Number of Participants With Vital Signs Data Meeting Pre-defined Criteria (Phase 1, Phase 2 and DDI Sub-study)
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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From first dose of study treatment to end of treatment (maximum of 8 years for Phase 1, maximum of 7.5 years for Phase 2 and up to a maximum of 6 years approx. for DDI sub study)
What was measured
Blood pressure (BP), including systolic BP (SBP) and diastolic BP (DBP), and pulse rate were recorded in sitting position. Body weight was also measured.
Analysis population: Safety analysis set: all enrolled participants who received at least 1 dose of PF-06463922. "Overall Number of Participants Analyzed": participants evaluable for this outcome measure. 'Number Analyzed': participants evaluable for specified row.
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.
EXP-1 (Phase 2)
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) 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.
EXP-2 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) 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.
EXP-3 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after crizotinib therapy and 1 or 2 prior regimens of chemotherapy given before or after crizotinib therapy, or participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 1 ALK inhibitor therapy other than crizotinib with or without any number of prior chemotherapy regimens in any disease setting were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) 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.
EXP-4 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 2 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) 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.
EXP-5 (Phase 2)
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after 3 prior lines of ALK inhibitor therapies were given PF-06463922 100 mg orally QD on Day -7 (only for participant scheduled for pharmacokinetic evaluation) 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.
EXP-6 (Phase 2)
Participants with advanced ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) 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.
DDI Sub-study
Participants with advanced ALK positive or ROS1-positive NSCLC who were treatment naïve or had any number of prior cancer therapies with or without asymptomatic CNS metastases were administered a single dose of a probe substrate alone on Day -2. Participants were given PF-06463922 100 mg orally QD starting on Cycle1 Day 1 and along with probe substrate on Day 15 Cycle 1.
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)
3
25 mg QD (Phase 1)
3
50 mg QD (Phase 1)
3
75 mg QD (Phase 1)
12
100 mg QD (Phase 1)
17
150 mg QD (Phase 1)
3
200 mg QD (Phase 1)
3
35 mg BID (Phase 1)
3
75 mg BID (Phase 1)
3
100 mg BID (Phase 1)
4
EXP-1 (Phase 2)
30
EXP-2 (Phase 2)
27
EXP-3 (Phase 2)
60
EXP-4 (Phase 2)
65
EXP-5 (Phase 2)
45
EXP-6 (Phase 2)
46
DDI Sub-study
32
Reported measurements
Increase in sitting SBP >=40 mmHg
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
3
25 mg QD (Phase 1)
3
50 mg QD (Phase 1)
3
75 mg QD (Phase 1)
12
100 mg QD (Phase 1)
17
150 mg QD (Phase 1)
3
200 mg QD (Phase 1)
3
35 mg BID (Phase 1)
3
75 mg BID (Phase 1)
3
100 mg BID (Phase 1)
4
EXP-1 (Phase 2)
30
EXP-2 (Phase 2)
26
EXP-3 (Phase 2)
60
EXP-4 (Phase 2)
65
EXP-5 (Phase 2)
45
EXP-6 (Phase 2)
44
DDI Sub-study
32
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
10 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
25 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
50 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
100 mg QD (Phase 1)
3
Not reported
Not reported
Not reported
Not reported
150 mg QD (Phase 1)
2
Not reported
Not reported
Not reported
Not reported
200 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
35 mg BID (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
75 mg BID (Phase 1)
1
Not reported
Not reported
Not reported
Not reported
100 mg BID (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
EXP-1 (Phase 2)
9
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
7
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
10
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
10
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
5
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
4
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
4
Not reported
Not reported
Not reported
Not reported
Increase in sitting SBP >=60 mmHg
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
3
25 mg QD (Phase 1)
3
50 mg QD (Phase 1)
3
75 mg QD (Phase 1)
12
100 mg QD (Phase 1)
17
150 mg QD (Phase 1)
3
200 mg QD (Phase 1)
3
35 mg BID (Phase 1)
3
75 mg BID (Phase 1)
3
100 mg BID (Phase 1)
4
EXP-1 (Phase 2)
30
EXP-2 (Phase 2)
26
EXP-3 (Phase 2)
60
EXP-4 (Phase 2)
65
EXP-5 (Phase 2)
45
EXP-6 (Phase 2)
44
DDI Sub-study
32
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
10 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
25 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
50 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
100 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
150 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
200 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
35 mg BID (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
75 mg BID (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
100 mg BID (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
EXP-1 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
2
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
0
Not reported
Not reported
Not reported
Not reported
Decrease in sitting SBP >=40 mmHg
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
3
25 mg QD (Phase 1)
3
50 mg QD (Phase 1)
3
75 mg QD (Phase 1)
12
100 mg QD (Phase 1)
17
150 mg QD (Phase 1)
3
200 mg QD (Phase 1)
3
35 mg BID (Phase 1)
3
75 mg BID (Phase 1)
3
100 mg BID (Phase 1)
4
EXP-1 (Phase 2)
30
EXP-2 (Phase 2)
26
EXP-3 (Phase 2)
60
EXP-4 (Phase 2)
65
EXP-5 (Phase 2)
45
EXP-6 (Phase 2)
44
DDI Sub-study
32
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
10 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
25 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
50 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
3
Not reported
Not reported
Not reported
Not reported
100 mg QD (Phase 1)
2
Not reported
Not reported
Not reported
Not reported
150 mg QD (Phase 1)
1
Not reported
Not reported
Not reported
Not reported
200 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
35 mg BID (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
75 mg BID (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
100 mg BID (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
EXP-1 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
2
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
5
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
2
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
2
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
3
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
1
Not reported
Not reported
Not reported
Not reported
Decrease in sitting SBP >=60 mmHg
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
3
25 mg QD (Phase 1)
3
50 mg QD (Phase 1)
3
75 mg QD (Phase 1)
12
100 mg QD (Phase 1)
17
150 mg QD (Phase 1)
3
200 mg QD (Phase 1)
3
35 mg BID (Phase 1)
3
75 mg BID (Phase 1)
3
100 mg BID (Phase 1)
4
EXP-1 (Phase 2)
30
EXP-2 (Phase 2)
26
EXP-3 (Phase 2)
60
EXP-4 (Phase 2)
65
EXP-5 (Phase 2)
45
EXP-6 (Phase 2)
44
DDI Sub-study
32
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
10 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
25 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
50 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
100 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
150 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
200 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
35 mg BID (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
75 mg BID (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
100 mg BID (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
EXP-1 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
0
Not reported
Not reported
Not reported
Not reported
Increase in sitting DBP >=20 mmHg
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
3
25 mg QD (Phase 1)
3
50 mg QD (Phase 1)
3
75 mg QD (Phase 1)
12
100 mg QD (Phase 1)
17
150 mg QD (Phase 1)
3
200 mg QD (Phase 1)
3
35 mg BID (Phase 1)
3
75 mg BID (Phase 1)
3
100 mg BID (Phase 1)
4
EXP-1 (Phase 2)
30
EXP-2 (Phase 2)
26
EXP-3 (Phase 2)
60
EXP-4 (Phase 2)
65
EXP-5 (Phase 2)
45
EXP-6 (Phase 2)
44
DDI Sub-study
32
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
10 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
25 mg QD (Phase 1)
2
Not reported
Not reported
Not reported
Not reported
50 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
100 mg QD (Phase 1)
7
Not reported
Not reported
Not reported
Not reported
150 mg QD (Phase 1)
3
Not reported
Not reported
Not reported
Not reported
200 mg QD (Phase 1)
1
Not reported
Not reported
Not reported
Not reported
35 mg BID (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
75 mg BID (Phase 1)
1
Not reported
Not reported
Not reported
Not reported
100 mg BID (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
EXP-1 (Phase 2)
11
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
12
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
21
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
15
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
15
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
12
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
7
Not reported
Not reported
Not reported
Not reported
Increase in sitting DBP >=40 mmHg
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
3
25 mg QD (Phase 1)
3
50 mg QD (Phase 1)
3
75 mg QD (Phase 1)
12
100 mg QD (Phase 1)
17
150 mg QD (Phase 1)
3
200 mg QD (Phase 1)
3
35 mg BID (Phase 1)
3
75 mg BID (Phase 1)
3
100 mg BID (Phase 1)
4
EXP-1 (Phase 2)
30
EXP-2 (Phase 2)
26
EXP-3 (Phase 2)
60
EXP-4 (Phase 2)
65
EXP-5 (Phase 2)
45
EXP-6 (Phase 2)
44
DDI Sub-study
32
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
10 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
25 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
50 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
100 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
150 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
200 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
35 mg BID (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
75 mg BID (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
100 mg BID (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
EXP-1 (Phase 2)
1
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
3
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
1
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
1
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
2
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
0
Not reported
Not reported
Not reported
Not reported
Decrease in sitting DBP >=20 mmHg
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
3
25 mg QD (Phase 1)
3
50 mg QD (Phase 1)
3
75 mg QD (Phase 1)
12
100 mg QD (Phase 1)
17
150 mg QD (Phase 1)
3
200 mg QD (Phase 1)
3
35 mg BID (Phase 1)
3
75 mg BID (Phase 1)
3
100 mg BID (Phase 1)
4
EXP-1 (Phase 2)
30
EXP-2 (Phase 2)
26
EXP-3 (Phase 2)
60
EXP-4 (Phase 2)
65
EXP-5 (Phase 2)
45
EXP-6 (Phase 2)
44
DDI Sub-study
32
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
10 mg QD (Phase 1)
2
Not reported
Not reported
Not reported
Not reported
25 mg QD (Phase 1)
1
Not reported
Not reported
Not reported
Not reported
50 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
5
Not reported
Not reported
Not reported
Not reported
100 mg QD (Phase 1)
3
Not reported
Not reported
Not reported
Not reported
150 mg QD (Phase 1)
2
Not reported
Not reported
Not reported
Not reported
200 mg QD (Phase 1)
2
Not reported
Not reported
Not reported
Not reported
35 mg BID (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
75 mg BID (Phase 1)
1
Not reported
Not reported
Not reported
Not reported
100 mg BID (Phase 1)
2
Not reported
Not reported
Not reported
Not reported
EXP-1 (Phase 2)
9
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
5
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
15
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
10
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
10
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
9
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
8
Not reported
Not reported
Not reported
Not reported
Decrease in sitting DBP >=40 mmHg
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
3
25 mg QD (Phase 1)
3
50 mg QD (Phase 1)
3
75 mg QD (Phase 1)
12
100 mg QD (Phase 1)
17
150 mg QD (Phase 1)
3
200 mg QD (Phase 1)
3
35 mg BID (Phase 1)
3
75 mg BID (Phase 1)
3
100 mg BID (Phase 1)
4
EXP-1 (Phase 2)
30
EXP-2 (Phase 2)
26
EXP-3 (Phase 2)
60
EXP-4 (Phase 2)
65
EXP-5 (Phase 2)
45
EXP-6 (Phase 2)
44
DDI Sub-study
32
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
10 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
25 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
50 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
100 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
150 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
200 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
35 mg BID (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
75 mg BID (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
100 mg BID (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
EXP-1 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
1
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
0
Not reported
Not reported
Not reported
Not reported
Sitting pulse rate <50 bpm
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
3
25 mg QD (Phase 1)
3
50 mg QD (Phase 1)
3
75 mg QD (Phase 1)
12
100 mg QD (Phase 1)
17
150 mg QD (Phase 1)
3
200 mg QD (Phase 1)
3
35 mg BID (Phase 1)
3
75 mg BID (Phase 1)
3
100 mg BID (Phase 1)
4
EXP-1 (Phase 2)
30
EXP-2 (Phase 2)
27
EXP-3 (Phase 2)
60
EXP-4 (Phase 2)
65
EXP-5 (Phase 2)
45
EXP-6 (Phase 2)
46
DDI Sub-study
32
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
10 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
25 mg QD (Phase 1)
1
Not reported
Not reported
Not reported
Not reported
50 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
100 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
150 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
200 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
35 mg BID (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
75 mg BID (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
100 mg BID (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
EXP-1 (Phase 2)
1
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
2
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
5
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
1
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
2
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
2
Not reported
Not reported
Not reported
Not reported
Sitting pulse rate >120 bpm
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
3
25 mg QD (Phase 1)
3
50 mg QD (Phase 1)
3
75 mg QD (Phase 1)
12
100 mg QD (Phase 1)
17
150 mg QD (Phase 1)
3
200 mg QD (Phase 1)
3
35 mg BID (Phase 1)
3
75 mg BID (Phase 1)
3
100 mg BID (Phase 1)
4
EXP-1 (Phase 2)
30
EXP-2 (Phase 2)
27
EXP-3 (Phase 2)
60
EXP-4 (Phase 2)
65
EXP-5 (Phase 2)
45
EXP-6 (Phase 2)
46
DDI Sub-study
32
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
10 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
25 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
50 mg QD (Phase 1)
1
Not reported
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
1
Not reported
Not reported
Not reported
Not reported
100 mg QD (Phase 1)
2
Not reported
Not reported
Not reported
Not reported
150 mg QD (Phase 1)
2
Not reported
Not reported
Not reported
Not reported
200 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
35 mg BID (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
75 mg BID (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
100 mg BID (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
EXP-1 (Phase 2)
2
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
1
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
5
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
9
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
4
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
2
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
3
Not reported
Not reported
Not reported
Not reported
Increase in sitting pulse rate >=30 bpm
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
3
25 mg QD (Phase 1)
3
50 mg QD (Phase 1)
3
75 mg QD (Phase 1)
12
100 mg QD (Phase 1)
17
150 mg QD (Phase 1)
3
200 mg QD (Phase 1)
3
35 mg BID (Phase 1)
3
75 mg BID (Phase 1)
3
100 mg BID (Phase 1)
4
EXP-1 (Phase 2)
30
EXP-2 (Phase 2)
26
EXP-3 (Phase 2)
60
EXP-4 (Phase 2)
65
EXP-5 (Phase 2)
44
EXP-6 (Phase 2)
44
DDI Sub-study
32
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
10 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
25 mg QD (Phase 1)
1
Not reported
Not reported
Not reported
Not reported
50 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
2
Not reported
Not reported
Not reported
Not reported
100 mg QD (Phase 1)
7
Not reported
Not reported
Not reported
Not reported
150 mg QD (Phase 1)
1
Not reported
Not reported
Not reported
Not reported
200 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
35 mg BID (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
75 mg BID (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
100 mg BID (Phase 1)
1
Not reported
Not reported
Not reported
Not reported
EXP-1 (Phase 2)
0
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
7
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
14
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
19
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
17
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
17
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
8
Not reported
Not reported
Not reported
Not reported
Decrease in sitting pulse rate >=30 bpm
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
3
25 mg QD (Phase 1)
3
50 mg QD (Phase 1)
3
75 mg QD (Phase 1)
12
100 mg QD (Phase 1)
17
150 mg QD (Phase 1)
3
200 mg QD (Phase 1)
3
35 mg BID (Phase 1)
3
75 mg BID (Phase 1)
3
100 mg BID (Phase 1)
4
EXP-1 (Phase 2)
30
EXP-2 (Phase 2)
26
EXP-3 (Phase 2)
60
EXP-4 (Phase 2)
65
EXP-5 (Phase 2)
44
EXP-6 (Phase 2)
44
DDI Sub-study
32
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
10 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
25 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
50 mg QD (Phase 1)
1
Not reported
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
2
Not reported
Not reported
Not reported
Not reported
100 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
150 mg QD (Phase 1)
1
Not reported
Not reported
Not reported
Not reported
200 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
35 mg BID (Phase 1)
1
Not reported
Not reported
Not reported
Not reported
75 mg BID (Phase 1)
1
Not reported
Not reported
Not reported
Not reported
100 mg BID (Phase 1)
2
Not reported
Not reported
Not reported
Not reported
EXP-1 (Phase 2)
11
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
2
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
8
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
7
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
3
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
5
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
4
Not reported
Not reported
Not reported
Not reported
Increase in weight: 10% to <20%
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
3
25 mg QD (Phase 1)
3
50 mg QD (Phase 1)
3
75 mg QD (Phase 1)
12
100 mg QD (Phase 1)
17
150 mg QD (Phase 1)
3
200 mg QD (Phase 1)
3
35 mg BID (Phase 1)
3
75 mg BID (Phase 1)
3
100 mg BID (Phase 1)
4
EXP-1 (Phase 2)
30
EXP-2 (Phase 2)
26
EXP-3 (Phase 2)
58
EXP-4 (Phase 2)
61
EXP-5 (Phase 2)
44
EXP-6 (Phase 2)
43
DDI Sub-study
32
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
10 mg QD (Phase 1)
1
Not reported
Not reported
Not reported
Not reported
25 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
50 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
8
Not reported
Not reported
Not reported
Not reported
100 mg QD (Phase 1)
6
Not reported
Not reported
Not reported
Not reported
150 mg QD (Phase 1)
2
Not reported
Not reported
Not reported
Not reported
200 mg QD (Phase 1)
2
Not reported
Not reported
Not reported
Not reported
35 mg BID (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
75 mg BID (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
100 mg BID (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
EXP-1 (Phase 2)
9
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
14
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
17
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
15
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
11
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
14
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
9
Not reported
Not reported
Not reported
Not reported
Increase in weight: >=20%
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
3
25 mg QD (Phase 1)
3
50 mg QD (Phase 1)
3
75 mg QD (Phase 1)
12
100 mg QD (Phase 1)
17
150 mg QD (Phase 1)
3
200 mg QD (Phase 1)
3
35 mg BID (Phase 1)
3
75 mg BID (Phase 1)
3
100 mg BID (Phase 1)
4
EXP-1 (Phase 2)
30
EXP-2 (Phase 2)
26
EXP-3 (Phase 2)
58
EXP-4 (Phase 2)
61
EXP-5 (Phase 2)
44
EXP-6 (Phase 2)
43
DDI Sub-study
32
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
10 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
25 mg QD (Phase 1)
2
Not reported
Not reported
Not reported
Not reported
50 mg QD (Phase 1)
1
Not reported
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
1
Not reported
Not reported
Not reported
Not reported
100 mg QD (Phase 1)
5
Not reported
Not reported
Not reported
Not reported
150 mg QD (Phase 1)
1
Not reported
Not reported
Not reported
Not reported
200 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
35 mg BID (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
75 mg BID (Phase 1)
1
Not reported
Not reported
Not reported
Not reported
100 mg BID (Phase 1)
1
Not reported
Not reported
Not reported
Not reported
EXP-1 (Phase 2)
12
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
2
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
10
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
16
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
9
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
9
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
3
Not reported
Not reported
Not reported
Not reported
Decrease in weight >=10%
Analysis denominator · Participants
Group
Source count
10 mg QD (Phase 1)
3
25 mg QD (Phase 1)
3
50 mg QD (Phase 1)
3
75 mg QD (Phase 1)
12
100 mg QD (Phase 1)
17
150 mg QD (Phase 1)
3
200 mg QD (Phase 1)
3
35 mg BID (Phase 1)
3
75 mg BID (Phase 1)
3
100 mg BID (Phase 1)
4
EXP-1 (Phase 2)
30
EXP-2 (Phase 2)
26
EXP-3 (Phase 2)
58
EXP-4 (Phase 2)
61
EXP-5 (Phase 2)
44
EXP-6 (Phase 2)
43
DDI Sub-study
32
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
10 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
25 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
50 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
75 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
100 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
150 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
200 mg QD (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
35 mg BID (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
75 mg BID (Phase 1)
0
Not reported
Not reported
Not reported
Not reported
100 mg BID (Phase 1)
2
Not reported
Not reported
Not reported
Not reported
EXP-1 (Phase 2)
2
Not reported
Not reported
Not reported
Not reported
EXP-2 (Phase 2)
1
Not reported
Not reported
Not reported
Not reported
EXP-3 (Phase 2)
3
Not reported
Not reported
Not reported
Not reported
EXP-4 (Phase 2)
4
Not reported
Not reported
Not reported
Not reported
EXP-5 (Phase 2)
2
Not reported
Not reported
Not reported
Not reported
EXP-6 (Phase 2)
2
Not reported
Not reported
Not reported
Not reported
DDI Sub-study
1
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
3
group Id
OG005
value
2
group Id
OG006
value
0
group Id
OG007
value
0
group Id
OG008
value
1
group Id
OG009
value
0
group Id
OG010
value
9
group Id
OG011
value
7
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
3
group Id
OG003
value
12
group Id
OG004
value
17
group Id
OG005
value
3
group Id
OG006
value
3
group Id
OG007
value
3
group Id
OG008
value
3
group Id
OG009
value
4
group Id
OG010
value
30
group Id
OG011
value
26
units
Participants
title
Increase in sitting SBP >=40 mmHg
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
group Id
OG006
value
0
group Id
OG007
value
0
group Id
OG008
value
0
group Id
OG009
value
0
group Id
OG010
value
0
group Id
OG011
value
0
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
3
group Id
OG003
value
12
group Id
OG004
value
17
group Id
OG005
value
3
group Id
OG006
value
3
group Id
OG007
value
3
group Id
OG008
value
3
group Id
OG009
value
4
group Id
OG010
value
30
group Id
OG011
value
26
units
Participants
title
Increase in sitting SBP >=60 mmHg
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
3
group Id
OG004
value
2
group Id
OG005
value
1
group Id
OG006
value
0
group Id
OG007
value
0
group Id
OG008
value
0
group Id
OG009
value
0
group Id
OG010
value
0
group Id
OG011
value
2
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
3
group Id
OG003
value
12
group Id
OG004
value
17
group Id
OG005
value
3
group Id
OG006
value
3
group Id
OG007
value
3
group Id
OG008
value
3
group Id
OG009
value
4
group Id
OG010
value
30
group Id
OG011
value
26
units
Participants
title
Decrease in sitting SBP >=40 mmHg
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
group Id
OG006
value
0
group Id
OG007
value
0
group Id
OG008
value
0
group Id
OG009
value
0
group Id
OG010
value
0
group Id
OG011
value
0
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
3
group Id
OG003
value
12
group Id
OG004
value
17
group Id
OG005
value
3
group Id
OG006
value
3
group Id
OG007
value
3
group Id
OG008
value
3
group Id
OG009
value
4
group Id
OG010
value
30
group Id
OG011
value
26
units
Participants
title
Decrease in sitting SBP >=60 mmHg
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
2
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
7
group Id
OG005
value
3
group Id
OG006
value
1
group Id
OG007
value
0
group Id
OG008
value
1
group Id
OG009
value
0
group Id
OG010
value
11
group Id
OG011
value
12
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
3
group Id
OG003
value
12
group Id
OG004
value
17
group Id
OG005
value
3
group Id
OG006
value
3
group Id
OG007
value
3
group Id
OG008
value
3
group Id
OG009
value
4
group Id
OG010
value
30
group Id
OG011
value
26
units
Participants
title
Increase in sitting DBP >=20 mmHg
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
group Id
OG006
value
0
group Id
OG007
value
0
group Id
OG008
value
0
group Id
OG009
value
0
group Id
OG010
value
1
group Id
OG011
value
3
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
3
group Id
OG003
value
12
group Id
OG004
value
17
group Id
OG005
value
3
group Id
OG006
value
3
group Id
OG007
value
3
group Id
OG008
value
3
group Id
OG009
value
4
group Id
OG010
value
30
group Id
OG011
value
26
units
Participants
title
Increase in sitting DBP >=40 mmHg
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
5
group Id
OG004
value
3
group Id
OG005
value
2
group Id
OG006
value
2
group Id
OG007
value
0
group Id
OG008
value
1
group Id
OG009
value
2
group Id
OG010
value
9
group Id
OG011
value
5
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
3
group Id
OG003
value
12
group Id
OG004
value
17
group Id
OG005
value
3
group Id
OG006
value
3
group Id
OG007
value
3
group Id
OG008
value
3
group Id
OG009
value
4
group Id
OG010
value
30
group Id
OG011
value
26
units
Participants
title
Decrease in sitting DBP >=20 mmHg
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
group Id
OG006
value
0
group Id
OG007
value
0
group Id
OG008
value
0
group Id
OG009
value
0
group Id
OG010
value
0
group Id
OG011
value
0
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
3
group Id
OG003
value
12
group Id
OG004
value
17
group Id
OG005
value
3
group Id
OG006
value
3
group Id
OG007
value
3
group Id
OG008
value
3
group Id
OG009
value
4
group Id
OG010
value
30
group Id
OG011
value
26
units
Participants
title
Decrease in sitting DBP >=40 mmHg
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
group Id
OG006
value
0
group Id
OG007
value
0
group Id
OG008
value
0
group Id
OG009
value
0
group Id
OG010
value
1
group Id
OG011
value
2
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
3
group Id
OG003
value
12
group Id
OG004
value
17
group Id
OG005
value
3
group Id
OG006
value
3
group Id
OG007
value
3
group Id
OG008
value
3
group Id
OG009
value
4
group Id
OG010
value
30
group Id
OG011
value
27
units
Participants
title
Sitting pulse rate <50 bpm
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
1
group Id
OG004
value
2
group Id
OG005
value
2
group Id
OG006
value
0
group Id
OG007
value
0
group Id
OG008
value
0
group Id
OG009
value
0
group Id
OG010
value
2
group Id
OG011
value
1
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
3
group Id
OG003
value
12
group Id
OG004
value
17
group Id
OG005
value
3
group Id
OG006
value
3
group Id
OG007
value
3
group Id
OG008
value
3
group Id
OG009
value
4
group Id
OG010
value
30
group Id
OG011
value
27
units
Participants
title
Sitting pulse rate >120 bpm
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
2
group Id
OG004
value
7
group Id
OG005
value
1
group Id
OG006
value
0
group Id
OG007
value
0
group Id
OG008
value
0
group Id
OG009
value
1
group Id
OG010
value
0
group Id
OG011
value
7
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
3
group Id
OG003
value
12
group Id
OG004
value
17
group Id
OG005
value
3
group Id
OG006
value
3
group Id
OG007
value
3
group Id
OG008
value
3
group Id
OG009
value
4
group Id
OG010
value
30
group Id
OG011
value
26
units
Participants
title
Increase in sitting pulse rate >=30 bpm
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
2
group Id
OG004
value
0
group Id
OG005
value
1
group Id
OG006
value
0
group Id
OG007
value
1
group Id
OG008
value
1
group Id
OG009
value
2
group Id
OG010
value
11
group Id
OG011
value
2
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
3
group Id
OG003
value
12
group Id
OG004
value
17
group Id
OG005
value
3
group Id
OG006
value
3
group Id
OG007
value
3
group Id
OG008
value
3
group Id
OG009
value
4
group Id
OG010
value
30
group Id
OG011
value
26
units
Participants
title
Decrease in sitting pulse rate >=30 bpm
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
3
group Id
OG003
value
12
group Id
OG004
value
17
group Id
OG005
value
3
group Id
OG006
value
3
group Id
OG007
value
3
group Id
OG008
value
3
group Id
OG009
value
4
group Id
OG010
value
30
group Id
OG011
value
27
units
Participants
description
Blood pressure (BP), including systolic BP (SBP) and diastolic BP (DBP), and pulse rate were recorded in sitting position. Body weight was also measured.
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)
description
Treatment-naïve participants with advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) with or without asymptomatic central nervous system (CNS) metastases were given PF-06463922 100 mg orally QD on Day -7 (only participants scheduled for pharmacokinetic evaluation) 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
OG010
title
EXP-1 (Phase 2)
description
Participants with advanced ALK-positive NSCLC with or without asymptomatic CNS metastases relapsing after only crizotinib therapy were given PF-06463922 100 mg orally QD on Day -7 (only for participants scheduled for pharmacokinetic evaluation) 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
OG011
title
EXP-2 (Phase 2)
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety analysis set: all enrolled participants who received at least 1 dose of PF-06463922. "Overall Number of Participants Analyzed": participants evaluable for this outcome measure. 'Number Analyzed': participants evaluable for specified row.
reporting Status
POSTED
time Frame
From first dose of study treatment to end of treatment (maximum of 8 years for Phase 1, maximum of 7.5 years for Phase 2 and up to a maximum of 6 years approx. for DDI sub study)
title
Number of Participants With Vital Signs Data Meeting Pre-defined Criteria (Phase 1, Phase 2 and DDI Sub-study)