00
value
0.0
group Id
OG009
spread
1.15
value
-0.3
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
3
group Id
OG002
value
1
group Id
OG003
value
9
group Id
OG004
value
16
group Id
OG005
value
3
group Id
OG006
value
2
group Id
OG007
value
2
group Id
OG008
value
2
group Id
OG009
value
3
units
Participants
title
Cycle 2 Day 1
categories
measurements
group Id
OG000
spread
0.00
value
2.0
group Id
OG001
spread
0.58
value
0.3
group Id
OG002
spread
0.71
value
-0.5
group Id
OG003
spread
1.85
value
-0.6
group Id
OG004
spread
1.52
value
0.2
group Id
OG005
spread
8.49
value
5.0
group Id
OG006
spread
2.83
value
3.0
comment
Standard deviation could not be calculated as only 1 participant was analyzed.
group Id
OG008
spread
NA
value
0.0
group Id
OG009
spread
1.00
value
-1.0
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
3
group Id
OG002
value
2
group Id
OG003
value
8
group Id
OG004
value
15
group Id
OG005
value
2
group Id
OG006
value
2
group Id
OG007
value
0
group Id
OG008
value
1
group Id
OG009
value
3
units
Participants
title
Cycle 3 Day 1
categories
measurements
comment
Standard deviation could not be calculated as only 1 participant was analyzed.
group Id
OG000
spread
NA
value
5.0
group Id
OG001
spread
0.71
value
0.5
group Id
OG002
spread
2.12
value
1.5
group Id
OG003
spread
1.81
value
-1.1
group Id
OG004
spread
1.47
value
0.0
group Id
OG005
spread
6.24
value
2.0
group Id
OG006
spread
3.54
value
-0.5
comment
Standard deviation could not be calculated as only 1 participant was analyzed.
group Id
OG008
spread
NA
value
0.0
group Id
OG009
spread
1.15
value
-0.7
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
2
group Id
OG002
value
2
group Id
OG003
value
8
group Id
OG004
value
14
group Id
OG005
value
3
group Id
OG006
value
2
group Id
OG007
value
0
group Id
OG008
value
1
group Id
OG009
value
3
units
Participants
title
Cycle 4 Day 1
categories
measurements
group Id
OG000
spread
3.54
value
0.5
group Id
OG001
spread
0.71
value
0.5
group Id
OG002
spread
2.12
value
1.5
group Id
OG003
spread
1.25
value
0.3
group Id
OG004
spread
1.72
value
-0.2
group Id
OG005
spread
8.14
value
4.7
group Id
OG006
spread
6.36
value
0.5
comment
Standard deviation could not be calculated as only 1 participant was analyzed.
group Id
OG008
spread
NA
value
0.0
group Id
OG009
spread
0.71
value
-0.5
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
2
group Id
OG002
value
2
group Id
OG003
value
7
group Id
OG004
value
11
group Id
OG005
value
3
group Id
OG006
value
2
group Id
OG007
value
0
group Id
OG008
value
1
group Id
OG009
value
2
units
Participants
title
Cycle 5 Day 1
categories
measurements
group Id
OG000
spread
2.12
value
2.5
group Id
OG001
spread
0.71
value
0.5
group Id
OG002
spread
1.41
value
1.0
group Id
OG003
spread
2.70
value
-0.4
group Id
OG004
spread
0.90
value
0.3
group Id
OG005
spread
5.86
value
4.3
group Id
OG006
spread
4.24
value
2.0
comment
Standard deviation could not be calculated as only 1 participant was analyzed.
group Id
OG008
spread
NA
value
0.0
group Id
OG009
spread
2.31
value
-1.3
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
2
group Id
OG002
value
2
group Id
OG003
value
7
group Id
OG004
value
11
group Id
OG005
value
3
group Id
OG006
value
2
group Id
OG007
value
0
group Id
OG008
value
1
group Id
OG009
value
3
units
Participants
title
Cycle 6 Day 1
categories
measurements
comment
Standard deviation could not be calculated as only 1 participant was analyzed.
group Id
OG000
spread
NA
value
2.0
group Id
OG001
spread
0.71
value
0.5
group Id
OG002
spread
2.12
value
1.5
group Id
OG003
spread
1.21
value
-0.1
group Id
OG004
spread
0.90
value
0.4
group Id
OG005
spread
8.33
value
4.7
group Id
OG006
spread
4.24
value
3.0
comment
Standard deviation could not be calculated as only 1 participant was analyzed.
group Id
OG008
spread
NA
value
0.0
group Id
OG009
spread
1.15
value
-0.7
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
2
group Id
OG002
value
2
group Id
OG003
value
7
group Id
OG004
value
12
group Id
OG005
value
3
group Id
OG006
value
2
group Id
OG007
value
0
group Id
OG008
value
1
group Id
OG009
value
3
units
Participants
title
Cycle 7 Day 1
categories
measurements
comment
Standard deviation could not be calculated as only 1 participant was analyzed.
group Id
OG000
spread
NA
value
-4.0
group Id
OG001
spread
0.71
value
0.5
group Id
OG002
spread
2.12
value
1.5
group Id
OG003
spread
2.34
value
-0.1
group Id
OG004
spread
1.34
value
0.2
group Id
OG005
spread
7.81
value
3.0
group Id
OG006
spread
4.24
value
4.0
comment
Standard deviation could not be calculated as only 1 participant was analyzed.
group Id
OG008
spread
NA
value
0.0
group Id
OG009
spread
0.00
value
0.0
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
2
group Id
OG002
value
2
group Id
OG003
value
7
group Id
OG004
value
12
group Id
OG005
value
3
group Id
OG006
value
2
group Id
OG007
value
0
group Id
OG008
value
1
group Id
OG009
value
3
units
Participants
title
Cycle 8 Day 1
categories
measurements
group Id
OG001
spread
0.00
value
0.0
comment
Standard deviation could not be calculated as only 1 participant was analyzed.
group Id
OG002
spread
NA
value
0.0
group Id
OG003
spread
2.31
value
-1.0
group Id
OG004
spread
2.10
value
0.3
group Id
OG005
spread
8.49
value
6.0
comment
Standard deviation could not be calculated as only 1 participant was analyzed.
group Id
OG006
spread
NA
value
6.0
group Id
OG009
spread
0.58
value
-0.3
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
2
group Id
OG002
value
1
group Id
OG003
value
7
group Id
OG004
value
11
group Id
OG005
value
2
group Id
OG006
value
1
group Id
OG007
value
0
group Id
OG008
value
0
group Id
OG009
value
3
units
Participants
title
Cycle 9 Day 1
categories
measurements
comment
Standard deviation could not be calculated as only 1 participant was analyzed.
group Id
OG000
spread
NA
value
-5.0
group Id
OG001
spread
0.71
value
0.5
comment
Standard deviation could not be calculated as only 1 participant was analyzed.
group Id
OG002
spread
NA
value
0.0
group Id
OG003
spread
0.00
value
0.0
group Id
OG004
spread
0.88
value
-0.1
group Id
OG005
spread
9.19
value
6.5
comment
Standard deviation could not be calculated as only 1 participant was analyzed.
group Id
OG006
spread
NA
value
6.0
comment
Standard deviation could not be calculated as only 1 participant was analyzed.
group Id
OG008
spread
NA
value
0.0
group Id
OG009
spread
1.53
value
-1.7
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
2
group Id
OG002
value
1
group Id
OG003
value
5
group Id
OG004
value
10
group Id
OG005
value
2
group Id
OG006
value
1
group Id
OG007
value
0
group Id
OG008
value
1
group Id
OG009
value
3
units
Participants
title
Cycle 10 Day 1
categories
measurements
group Id
OG001
spread
0.71
value
-0.5
comment
Standard deviation could not be calculated as only 1 participant was analyzed.
group Id
OG002
spread
NA
value
0.0
group Id
OG003
spread
1.70
value
0.3
group Id
OG004
spread
1.53
value
-0.2
group Id
OG005
spread
8.49
value
7.0
group Id
OG006
spread
3.54
value
3.5
comment
Standard deviation could not be calculated as only 1 participant was analyzed.
group Id
OG008
spread
NA
value
0.0
group Id
OG009
spread
0.00
value
0.0
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
2
group Id
OG002
value
1
group Id
OG003
value
7
group Id
OG004
value
12
group Id
OG005
value
2
group Id
OG006
value
2
group Id
OG007
value
0
group Id
OG008
value
1
group Id
OG009
value
3
units
Participants
title
Cycle 11 Day 1
categories
measurements
group Id
OG001
spread
0.71
value
0.5
group Id
OG003
spread
2.19
value
-0.6
group Id
OG004
spread
2.33
value
-0.2
group Id
OG005
spread
9.19
value
6.5
group Id
OG006
spread
3.54
value
3.5
comment
Standard deviation could not be calculated as only 1 participant was analyzed.
group Id
OG008
spread
NA
value
0.0
group Id
OG009
spread
0.58
value
-0.7
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
2
group Id
OG002
value
0
group Id
OG003
value
5
group Id
OG004
value
12
group Id
OG005
value
2
group Id
OG006
value
2
group Id
OG007
value
0
group Id
OG008
value
1
group Id
OG009
value
3
units
Participants
title
Cycle 12 Day 1
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
3
group Id
OG002
value
3
group Id
OG003
value
9
group Id
OG004
value
16
group Id
OG005
value
3
group Id
OG006
value
2
group Id
OG007
value
2
group Id
OG008
value
3
group Id
OG009
value
4
units
Participants
description
In Phase 1, the MMSE was collected to assess mental status. The MMSE is a 30 item questionnaire that tests 5 areas of cognitive function: orientation, registration, attention and calculation, recall and language. The maximum score is 30 and minimum score is 0. Highest score indicates no cognitive impairment, lowest score indicates severe cognitive impairment. The MMSE was removed under Amendment 6 of the study protocol, and not required for Phase 2, as the tool was not considered meaningful for assessment of cognitive function.
dispersion Type
Standard Deviation
groups
description
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
id
OG000
title
10 mg QD (Phase 1)
description
PF-06463922 25 mg was orally given QD in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
id
OG001
title
25 mg QD (Phase 1)
description
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
id
OG002
title
50 mg QD (Phase 1)
description
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
id
OG003
title
75 mg QD (Phase 1)
description
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
id
OG004
title
100 mg QD (Phase 1)
description
PF-06463922 150 mg was orally given QD in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
id
OG005
title
150 mg QD (Phase 1)
description
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
id
OG006
title
200 mg QD (Phase 1)
description
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
id
OG007
title
35 mg BID (Phase 1)
description
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
id
OG008
title
75 mg BID (Phase 1)
description
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
id
OG009
title
100 mg BID (Phase 1)
param Type
MEAN
population Description
MMSE assessment evaluable analysis set included all participants in the safety analysis set (all participants who received at least 1 dose of PF-06463922) who completed a baseline and at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, "Number Analyzed" signifies participants evaluable for specified rows.
reporting Status
POSTED
time Frame
Baseline, Day 1 of Cycle 1-52, and end of treatment (up to 3 years)
title
Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)
Triangle